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Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults

NCT00741637 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-03-30

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and immunogenicity of Peru-15 (CholeraGarde®) vaccine in HIV seropositive adult population of Bangkok Thailand

Conditions

Interventions

BIOLOGICAL

CholeraGarde®

Live attenuated oral Cholera vaccine Each vial of CholeraGarde® contains 5x107 to 1x109 CFU of Peru-15, 6.75 mg KH2PO4, and 300 mg trehalose as a lyophilized cake in 5 mL single-dose vials

BIOLOGICAL

Placebo

A buffer solution containing 2.5 g sodium bicarbonate, and 1.65 g ascorbic acid.

Sponsors & Collaborators

  • Vaccine Technologies Inc.

    collaborator INDUSTRY

  • Siriraj Hospital

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Winai Ratanasuwan, MD, MPH · Siriraj Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • Thailand

Study Locations

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Entities

Drugs
Diseases

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 NCT00741637 on ClinicalTrials.gov