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Contraception development research center to advance a novel intravaginal ring as a non-hormonal multipurpose prevention technology

Award Number: P50HD106793
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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OVERALL – ABSTRACT The overarching goal of the Population Council’s (PC) P50 proposal is to develop an innovative non-hormonal multipurpose prevention technology (MPT) intravaginal ring (IVR) with the potential to improve the lives of millions of women globally by combatting the overlapping burdens of unintended pregnancy and sexually transmitted infections (STIs), including HIV. Emerging data indicate that women overwhelmingly prefer products that prevent pregnancy and STIs/HIV over ones that prevent only pregnancy or only STI/HIVs. Our ‘CZL-IVR’ is a user-controlled 30-day IVR containing three active pharmaceutical ingredients (APIs), copper (C), zinc acetate (Z), and lactide (L) (a lactic acid prodrug) that together have non-hormonal contraceptive and anti-STI/HIV activity including chlamydia (CT), gonorrhea (GC), HSV-2, and HIV-1. Lactide maintains optimal vaginal pH and provides antibacterial, antiviral, and anti-bacterial vaginosis (BV) effects. We will advance development of our CZL-IVR through implementation of three integrated research projects. In Project 1 we aim to formulate and manufacture CZL-IVRs that achieve 30-day API delivery, manufacture and characterize in vitro mechanical performance of IVRs with varying dimensions and polymers with the selection of four candidates with a range of mechanical characteristics to evaluate in end-user research, and establish Good Manufacturing Practice (GMP) production for non-medicated rings for research conducted in Project 3. In Project 2 we aim to define the optimal API delivery doses of the three APIs alone and in combination, and to confirm the efficacy and safety of the prototype CZL-IVR by conducting essential preclinical studies including in-vitro and in-vivo contraceptive efficacy and antimicrobial efficacy and toxicity studies of APIs and of prototype human-sized and rhesus macaque-sized CZL- IVRs. In Project 3 we will inform CZL-IVR development and the field more broadly through end-user research employing novel mixed method approaches including a controlled setting cross-over study of the four selected candidate non-medicated IVRs of varying mechanical characteristics, a 30-day continuous use study of a non- medicated prototype IVR with an embedded temperature sensor, and a national cross-sectional survey with a discrete choice experiment (DCE) and latent class analysis (LCA). The Administrative Core will support and synergize our interdisciplinary collaborative research, provide scientific, administrative, and operational expertise and oversight, and manage advisory committees to ensure adherence to timelines and success in achieving our aims through rigorous science. Our P50 Center will be a hub fostering careers of early stage investigators and inspiring MPT product development through fellowships and pilot project grants. Drawing from our world-class Center for Biomedical Research and building on decades of successful contraceptive product development, the PC’s P50 Center will capitalize on the rich, collaborative, and interdisciplinary environment and the vast experience of the PC and our partners to advance development of an innovative MPT product.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $2,116,301 )
2023	2023	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	001	3	9/19/2023	NON-COMPETING CONTINUATION	$0
2023	2023	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	000	3	8/28/2023	NON-COMPETING CONTINUATION	$2,116,301
														Subtotal = $2,116,301

Issue Date FY: 2022 ( Subtotal = $2,334,952 )
2022	2022	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	002	2	9/6/2022	NON-COMPETING CONTINUATION	$2,334,952
2022	2022	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	003	2	9/21/2022	NON-COMPETING CONTINUATION	$0
2022	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	000	1	11/9/2021	NEW	$0
2022	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	001	1	8/23/2022	NEW	$0
														Subtotal = $2,334,952

Issue Date FY: 2021 ( Subtotal = $2,000,000 )
2021	2021	POPULATION COUNCIL, INC., THE	1 DAG HAMMARSKJOLD PLZ FL 3	NEW YORK	NY	10017	NEW YORK	USA	Child Health and Human Development Extramural Research	000	1	9/22/2021	NEW	$2,000,000
														Subtotal = $2,000,000

Grand Total All Awards = $6,451,253

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Contraception development research center to advance a novel intravaginal ring as a non-hormonal multipurpose prevention technology

Award Number: P50HD106793

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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