search
Back to results

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

Primary Purpose

Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Group B streptococcus vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcal Infections focused on measuring Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Limbe Health Center
  • Chris Hani Baragwanath Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

HIVneg

HIVposCD4HIGH

HIVposCD4LOW

Arm Description

HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine.

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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
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
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
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

Full Information

First Posted
August 8, 2011
Last Updated
September 5, 2014
Sponsor
Novartis Vaccines
search

1. Study Identification

Unique Protocol Identification Number
NCT01412801
Brief Title
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Official Title
A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
Keywords
Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIVneg
Arm Type
Experimental
Arm Description
HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine.
Arm Title
HIVposCD4HIGH
Arm Type
Experimental
Arm Description
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.
Arm Title
HIVposCD4LOW
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Group B streptococcus vaccine
Intervention Description
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
Primary Outcome Measure Information:
Title
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
Description
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
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Description
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
Title
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
Description
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
Title
Percentages of Subjects With Solicited Local Adverse Events (AEs)
Description
Safety was assessed in terms of the number of subjects with solicited local 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
Title
Percentages of Subjects With Solicited Systemic AEs
Description
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
Title
Percentages of Subjects Who Experienced Unsolicited Adverse Events
Description
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
Title
Percentages of Infants Who Experienced Unsolicited Adverse Events
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Limbe Health Center
City
Blantyre
Country
Malawi
Facility Name
Chris Hani Baragwanath Hospital
City
Bertsham
ZIP/Postal Code
2013
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
26869376
Citation
Heyderman RS, Madhi SA, French N, Cutland C, Ngwira B, Kayambo D, Mboizi R, Koen A, Jose L, Olugbosi M, Wittke F, Slobod K, Dull PM. Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial. Lancet Infect Dis. 2016 May;16(5):546-555. doi: 10.1016/S1473-3099(15)00484-3. Epub 2016 Feb 8.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs