Phase 2
N=536
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Streptococcal Infections · Gram-Positive Bacterial Infections · Bacterial Infections
Bottom Line
View on ClinicalTrials.gov: NCT01412801 ↗Enrolled (actual)
536
Serious AEs
24.5%
Results posted
Sep 2014
Primary outcome: Primary: Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth — 2.07; 2.31; 3.98; 1.01 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Group B streptococcus vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Vaccines
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth |
2.07; 2.31; 3.98; 1.01; 1.22; 3.91 | — |
| PRIMARY 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. |
0.58; 0.6; 0.72; 0.51; 0.64; 0.49 | — |
| SECONDARY Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery |
0.24; 0.25; 0.38; 2.62; 2.95; 5.61 | — |
| SECONDARY 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 |
100; 99; 100; 67; 71; 82 | — |
| SECONDARY Percentages of Subjects With Solicited Local Adverse Events (AEs) |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY Percentages of Subjects With Solicited Systemic AEs |
9; 14; 22; 13; 17; 22 | — |
| SECONDARY Percentages of Subjects Who Experienced Unsolicited Adverse Events |
74; 76; 78; 7; 13; 23 | — |
| SECONDARY Percentages of Infants Who Experienced Unsolicited Adverse Events |
41; 49; 43; 0; 2; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01412801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.