Gonorrhea Vaccines

Gonorrhea Vaccines 2024

The WHO Global Health Sector Strategy on Sexually Transmitted Infections (STIs) set goals for reducing gonorrhea incidence by vaccination by 90% by 2030. As of September 2024, no gonorrhea vaccines have been approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) to prevent gonorrhea infection. However, the United Kingdom supports vaccinations to prevent gonorrhea. A systematic review of 12 studies published in 2024 evaluated the evidence of vaccine effectiveness (VE) of meningococcal B (MenB) outer membrane vesicle (OMV) vaccines against gonorrhea and a non-OMV-based vaccine (MenB-FHbp). This study concluded that 4CMenB and MenB-OMV vaccines show moderate effectiveness against gonorrhea infection.

Repurposed Vaccines Against Gonorrhea

On November 10, 2023, the U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) advised the government of a routine targeted vaccination program to prevent gonorrhea. The JCVI agreed that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection. In addition,  a modeling study indicated that vaccinating at-risk people could prevent 110,000 gonorrhea cases in England. Meningococcal (MenB-4C, Bexsero) vaccination is recommended in France against Gonorrhea.

A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that the Outer Membrane Vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29. These results are consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea. Other STI vaccine news (herpes, HPV, mpox) is posted at this link.

On February 19, 2023, Mark Mascolini reported a meningococcal vaccine (4CMenB) continued to cut the risk of STIs in MSM using preexposure prophylaxis (PrEP) in the DOXYVAC trial. A study published in Clinical Infectious Diseases on June 1, 2022, suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection. Clinical studies (April 22) published in the Lancet Infectious Diseases reported that two doses of the 4CMenB vaccine were around 33% to 40% effective against gonorrhea in adolescents and young adults.

On July 17, 2017, a GSK-funded study concluded that exposure to MeNZB was associated with reduced rates of gonorrhea diagnosis. This is the first time a vaccine has shown any protection against gonorrhea. The results of this study provide proof of principle that can inform prospective vaccine development not only for gonorrhea but also for meningococcal vaccines.

Gonorrhea Vaccine Candidates

GSK announced on June 27, 2023, that the U.S. FDA had granted a Fast Track designation for its Neisseria gonorrhea (NgG) investigational vaccine. GSK is conducting a Phase I/II first-time in-human clinical study evaluating the vaccine candidate's safety and efficacy in individuals aged 18-50. Phase I of the study was a completed dose-escalation safety lead-in conducted in healthy adults; the Phase II segment of the study is ongoing and aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.

Intravacc's Avacc 11® is an experimental gonococcal vaccine consisting of outer membrane vesicles (OMVs) and microsphere (ms)-encapsulated interleukin-12 (IL-12 ms) that induces Th1-driven immunity. The prophylactic intranasal gonorrhea candidate vaccine is being developed in partnership with Therapyx Inc. Clinical study results were published in the journal MSphere of the American Society of Microbiology in December 2022. In October 2022, Intravacc was awarded a $14.6 Million NIH/NIAID contract to develop this intranasal candidate gonorrhea vaccine further. On January 16, 2024, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator awarded $633k to Intravacc to develop a Neisseria gonorrhoeae preventive vaccine.

LimmaTech Biologics AG is advancing the development of its novel vaccine candidate targeted to prevent Neisseria gonorrhoeae infections.

UMass Chan Medical School received a U.S. National Institutes of Health (NIH) grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion. A report was published in the journal mBio in 2019.

Evaxion Biotech A/S EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate. The novel preclinical data for the mRNA-version of the vaccine substantiates that AI-Immunology™ identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities.

Gonorrhea Vaccine News

September 9, 2024 - Evaxion Biotech A/S announced new preclinical data demonstrating the ability of its novel EVX-B2 mRNA gonorrhea vaccine candidate to eliminate gonorrhea bacteria by triggering a targeted immune response.

March 28, 2024 - The U.S. CDC Morbidity and Mortality Weekly Reports confirmed the China Gonococcal Resistance Surveillance Program revealed that the prevalence of ceftriaxone-resistant Neisseria gonorrhoeae was 8.1% in 2022, nearly three times the 2.9% prevalence reported in 2017. 

February 27, 2024 - "Resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. LimmaTech's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

January 16, 2024 - "Drug-resistant strains of Neisseria gonorrhoeae have evaded all but one existing antibiotic (ceftriaxone)," said Erin Duffy, PhD, R&D Chief of CARB-X. "Vaccines are powerful tools in the prevention of bacterial infections. With an appropriate vaccination strategy, Intravacc's vaccine project, if successful, could prevent the disease and significantly curb the spread of resistant bacteria across the globe."

November 10, 2023—The U.K.'s Joint Committee on Vaccination and Immunisation published an Independent Report agreeing that a targeted program should be initiated using the 4CMenB vaccine to prevent gonorrhea in those at the highest risk of infection.

August 31, 2023 - Researchers with the Oregon Public Health Division suggest that the meningococcal group B vaccine may offer protection against gonorrhea infection.

June 27, 2023 - GSK plc announced today the US FDA has granted a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine. 

April 29, 2023 - Gonorrhea Risk Reduced with Oral Antibiotic.

April 11, 2023 - The U.S. CDC published - U.S. STI Epidemic Showed No Signs of Slowing in 2021 – Cases Continued to Escalate.

March 1, 2023 - Developing advanced vaccines for STI pathogens gains U.S. NIAID support.

February 17, 2023 - Promising gonorrhea vaccine may prevent 40% of cases.

January 16, 2023 - Intravacc announced favorable preclinical data for Avacc 11®, the prophylactic intranasal gonorrhea candidate vaccine developed with Therapyx Inc. Dr. Jan Groen, Intravacc's CEO, commented, "This intranasal gonococcal vaccine is more suitable to fight gonorrhea infections, which are becoming increasingly resistant to antibiotic treatments."

December 20, 2022 - mSphere published: Microencapsulated IL-12 Drives Genital Tract Immune Responses to Intranasal Gonococcal Outer Membrane Vesicle Vaccine and Induces Resistance to Vaginal Infection with Diverse Strains of Neisseria gonorrhoeae.

September 29, 2022 - The UMass Chan Medical School received a U.S. NIH grant for the preclinical development of gonorrhea vaccine candidates identified by Evaxion, a clinical-stage biotech company in Denmark.

July 27, 2022 - Aidsmap published: Taking antibiotic after sex cuts STIs by two-thirds, 'DoxyPEP' study finds.

April 12, 2022—The Lancet published effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhea: a retrospective observational study. MenB-4C vaccination was associated with a reduced prevalence of gonorrhea and could offer cross-protection against Neisseria gonorrhoeae. 

April 11, 2022 - The journal Frontiers published: Recent Progress Towards a Gonococcal Vaccine.

January 4, 2022 - The NEJM published Eliminating gonorrhea with a Vaccine?

Gonorrhea Test

On November 15, 2023, the U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test for use in adult patients ages 18. LetsGetChecked is the first OTC diagnostic test for gonorrhea with at-home sample collection to be granted marketing authorization. Before today's authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor's office.