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:
International Vaccine Institute
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
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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:
- Male or female infants aged 9 - 12 months whose parents or primary caretaker have given the written informed consent prior to study entry
- Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
Healthy subjects as determined by:
- Medical history
- Physical examination
- Clinical judgment of the investigator
Exclusion Criteria:
- Parents or primary caregiver are unwilling or unable to give written informed consent to participate in the study
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- Intake of any anti-diarrheal medicine in the past week
- 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
- Receipt of antibiotics in the past 2 weeks
- Receipt of live or killed enteric vaccine in the last 4 weeks
- Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
- One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- Receipt of killed oral cholera vaccine
- Have previously received a dose of a measles-containing vaccine (MCV)
- Have previously presented with a disease potentially related to measles
- Receipt of blood, blood products or a parenteral immunoglobulin preparation in the previous 3 months
- History of anaphylaxis, any serious vaccine reaction, allergy to eggs, egg products or to any measles vaccine component
- 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 May 23, 2013