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

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ClinicalTrials.gov Identifier: NCT01150123
Recruitment Status : Completed
First Posted : June 24, 2010
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Group B Streptococcus Biological: Group B streptococcus (GBS) vaccine- low dose Biological: Group B streptococcus (GBS) vaccine- High dose Biological: Placebo- Saline Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Study Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : October 2012

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



Primary Outcome Measures :
  1. Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1 [ Time Frame: 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.

  2. Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61 [ Time Frame: 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.

  3. Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype [ Time Frame: 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.

  4. Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2 [ Time Frame: 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.

  5. Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361 [ Time Frame: 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.

  6. Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361 [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1 [ Time Frame: 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.

  2. Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2 [ Time Frame: 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.

  3. Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1 [ Time Frame: 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.

  4. Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2 [ Time Frame: 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.

  5. Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1 [ Time Frame: 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.

  6. Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2 [ Time Frame: 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.

  7. Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1 [ Time Frame: 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.

  8. Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150123


Locations
Belgium
Gent, Belgium
Sponsors and Collaborators
Novartis Vaccines
GlaxoSmithKline
Investigators
Study Chair: Novartis Vaccines Novartis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01150123     History of Changes
Other Study ID Numbers: V98_06
First Posted: June 24, 2010    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Novartis ( Novartis Vaccines ):
Group B streptococcus
GBS
Vaccine
Group B streptococcus (GBS) disease

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs