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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

Conditions
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Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections

Intervention / Treatment
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* Biological: Group B streptococcus vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIVneg<br>HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine. | Biological: Group B streptococcus vaccine<br>* Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.<br>|
| Experimental: HIVposCD4HIGH<br>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<br>* Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.<br>|
| Experimental: HIVposCD4LOW<br>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<br>* Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day of delivery/birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | 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 | Birth to Study Termination, for up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GBS, Group B streptococcus, Vaccine, Prevention of group B streptococcus infection