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Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus jensenii 1153-1666) Administered Vaginally to Healthy Women

Award Number: U01AI186333
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 11/22/2024
PERIOD OF PERFORMANCE END DATE: 10/31/2027

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Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus jensenii 1153-1666) Administered Vaginally to Healthy Women - MUCOCEPT-CVN: ABSTRACT Women bear the brunt of the HIV epidemic. Thus, female-initiated prevention methods including live biotherapeutic products (LBPs) are urgently needed to help curtail the HIV epidemic worldwide. The vaginal mucosa is densely populated with commensal bacteria dominated by Lactobacillus strains that play a critical role in the maintenance of vaginal health. The loss of lactobacilli leads to vaginal dysbiosis, and an increased risk of heterosexual transmission of HIV and other sexually transmitted infections (STIs). MucoCept-CVN contains Lactobacillus jensenii 1153-1666, a natural component of the human vaginal microbiota that has been bioengineered into a recombinant vaginally administered LBP which continuously expresses the potent HIV entry inhibitor modified-cyanovirin-N (mCV-N) right at the site of infection. Preclinical studies have been completed and showed a 63% reduction in simian/HIV (SHIV) transmission after repeated vaginal challenges of macaques treated with L. jensenii 1153-1666 compared to placebo. We propose a first-in-human Phase 1 randomized, placebo-controlled study of one and three doses of vaginally administered MucoCept-CVN in 12 women. The study is designed to collect critical data needed to advance the clinical development of MucoCept- CVN, specifically (1) understanding factors that influence vaginal colonization by L. jensenii 1153-1666, including dose and endogenous vaginal microbiota; and (2) pharmacokinetic, tissue and systemic effects of L. jensenii 1153-1666, such as adverse events (AE) and findings in colposcopy and vaginal biopsy, and (3) changes to the vaginal microbiota. We also need to show that (4) L. jensenii 1153-1666 can be sufficiently cleared with antibiotics should the need arise for rescue therapy. As a long-acting, self-generating LBP with a low risk of significant adverse events, MucoCept-CVN has characteristics that should translate to high acceptability and excellent adherence. In addition, MucoCept-CVN is cost-effective and has promise as a potential multipurpose prevention technology to avert other genital tract infections. Research to date is proof- of-concept that MucoCept-CVN may be safe and lead to a significant reduction in female HIV acquisition. The proposed research is a critical step toward a safe, effective, durable, self-renewing, coitally independent, potentially multi-purpose prevention product for women that promotes vaginal health and provides protection from HIV and potentially other STIs.


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: 2026 ( Subtotal = $1,538,375 )
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	2	12/10/2025	NON-COMPETING CONTINUATION	$1,538,375
														Subtotal = $1,538,375

Issue Date FY: 2025 ( Subtotal = $1,533,177 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	1	11/22/2024	NEW	$1,533,177
														Subtotal = $1,533,177

Grand Total All Awards = $3,071,552

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Phase 1 Randomized Double-Blind Placebo-Controlled Safety Study of MucoCept-CVN (Lactobacillus jensenii 1153-1666) Administered Vaginally to Healthy Women

Award Number: U01AI186333

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 11/22/2024

PERIOD OF PERFORMANCE END DATE: 10/31/2027

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