B Cell Immunology Program for HIV-1 Vaccine Development (BCIP) (R01)

B Cell Immunology Program for HIV-1 Vaccine Development (BCIP) (R01)maxresdefault

Research Objectives

Emerging research findings about B cell biology need to be harnessed for developing rationally-designed vaccines against HIV-1. This FOA will support mechanistic studies with the goal of informing novel immunization strategies for generating optimal/preferable B cell responses against HIV-1.

This FOA will also support studies focused on acquiring a deeper understanding of the mechanisms by which current HIV-1 vaccine platforms induce Ab responses and the development of strategies to improve these responses. HIV-1 vaccine research is entering a time of great opportunity, and integrated approaches that dissect the mechanisms governing vaccine-induced, antigen-specific immune responses in humans will be valuable in developing an effective HIV-1 vaccine.

Specific Areas of Research Interest

This FOA is restricted to hypothesis-driven mechanistic studies. Applicants are strongly encouraged to contact, well in advance of submission, the Scientific/Research Contact  to discuss the appropriateness of the scope of the proposed project.

Areas of interest include, but are not limited to, the following:

  • Acquire a better understanding of the consequences of modulating innate and/or T cell pathways on the humoral immune response against HIV-1.
  • Explore approaches to direct B cell fate for the generation of long-term memory and persistent Ab production.  Examples may include previously established adjuvants, immunomodulators, and antigen delivery systems, either alone or in combination.
  • Identify ways to induce and maintain B cell lineages in relevant anatomical niches following vaccination against HIV-1.
  • Acquire an understanding of the relationship between the subpopulations of B cells generated during vaccination and affinity maturation or the durability of the anti-HIV-1 Ab response.
  • Studies that benchmark the response to HIV-1 immunogens against the response to other infectious agents or model systems.
  • Studies that employ multiparametric analysis (e.g. specificity, class, affinity, post-translational modifications) for profiling Ab responses to HIV-1 immunogens and the application of this knowledge to regulate desirable B cell responses in improved HIV-1 vaccine platforms.
  • Acquire an understanding of the antigenic variation, vaccine design (e.g. protein vs. DNA vs. live vector) and immunization strategies (e.g. prime-boost, differential dosing and number of immunizations, and intervals) for programming Ag-specific B cells at prime and/or during recall.
  • Studies designed to harness the role of B cells in regulating T cell immunity against HIV-1.
  • Studies to modulate desirable Ab-effector functions with durable protective properties against HIV-1 acquisition.
  • Studies exploring immunocomplexes for the maturation of the antibody response against HIV-1.

SOURCE: National Institute of Allergy and Infectious Diseases (NIAID)
APPLICATION DEADLINE: Letter of Intent: 2/17/16. Application: 3/17/16 by 5 pm local time of applicant organization.
$ AVAILABLE: NIAID intends to commit $2 million in FY2017 to fund two to three awards.
ELIGIBILITY: * Public/state/private controlled institutions of higher education.
* Hispanic-serving institutions.
* Historically Black Colleges and Universities (HBCUs).
* Tribally Controlled Colleges and Universities (TCCUs).
* Alaska native and native Hawaiian serving institutions.
* Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
* Nonprofits with or without 501(c)(3) IRS status (other than institutions of higher education).
* Small businesses.
* For-profit organizations (other than small businesses).
* State governments.
* County governments.
* City or township governments.
* Special district governments.
* Indian/Native American tribal governments (federally recognized and other than federally recognized).
* Eligible agencies of the federal government.
* U.S. territories or possessions.
* Independent school districts.
* Public housing authorities/Indian housing authorities.
* Native American tribal organizations (other than federally recognized tribal governments).
* Faith-based or community-based organizations.
* Regional organizations.
* Non-domestic (non-U.S.) entities (foreign institutions).
PURPOSE: The objective of this Funding Opportunity Announcement (FOA) is to solicit hypothesis-driven, multidisciplinary research to elucidate the complexities and developmental plasticity of B cells associated with the induction of potent, durable, adaptive immune responses against HIV-1.
CFDA: 93.855, 93.856
CONTACT: Please see URL for multiple contacts.

