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

Group B Streptococcus Clinical Trial

Official title:

A Phase Ib Randomized, Observer-Blind, Controlled, Single Center, Dose-Ranging Study of a Group B Streptococcus Vaccine in Healthy Women 18-40 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150123
• Other study ID #: V98_06
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2010
• Last updated: May 8, 2017
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 678
• Est. completion date: October 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Group B Streptococcus

Intervention

Biological:
• Group B streptococcus (GBS) vaccine- low dose

• Group B streptococcus (GBS) vaccine- High dose

• Placebo- Saline

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 and Day 61
Primary	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.	Day 1 and Day 61
Primary	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.	Day 61/Day 1
Primary	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.	Day 1 and Day 361
Primary	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.	Day 1 and Day 361
Primary	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.	Day 1 and day 361
Secondary	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.	Day 1 to Day 7
Secondary	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.	Day 1 to Day 7
Secondary	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.	Day 1 through Day 721
Secondary	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.	Day 1 through Day 721
Secondary	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.	Day 1 and Day 721
Secondary	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.	Day 1 and Day 721
Secondary	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.	Day 1 and Day 721
Secondary	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.	Day 1 and Day 721