ArticleAmerican journal of obstetrics and gynecology2023
ZB-06, a vaginal film containing an engineered human contraceptive antibody (HC4-N), demonstrates safety and efficacy in a phase 1 postcoital test and safety study.
Article in American journal of obstetrics and gynecology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
14 citing papers in PubMed.
- Complement protein concentrations and activity in human cervical mucus.bioRxiv : the preprint server for biology · 2026Article
- A versatile capsule-intravaginal ring platform enables rapid and sustained release of monoclonal antibodies for non-hormonal contraception.Journal of controlled release : official journal of the Controlled Release Society · 2026Article
- Design of Experiments in the Formulation and Characterization of 3D-Printed Vaginal Films Loaded with Curcumin Solid Lipid Nanoparticles for Cervical Dysplasia.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Engineering Decavalent, Sperm-Binding Laminin-IgG Hybrid Antibodies for Potent Non-Hormonal Contraception.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- Revolutionizing male contraception: Personal lubricants as a novel way to deliver the Human Contraception Antibody.bioRxiv : the preprint server for biology · 2025Article
- PSA inhibitors for contraception: insights from prostate cancer.Trends in pharmacological sciences · 2025Review
- Review
- Vaginally-delivered fast-dissolving antibody tablets (FDAT) for on-demand non-hormonal contraception and multi-purpose protection.Journal of controlled release : official journal of the Controlled Release Society · 2025Article
- Antibody-dependent complement-mediated sperm cytotoxicity in the endocervix is a dominant contraceptive mechanism of ZB-06 vaginal film.Fertility and sterility · 2025Article
- Article
- Platform-Specific FcAntibodies (Basel, Switzerland) · 2024Article
- Reversible female contraceptives: historical, current, and future perspectives†.Biology of reproduction · 2024Review
- Innovations in monoclonal antibody-based multipurpose prevention technology (MPT) for the prevention of sexually transmitted infections and unintended pregnancy.Frontiers in reproductive health · 2023Review
- Exploring the Efficacy of ZB-06 Vaginal Biofilm as a Novel Treatment for Recurrent Bacterial Vaginosis.Journal of mid-life healthArticle
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
backgroundWith an unplanned pregnancy rate of 50% or more in many countries, there is an urgent need for contraceptives that are more accessible and acceptable. To meet the growing demand for new contraceptives, ZabBio developed ZB-06, a vaginal film containing HC4-N, a human contraceptive antibody that inactivates sperm.
objectiveThis study aimed to assess the potential contraceptive activity of the ZB-06 film using a surrogate assessment for contraceptive efficacy, the postcoital test. We also assessed clinical safety of film use among healthy heterosexual couples. Serum, cervical mucus, and vaginal fluid HC4-N antibody concentrations and sperm agglutination potency were determined after single film use. Changes in the concentration of soluble proinflammatory cytokines and vaginal Nugent score after film use were measured as subclinical safety endpoints. STUDY
designThis was a phase 1, first-in-woman, open-label, proof-of-concept, postcoital test and safety study.
resultsA total of 20 healthy women were enrolled in the study, and 8 heterosexual couples completed all study visits. The product was safe for both female participants and their male sexual partners. The postcoital test performed on ovulatory cervical mucus at baseline (no product use) revealed a mean of 25.9 (±30.6) progressively motile sperm per high-power field. After use of a single ZB-06 film before intercourse, this number dropped to 0.04 (±0.06) progressively motile sperm per high-power field (P<.0001). At the follow-up postcoital test visit approximately 1 month later (no product use), a mean of 47.4 (±37.4) progressively motile sperm per high-power field was observed, indicating contraceptive reversibility.
conclusionA single dose of the ZB-06 film applied before intercourse was safe and met efficacy surrogate benchmarks of excluding progressively motile sperm from ovulatory cervical mucus. These data indicate that ZB-06 is a viable contraceptive candidate warranting further development and testing.
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