For more information see http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-15-055.html
From CDC National Prevention Information Network’s (NPIN) HIV/Hepatitis/STD/TB Funding Information email, 10/29/15icon
Subject(s) HIV/AIDS research

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Supporting the National Blood Transfusion Service (NBTS) in the implementation and expansion of Blood Safety activities in the Republic of Zambia under the President’s Emergency plan for AIDS Relief (PEPFAR)

CDC-RFA-GH16-1709
Supporting the National Blood Transfusion Service (NBTS) in the implementation and expansion of Blood Safety activities in the Republic of Zambia under the President’s Emergency plan for AIDS Relief (PEPFAR)
Department of Health and Human ServicesSHARMAINE-Byrne-Mwenda-blood-donor-donation-ZNBTS-Joseph-Mulenga
Centers for Disease Control and Prevention

FOA Summary

The purpose of this FOA is to support the Zambia National Blood Transfusion Service (NBTS) in the provision of safe and adequate supply of blood and blood products to health facilities in Zambia. This support will cover a one year period as the institution transitions to full host government support. In particular, the funding will support activities to improve blood donations from repeat, regular voluntary non-remunerated donors (VNRD); to ensure safety through a centralized testing system by the Zambia National Blood Transfusion Services; and to promote appropriate use of blood and blood components. It will also link with other HIV prevention activities through integration of prevention education in youth and adult donor recruitment and in notification of donor test results with appropriate referral to care and treatment services. The NBTS will also support, coordinate and guide the activities of all other partners involved in mobilization and retention of volunteer blood donors.
The ZNBTS will work in collaboration with the HHS/CDC Zambia office and the Zambian MOH, to achieve program outcomes. All activities implemented under this program should follow national policies and guidelines for the delivery of Blood Safety interventions. The recipient will work in collaboration with the Zambian MOH, the U.S. Government in-country Emergency Plan team, and the HHS/CDC Zambia office to improve the breadth, scale, and quality of the Blood Safety program (including mobilization of low-risk, voluntary non-remuneratedblood donors, blood collection, transport through the cold chain, testing for transfusion transmissible infections (HIV, HBV, HCV, syphilis) at quality assured laboratories, establishment of national quality system, including guidelines, standard operating procedures, accurate records, monitoring and evaluation, distribution of blood and blood products to the health facilities, coordinate and monitor the appropriate clinical use of blood and outcomes of transfusion (hemovigilance) and the establishment of a comprehensive quality system covering the entire transfusion process, from donor recruitment to the follow-up of recipients of transfusion).
The emphasis is to have quality systems in place while at the same time implementing evidence based strategies and improving on program management and evaluation (M&E). Since children below five years and women of reproductive age receive approximately two thirds of the national blood collections, the preparation of pediatric blood packs will be a significant component of blood safety activities.
In addition to program implementation, ZNBTS should continue to develop methods to create and build the capacity of its own and other organizations responsible for blood safety and transfusion services.
The ZNBTS will seek to obtain final government commitment for its own support and recognition as a separate unit with an adequate budget, necessary legislation/regulation, management team, and the formation of an organization with responsibility and authority for the ZNBTS. Additionally, the ZNBTS will foster development and implementation of a budgeting and finance system to ensure a sustainable blood program through cost recovery and/or annual budget allocation.
The ZNBTS must promote sustainability with continued, high-quality and evidence based interventions through local and indigenous organizations in collaboration with the Zambian MOH. In particular it should build the local indigenous capacity to be able to carry out various blood safety related interventions. NBTS will demonstrate increased financial support of blood transfusion services and this should be evident though increased donor mobilization, continued staff training and improved high-quality testing and processing of blood.
The ZNBTS will work with other Emergency Plan partners if necessary to evaluate and explore donor recruitment and cost effective strategies.
To avoid the overdependence on a sole donor, the recipient will be expected to diversify the funding base by applying and managing additional grants from other international development and funding agencies.
The overall outcome is to increase the supply of safe blood for transfusion to sufficient levels in the next one year to prevent biomedical transmission of HIV (and other transfusion transmissible infections [TTIs]).

General Information

Document Type: Grants Notice
Funding Opportunity Number: CDC-RFA-GH16-1709
Funding Opportunity Title: Supporting the National Blood Transfusion Service (NBTS) in the implementation and expansion of Blood Safety activities in the Republic of Zambia under the President’s Emergency plan for AIDS Relief (PEPFAR)
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards: 1
CFDA Number(s): 93.067 — Global AIDS
Cost Sharing or Matching Requirement: No
Posted Date: Oct 26, 2015
Creation Date: Oct 26, 2015
Original Closing Date for Applications: Dec 26, 2015  
Current Closing Date for Applications: Dec 26, 2015  
Archive Date: Jan 25, 2016
Estimated Total Program Funding:
Award Ceiling: $1,353,644
Award Floor: $0

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Zambia National Blood Transfusion Service (ZNBTS)

Additional Information

Agency Name: Centers for Disease Control and Prevention
Description: To ensure adequacy and equitable access to cost effective and affordable safe blood and blood products throughout the country, in accordance with the set goals, objectives and targets, CDC intends through this FOA to provide funding support to the Government mandated institution to collect, screen, and distribute blood and blood products to health facilities; with the ultimate goals of reducing child mortality, improving maternal health and combating HIV/AIDS, malaria and other diseases.
Link to Additional Information:  http://www.grants.gov/web/grants/view-opportunity.html?oppId=279838
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Technical Information Management Section Department of Health and Human Services CDC Procurement and Grants Office 2920 Brandywine Road, MS E-14 Atlanta, GA 30341 Telephone: 770-488-2700
pgotim@cdc.gov

