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:
Novartis Vaccines
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
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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
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 May 21, 2013