Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

NCT05782179 | Completed Phase 1 Results

• 2 other identifiers: MVX00062022-003681-20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.

Conditions

Group B Streptococcal Infections

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine

  * Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.

  Up to 28 days after each vaccination

Secondary Outcomes (5)

• Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps

  Day 197

• Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps

  4 weeks after each vaccination (Days 29, 57 and 197)

• Seroconversion Rate at Any Time Post Vaccination

  Up to 6 months after last vaccination

• Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps

  Up to day 197

• Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)

  Up to day 365

Study Arms (8)

Cohort 1 - Active

EXPERIMENTAL

Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: GBS-NN/NN2

Cohort 1 - Placebo

PLACEBO COMPARATOR

Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: Placebo

Cohort 2 - Active

EXPERIMENTAL

Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: GBS-NN/NN2

Cohort 2 - Placebo

PLACEBO COMPARATOR

Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: Placebo

Cohort 3 - Active

EXPERIMENTAL

Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: GBS-NN/NN2

Cohort 3 - Placebo

PLACEBO COMPARATOR

Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: Placebo

Cohort 4 - Active

EXPERIMENTAL

Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: GBS-NN/NN2

Cohort 4 - Placebo

PLACEBO COMPARATOR

Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Biological: Placebo

Interventions

GBS-NN/NN2 BIOLOGICAL

GBS-NN/NN2 bound to alhydrogel as an adjuvant

Cohort 1 - Active; Cohort 2 - Active; Cohort 3 - Active; Cohort 4 - Active

Placebo BIOLOGICAL

Normal Saline 0.9 %

Cohort 1 - Placebo; Cohort 2 - Placebo; Cohort 3 - Placebo; Cohort 4 - Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 55 to 75 years.
• Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants.
• Able to voluntarily provide written informed consent to participate in the study.
• Female participants must be post-menopausal.
• Participants capable and willing to follow trial schedule and procedures.

You may not qualify if:

• Participants who have received a GBS vaccine previously.
• Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
• NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4.
• Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
• Current or history of drug or alcohol abuse per investigator judgement.
• Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Participants currently participating in a clinical trial.
• Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study.
• Any significant illness during the 4 weeks preceding the vaccination visit, per investigator judgement.
• Participants with a history of severe allergic reactions after previous vaccination.
• Participants who have received any vaccine within 30 days of first IMP administration, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each vaccination.
• NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days before or after study vaccination.
• Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months prior to screening.
• Participants within a 7-day period after an acute infection in the 7 days preceding vaccination, as per investigator judgement, or with fever (oral temperature \>37.9°C) in the 72 hours preceding vaccination.
• Participants who have received antipyretics/analgesics treatment within 72 hours prior to dosing.

Sponsors & Collaborators

• Minervax ApS: lead
• Iqvia Pty Ltd: collaborator

Study Sites (1)

University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Cornelia Oostvogels/Chief Medical Officer (CMO)
• Organization: MinervaX

lio@minervax.com

00491515092821

Study Officials

• Geoff Kitson

  gkitson@propharmapartners.uk.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 23, 2023
• Study Start: March 1, 2023
• Primary Completion: December 14, 2023
• Study Completion: May 23, 2024
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)