For more grant funding opportunities like this one please see:

http://www.grants.gov/web/grants/view-opportunity.html?oppId=279839

http://www.grants.gov/web/grants/view-opportunity.html?oppId=279840

http://www.grants.gov/web/grants/view-opportunity.html?oppId=279841

PEPFAR Small Grants Program 2015-2016, U.S. Embassy Maseru [Communities Affected by AIDS/HIV]

DOS-MSU-PFSGP-FY16
PEPFAR Small Grants Program 2015-2016, U.S. Embassy Maseru
Department of State
U.S. Mission to Maseru-Lesotho

Everyone is Lesotho is either infected or affected by HIV/AIDS.

HL-Youth-AIDS-Day-Seotlong-Centre-2

Source: http://www.helplesotho.org/lesotho/hivaids-in-lesotho/

Criteria for Funding

Consideration will only be given to projects which:

  • Address the needs of OVC and/or support community-based HIV and AIDS palliative care and home health care
  • Have at least eight project members
  • Improve basic economic or social conditions at the local community or village level
  • Support high impact, quick implementation activities that benefit a substantial number of people within one year without requiring further assistance or funding
  • Are oriented toward communities, not individuals
  • Involve at least a 10% contribution of cash, labor, or materials by members of the local community
  • Are within the ability of the local community to operate and maintain
  • Are managed and run by local Basotho groups, e.g. community-based organizations, faith-based organizations and/or groups of people living with HIV or AIDS
  • Can be measured through tangible results and reports, e.g. number of people supported and/or trained
  • Are a direct response to the initiative and aspirations of the local community

Grant Conditions

PEPFAR Small Grants program funds can be used for:

  • Home-based caregiver kits and medical supplies
  • Training for caregivers and care providers
  • Equipment for OVC centers
  • Educational materials and training supplies
  • Equipment, materials and technical training for income-generation projects
  • Ongoing administrative or operating costs (but no more than 10% of total requested funds budget)
  • Structured and measurable prevention and awareness campaigns, workshops and outreach sessions

PEPFAR Small Grants program funds cannot be used for:

  • Remodeling or renovating an existing facility that is in disrepair as a result of neglect or lack of money
  • Projects managed by private businesses, private crèches or public schools
  • Food and food parcels
  • School uniforms, school fees or student bursaries
  • Salaries and/or personal expenses
  • Motorized vehicles or tractors
  • Pesticides, fungicides, and herbicides
  • Office equipment such as computers, fax machines, or photocopiers
  • Military activities (including those relating to police, prisons or other law enforcement activities)
  • Activities with unmitigated and negative environmental consequences, e.g. dams or forest roads 

Measurable Results Requirement

PEPFAR Small Grants program funds can only be used for projects which are able to measure and report on how they contribute to HIV/AIDS and OVC care.  Projects must be able to count or describe the following on a quarterly basis:

Orphans and Vulnerable Children (OVC) Projects

  • Services provided (e.g. healthcare, shelter, child protection, HIV and AIDS prevention education)
  • Number of children served
  • Number of providers and/or caregivers trained

Community-based Palliative and Home Care Projects

  • Number of individuals provided with general HIV-related palliative and home care
  • Type of care provided (such as physical, spiritual, psychological, or social support)
  • Number of caregivers trained to provide general HIV-related palliative and home care

General Information

Document Type: Grants Notice
Funding Opportunity Number: DOS-MSU-PFSGP-FY16
Funding Opportunity Title: PEPFAR Small Grants Program 2015-2016, U.S. Embassy Maseru
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation: Health, HIV/AIDS, Orphan and Vulnerable Children (OVC)
Expected Number of Awards:
CFDA Number(s): 19.029 — The U.S. President’s Emergency Plan for AIDS Relief Programs
Cost Sharing or Matching Requirement: No

Posted Date:Oct 22, 2015

Creation Date:Oct 22, 2015

Original Closing Date for Applications:Jan 31, 2016 

 Current Closing Date for Applications:Jan 31, 2016 

 Archive Date:Mar 1, 2016

Estimated Total Program Funding:$150,000

Award Ceiling:$25,000

Award Floor:$5,000
Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: All applicants must be non-profit local community based organizations that address the needs of orphans and vulnerable children (OVC) and/or support community based HIV and AIDS care initiatives.

