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Completed

NCT Number: NCT01150123

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

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

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Key information

Conditions

Group B Streptococcus Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Disease Attributes Guillain-Barre Syndrome Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group B streptococcus (GBS) vaccine- low dose

Biological

Group B streptococcus (GBS) vaccine- High dose

Biological

Placebo- Saline

Biological

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 24, 2010
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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