NCT05782179

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

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of Group B Streptococcus Vaccine (GBS NN/NN2 With Alhydrogel®) in Elderly Participants Aged 55 to 75

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Minervax ApS · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts. Participants will be involved in the study for approximately one year including screening and safety follow-up. Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively.

Conditions

• Group B Streptococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	GBS-NN/NN2	GBS-NN/NN2 bound to alhydrogel as an adjuvant
BIOLOGICAL	Placebo	Normal Saline 0.9 %

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-14
• Completion: 2024-05-23
• First posted: 2023-03-23
• Last updated: 2025-09-05
• Results posted: 2025-09-05

Locations

1 site across 1 country: Belgium