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

NCT01412801 | Completed Phase 2 Results

• 1 other identifier: V98_05
• Study Type: interventional
• Target: 270
• Locations: 2 countries
• Sites: 2

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.

Conditions

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections

Keywords

Group B streptococcus; GBS; Vaccine; Prevention of group B streptococcus infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery

  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

  Day of Delivery

• Percentages of Subjects With Solicited Local Adverse Events (AEs)

  From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks

• Percentages of Subjects With Solicited Systemic AEs

  From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks

• Percentages of Subjects Who Experienced Unsolicited Adverse Events

  Day 1 to Study Termination, for up to 24 weeks

Study Arms (3)

HIVneg

EXPERIMENTAL

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

Biological: Group B streptococcus vaccine

HIVposCD4HIGH

EXPERIMENTAL

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

HIVposCD4LOW

EXPERIMENTAL

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

Interventions

Group B streptococcus vaccine BIOLOGICAL

Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.

HIVneg; HIVposCD4HIGH; HIVposCD4LOW

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

Limbe Health Center

Blantyre, Malawi

Location

Chris Hani Baragwanath Hospital

Bertsham, 2013, South Africa

Location

Related Publications (1)

• 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.

  PMID: 26869376 DERIVED

MeSH Terms

Conditions

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 12, 2014
• Results First Posted: September 12, 2014

Record last verified: 2014-09

Locations

MA (1); ZA (1)