Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
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
1 other identifier
interventional
678
1 country
1
Brief Summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
May 15, 2017
CompletedMay 15, 2017
May 1, 2017
1.5 years
March 31, 2010
April 3, 2014
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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 Outcomes (8)
Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Day 1 to Day 7
Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Day 1 to Day 7
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Day 1 through Day 721
Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Day 1 through Day 721
Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Day 1 and Day 721
- +3 more secondary outcomes
Study Arms (9)
5 µg_No Adj
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (5 µg) without any adjuvant
20 µg_No Adj
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (20 µg) without any adjuvant.
5 µg_Alum
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
20 µg_Alum
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (5 µg) with Alum adjuvant.
5 µg_MF59-H
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 4.87 mg of MF59
20 µg_MF59-H
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 4.87 mg of MF59
5 µg_MF59-F
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (5 µg) adjuvanted with 9.75 mg of MF59
20 µg_MF59-F
EXPERIMENTALSubjects received either 1 or 2 doses of active vaccine (20 µg) adjuvanted with 9.75 mg of MF59
Placebo
PLACEBO COMPARATORSubjects received 2 injections of placebo administered 1 month apart
Interventions
Eligibility Criteria
You may qualify if:
- Healthy females 18-40 years of age inclusive.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Vaccineslead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Unknown Facility
Ghent, Belgium
Related Publications (1)
Leroux-Roels G, Maes C, Willekens J, De Boever F, de Rooij R, Martell L, Bedell L, Wittke F, Slobod K, Dull P. A randomized, observer-blind Phase Ib study to identify formulations and vaccine schedules of a trivalent Group B Streptococcus vaccine for use in non-pregnant and pregnant women. Vaccine. 2016 Apr 4;34(15):1786-91. doi: 10.1016/j.vaccine.2016.02.044. Epub 2016 Mar 5.
PMID: 26928074DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
June 24, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
October 1, 2012
Last Updated
May 15, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-05