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
  Purpose

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.


Condition Intervention Phase
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Biological: Group B streptococcus vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 270
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIVneg
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine.
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: 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.
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: 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01412801

Locations
Malawi
Limbe Health Center
Blantyre, Malawi
South Africa
Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01412801     History of Changes
Other Study ID Numbers: V98_05
Study First Received: August 8, 2011
Results First Received: June 20, 2014
Last Updated: September 5, 2014
Health Authority: South Africa: Medicines Control Council
Malawi: PMPB (Pharmacy, Medicine and Poisons Board)

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

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Communicable Diseases
HIV Seropositivity
Infection
Streptococcal Infections
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014