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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01412801
Other study ID # V98_05
Secondary ID
Status Completed
Phase Phase 2
First received August 8, 2011
Last updated September 5, 2014
Start date September 2011
Est. completion date December 2012

Study information

Verified date September 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority South Africa: Medicines Control CouncilMalawi: PMPB (Pharmacy, Medicine and Poisons Board)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Malawi Limbe Health Center Blantyre
South Africa Chris Hani Baragwanath Hospital Bertsham

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Malawi,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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. 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 No
Secondary 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 No
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 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 No
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
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