Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine (LTBNG601)

August 10, 2026 updated by: LimmaTech Biologics AG

A First in Human Phase I Randomized and Controlled Trial to Test Safety and Immunogenicity of a Multivalent Vaccine Against Neisseria Gonorrhoeae

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

LTB-NG6 is a vaccine including 6 N. gonorrhoeae antigens. During the study, healthy adults will be randomized to receive 1 of 5 different vaccine doses, or a placebo.

Participants will receive a 2-dose schedule.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Neu-Ulm, Bavaria, Germany, 89231
        • Recruiting
        • Nuvisan GmbH
        • Contact:
          • Steffen Haffner, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants receive 2 administrations of Sodium chloride 0.9%
Other: Sodium Chloride 0.9%
sodium chloride 0.9% used as a diluent in LTB-NG6 and as a placebo
Experimental: Dose 1
Participants receive 2 Dose 1 administrations of the investigational product
Biological: LTB-NG6
LTB-NG6 administrated at 5 different doses
Experimental: Dose 2
Participants receive 2 Dose 2 administrations of the investigational product
Biological: LTB-NG6
LTB-NG6 administrated at 5 different doses
Experimental: Dose 3
Participants receive 2 Dose 3 administrations of the investigational product
Biological: LTB-NG6
LTB-NG6 administrated at 5 different doses
Experimental: Dose 4
Participants receive 2 Dose 4 administrations of the investigational product
Biological: LTB-NG6
LTB-NG6 administrated at 5 different doses
Experimental: Dose 5
Participants receive 2 Dose 5 administrations of the investigational product
Biological: LTB-NG6
LTB-NG6 administrated at 5 different doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: local and systemic AEs (7-days-post)
Time Frame: During 7 days following 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 each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).
During 7 days following each injection
Safety: any events after each injection
Time Frame: During 28 days following 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
During 28 days following each injection
Safety: unsolicited AEs, SAEs, MAAEs
Time Frame: Through study completion, an average of 18 months

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.
Through study completion, an average of 18 months
Immunogenicity - primary IgGs GMT
Time Frame: At 28 days after the second injection
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
At 28 days after the second injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity - secondary IgGs
Time Frame: At baseline and 28 days after the second injection

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.
At baseline and 28 days after the second injection
Safety: AEs relatedness to injection, vaccine vs. placebo
Time Frame: Through study completion, an average of 18 months
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.
Through study completion, an average of 18 months
Safety: lab abnormalities
Time Frame: At baseline and 7 days after each injection
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.
At baseline and 7 days after each injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LimmaTech Biologics AG

Collaborators

German Federal Ministry of Education and Research
Wellcome Trust
Nuvisan, Germany
Novo Nordisk Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 19, 2026

Primary Completion (Estimated)

April 26, 2027

Study Completion (Estimated)

September 23, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 10, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTBNG601
  • 224842/Z/21/Z (Other Grant/Funding Number: Wellcome Trust)
  • NNF23SA0088536 (Other Identifier: Novo Nordisk Foundation (NNF))
  • OTA No. 75A50122C00028 (Other Grant/Funding Number: HHS/BARDA)
  • Agreement Dated 1/30/23 (Other Grant/Funding Number: Germany's Federal Ministry of Research, Technology, and Space (BMFTR))
  • 2026-526168-19-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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