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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
History of Changes

August 8, 2011
December 17, 2012
September 2011
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01412801 on ClinicalTrials.gov Archive Site
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 ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Streptococcal Infections
  • Gram-Positive Bacterial Infections
  • Bacterial Infections
Biological: Group B streptococcus vaccine
Subjects receive one dose of 5mcg of each of the 3 glycoconjugates present in the vaccine.
  • Experimental: HIV negative
    Intervention: Biological: Group B streptococcus vaccine
  • Experimental: HIV negative-CD4 high
    Intervention: Biological: Group B streptococcus vaccine
  • Experimental: HIV positive- CD4 low
    Intervention: Biological: Group B streptococcus vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi,   South Africa
 
NCT01412801
V98_05
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP