Can a vaccine stop Antibiotic-Resistant gonorrhea?
NCT ID NCT07758972
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This first-in-human trial tests an experimental vaccine called LTB-NG6, designed to protect against gonorrhea. The study will enroll healthy adults aged 18-50 to evaluate the vaccine's safety and its ability to trigger an immune response. Participants will receive either the vaccine at different doses or a placebo, and researchers will monitor for side effects and measure antibody levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LTB-NG6, an experimental vaccine against Neisseria gonorrhoeae
- What this could lead to
- If successful, this could lead to a vaccine that prevents gonorrhea, a common sexually transmitted infection with rising antibiotic resistance.
- What could go wrong
- This is an early-phase trial focused on safety and immune response, not effectiveness. The vaccine may not produce a strong enough immune response or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 142 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-50 years (inclusive) at the time of the first injection 2. Good and stable general health, determined by medical history, laboratory findings and physical examination as judged by the Investigator before receiving the first injection. 3. Willingness and ability to comply with the requirements of the protocol (e.g., completion of the diary forms, return for follow-up visits) 4. Signed written informed consent obtained 5. Availability for the trial duration, including all planned follow-up visits and phone calls 6. Negative urine pregnancy test for WOCBP. WOCBP must be willing to use a highly effective method of contraception during the trial Exclusion Criteria: 1. Health conditions that, in the opinion of the Investigator, may interfere with optimal participation in the trial or place the participant at increased risk of adverse events 2. Acute or active infectious disease (including symptomatic sexually transmitted infections or any other ongoing acute infections), fever (oral temperature ≥38.0°C), or acute illness at the time of enrollment. 3. History of gonorrhea at any time (either self-reported or medically confirmed) or confirmed at screening by a positive nucleic acid amplification test (NAAT) result for Neisseria gonorrhoeae 4. History of prior confirmed N. meningitidis infection 5. Previous vaccination with Bexsero or any meningococcal serogroup B vaccine (including self-report) 6. Any deviation from the normal range in biochemistry or hematology blood tests clinically significant in the opinion of the Investigator, measured at the screening visit 7. Clinical conditions representing contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder) 8. Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder) 9. Positive test for active HBV infection (positive HBsAG test), any HCV infection (positive HCV antibody test), or any HIV-1/2 infection 10. Planned or actual administration of any licensed vaccine within 14 days prior to enrollment. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by the public health authorities, the time period described above can be reduced, if necessary, for that vaccine, provided that it is licensed or authorized and that it is used according to the local governmental recommendations, and provided that a written approval from the Sponsor is obtained 11. Body Mass Index (BMI) ≤19 or ≥35 12. History of systemic administration of corticosteroids (PO/IV/IM) within the last month prior to injection or for more than 14 consecutive days within 3 months prior to injection (i.e., prednisone or equivalent ≥20 mg/day). Inhaled and topical steroids are allowed 13. Administration of antineoplastic, immune-modulating, immunosuppressive agents or chemotherapy within 3 months prior to injection 14. Suspected or known hypersensitivity (including allergy) to any of the vaccine components or medical equipment whose use is foreseen in this trial 15. Concurrently participating in another clinical trial or planned participation at any time during the trial period, in which the participant has been or will be exposed to an investigational or a non-investigational interventional vaccine/product (pharmaceutical product) 16. History of any chronic or progressive disease that according to judgment of the Investigator could interfere with the trial outcomes or pose a threat to the participant's health 17. Received an investigational or non-registered product (medicinal drug or vaccine), within 3 months prior to enrollment or planned use during the trial period 18. Administration of immunoglobulin and/or any blood products within the three months prior to enrollment 19. Blood donation equal or greater to 500 mL of blood drawn within 3 months prior to enrollment 20. Participants with an elective surgical intervention, planned during the trial period until one month after second injection 21. Female participants lactating, pregnant, or intending to become pregnant as reported by the participant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nuvisan GmbH
RECRUITINGNeu-Ulm, Bavaria, 89231, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.