# Capsule-intravaginal ring for sustained release of antibodies for non-hormonal contraception and vaginal protection against HIV

> **NIH NIH R44** · MUCOMMUNE, LLC · 2021 · $910,955

## Abstract

Summary
 There is a critical need for improved methods for both contraception and HIV prevention. Nearly half of
all pregnancies in the U.S. are unintended, and globally there are >85 million unintended pregnancies and 2
million new HIV infections each year. Not surprisingly, unintended pregnancies occur most often in women
who are non-users of contraception: many women are averse to using exogenous hormones due to real and
perceived side effects, and frequently discontinue hormonal contraception. This underscores the need for a
non-hormonal contraceptive method that does not require coitally-timed actions, nor daily intervention. We
believe adding contraception to an HIV prevention method would also strongly improve user adherence, since
few couples self-identify as at risk of HIV, while nearly all self-identify as at risk of pregnancy.
 Inspired by nature, where some infertile women express antibodies that bind surface antigens on sperm
and block sperm penetration through their cervical mucus, we have investigated a fully human monoclonal
antibody (mAb) that can quickly bind a unique antigen present only on the surface of human sperm; we refer
to this mAb as human contraceptive antibody (HCA). Importantly, HCA agglutinated >90% of sperm within
seconds in all 100 fresh semen samples tested from men spanning diverse demographics. A similiar mAb that
binds rabbit sperm reduced egg fertilization by ~95% in the highly fertile rabbit model. Major strides have been
made with discovering and testing broadly neutralizing mAb (bnAb) against HIV, including protection against
vaginal HIV transmission. Indeed, members of our team led the first clinical trial of VRC01 delivered vaginally.
 To realize the vision of a mAb-based MPT product, the next step in our development is to (i) formulate
mAb into a delivery system that maintains effective levels of mAb in the female reproductive tract, and (ii)
further validate efficacy in large animal models. Thus, during Phase I of this Fast-Track application, we will
formulate sustained release polymeric capsules encapsulating a cocktail of mAbs (HCA and VRC01+N6 for
HIV prevention), and can be embedded into intravaginal rings (IVR). The goal is to demonstrate that loaded
mAbs will remain sufficiently stable and active (neutralize/trap HIV and agglutinate/trap sperm) when exposed
and released into human cervicovaginal secretions over a 35 day period. Pending successful completion of
Phase I milestone, we will perform repeated low-dose vaginal SHIV challenges to confirm if mAb released from
the engineered polymeric capsules can effectively reduce vaginal transmission. If successful, our proposed
work will strongly support clinical development of our combination contraceptive and HIV-prevention MPT-IVR
that could address a major unmet need in the marketplace.

## Key facts

- **NIH application ID:** 9799170
- **Project number:** 4R44HD097063-02
- **Recipient organization:** MUCOMMUNE, LLC
- **Principal Investigator:** Keiichiro Kushiro
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $910,955
- **Award type:** 4N
- **Project period:** 2021-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9799170

## Citation

> US National Institutes of Health, RePORTER application 9799170, Capsule-intravaginal ring for sustained release of antibodies for non-hormonal contraception and vaginal protection against HIV (4R44HD097063-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9799170. Licensed CC0.

---

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