Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
- Conditions
- Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial Infections
- Interventions
- Biological: Group B streptococcus vaccine
- Registration Number
- NCT01412801
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 270
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIVneg Group B streptococcus vaccine HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine. HIVposCD4HIGH Group B streptococcus vaccine 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. HIVposCD4LOW Group B streptococcus vaccine 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
- Primary Outcome Measures
Name Time Method Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth Day of delivery/birth 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. Day of delivery/birth 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
Name Time Method Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery Day 1, 15, 31 and at Delivery 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 Day of Delivery 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) From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks 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 From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks 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 Day 1 to Study Termination, for up to 24 weeks 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 Birth to Study Termination, for up to 24 weeks Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Trial Locations
- Locations (2)
Chris Hani Baragwanath Hospital
🇿🇦Bertsham, South Africa
Limbe Health Center
🇲🇼Blantyre, Malawi