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

Sponsors and Collaborators:	International Vaccine Institute International Centre for Diarrhoeal Disease Research, Bangladesh Christian Medical College, Vellore, India Avant Immunotherapeutics
Information provided by:	International Vaccine Institute
ClinicalTrials.gov Identifier:	NCT00624975

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 Biological: Placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Multi-Site, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Teh 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:

MedlinePlus related topics: Diarrhea Measles Nausea and Vomiting

Drug Information available for: Measles Vaccine

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 ]

Estimated Enrollment:	148
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Peru-15 up to 1 x 10^9 CFU of Peru-15 given in 5ml single dose vials with 100 ml buffer solution, given once
2: Placebo Comparator	Biological: Placebo 25 mL of buffer solution (2.5 g sodium bicarbonate and 1.65 g ascorbic acid per 100mL potable water

Eligibility

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

Investigators

Principal Investigator:

John Clemens, MD

International Vaccine Insititute

More Information

No publications provided

Responsible Party:	International Vaccine Institute ( Dr. Anna Lena Lopez, Scientist )
Study ID Numbers:	CHPR-01
Study First Received:	February 19, 2008
Last Updated:	June 25, 2009
ClinicalTrials.gov Identifier:	NCT00624975 History of Changes
Health Authority:	Bangladesh: Bangladesh Medical Research Council; Bangladesh: Directorate of Drug Administration; Bangladesh: Ethical Review Committee; India: Drugs Controller General of India; India: Indian Council of Medical Research

Study placed in the following topic categories:

Vitamin C
Bacterial Infections
Diarrhea
Measles
Vibrio Infections

Cholera
Healthy
Ascorbic Acid
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
Vibrio Infections
Cholera
Infection
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 04, 2009