Additional Information

Agency Name: U.S. Mission to Maseru-Lesotho
Description: Funded by the U.S. President’s Emergency Plan for AIDS Relief, PEPFAR. The PEPFAR Small Grants Program is for community initaited projects which aim to strengthen health services in communities affected by HIV and AIDS. The program supports projects that support and protect vulnerable children (OVC) and adolecents, and community based HIV and AIDS care initiatives. The funds can only be used for projects which are able to measure and report on how they contribute to HIV and AIDS, and OVC care. The U.S. Embassy Maseru will prioritize proposals that present creative, original and innovative ideas and that improve basic economi or social conditions at the local community or village level.
Link to Additional Information: http://maseru.usembassy.gov/pepfar-small-grants-program.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

Special Projects Office, U.S. Embassy Maseru +266 2231 2666
grantsmaseru@state.gov

Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program

HRSA-16-021RWhomepg2
Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program
Department of Health and Human Services
Health Resources and Services Administration

General Information

Document Type: Grants Notice
Funding Opportunity Number: HRSA-16-021
Funding Opportunity Title: Ryan White HIV/AIDS Program Part A HIV Emergency Relief Grant Program
Opportunity Category: Discretionary
Funding Instrument Type: Grant
Category of Funding Activity: Health
Category Explanation: https://grants.hrsa.gov/2010/Web2External/Interface/FundingCycle/ExternalView.aspx?fCycleID=201a99bc-b2b4-4222-9ff7-5a45fb0cef86
Expected Number of Awards: 53
CFDA Number(s): 93.914 — HIV Emergency Relief Project Grants
Cost Sharing or Matching Requirement: No
Posted Date: Aug 27, 2015
Creation Date: Aug 27, 2015
Original Closing Date for Applications: Nov 2, 2015  
Current Closing Date for Applications: Nov 2, 2015  
Archive Date: Jan 1, 2016
Estimated Total Program Funding: $620,079,915
Award Ceiling: $0
Award Floor: $0

Additional Information

Agency Name: Health Resources and Services Administration
Description This announcement solicits applications for the Ryan White HIV/AIDS Program (RWHAP) Part A HIV Emergency Relief Grant Program.  Part A funds provide direct financial assistance to an eligible metropolitan area (EMA) or a transitional grant area (TGA) that has been severely affected by the HIV epidemic.  Grants assist eligible program areas in developing or enhancing access to a comprehensive continuum of high quality, community-based care for low-income individuals and families with HIV through the provision of formula, supplemental, and Minority AIDS Initiative (MAI) funds.  Based on an assessment of the services and gaps in the HIV Care Continuum within a jurisdiction or service area, planning bodies and recipients may identify specific service categories to fund. Funded service categories should facilitate improvements at specific stages of the HIV Care Continuum.  Comprehensive HIV/AIDS care consists of core medical services and supportive services that meet the criteria of enabling individuals and families living with HIV/AIDS to access and remain in primary medical care to improve their medical outcomes. HRSA/HAB recognizes that Part A EMAs and TGAs must use grant funds to support and further develop and/or expand systems of care to meet the needs of PLWH within the EMA/TGA and strengthen strategies to reach minority populations.  HAB requires EMAs/TGAs to collect data to support identification of need, for planning purposes, and to validate the use of RWHAP funding.  A comprehensive application should reflect how those data were used to develop and expand the system of care in EMA/TGA jurisdictions.  Needs assessments conducted by individual jurisdictions should also review/reference relevant needs assessments conducted by other HIV/AIDS programs, such as HRSA’s Bureau of Primary Health Care, Centers for Disease Control and Prevention (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), and the U.S. Department of Housing and Urban Development (HUD). Ongoing CDC initiatives, as well as HAB’s efforts with recipients to estimate and address unmet need of those aware of their HIV status and the newer requirement to identify and bring into care persons in their jurisdictions who are unaware of their positive HIV status, should result in many more PLWH entering into the EMA/TGA care system.  

The EMA/TGA planning process must ensure that essential core medical services have been adequately funded to meet the needs of those already in care and those being newly linked to care. As of November 2014, the CDC estimates more than 1.2 million people are living with HIV and 1 in 7 (14 percent) are not aware of their HIV status.  The ultimate goal within the United States (U.S.) is to inform all HIV-positive persons of their status and bring them into care in order to improve their health status, prolong their lives, and slow the spread of the epidemic in the U.S. through enhanced prevention efforts.  Important Notes: ·

  •   In accordance with the RWHAP legislation (Sec. 2603 (a)(4)) of the PHS Act hold harmless will not be a factor in the FY 2016 RWHAP Part A awards. · 
  •  Information on Ryan White and the Affordable Care Act, along with Policy Clarification Notices can be found at http://hab.hrsa.gov/affordablecareact/. ·
  •  Greater emphasis has been placed on the HIV Care Continuum.  Applicants are expected to include a graph illustrating the HIV Care Continuum in the EMA/TGA and an explanation of how the HIV Care Continuum is utilized in your jurisdiction.  Refer to the Needs Assessment Section IV.2.ii for requirements. ·      
  •    The Unmet Need requirements in this funding announcement have been updated and included in Section IV.2.ii. Needs Assessment 3) b. Unmet Need. 

Please review carefully when preparing this section of your application. The following information will assist in understanding and completing this year’s grant application: · As an applicant and current recipient, you are required to have implemented the Part A National Monitoring Standards at the grant recipient and provider/subrecipient levels.  HRSA has developed and distributed guidelines outlining the responsibilities of HRSA, the grant recipient, and provider/subrecipient staff.  The National Monitoring Standards can be found at: http://hab.hrsa.gov/manageyourgrant/granteebasics.html. ·Women, Infants, Children and Youth (WICY) waiver requests are no longer part of the application process.  The WICY waiver reporting format was revised to allow recipients to submit a waiver request and provide supporting data with the annual progress report. Part A funds are subject to Section 2604(c) of the PHS Act which requires that not less than 75 percent of the funds remaining after reserving funds for administration and clinical quality management be used to provide core medical services that are needed in the EMA/TGA for individuals with HIV/AIDS who are identified and eligible under the RWHAP.  Core medical services are listed in section 2604(c)(3) of the PHS Act, and support services allowed under Part A are limited to services that are needed for individuals with HIV/AIDS to achieve their medical outcomes, as defined by the RWHAP.  The most recent service definitions can be found in the latest version of the National Monitoring Standards, located at http://hab.hrsa.gov/manageyourgrant/granteebasics.html.  The burden is on the applicant to accurately propose plans and projections using the most recent versions of the Standards and definitions that are posted when an application is submitted. · Applicants seeking a waiver to the core medical services requirement must submit a waiver request either with this grant application, at any time up to the application submission, or up to four months after the start of the grant award for FY 2016.  Submission should be in accordance with the information and criteria published by HRSA in the Federal Register Notice, Vol. 78, No. 101, dated Friday, May 24, 2013, and may be found at

http://www.gpo.gov/fdsys/pkg/FR- 2013-05-24/pdf/2013-12354.pdf

Sample letters may be found at http://hab.hrsa.gov/affordablecareact/samplereqwaiverletters.pdf.  In addition, recipients are advised that an FY 2016 Part A waiver request must include funds awarded under the Minority AIDS Initiative (MAI).  A waiver request that does not include MAI will not be considered.  If submitting with the application, a core medical services waiver request should be included as Attachment 9. ·EMA/TGA Agreements and Compliance Assurances are included (Appendix A) with this funding opportunity announcement (FOA), and require the signature of the CEO, or the CEO’s designee; this document should be included as Attachment 2.

Oral HIVacc: Oral Mucosal Immunization Approaches for HIV Prevention (R01)

RFA-DE-16-006HVAD_Logo_1.1
Oral HIVacc: Oral Mucosal Immunization Approaches for HIV Prevention (R01)
Department of Health and Human Services
National Institutes of Health

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits research projects to develop and test novel HIV vaccines for direct administration into oral lymphoid tissues to trigger protective, local and systemic immunity.  Specifically, this FOA seeks research projects to: 1) define the mechanisms by which direct HIV vaccination of oral lymphoid tissues induce oral innate as well as local and systemic adaptive immune responses; 2) determine the mechanisms by which new adjuvants used together with oral HIV vaccine candidates enhance local and systemic immunity; 3) test innovative, oral vaccine vectors expressing HIV vaccine antigens to trigger protective immunity; 4) compare different HIV vaccine immunization strategies and schemes for the oral mucosa to maximize protection; and 5) delineate the role of dynamic changes in oral and immune cell subsets and their interactions to enhance immunity upon oral HIV vaccination.

Key Dates
Posted Date

August 10, 2015

Open Date (Earliest Submission Date)

October 24, 2015

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 24, 2015 and November 23, 2016, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2016 and March 2017

Advisory Council Review

May 2016 and May 2017

Earliest Start Date

June 2016 and June 2017

Expiration Date

November 24, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons.

Research Objectives

This Funding Opportunity Announcement (FOA) solicits research projects to develop and test novel HIV vaccines for direct administration into oral lymphoid tissues to trigger protective, local and systemic immunity.  Specifically, this FOA seeks research projects to: 1) define the mechanisms by which direct HIV vaccination of oral lymphoid tissues induce oral innate as well as local and systemic adaptive immune responses; 2) determine the mechanisms by which new adjuvants used together with oral HIV vaccine candidates enhance local and systemic immunity; 3) test innovative, oral vaccine vectors expressing HIV vaccine antigens to trigger protective immunity; 4) compare different HIV vaccine immunization strategies and schemes for the oral mucosa to maximize protection; and 5) delineate the role of dynamic changes in oral and immune cell subsets and their interactions to enhance immunity upon oral HIV vaccination.

Background

Substantial progress has been made worldwide in improving life expectancy and quality of life for millions of people infected with HIV by introducing antiretroviral therapy.  Of equal importance is the goal of preventing HIV infections.  One of the most cost effective and safe strategies to prevent HIV/AIDS globally is through the development and application of a prophylactic HIV vaccine.  This is especially urgent for the developing world where this pandemic has caused devastating effects.

