Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine
ConditionNeisseria Gonorrhea
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorLimmaTech Biologics AG
About this trial
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
History of prior confirmed N. meningitidis infection
Trial design
Treatments tested in this trial
- LTB-NG6
- Sodium Chloride 0.9%
Treatment groups
142 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
LimmaTech Biologics AG
Lead sponsor
Nuvisan, Germany
Collaborator
Wellcome Trust
Collaborator
German Federal Ministry of Education and Research
Collaborator
Novo Nordisk Foundation
Collaborator
Source ClinicalTrials.gov