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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
Simbec Research Limited
Merthyr Tydfil, Wales, United Kingdom
Number of Participants With Treatment Emergent Adverse Events
Number of Participants with Treatment Emergent Adverse Events
Time frame: 85 days
Immunoglobulin(Ig)G Antibody Concentration
Adjusted geometric mean concentration (GMC)
Time frame: Day 85
Fold Change in Antibody Concentration
Geometric mean fold change in antibody concentration from Day 1 to Day 85 for each group.
Time frame: Day 1 to Day 85
Seroconversion Rate
4-fold increase in Immunoglobulin(Ig)G antibody concentration
Time frame: Day 85
Number of Participants With an Immune Response to First and Second Doses
Number of participants with Immunoglobulin(Ig)G antibody concentration above thresholds
Time frame: Day 29 and Day 85
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GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart