Trial record 15 of 28 for:    " July 30, 2008":" August 29, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborators:
Vaccine Technologies, Inc.
Siriraj Hospital, Mahidol University
Information provided by (Responsible Party):
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00741637
First received: August 25, 2008
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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
Cholera
Vibrio Infections
Diarrhea
Biological: CholeraGarde®
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Proportion of subjects receiving CholeraGarde® or placebo with any of the following events within 7 days of dosing: Gas, headache, vomiting, abdominal cramps, myalgias, diarrhea, fever [ Time Frame: 0,1,2,3,4,5,6,7,14,30,90 days post intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies to 01 serogroup El Tor Inaba organisms, relative to baseline, one week after a single dose of CholeraGarde® or placebo [ Time Frame: 0,1,2,3,4,5,6,7,14,30,90 days post vaccination ] [ Designated as safety issue: Yes ]
  • Proportion of subjects given CholeraGarde® or placebo with any of the following adverse events [ Time Frame: 30 minutes after adminstration and throughout the trial ] [ Designated as safety issue: Yes ]
  • Geometric mean serum vibriocidal IgG antibody titers measured at baseline and one week after a single dose of CholeraGarde® or placebo [ Time Frame: One week ] [ Designated as safety issue: Yes ]
  • Proportion of subjects given CholeraGarde® or placebo with fecal excretion of CholeraGarde® [ Time Frame: At 3, 7, 14, and 30 days post-dosing ] [ Designated as safety issue: Yes ]
  • Mean HIV viral load (copies/ml) increases, with CholeraGarde® or placebo [ Time Frame: relative to baseline, at 7, 30, and 90 days post-dosing ] [ Designated as safety issue: Yes ]
  • Mean CD4 lymphocyte count, with CholeraGarde® or placebo [ Time Frame: relative to baseline, at 90 days post-dosing ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
Live attenuated oral CholeraGarde® (5x107 to 1x109 CFU) vaccine
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

Other Name: CholeraGarde®
Placebo Comparator: Placebo
A buffer solution containing 2.5 g sodium bicarbonate, and 1.65 g ascorbic acid.
Biological: Placebo
A buffer solution containing 2.5 g sodium bicarbonate, and 1.65 g ascorbic acid.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. Male and female HIV seropositive adults aged 18 to 45 years old who have given the written informed consent.
  2. Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
  3. 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.

  1. History of CD4 nadir >150/mm3
  2. Viral load (HIV-1 RNA levels) <200 copies/mL for at least 6 months prior to inclusion

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:

  1. 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
  2. Ongoing serious chronic illness (e.g. with signs of cardiac or renal failure)
  3. Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
  4. Presence of V. cholerae 01 or 0139, Shigella, or Cryptosporidium in stool at baseline
  5. Intake of any anti-diarrhoeal medicine in the past week
  6. 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
  7. Receipt of antibiotics in the past 2 weeks
  8. Receipt of live or killed enteric vaccine in the last 4 weeks
  9. Receipt of killed oral cholera vaccine in the past
  10. Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
  11. One or more episodes of diarrhea lasting for more than 2 weeks in the past 6 months
  12. One or more episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
  13. Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 6 months
  14. Receipt of any immunosuppressive therapy during the past 6 months
  15. A woman pregnant or planning to become pregnant during the period of subject's participation
  16. Any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741637

Locations
Thailand
Department of Preventive and Social Medicine Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
International Vaccine Institute
Vaccine Technologies, Inc.
Siriraj Hospital, Mahidol University
Investigators
Principal Investigator: Winai Ratanasuwan, MD, MPH Faculty of Medicine Siriraj Hospital
  More Information

No publications provided

Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00741637     History of Changes
Other Study ID Numbers: CH-PR-02
Study First Received: August 25, 2008
Last Updated: March 29, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by International Vaccine Institute:
Vibrio Cholerae
Diarrhea
Live oral Vaccines
Immunogenicity
Safety
HIV

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Cholera
Diarrhea
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014