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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01193920
First received: September 1, 2010
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Streptococcal Infections
Biological: Group B streptococcus (GBS) vaccine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Percentages of 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 ] [ Designated as safety issue: No ]
    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.

  • Geometric Mean Concentrations (GMC) of Antibodies at One Month After the Second Vaccination. [ Time Frame: Day 61, one month after the second vaccination ] [ Designated as safety issue: No ]
    Antibody Geometric Mean Concentrations (GMC) per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .

  • Number of Subjects Reporting Solicited and Unsolicited Adverse Events [ Time Frame: Day 61 ] [ Designated as safety issue: Yes ]
    Number of 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

  • The Percentages of Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
    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.

  • Antibody Geometric Mean Concentrations (GMC) at Day of Delivery [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
    Antibody Geometric Mean Concentrations (GMC) per serotype at day of delivery following one administration of one of three different doses of the study vaccine or placebo.


Secondary Outcome Measures:
  • The Percentages of Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. [ Time Frame: Day 31, one month after vaccination ] [ Designated as safety issue: No ]
    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.

  • Antibody GMC Per Serotype at One Month After Vaccination [ Time Frame: day 31 ] [ Designated as safety issue: No ]
    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.

  • The Percentage of Subjects With Antibody (Ab) Concentrations Above a Defined Threshold at One Year After the First Vaccination. [ Time Frame: Day 361, one year after the first vaccination ] [ Designated as safety issue: No ]
    The percentage of non-pregnant subjects with Ab 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

  • Geometric Mean Concentrations (GMC) of Antibodies at One Year After the First Vaccination [ Time Frame: Day 361, one year after the first vaccination ] [ Designated as safety issue: No ]
    Antibody Geometric Mean Concentrations (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.

  • Number of Subjects Reporting Solicited and Unsolicited Adverse Events [ Time Frame: From day 1 to one year after delivery ] [ Designated as safety issue: Yes ]
    Number of subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.

  • Antibody GMC Per Serotype at Different Time Points in Infants [ Time Frame: Day 4, day 43 and day 91 after birth ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: one year after birth ] [ Designated as safety issue: Yes ]
    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


Enrollment: 380
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1: Glycoconjugate (GC) Concentration - 20/20/20
Enrollment Group 1: Non-Pregnant Women
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.
Placebo Comparator: 2: Placebo - Sterile saline
Enrollment Group 1: Non-Pregnant Women
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.
Placebo Comparator: 3: GC Concentration - 0.5/0.5/0.5 µg
Enrollment Group 2: Pregnant Women
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.
Placebo Comparator: 4: GC Concentration - 2.5/2.5/2.5 µg
Enrollment Group 2: Pregnant Women
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.
Placebo Comparator: 5: GC Concentration - 5/5/5 µg
Enrollment Group 2: Pregnant Women
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.
Placebo Comparator: 6: Placebo - Sterile saline
Enrollment Group 2: Pregnant Women
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193920

Locations
South Africa
Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Johannesburg, South Africa
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines and Diagnostics Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01193920     History of Changes
Other Study ID Numbers: V98_08, MCC Reference n° 20100601
Study First Received: September 1, 2010
Results First Received: December 17, 2013
Last Updated: April 3, 2014
Health Authority: South Africa: Medicines Control Council (MCC)

Keywords provided by Novartis:
Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014