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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
270
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
Limbe Health Center
Blantyre, Malawi
Chris Hani Baragwanath Hospital
Bertsham, South Africa
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at 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.
Time frame: Day of delivery/birth
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.
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.
Time frame: Day of delivery/birth
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at 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.
Time frame: Day 1, 15, 31 and at Delivery
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
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.
Time frame: Day of Delivery
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine
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Time frame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
Percentages of Subjects With Solicited Systemic AEs
Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine
Time frame: From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine
Time frame: Day 1 to Study Termination, for up to 24 weeks
Percentages of Infants Who Experienced Unsolicited Adverse Events
Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Time frame: Birth to Study Termination, for up to 24 weeks