Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • LTB-NG6

    Biological/Vaccine

    LTB-NG6 administrated at 5 different doses

  • Sodium Chloride 0.9%

    Other intervention

    sodium chloride 0.9% used as a diluent in LTB-NG6 and as a placebo

Treatment groups

142 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: PlaceboPlacebo comparator 1 intervention
Group B: Dose 1Experimental treatment 1 intervention
Group C: Dose 2Experimental treatment 1 intervention
Group D: Dose 3Experimental treatment 1 intervention
Group E: Dose 4Experimental treatment 1 intervention
Group F: Dose 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: \- Percentage of participants reporting each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).

Time frame
During 7 days following each injection
2

Safety: any events after each injection

To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants reporting any adverse event (AE) following each injection * Percentage of participants reporting each severity level (Grade 1-4) of solicited local, systemic and unsolicited AEs following each injection

Time frame
During 28 days following each injection
3

Safety: unsolicited AEs, SAEs, MAAEs

To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants with unsolicited AEs. * Percentage of participants with serious adverse events (SAEs) following each injection. * Percentage of participants with medically attended adverse events (MAAEs) following each injection.

Time frame
Through study completion, an average of 18 months
4

Immunogenicity - primary IgGs GMT

To evaluate the immunogenicity of different doses of LTB-NG6 to identify the preferred dose(s). Serum IgG geometric mean titers (GMTs) against each of the N. gonorrhoeae antigens included in LTB-NG6 summarized by treatment group

Time frame
At 28 days after the second injection

Secondary outcomes

1

Immunogenicity - secondary IgGs

To expand the evaluation of the immunogenicity of LTB-NG6 for each treatment group at baseline and 28 days after each injection for each of the antigens included in LTB-NG6: * Serum IgG GMTs (except for primary endpoint) * Serum IgG geometric mean fold ratio (GMFR) * Percentage of participants with ≥ 4-fold increase in serum IgG titer.

Time frame
At baseline and 28 days after the second injection
2

Safety: AEs relatedness to injection, vaccine vs. placebo

To further evaluate the safety of LTB-NG6. Percentage of participants with solicited local, systemic, unsolicited AEs, and SAEs according to relatedness to injection, in vaccinees vs. placebo.

Time frame
Through study completion, an average of 18 months
3

Safety: lab abnormalities

To evaluate changes in hematological and blood chemistry parameters following each injection. Percentage of participants with hematological and blood chemistry laboratory abnormalities at 7 days after each injection compared to baseline in vaccinees vs. placebo.

Time frame
At baseline and 7 days after each injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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