Status:
COMPLETED
Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
Vaccine Technologies Inc.
Siriraj Hospital
Conditions:
Cholera
Vibrio Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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
Detailed Description
Cholera re-emerged in 2006 as a global threat with a 79% increase in 2006 compared to the previous year. The re-emergence of cholera increased with increasing numbers of displaced populations living i...
Eligibility Criteria
Inclusion
- HIV-seropositive, non-pregnant adults, aged 18 - 45 years old who have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment or who have never started HAART regimen will be recruited in the study.
- All subjects must satisfy the following criteria at study entry:
- Male and female HIV seropositive adults aged 18 to 45 years old who have given the written informed consent.
- Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
- CD4 T-lymphocyte count \>500/mm3 for at least 6 months prior to inclusion
- Subjects that have never started HAART regimen must satisfy the following additional criteria at study entry.
- 1\. Asymptomatic HIV infection as determined by: Medical history, Physical examination, Laboratory tests, Clinical judgment of the investigator
- Subjects that have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment must satisfy the following additional criteria at study entry.
- History of CD4 nadir \>150/mm3
- Viral load (HIV-1 RNA levels) \<200 copies/mL for at least 6 months prior to inclusion
Exclusion
- 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:
- Overt signs of immunodeficiency e.g. oral thrush, rapid weight loss, recurrent pneumonia (i.e. Stage 3 or 4 of the WHO clinical staging system for HIV infection and disease in adults and adolescents
- Ongoing serious chronic illness (e.g. with signs of cardiac or renal failure)
- Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- Presence of V. cholerae 01 or 0139, Shigella, or Cryptosporidium in stool at baseline
- Intake of any anti-diarrhoeal medicine in the past week
- Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral or otic) warrants deferral of the vaccination pending recovery of the subject
- Receipt of antibiotics in the past 2 weeks
- Receipt of live or killed enteric vaccine in the last 4 weeks
- Receipt of killed oral cholera vaccine in the past
- Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
- One or more episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- One or more episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 6 months
- Receipt of any immunosuppressive therapy during the past 6 months
- A woman pregnant or planning to become pregnant during the period of subject's participation
- Any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00741637
Start Date
July 1 2010
End Date
June 1 2011
Last Update
March 30 2012
Active Locations (1)
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1
Department of Preventive and Social Medicine Siriraj Hospital
Bangkok, Thailand, 10700