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Completed

NCT Number: NCT01193920

Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

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Key information

Conditions

Streptococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chris Hani Baragwanath Hospital

Chris Hani Rd, Soweto, Johannesburg, South Africa

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
  • Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Exclusion criteria

  • Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
  • Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive

Treatment and study plan

Group B Streptococcus Trivalent Vaccine - 20/20/20 μg

Biological

Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.

Saline solution

Other

Subjects received two injection of saline solution.

Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg

Biological

Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg

Biological

Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Group B Streptococcus Trivalent Vaccine - 5/5/5 μg

Biological

Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.

Primary outcomes

  1. The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.

    Time frame: Day 61, one month after the second vaccination

    The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.

  2. Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.

    Time frame: Day 61, one month after the second vaccination

    Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .

  3. The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.

    Time frame: Day of delivery

    The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.

  4. Antibody GMC in Maternal Subjects at Day of Delivery

    Time frame: Day of delivery

    Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.

Secondary outcomes

  1. The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.

    Time frame: Day 31, one month after vaccination

    The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.

  2. Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination

    Time frame: day 31

    Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.

  3. The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.

    Time frame: Day 361, one year after the first vaccination

    The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.

  4. Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination

    Time frame: Day 361, one year after the first vaccination

    Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.

  5. Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events

    Time frame: Day 61

    Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.

  6. Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events

    Time frame: From day 1 to one year after delivery

    Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.

  7. Antibody GMC Per Serotype at Different Time Points in Infants

    Time frame: Day 4, day 43 and day 91 after birth

    Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.

  8. Number of Infants Reporting Serious Adverse Events

    Time frame: one year after birth

    Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Aug 22, 2014

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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