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Safety and Immunogenicity of Anti-Pneumococcal Vaccines in HIV-Infected Pregnant Women

NCT02717494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2020-01-18

Study results available
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Summary

The purpose of this study was to determine the safety, reactogenicity, immunogenicity, transplacental antibody transfer and interference with infant responses to childhood vaccination of maternal vaccination with pneumococcal conjugate 10-valent vaccine (PCV-10) or pneumococcal polysaccharide 23-valent vaccine (PPV-23) by comparison with placebo.

Conditions

  • PNC Vaccine
  • HIV-infected Pregnant Women

Interventions

BIOLOGICAL

PPV-23

PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.

BIOLOGICAL

PCV-10

PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.

OTHER

NaCl

NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Westat

    lead OTHER

Principal Investigators

  • Adriana Weinberg, MD · University of Colorado, Denver

  • Marisa Mussi, MD · University of Sao Paulo Ribeirão Preto School of Medicine

  • Geraldo Duarte, MD · University of Sao Paulo Ribeirão Preto School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-11-30
Completion
2019-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717494 on ClinicalTrials.gov