# Meningococcal and gonococcal vaccine to prevent invasive disease and carriage

> **NIH NIH R01** · OMVAX, INC. · 2020 · $292,679

## Abstract

Project Summary/Abstract
Neisseria meningitidis (Nm) cause life-threatening bacterial meningitis and sepsis and N. gonorrhoeae
(Ng) cause millions of sexually transmitted infections annually. Emerging multiple antibiotic resistance
by Ng and recent increases in incidence have led to its designation as an urgent threat by the CDC.
There are no licensed Nm vaccines in the US for <10 year olds, the population at greatest risk of
disease and no licensed Ng vaccine. We have developed an Nm serogroup B (NmB) vaccine based on
native outer membrane vesicles (NOMV) with genetically attenuated endotoxin activity and over-
expressed mutant Factor H binding protein (FHbp) with reduced FH binding. In both mice and infant
macaques, the vaccine elicited much higher human complement-mediated serum bactericidal antibody
(SBA) responses than a licensed NmB vaccine. The vaccine, NOMV-FHbp, also elicited SBA against
Ng in mice and in infant macaques. We used anti-NOMV-FHbp antibodies to identify Ng antigens that
are highly conserved between Nm and Ng. Our hypothesis is that an NOMV vaccine with over
produced mutant FHbps from subfamilies A and B and conserved Nm/Ng antigens will elicit antibodies
that provide broad protection against disease by both pathogens in all age groups. In Aim 1, we will use
an engineered promoter to over produce mutant FHbps from subfamilies A and B and two or more
highly conserved Ng antigens that elicit protective antibodies (NmNg-NOMV vaccine). In Aim 2, we will
test the ability of NmNg-NOMV to prevent colonization and invasion in immortalized and primary nasal
and cervical cell culture models. In Aim 3, we will test the ability of optimized NmNg-NOMV vaccines to
prevent colonization and symptoms of disease in transgenic mouse models of meningococcal nasal
colonization and meningitis and in a female estradiol-treated Tg mouse model of gonococcal vaginal
colonization. Preventing colonization and invasion is important for providing individual protection
against disease and preventing transmission between individuals (i.e. “community immunity”). The
overall goal is development of an NOMV vaccine platform for expression of conserved Neisseria
antigens with native structures that can elicit broadly protective antibodies against both pathogens.
Successful development of an NmNg-NOMV vaccine would have a significant public health impact
world-wide.

## Key facts

- **NIH application ID:** 10144558
- **Project number:** 7R01AI046464-19
- **Recipient organization:** OMVAX, INC.
- **Principal Investigator:** GREGORY ROBERT MOE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $292,679
- **Award type:** 7
- **Project period:** 2000-07-05 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10144558

## Citation

> US National Institutes of Health, RePORTER application 10144558, Meningococcal and gonococcal vaccine to prevent invasive disease and carriage (7R01AI046464-19). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10144558. Licensed CC0.

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