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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HIVneg

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

Group Type EXPERIMENTAL

Group B streptococcus vaccine

Intervention Type BIOLOGICAL

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

HIVposCD4HIGH

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.

Group Type EXPERIMENTAL

Group B streptococcus vaccine

Intervention Type BIOLOGICAL

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

HIVposCD4LOW

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

Group Type EXPERIMENTAL

Group B streptococcus vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Group B streptococcus vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No