Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine

NCT07758972 | Recruiting Phase 1 DMC

• 6 other identifiers: LTBNG601OTA No. 75A50122C00028224842/Z/21/ZAgreement Dated 1/30/23NNF23SA00885362026-526168-19-00
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neisseria Gonorrhea

Outcome Measures

Primary Outcomes (4)

• 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).

  During 7 days following each injection

• 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

  During 28 days following each injection

• 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.

  Through study completion, an average of 18 months

• 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

  At 28 days after the second injection

Secondary Outcomes (3)

• Immunogenicity - secondary IgGs

  At baseline and 28 days after the second injection

• Safety: AEs relatedness to injection, vaccine vs. placebo

  Through study completion, an average of 18 months

• Safety: lab abnormalities

  At baseline and 7 days after each injection

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Participants receive 2 administrations of Sodium chloride 0.9%

Other: Sodium Chloride 0.9%

Dose 1

EXPERIMENTAL

Participants receive 2 Dose 1 administrations of the investigational product

Biological: LTB-NG6

Dose 2

EXPERIMENTAL

Participants receive 2 Dose 2 administrations of the investigational product

Biological: LTB-NG6

Dose 3

EXPERIMENTAL

Participants receive 2 Dose 3 administrations of the investigational product

Biological: LTB-NG6

Dose 4

EXPERIMENTAL

Participants receive 2 Dose 4 administrations of the investigational product

Biological: LTB-NG6

Dose 5

EXPERIMENTAL

Participants receive 2 Dose 5 administrations of the investigational product

Biological: LTB-NG6

Interventions

LTB-NG6 BIOLOGICAL

LTB-NG6 administrated at 5 different doses

Dose 1; Dose 2; Dose 3; Dose 4; Dose 5

Sodium Chloride 0.9% OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Previous vaccination with Bexsero or any meningococcal serogroup B vaccine (including self-report)
• 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
• Clinical conditions representing contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder)
• Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder)
• Positive test for active HBV infection (positive HBsAG test), any HCV infection (positive HCV antibody test), or any HIV-1/2 infection
• 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
• Body Mass Index (BMI) ≤19 or ≥35
• 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
• Administration of antineoplastic, immune-modulating, immunosuppressive agents or chemotherapy within 3 months prior to injection
• Suspected or known hypersensitivity (including allergy) to any of the vaccine components or medical equipment whose use is foreseen in this trial
• 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)

Sponsors & Collaborators

• LimmaTech Biologics AG: lead
• Nuvisan, Germany: collaborator
• Wellcome Trust: collaborator
• German Federal Ministry of Education and Research: collaborator
• Novo Nordisk Foundation: collaborator

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Bavaria, 89231, Germany

RECRUITING

Related Publications (8)

• Hedges SR, Mayo MS, Mestecky J, Hook EW 3rd, Russell MW. Limited local and systemic antibody responses to Neisseria gonorrhoeae during uncomplicated genital infections. Infect Immun. 1999 Aug;67(8):3937-46. doi: 10.1128/IAI.67.8.3937-3946.1999.

  PMID: 10417159 BACKGROUND

• Petousis-Harris H, Paynter J, Morgan J, Saxton P, McArdle B, Goodyear-Smith F, Black S. Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case-control study. Lancet. 2017 Sep 30;390(10102):1603-1610. doi: 10.1016/S0140-6736(17)31449-6. Epub 2017 Jul 10.

  PMID: 28705462 BACKGROUND

• Russell MW, Jerse AE, Gray-Owen SD. Progress Toward a Gonococcal Vaccine: The Way Forward. Front Immunol. 2019 Oct 15;10:2417. doi: 10.3389/fimmu.2019.02417. eCollection 2019.

  PMID: 31681305 BACKGROUND

• Wi T, Lahra MM, Ndowa F, Bala M, Dillon JR, Ramon-Pardo P, Eremin SR, Bolan G, Unemo M. Antimicrobial resistance in Neisseria gonorrhoeae: Global surveillance and a call for international collaborative action. PLoS Med. 2017 Jul 7;14(7):e1002344. doi: 10.1371/journal.pmed.1002344. eCollection 2017 Jul.

  PMID: 28686231 BACKGROUND

• Zhu W, Thomas CE, Chen CJ, Van Dam CN, Johnston RE, Davis NL, Sparling PF. Comparison of immune responses to gonococcal PorB delivered as outer membrane vesicles, recombinant protein, or Venezuelan equine encephalitis virus replicon particles. Infect Immun. 2005 Nov;73(11):7558-68. doi: 10.1128/IAI.73.11.7558-7568.2005.

  PMID: 16239559 BACKGROUND

• Bruxvoort KJ, Lewnard JA, Chen LH, Tseng HF, Chang J, Veltman J, Marrazzo J, Qian L. Prevention of Neisseria gonorrhoeae With Meningococcal B Vaccine: A Matched Cohort Study in Southern California. Clin Infect Dis. 2023 Feb 8;76(3):e1341-e1349. doi: 10.1093/cid/ciac436.

  PMID: 35642527 BACKGROUND

• Abara WE, Bernstein KT, Lewis FMT, Schillinger JA, Feemster K, Pathela P, Hariri S, Islam A, Eberhart M, Cheng I, Ternier A, Slutsker JS, Mbaeyi S, Madera R, Kirkcaldy RD. Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhoea: a retrospective observational study. Lancet Infect Dis. 2022 Jul;22(7):1021-1029. doi: 10.1016/S1473-3099(21)00812-4. Epub 2022 Apr 12.

  PMID: 35427490 BACKGROUND

• Belcher T, Rollier CS, Dold C, Ross JDC, MacLennan CA. Immune responses to Neisseria gonorrhoeae and implications for vaccine development. Front Immunol. 2023 Aug 17;14:1248613. doi: 10.3389/fimmu.2023.1248613. eCollection 2023.

  PMID: 37662926 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Steffen Haffner, Dr.

CONTACT

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

Christian Reh, Dr.

CONTACT

+49 731 9840 131; Christian.Reh@nuvisan.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 19, 2026
• Primary Completion (Estimated): April 26, 2027
• Study Completion (Estimated): September 23, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)