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

Active Project Grant Awarded Last action

Award ID
P50HD106793
Recipient
Awarding agency
Obligated
$21,871,724

Award facts

Completion date 85% complete
Originally
Funding
  • $19,871,724.00 Federal
  • $2,000,000.00 Non-federal
Place of performance
New York, NY 10065, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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.

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Original award $2,000,000 $2,000,000
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Subawards

Subrecipient Amount Awarded
The Leland Stanford Junior University Development of HIPK4 inhibitors for non-hormonal male contraception $77,000
The Queen's University Of Belfast QUB will be responsible for all aspects of non-GMP formulation development and in vitro testing, and ultimately supply of materials for animal as part of… $958,023
Weill Medical College Of Cornell University Anti-sperm testing active pharmaceutical agents; Anti-sperm of release medium from prototype vaginal rings. $237,500
Emory University Emory will implement the studies in Aims 1 and 2 as well as the formative research in Aim 3. Jessica Sales will serve as Co-I as well as Subaward PI for all 3… $193,536
Louisiana State University Health Sciences Center New Orleans Dr. Quayle’s laboratory will be responsible for teaching a member of Dr. Teleshova’s laboratory all the relevant protocols and procedures for… $32,406

Quick answers

Who received award P50HD106793?

P50HD106793 was awarded to The Population Council, Inc. by National Institute of Child Health and Human Development (National Institutes of Health) on September 22, 2021.

How much is award P50HD106793 worth?

$21,871,724 has been obligated on P50HD106793: $19,871,724 in federal funding and $2,000,000 in non-federal funding.

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