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Sponsors and Collaborators: |
International Vaccine Institute Avant Immunotherapeutics Siriraj Hospital |
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Information provided by: | International Vaccine Institute |
ClinicalTrials.gov Identifier: | NCT00741637 |
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
Condition | Intervention | Phase |
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Cholera Vibrio Infections Diarrhea |
Biological: CholeraGarde® Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Single Dose Regimen of Live Attenuated Oral Cholera Vaccine (Choleragarde®) in HIV-Seropositive Adults in Thailand |
Estimated Enrollment: | 32 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Live attenuated oral CholeraGarde® (5x107 to 1x109 CFU) vaccine
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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 |
2: Placebo Comparator
A buffer solution containing 2.5 g sodium bicarbonate, and 1.65 g ascorbic acid.
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Biological: Placebo
A buffer solution containing 2.5 g sodium bicarbonate, and 1.65 g ascorbic acid.
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HIV-seropositive, non-pregnant adults, aged 18 - 45 years old who have been on standard highly active anti-retroviral therapy (HAART) for at least 6 months prior to enrolment or who have never started HAART regimen will be recruited in the study.
All subjects must satisfy the following criteria at study entry:
Exclusion Criteria:
The following criteria should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study:
Contact: Anna L Lopez, MD, MPH | 82 2 881 1129 | anlopez@ivi.int |
Contact: Mohammad I Khan, MSc | 82 2 881 1135 | imran@ivi.int |
Thailand | |
Department of Preventive and Social Medicine Siriraj Hospital | |
Bangkok, Thailand, 10700 |
Principal Investigator: | John D Clemens, MD | International Vaccine Institute |
Responsible Party: | Siriraj Hospital ( Dr. Winai Ratanasuwan ) |
Study ID Numbers: | CH-PR-02 |
Study First Received: | August 25, 2008 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00741637 |
Health Authority: | Thailand: Ethical Committee |
Vibrio Cholerae Diarrhea Live oral Vaccines |
Immunogenicity Safety HIV |
Bacterial Infections Signs and Symptoms Diarrhea Signs and Symptoms, Digestive HIV Infections |
Vibrio Infections Acquired Immunodeficiency Syndrome Cholera Ascorbic Acid Gram-Negative Bacterial Infections |
Infection |