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Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults

NCT02741128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-07-19

Study results available
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Summary

The aim of the study was to evaluate the safety and immunogenicity of the Dengue vaccine in a population of special interest, such as HIV-positive adults previously exposed to dengue.

Primary Objective:

* To describe the safety of each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.

Secondary Objectives:

* To describe the humoral immune response to each dengue serotype at baseline and after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.
* To detect the CYD dengue vaccinal viremia post-Inj 1 in HIV-positive adults previously exposed to dengue.
* To describe changes in CD4 count and HIV RNA viral load after each injection of CYD dengue vaccine in HIV-positive adults previously exposed to dengue.

Observational Objective:

* To describe the FV (YF, Dengue, Zika) serological status in the study population at baseline.

Conditions

  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Human Immunodeficiency Virus

Interventions

BIOLOGICAL

CYD Dengue Vaccine

0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

BIOLOGICAL

Placebo (NaCl 0.9%) vaccine group

0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2023-01-19
Completion
2023-01-19

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 NCT02741128 on ClinicalTrials.gov