# A novel vaccine against multidrug-resistant gonorrhea

> **NIH NIH R01** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2021 · $1,227,829

## Abstract

ABSTRACT
Gonorrhea is the second most common bacterial sexually transmitted infection – the most common is
chlamydia, which often coinfects with gonorrhea. About 80 million new cases of gonorrhea occur worldwide
annually. Over 450,000 cases are reported yearly in the U.S. Serious sequelae of gonorrhea in women
includes infertility, ectopic pregnancy and chronic pelvic pain. Neisseria gonorrhoeae (Ng), the causative agent
of gonorrhea, has become resistant to almost every antibiotic in clinical use. Resistance to ceftriaxone and
azithromycin – the recommended first-line of treatment –portends an era of untreatable gonorrhea. The CDC
has listed Ng as a microorganism with a threat level of “Urgent”. Development of a safe and effective vaccine
against gonorrhea is a public health priority. Furthermore, Ng and chlamydia coinfection is a frequent event
and a successful gonococcal vaccine will prevent infection even when chlamydia infection is present.
We identified a monoclonal antibody (mAb) called 2C7 that recognizes a lipooligosaccharide (LOS) epitope
expressed by >95% of Ng in vivo and is critical for virulence in mice. mAb 2C7 is bactericidal and significantly
reduces the duration and burden of Ng infection in mice. Its ubiquitous expression, key role in virulence, and
the bactericidal nature of Ab against the 2C7 epitope makes it an attractive vaccine antigen. To circumvent
limitations of LOS as a vaccine antigen, we identified a peptide mimic of the 2C7 epitope, which when
configured as a multi-antigen peptide (MAP), elicited bactericidal Abs and attenuated Ng infection in mice.
A Product Development Plan overseen by NIAID/NIH partnered us with ABL Inc., Peptides International and
the Infectious Diseases Research Institute (IDRI). The objectives of the PDP have been met and has resulted
in design of a novel tetra-MAP structure (TMCP2) and identification of GLA-SE as the optimal adjuvant based
on immunogenicity in mice. In Aim 1, Peptides International will produce TMCP2, perform stability testing and
transfer technology to the cGMP manufacturer. In Aim 2 (UMass), mice and non-human primates will be
immunized with development-grade TMCP2 plus GLA-SE to evaluate i) immunogenicity and ii) functionality of
elicited Ab in Ng infected or (separately) in Ng/chlamydia co-infected mice. Ng bind the complement inhibitors,
factor H (FH) and C4b-binding protein (C4BP) in a human-specific manner, which dampens activity of vaccine
Ab. Therefore, we will test vaccine efficacy in novel transgenic mice that express human FH and C4BP to
simulate conditions in humans. Anti-LOS Ab purified from immunized Rhesus macaques will be assayed for
bactericidal activity and for its ability to attenuate colonization in single Ng and Ng/chlamydia coinfected mice.
ABL Inc. will qualify ELISAs and SBAs. A GLP-grade safety and toxicology study in New Zealand White
Rabbits (ABL, Inc.) which is essential for product development will be performed in Aim 3. Pre-IND enabling
studies ...

## Key facts

- **NIH application ID:** 10083175
- **Project number:** 5R01AI141181-03
- **Recipient organization:** UNIV OF MASSACHUSETTS MED SCH WORCESTER
- **Principal Investigator:** SANJAY RAM
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,227,829
- **Award type:** 5
- **Project period:** 2019-01-01 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10083175

## Citation

> US National Institutes of Health, RePORTER application 10083175, A novel vaccine against multidrug-resistant gonorrhea (5R01AI141181-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10083175. Licensed CC0.

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