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

Phase 1

Completed

• Conditions: Group B Streptococcus
• Interventions: Biological: Group B streptococcus (GBS) vaccine- low dose; Biological: Group B streptococcus (GBS) vaccine- High dose; Biological: Placebo- Saline

• Registration Number: NCT01150123
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-31
• Study Start: 2010-05
• Study First Submitted QC: 2010-06-23
• Study First Posted: 2010-06-24
• Primary Completion: 2011-11
• Study Completion: 2012-10
• Results First Submitted: 2014-04-03
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Results First Posted: 2017-05-15
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 678

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 µg_No Adj	Group B streptococcus (GBS) vaccine- low dose	Subjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant
20 µg_Alum	Group B streptococcus (GBS) vaccine- High dose	Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
5 µg_MF59-H	Group B streptococcus (GBS) vaccine- low dose	Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59
20 µg_MF59-H	Group B streptococcus (GBS) vaccine- High dose	Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59
5 µg_MF59-F	Group B streptococcus (GBS) vaccine- low dose	Subjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59
20 µg_No Adj	Group B streptococcus (GBS) vaccine- High dose	Subjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.
5 µg_Alum	Group B streptococcus (GBS) vaccine- low dose	Subjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
Placebo	Placebo- Saline	Subjects received 2 injections of placebo administered 1 month apart
20 µg_MF59-F	Group B streptococcus (GBS) vaccine- High dose	Subjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1	Day 1 and Day 61	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.
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype	Day 61/Day 1	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.
Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361	Day 1 and 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.
Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2	Day 1 and Day 361	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.
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61	Day 1 and 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.
Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361	Day 1 and 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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2	Day 1 through Day 721	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.
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1	Day 1 through Day 721	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.
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2	Day 1 and Day 721	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.
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1	Day 1 and Day 721	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.
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2	Day 1 to Day 7	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.
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2	Day 1 and Day 721	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.
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1	Day 1 to Day 7	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.
Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1	Day 1 and Day 721	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.