RecruitingPhase 1

Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine

Germany142 participantsStarted 2026-08-19

Plain-language summary

The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 18-50 years (inclusive) at the time of the first injection
. Good and stable general health, determined by medical history, laboratory findings and physical examination as judged by the Investigator before receiving the first injection.
. Willingness and ability to comply with the requirements of the protocol (e.g., completion of the diary forms, return for follow-up visits)
. Signed written informed consent obtained
. Availability for the trial duration, including all planned follow-up visits and phone calls
. Negative urine pregnancy test for WOCBP. WOCBP must be willing to use a highly effective method of contraception during the trial

Exclusion criteria

. 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
. 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.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: local and systemic AEs (7-days-post)

Timeframe: During 7 days following each injection

Safety: any events after each injection

Timeframe: During 28 days following each injection

Safety: unsolicited AEs, SAEs, MAAEs

Timeframe: Through study completion, an average of 18 months

Immunogenicity - primary IgGs GMT

Timeframe: At 28 days after the second injection

Trial details

NCT IDNCT07758972

SponsorLimmaTech Biologics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-26

Contact for this trial

Steffen Haffner, Dr.

+49 731 9840 452 Steffen.Haffner@nuvisan.com

View on ClinicalTrials.gov More Neisseria Gonorrhea trials