Historically, two institutes of the National Institutes of Health have supported HIV vaccine research.  The National Institute of Allergy and Infectious Diseases (NIAID) has led the field of antigen discovery, systemic HIV vaccine development and clinical testing.  NIDCR has complemented the NIAID efforts by focusing on oral mucosal prophylactic HIV vaccines for two reasons.  First, the oral cavity is an excellent model to understand innate and mucosal immunity against infectious diseases such as AIDS.  Second, the oral lymphoid tissue is an effective and easily accessible immunization route against HIV.  One of the goals in prevention efforts is to use an oral mucosal prophylactic HIV vaccine injected directly into the oral lymphoid tissue in combination with other HIV vaccinations administered through other immunization routes to confer protective immunity.

During vaccination, the immune system is optimally primed and boosted with an immunogen or combination of immunogens in the presence or absence of adjuvants that serve as immune enhancers.  Then, upon an infectious challenge, a quick and effective immune response is generated that clears the infection with no permanent health effects.  There are many considerations when developing and using a vaccine, including: the nature and composition of the immunogen or mix of immunogens; adjuvant use; immunization route; vaccination scheme; age, gender, and genetic makeup of cohorts; and the breadth and the quality of the immune responses induced.  Currently, the HIV vaccine pipeline is complex and includes developing and testing strategies that differ in the following: vaccine vectors, multiple combinations of HIV antigens from different subtypes, adjuvants, routes of immunizations, vaccination schemes and geographical areas reflecting different genetic makeup.

Vaccine strategies include testing candidates that stimulate immune responses in the mucosal surfaces such as the gut and the oral cavity.  The development and use of an effective mucosal HIV vaccine offers the advantage of inducing protective immunity at the first line of defense as well as conferring systemic immunity.  As most HIV infections begin at mucosal surfaces, induction of innate as well as mucosal humoral and cellular immunity post-vaccination is essential to arrest and clear HIV infections before systemic dissemination.  The richness of the lymphoid tissue and immune cells in the oral cavity offers an easily accessible site for direct vaccination.  The oral cavity contains a regional lymphatic ring called the Waldeyer’s tonsillar ring (WTR), which is an intrinsic part of the systemic lymphatic network.  The WTR is a complex lymphoid arrangement located in the naso- and oropharynx.  The WTR is comprised of the pharyngeal tonsils or adenoids (located posterior to the nasal cavity, in the roof of the nasopharynx), bilateral tubal tonsils (placed posterior to the opening of the Eustachian tube into the nasopharynx), bilateral palatine tonsils (situated at the back of the throat), and the lingual tonsils (found on the dorsal surface at the base of the tongue).

Direct oral lymphoid vaccination in combination with other immunization routes, may confer effective immune protection against HIV infection.  Findings from Simian Immunodeficiency Virus (SIV) vaccine studies in animal models support this strategy.  For example, the DNA prime and boost vaccination strategy has been successfully used with different SIV genes for priming and diverse SIV proteins for boosting the sublingual lymphoid tissue of rhesus macaques in independent vaccine studies.  These vaccines have been immunogenic and the sublingual, prime/boost immunization strategy has induced diverse and significant mucosal and systemic immune responses.  Additionally, direct prophylactic SIV vaccination of the oropharynx/tonsils of animal models has also been reported.  These studies have demonstrated the induction of immune responses distantly at the genital mucosa and the gastrointestinal system.

Despite the progress described above, many aspects of oral HIV vaccine development, testing and induction of immune responses remain unclear and require further investigation.  For instance, persisting gaps include: lack of oral immune correlates of protection; absence of an efficacious vaccine that confers protection against HIV acquisition at mucosal surfaces, including the oral cavity; incomplete understanding of vaccine induced immune responses at mucosal sites such as the oral mucosa and systemically; insufficient knowledge about the immune enhancing role of adjuvants; and fragmented information regarding the impact that genetic makeup of populations has on vaccine-induced oral immune responses.  It is critical to build upon the results obtained to develop and test effective oral mucosal prophylactic HIV vaccines that will elicit protective mucosal and systemic immune responses against HIV.

