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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412801
• Other study ID #: V98_05
• 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

• Bacterial Infections
• Communicable Diseases
• Gram-Positive Bacterial Infections
• Infection
• Streptococcal Infections

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