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Safety and Immunogenicity of Peru-15 Vaccine When Given With Measles Vaccine in Healthy Indian and Bangladeshi Infants

This study has been terminated.
(one of site was not able to get an approval from the national regulatory authority.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624975
First Posted: February 28, 2008
Last Update Posted: August 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Christian Medical College, Vellore, India
Avant Immunotherapeutics
Vaccine Technologies Inc.
Information provided by (Responsible Party):
International Vaccine Institute
  Purpose
The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in infants when given simultaneously with measles vaccine.

Condition Intervention Phase
Cholera Diarrhea Vibrio Infections Biological: Peru-15 Vaccine Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multi-site, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Trehalose-reformulated Peru-15 (Choleragarde)Vaccine Given Simultaneously With Measles Vaccine in Healthy Indian and Bangladeshi Infants

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • proportion of subjects with the following adverse events: headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, loss of appetite, myalgias, general ill feeling [ Time Frame: 28 days ]
  • proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies to serogroup O1 El Tor Inaba [ Time Frame: relative to baseline, 1 week after dose ]
  • proportion of subjects who develop >150 mIU/ml measles IgG antibodies [ Time Frame: 28 days after dose ]

Secondary Outcome Measures:
  • evaluate fecal excretion and genetic stability of the vaccine strain [ Time Frame: 1,3,7,14 days after dosing ]
  • compare proportion of subjects given vaccine or placebo with any of the following adverse events: immediate events 30 minutes after dosing, serious adverse events throughout the trial [ Time Frame: 30 minutes for adverse events, 28 days for serious adverse events ]
  • geometric mean serum vibriocidal, IgG anti-CTB and IgG anti-LPS (serogroup O1) antibody titers after vaccine or placebo [ Time Frame: baseline and 1 week after dose ]

Enrollment: 74
Study Start Date: November 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine Biological: Peru-15 Vaccine
up to 1 x 10^9 CFU of Peru-15 given in 5ml single dose vials with 20 ml buffer solution, given once
Other Name: CholeraGarde
Placebo Comparator: Placebo Biological: Placebo
25 mL of buffer solution (2.5 g sodium bicarbonate and 1.65 g ascorbic acid per 100mL potable water)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy male and female infants aged 9 - 12 months will be recruited from Vellore, India and Dhaka, Bangladesh.

All subjects must satisfy the following criteria at study entry:

  1. Male or female infants aged 9 - 12 months whose parents or primary caretaker have given the written informed consent prior to study entry
  2. Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
  3. Healthy subjects as determined by:

    • Medical history
    • Physical examination
    • Clinical judgment of the investigator

Exclusion Criteria:

  1. Parents or primary caregiver are unwilling or unable to give written informed consent to participate in the study
  2. Ongoing serious chronic disease
  3. Immunocompromising condition or therapy
  4. Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
  5. Intake of any anti-diarrheal medicine in the past week
  6. Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral) or axillary temperature ≥ 37.5ºC 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. Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
  10. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
  11. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
  12. Receipt of killed oral cholera vaccine
  13. Have previously received a dose of a measles-containing vaccine (MCV)
  14. Have previously presented with a disease potentially related to measles
  15. Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 3 months
  16. History of anaphylaxis, any serious vaccine reaction, allergy to eggs, egg products or to any measles vaccine component
  17. any condition which in the opinion of the investigator, might interfere with the evaluation of the study objectives
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624975


Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
India
Christian Medical College
Vellore, India
Sponsors and Collaborators
International Vaccine Institute
International Centre for Diarrhoeal Disease Research, Bangladesh
Christian Medical College, Vellore, India
Avant Immunotherapeutics
Vaccine Technologies Inc.
Investigators
Principal Investigator: John Clemens, MD International Vaccine Insititute
  More Information

Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00624975     History of Changes
Other Study ID Numbers: CHPR-01
First Submitted: February 19, 2008
First Posted: February 28, 2008
Last Update Posted: August 1, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Diarrhea
Cholera
Vibrio Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs