# Efficacy of immunization with 4C-MenB in preventing experimental urethral infection with Neisseria gonorrhoeae.

> **NIH NIH U01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2022 · $780,724

## Abstract

Abstract:
Rates of sexually transmitted infections are on the rise in the United States, including those caused by
Neisseria gonorrhoeae. Antibiotic resistance in N. gonorrhoeae is also increasing and has been recognized as a
serious emerging public health threat by WHO and the US CDC. A vaccine against N. gonorrhoeae could help
combat the spread of antibiotic resistant N. gonorrhoeae, however, an effective vaccine for N. gonorrhoeae has
thus far eluded discovery. Individuals infected with N. gonorrhoeae do not develop immunity to subsequent
infection, limiting our understanding of the immune responses required for protection from infection. Mass
vaccination campaigns in New Zealand and other countries with vaccines against N. meningitidis serogroup B
made from outer membrane vesicles have been followed by reduced reported rates of N. gonorrhoeae
infections in those countries. The US FDA-approved N. meningitidis serogroup B vaccine (4C-MenB) contains
both N. meningitidis outer membrane vesicles and two recombinant antigens that are highly related to N.
gonorrhoeae homologs of the antigens. Our research team currently uses a unique human experimental
infection model to study N. gonorrhoeae in its natural host. Because the use of the 4C-MenB vaccine is not yet
widespread within the US, there is a unique and time-sensitive opportunity to test the effectiveness of this
vaccine in preventing N. gonorrhoeae using our human challenge model. The proposed clinical trial will also
allow us to study immune responses to the 4C-MenB vaccine and determine which responses are essential to
the protective effect of the vaccine. The current proposal requests support for the implementation of the
proposed clinical trial, which represents an important step in the development of an effective N. gonorrhoeae
vaccines.

## Key facts

- **NIH application ID:** 10435532
- **Project number:** 5U01AI162457-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** JOSEPH A DUNCAN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $780,724
- **Award type:** 5
- **Project period:** 2021-07-01 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10435532

## Citation

> US National Institutes of Health, RePORTER application 10435532, Efficacy of immunization with 4C-MenB in preventing experimental urethral infection with Neisseria gonorrhoeae. (5U01AI162457-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10435532. Licensed CC0.

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