Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01412801
First received: August 8, 2011
Last updated: September 5, 2014
Last verified: September 2014

August 8, 2011
September 5, 2014
September 2011
October 2012   (final data collection date for primary outcome measure)
  • Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth [ Time Frame: Day of delivery/birth ] [ Designated as safety issue: No ]
    GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
  • Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth. [ Time Frame: Day of delivery/birth ] [ Designated as safety issue: No ]
    The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Transplacental transfer of anti-Group B strep specific antibodies following GBS vaccination among HIV+ and HIV- subjects [ Time Frame: Antibody concentration at delivery / birth ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01412801 on ClinicalTrials.gov Archive Site
  • Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery [ Time Frame: Day 1, 15, 31 and at Delivery ] [ Designated as safety issue: No ]
    Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.
  • Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery [ Time Frame: Day of Delivery ] [ Designated as safety issue: No ]
    Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.
  • Percentages of Subjects With Solicited Local Adverse Events (AEs) [ Time Frame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine
  • Percentages of Subjects With Solicited Systemic AEs [ Time Frame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine
  • Percentages of Subjects Who Experienced Unsolicited Adverse Events [ Time Frame: Day 1 to Study Termination, for up to 24 weeks ] [ Designated as safety issue: Yes ]
    Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine
  • Percentages of Infants Who Experienced Unsolicited Adverse Events [ Time Frame: Birth to Study Termination, for up to 24 weeks ] [ Designated as safety issue: Yes ]
    Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Concentration of anti-Group B strep specific antibodies in sera collected from HIV+ and HIV- subjects and from their infants at different time points [ Time Frame: at vaccination, 14 and 30 days after vaccination and at delivery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Streptococcal Infections
  • Gram-Positive Bacterial Infections
  • Bacterial Infections
Biological: Group B streptococcus vaccine
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
  • Experimental: HIVneg
    HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine.
    Intervention: Biological: Group B streptococcus vaccine
  • Experimental: HIVposCD4HIGH
    HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of Group B streptococcus vaccine.
    Intervention: Biological: Group B streptococcus vaccine
  • Experimental: HIVposCD4LOW
    HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of Group B streptococcus vaccine
    Intervention: Biological: Group B streptococcus vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
December 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women 18-40 years of age between 24-35 weeks gestation
  • Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts > 50 cells/µL

Exclusion Criteria:

  • Women who had CD4+ count ≤ 50 cells/µL
  • Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   Malawi
 
NCT01412801
V98_05
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP