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

COMPLETEDPHASE2

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

A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

NCT01412801•Novartis Vaccines

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 40 years

Sex

FEMALE

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

Locations (2)

Limbe Health Center

Blantyre, Malawi

Chris Hani Baragwanath Hospital

Bertsham, South Africa

Key Dates

Start Date

September 1, 2011

Primary Completion Date

October 1, 2012

Completion Date

December 1, 2012

Last Updated

September 12, 2014

Enrollment

270

ACTUAL participants

Conditions

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial Infections

Interventions

Group B streptococcus vaccine

BIOLOGICAL

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

NCT04263792

Bacterial Infections

View study

RECRUITING

Factors Associated With Mortality in Streptococcal Anginosus Bacteremia

NCT07343167

Streptococcal Infections

View study

RECRUITINGPHASE2

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

Factors Associated With Mortality in Streptococcal Anginosus Bacteremia

Clinical Trial to Study the Efficacy and Safety of Fluorothiazinone (N.F. Gamaleya NRCEM) in Prophylaxis of Nosocomial Bacterial Infections With Participation of Patients on MV

Use of Low-cost Molecular Diagnostic Techniques as a New Surveillance Model for Diseases Preventable by Vaccinations.

Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease