# Next Generation Multipurpose Prevention Technology: An Intravaginal Ring for HIV Prevention and Nonhormonal Contraception

> **NIH NIH R01** · OAK CREST INSTITUTE OF SCIENCE · 2022 · $740,660

## Abstract

ABSTRACT
New HIV infection rates far outpace the targets set by global health organizations, despite important progress
in curbing the progression of the epidemic. In 2017, an estimated 1.8 million people became newly HIV
infected globally. New HIV pre-exposure prophylaxis (PrEP) strategies are needed urgently to curb this
alarming situation, particularly in young sub-Saharan African women who are disproportionately at risk. A high
proportion of women at risk of becoming HIV-infected also are interested in family planning, suggesting that a
dual-purpose product providing HIV prevention and contraception would significantly increase the likelihood of
higher uptake relative to single-purpose products, since unsurprisingly, women do not self-identify as being at
risk of HIV, but do so identify for pregnancy. Many women are averse to exogenous hormones and would
strongly prefer a nonhormonal method, and one that does not require use immediately before or after sex. Our
application integrates two leading innovations in developing a next generation multi-purpose technology (MPT)
intravaginal ring (IVR): (1) developing a novel, nonhormonal contraceptive agent based on a multivalent
monoclonal antibody (mAb) that blocks sperm from swimming through mucus and accessing the egg; and (2)
formulating the mAb contraceptive with antiretroviral (ARV) agents with demonstrated clinical efficacy in
preventing HIV in a behavior-monitoring IVR. We have recently engineered a unique IgG-based multivalent
mAb with 10 Fab arms against CD52g, a validated antigen target for contraception that is found only on cells in
the human male genital tract. This molecule, even at sub-nanomolar concentrations, effectively agglutinates
>99% of sperm within seconds, thus offering potentially potent yet cost-effective contraception. To complement
this novel agent, our team has developed an innovative IVR platform that delivers drug combinations including
small molecule drugs and mAbs. A low-cost module has been incorporated into the IVR to monitor temperature
as a surrogate measure of adherence. The MPT IVR will be formulated to provide long-term (30 days) dual
protection while evaluating adherence. In Aim 1, we will further enhance the mAb constructs against CD52g
through affinity maturation of anti-CD52g Fab using yeast-display, incorporate the optimized Fab into similar
multimeric mAb formats, and characterize their sperm agglutination potencies rigorously. In Aim 2, we will
formulate and evaluate in vitro human- and macaque-sized MPT IVRs to deliver our lead contraceptive mAb
candidate in combination with ARV drugs at target in vitro rates based on existing in vivo PK-PD data. We will
optimize and expand the adherence IVR design and evaluate prototypes in sheep. In Aim 3, we will assess the
pharmacokinetics and pharmacodynamics (safety and efficacy) of MPT IVR candidates in sheep and pigtailed
macaques. This project builds on an established collaboration of investigators and will ad...

## Key facts

- **NIH application ID:** 10359111
- **Project number:** 5R01HD101344-03
- **Recipient organization:** OAK CREST INSTITUTE OF SCIENCE
- **Principal Investigator:** Marc Michael Baum
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $740,660
- **Award type:** 5
- **Project period:** 2020-05-05 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10359111

## Citation

> US National Institutes of Health, RePORTER application 10359111, Next Generation Multipurpose Prevention Technology: An Intravaginal Ring for HIV Prevention and Nonhormonal Contraception (5R01HD101344-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10359111. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*