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

NCT00741637 | Completed Phase 2 DMC

• 1 other identifier: CH-PR-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Cholera; Vibrio Infections; Diarrhea

Keywords

Vibrio Cholerae; Diarrhea; Live oral Vaccines; Immunogenicity; Safety; HIV

Outcome Measures

Primary Outcomes (1)

• 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

  0,1,2,3,4,5,6,7,14,30,90 days post intervention

Secondary Outcomes (6)

• 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

  0,1,2,3,4,5,6,7,14,30,90 days post vaccination

• Proportion of subjects given CholeraGarde® or placebo with any of the following adverse events

  30 minutes after adminstration and throughout the trial

• Geometric mean serum vibriocidal IgG antibody titers measured at baseline and one week after a single dose of CholeraGarde® or placebo

  One week

• Proportion of subjects given CholeraGarde® or placebo with fecal excretion of CholeraGarde®

  At 3, 7, 14, and 30 days post-dosing

• Mean HIV viral load (copies/ml) increases, with CholeraGarde® or placebo

  relative to baseline, at 7, 30, and 90 days post-dosing

Study Arms (2)

Vaccine

EXPERIMENTAL

Live attenuated oral CholeraGarde® (5x107 to 1x109 CFU) vaccine

Biological: CholeraGarde®

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

CholeraGarde® BIOLOGICAL

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

Vaccine

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Subjects that have never started HAART regimen must satisfy the following additional criteria at study entry.
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• Vaccine Technologies Inc.: collaborator
• Siriraj Hospital: collaborator

Study Sites (1)

Department of Preventive and Social Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Cholera; Vibrio Infections; Diarrhea

Interventions

Peru 15

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Winai Ratanasuwan, MD, MPH

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

TH (1)