NCT03807245

Group B Streptococcus Vaccine in Healthy Females

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Group B Streptococcus Vaccine (GBS-NN/NN2 With Alhydrogel®) in Healthy Female Subjects Aged 18 to 40

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Minervax ApS · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.

Detailed description

There will be 4 arms in 2 cohorts of 30 subjects. Cohort 1 will receive two 0.5 mL injections, 4 weeks apart, each consisting of 25 μg of GBS-NN and 25 μg of GBS-NN2 (24 subjects) or placebo (6 subjects). Cohort 2 (30 subjects) will receive two 0.5 mL injections, 4 weeks apart, each consisting of 50 μg of GBS-NN and 50 μg of GBS-NN2 (24 subjects) or placebo (6 Subjects). All vaccines will be adsorbed to 500 μg Al3+ as Alhydrogel®. Safety will be assessed after all subjects have completed Visit 4 (Day 8) for Cohort 1, at which point the decision will be made as to whether proceeding with administration of the doses in cohort 2 is appropriate.

Conditions

• Group B Strep Infection

Interventions

Type	Name	Description
BIOLOGICAL	GBS-NN/NN2 with Alhydrogel® 25	GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
BIOLOGICAL	Placebo GBS-NN/NN2 with Alhydrogel® 25	GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
BIOLOGICAL	Placebo GBS-NN/NN2 with Alhydrogel® 50	GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
BIOLOGICAL	GBS-NN/NN2 with Alhydrogel® 50	GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart

Timeline

• Start date: 2019-01-09
• Primary completion: 2019-10-14
• Completion: 2020-05-07
• First posted: 2019-01-16
• Last updated: 2021-02-02
• Results posted: 2020-12-24

Locations

1 site across 1 country: United Kingdom