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:
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
ClinicalTrials.gov Identifier:
NCT00624975
First received: February 19, 2008
Last updated: July 30, 2012
Last verified: July 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • proportion of subjects who develop >150 mIU/ml measles IgG antibodies [ Time Frame: 28 days after dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluate fecal excretion and genetic stability of the vaccine strain [ Time Frame: 1,3,7,14 days after dosing ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   9 Months to 12 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00624975     History of Changes
Other Study ID Numbers: CHPR-01
Study First Received: February 19, 2008
Last Updated: July 30, 2012
Health Authority: Bangladesh: Directorate of Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Cholera
Diarrhea
Measles
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014