Examples of Research Considered within the Scope of this FOA
  • HIV-specific immunity induced by direct immunization of the oral mucosa
  • Mucosal adjuvants to enhance vaccine immunogenicity and efficacy
  • Immune control of HIV infection, replication and spread upon oral vaccination
  • HIV/SIV/SHIV antigens expressed in new oral vaccine vectors for testing in animal models
  • Cross-talk between oral and systemic immunity upon oral mucosal, prophylactic HIV vaccination
  • Changes in oral innate immunity post-HIV/SIV/SHIV oral mucosal vaccination
  • Responses in oral cell types post-vaccination and interactions to trigger immunity
  • Oral vaccines that induce sustained high levels of broadly reactive neutralizing antibodies
  • Oral vaccine-enhanced immunologic memory and long term protection against HIV
  • Changes in helper and cytotoxic immunity post-vaccination and enabling protective immunity
  • Oral microbiome, mycobiome and viriome’s influence in oral mucosal, prophylactic HIV vaccine-induced immunity and protection
  • Immune correlates of oral and systemic protection against HIV defined with new approaches

The following areas will be considered non-responsive to this FOA.  Applications focused on these areas will not proceed to review.

  • Planning, piloting or conducting clinical HIV vaccine trials
  • Secondary data analysis of previously collected datasets on HIV vaccine testing
  • Theoretical or computational modeling studies on HIV vaccines
  • Studies solely focused on systemic immunization with new HIV/SIV/SHIV vaccines
  • Enteric vaccines for oral lymphoid tissue immunization
  • Nasal HIV/SIV/SHIV immunization methods
  • Therapeutic HIV vaccine development and testing
  • Vaccine antigen discovery research

Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)

PAR-15-327hiv-aids
Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)
Department of Health and Human Services – National Institutes of Health

Purpose

This funding opportunity announcement (FOA) seeks applications to addresses ethical, legal, and policy challenges in HIV-related research and program implementation among key populations. The term “key populations” describes populations that experience high risk of HIV acquisition due to certain behaviors and risk exposures.  2014 WHO Guidance states: “Key populations are defined groups who, due to specific higher-risk behaviors, are at increased risk of HIV irrespective of the epidemic type or local context. Also, they often have legal and social issues related to their behaviors that increase their vulnerability to HIV The 2014 WHO guidance addresses five key populations: (1) men who have sex with men; (2) people who inject drugs; (3) people in prisons and other closed settings; (4) sex workers and (5) transgender people.  This FOA calls for research related to those five groups and also includes research related to adolescent girls and young women at high risk of HIV acquisition or living with HIV.

Adolescent girls and young women are not at high risk in all settings, and therefore, this FOA is directed to research in settings known to have a high incidence of HIV in this age group.  Young women are included in this FOA because social, legal and ethical issues related to inclusion of minors in research, structural factors affecting risk, and other complex contextual issues can pose challenges for research with adolescents and young women.

Research applications may include scholarship in ethical, legal or policy areas and can include conceptual analysis, empirical analysis using qualitative or quantitative methodology, or combined conceptual and empirical work.  This FOA will not include clinical trials.

Support for the “Ethical, Legal and Policy Issues in HIV Research with Key Populations” is available under two separate companion FOAs that are being published concurrently. This FOA is soliciting for R21 applications that will support shorter term (up to two years) developmental/exploratory research activities, whereas the companion R01 FOA will support more developed (up to 5 years) applications.

Background

HIV prevention, care and treatment for key populations are critical.  Because key populations have a high risk of HIV acquisition, reaching them with effective prevention, care and treatment is critical to ending the epidemic.  But the same behaviors or characteristics that lead to high risk of acquisition also lead to significant challenges in engaging with them, due to stigma, criminalization of certain behaviors, violence, marginalization, social isolation, and other social and economic factors.  Thus, development of effective research studies and accessible prevention, care and treatment programs is both necessary and profoundly complex in key populations.

There are challenges in research and program implementation with key populations.  Research and program activities involving key populations can be risky for study participants, care providers, and researchers.  Cultural, legal and political environments can increase stigma, risk of violence, social harm, or criminal sanctions.   These conditions also complicate the scientific and ethical conduct of research studies, including epidemiology, social science and behavioral studies, structural and policy interventions, clinical trials, and implementation studies.

At the same time, failure to include key populations in important research activities, or exclusion from health programming, leads to further exacerbation of HIV risk, poor health outcomes and increased transmission dynamics within affected communities. Previous studies have documented severe disparities in access to prevention, care and treatment for key populations in many settings.  These conditions are serious public health and human rights concerns, and impede efforts to control and reduce the impact of HIV.

In addition to challenging background conditions, many of the prevention and treatment interventions that have been tested or are under development do not address specific health needs of key populations, or may not be suited to the social, political or economic context in which they live.  Research studies developing and testing new approaches will need to include key populations at all stages of research and in some cases, tailor or adapt interventions to ensure their effectiveness, feasibility, acceptability and safety in these groups.

Topics of interest

Research projects addressing ethical, legal and policy issues of particular interest are described below.   This list is not exhaustive and applications may address other topics within the scope of the FOA.

