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

Novartis

Status and phase: Completed; Phase 2

Conditions: Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections

Treatments: Biological: Group B streptococcus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01412801

V98_05

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

HIVneg

Experimental group

Description:

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

Treatment:

Biological: Group B streptococcus vaccine

HIVposCD4HIGH

Experimental group

Description:

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.

Treatment:

Biological: Group B streptococcus vaccine

HIVposCD4LOW

Experimental group

Description:

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

Treatment:

Biological: Group B streptococcus vaccine