Extent of the Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in HIV Positive and HIV Negative Pregnant Women and Their Offsprings.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01412801
First received: August 8, 2011
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

The study will compare the strength of the immune response induced by the Group B streptococcus vaccine in HIVpositive and HIVnegative pregnant women. In addition the study will investigate the amount of vaccine induced immune response, which is transferred to the newborn.


Condition Intervention Phase
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Biological: Group B streptococcus vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Open-Label, International Multi-Center Study of a Group B Streptococcus Polysaccharide Conjugate Vaccine Administered Intramuscularly to HIV Positive and HIV Negative Pregnant Women

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Transplacental transfer of anti-Group B strep specific antibodies following GBS vaccination among HIV+ and HIV- subjects [ Time Frame: Antibody concentration at delivery / birth ] [ Designated as safety issue: No ]
  • Measurement of safety and tolerability in pregnant women and infants by analysis of local reactogenicity, AEs and SAEs, HIV viral load. [ Time Frame: Responses will be analyzed up to 6 weeks post delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Concentration of anti-Group B strep specific antibodies in sera collected from HIV+ and HIV- subjects and from their infants at different time points [ Time Frame: at vaccination, 14 and 30 days after vaccination and at delivery; 6 week time point for infants ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV negative Biological: Group B streptococcus vaccine
Subjects receive one dose of 5mcg of each of the 3 glycoconjugates present in the vaccine.
Experimental: HIV negative-CD4 high Biological: Group B streptococcus vaccine
Subjects receive one dose of 5mcg of each of the 3 glycoconjugates present in the vaccine.
Experimental: HIV positive- CD4 low Biological: Group B streptococcus vaccine
Subjects receive one dose of 5mcg of each of the 3 glycoconjugates present in the vaccine.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women 18-40 years of age between 24-35 wks gestation
  • Women who are HIV- or HIV+ with WHO stage I or II disease and with CD4+ counts > 50 cells/µL

Exclusion Criteria:

- CD4+ count ≤ 50 cells/µL., women who are HIV+ with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412801

Locations
Malawi
Limbe Health Center
Blantyre, Malawi
South Africa
Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01412801     History of Changes
Other Study ID Numbers: V98_05
Study First Received: August 8, 2011
Last Updated: December 17, 2012
Health Authority: South Africa: Medicine Control Council
Malawi: PMPB (Pharmacy, Medicine and Poisons Board)

Keywords provided by Novartis:
Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection

Additional relevant MeSH terms:
Bacterial Infections
HIV Seropositivity
Streptococcal Infections
Gram-Positive Bacterial Infections
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014