Minimizing and Managing Risk  

Social and political conditions lead to key populations experiencing diverse risks, including social harm, violence, stigma, criminalization, aggressive policing practices, social isolation, loss of employment or housing, or other adverse outcomes.  Research studies have the potential to exacerbate these risks, to provide some level of protection from harm, or to elicit a mixture of harms and benefits.  Researchers and care providers may also experience some risks in settings where working with specific populations is illegal or stigmatized.  While it is critical for relevant research studies to include key populations, any risks imposed by the research itself, or exacerbation of background risks, must be minimized and managed appropriately.  The assessment of overall risks and benefits of research will need to take into account the level of baseline risk, whether or how research may affect risk, ways to mitigate these risks, and what kinds of benefits of research participation, if any, may offset risks.

Possible topics related to risk minimization and management include, but are not limited to:

  • Risk assessment and risk mitigation strategies for social, legal or other kinds of harms in the context of research; including threats to physical or mental health; problems with family or other relationships; economic issues such as loss of housing or employment, and other types of adverse consequences; risks related to data security or data breaches in the context of research or clinical care.
  • Development and testing of methods for risk management as part of site-preparedness activities for clinical research; activities might include rapid policy assessment, stakeholder engagement; creation of partnerships with government agencies or NGOs; agreements for referral arrangements for needed ancillary care, social services, or other mechanisms
  • Development and assessment of strategies for capacity building for risk assessment and risk mitigation in the context of research and implementation studies; for example, strategies to improve sustainability of risk mitigation efforts.
  • Empirical and conceptual analysis of benefits and risks of research participation for key populations; for example, questions of whether benefits of research participation can reasonably offset risks; whether any limits on research participation ought to be imposed based on background risks, and whether or how these limits could be set.

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Mental Health (NIMH)

Funding Opportunity Title

Ethical, Legal and Policy Issues in HIV Research with Key Populations (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-15-327

Companion Funding Opportunity

PAR-15-328 R01 Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855, 93.856; 93.242

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications to analyze and address ethical, legal, or policy challenges specific to work with key populations in HIV research or health care.

Proposed projects should be focused on ethical, legal or policy challenges in relation to research studies or program implementation for HIV or associated co-morbidities, affecting one or more of the following key populations: (1) men who have sex with men; (2) people who inject drugs; (3) people in prisons and other closed settings; (4) sex workers; (5) transgender people or (6) adolescent girls and young women at high risk of HIV acquisition or who are living with HIV.  This FOA encourages both empirical and conceptual research projects addressing these topics.

Key Dates

Posted Date

August 7, 2015

Open Date (Earliest Submission Date)

December 7, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

January 7, 2016; September 7, 2016; January 7, 2017; September 7, 2017; January 8, 2018; September 7, 2018, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

February 2016; October 2016; February 2017; October 2017; February 2018; October 2018

Advisory Council Review

May 2016; January 2017; May 2017; January 2018; May 2018; January 2019

Earliest Start Date

July 2016; April 2017; July 2017; April 2018; July 2018; April 2019

Expiration Date

September 8, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons.

Minority HIV/AIDS Research Initiative (MARI) to Build HIV Prevention, Treatment and Research Capacity in Disproportionately Affected Black and Hispanic Communities and Among Historically Underrepresented Researchers

RFA-PS-16-001

Minority HIV/AIDS Research Initiative (MARI) to Build HIV Prevention, Treatment and Research Capacity in Disproportionately Affected Black and Hispanic Communities and Among Historically Underrepresented Researchers

Department of Health and Human Services
Centers for Disease Control and Prevention

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-PS-16-001
Funding Opportunity Title: Minority HIV/AIDS Research Initiative (MARI) to Build HIV Prevention, Treatment and Research Capacity in
Opportunity Category: Discretionary
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards: 8
CFDA Number(s): 93.941 — HIV Demonstration, Research, Public and Professional Education Projects
Cost Sharing or Matching Requirement: No

Posted Date:Aug 7, 2015

Creation Date:Aug 7, 2015

Original Closing Date for Applications:Oct 14, 2015  

Current Closing Date for Applications:Oct 14, 2015 

 Archive Date:Nov 13, 2015

Estimated Total Program Funding:$9,600,000

Award Ceiling:$300,000

Award Floor:$0

Eligibility

Eligible Applicants:
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility: Eligibility Category: State governments County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education: Nonprofits (Other than Institutions of Higher Education) Governments: Eligible Agencies of the Federal Government U.S. Territory or Possession Other:Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via http://www.grants.gov. Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency’s existing in-house or contractor resources. FFRDC’s enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http:// ecfr.gpoaccess.gov /cgi/t/text/ text-idx?c=ecfr& sid=512ff78311f427c00454772dcf21523a&rgn=div8 &view=text&node=48:1.0.1.6.34.0.1.18& idno=48 2. Foreign Organizations Foreign Organizations are not eligible to apply. Foreign components of U.S. Organizations are not eligible to apply. For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply. 3. Special Eligibility Requirements Foreign institutions and components of foreign institutions are not eligible to apply.