Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

Phase 1CompletedNCT01150123

Novartis Vaccines678 enrolled

Overview

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

678

Conditions

Group B Streptococcus

Interventions

Group B streptococcus (GBS) vaccine- low doseBIOLOGICAL

Group B streptococcus (GBS) vaccine- High doseBIOLOGICAL

Placebo- SalineBIOLOGICAL

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy females 18-40 years of age inclusive. Exclusion Criteria: * Individuals who are pregnant or nursing. * Individuals who have had a previous immunization with a vaccine containing streptococcus antigens or any vaccine within 30 days of enrollment through 30 days of study completion. * Individuals with a history of severe allergic reactions after previous vaccination * Individuals with designated blood tests that are not within normal range

Locations (1)

Unnamed facility

Ghent, Belgium

Outcomes

Primary Outcomes

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1

The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.

Time frame: Day 1 and Day 61

Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61

Serotype-specific (Ia, Ib \& III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.

Time frame: Day 1 and Day 61

Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype

Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.

Time frame: Day 61/Day 1

Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2

The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.

Time frame: Day 1 and Day 361

Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361

Serotype-specific (Ia, Ib \& III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.

Time frame: Day 1 and Day 361

Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361

GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.

Data from ClinicalTrials.gov

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Secondary Outcomes

Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1

Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.

Time frame: Day 1 to Day 7

Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2

Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.

Time frame: Day 1 to Day 7

Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1

Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.

Time frame: Day 1 through Day 721

Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2

Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.

Time frame: Day 1 through Day 721

Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1

The persistence of Serotype-specific (Ia, Ib \& III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.

Time frame: Day 1 and Day 721

Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2

The persistence of Serotype-specific (Ia, Ib \& III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.

Time frame: Day 1 and Day 721

Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1

GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.

Time frame: Day 1 and Day 721

Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2

GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.

Time frame: Day 1 and Day 721