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: December 18, 2012
Last verified: December 2012
  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, 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:
  • 1. Measurement of safety and tolerability in non-pregnant and pregnant women and infants by analysis of local reactogenicity, AEs and SAEs [ Time Frame: Responses will be analyzed up to 1 yr post last injection ] [ Designated as safety issue: Yes ]
    Tolerability data will be collected in this study

  • 2. Evaluation of Ab responses (ELISA) induced by different vaccine doses in pregnant women to select one dose for subsequent use [ Time Frame: Dose selection based on evaluation of data collected until delivery ] [ Designated as safety issue: No ]
    Tolerability data will be collected in this study


Secondary Outcome Measures:
  • Persistence of Ab induced by different vaccine doses will be evaluated over time (from screening to up to 1 yr post last injection) [ Time Frame: 1 month post last injection and 12 months post last injection ] [ Designated as safety issue: Yes ]
    Tolerability and safety will be assessed

  • Effect of vaccine on GBS colonization will be assessed at screening, delivery and 3 mo following delivery [ Time Frame: 1 month post last injection and 12 months post last injection ] [ Designated as safety issue: Yes ]
    Tolerability and safety will be assessed

  • Persistence of vaccine-induced Ab in infants will be measured at birth, at 6 weeks and 3 mo of age [ Time Frame: 1 month post last injection and 12 months post last injection ] [ Designated as safety issue: Yes ]
    Tolerability and safety will be assessed

  • Evaluation of the immune-response to routine anti-diphtheria and anti-pneumococcal vaccinations among infants born to vaccine and placebo injected pregnant women [ Time Frame: at 18 weeks and 10 months of age ] [ Designated as safety issue: Yes ]

Enrollment: 380
Study Start Date: September 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 30-34 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193920

Locations
South Africa
Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Gauteng, 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
Last Updated: December 18, 2012
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 April 22, 2014