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

NCT00624975 | Terminated Phase 2 DMC

• 1 other identifier: CHPR-01
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to confirm the safety and immunogenicity of Peru-15 vaccine in infants when given simultaneously with measles vaccine.

Conditions

Cholera; Diarrhea; Vibrio Infections

Outcome Measures

Primary Outcomes (3)

• proportion of subjects with the following adverse events: headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, loss of appetite, myalgias, general ill feeling

  28 days

• proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies to serogroup O1 El Tor Inaba

  relative to baseline, 1 week after dose

• proportion of subjects who develop >150 mIU/ml measles IgG antibodies

  28 days after dose

Secondary Outcomes (3)

• evaluate fecal excretion and genetic stability of the vaccine strain

  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

  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

  baseline and 1 week after dose

Study Arms (2)

Vaccine

EXPERIMENTAL

Biological: Peru-15 Vaccine

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Peru-15 Vaccine BIOLOGICAL

up to 1 x 10\^9 CFU of Peru-15 given in 5ml single dose vials with 20 ml buffer solution, given once

Also known as: CholeraGarde

Vaccine

Placebo BIOLOGICAL

25 mL of buffer solution (2.5 g sodium bicarbonate and 1.65 g ascorbic acid per 100mL potable water)

Placebo

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Christian Medical College, Vellore, India: collaborator
• Avant Immunotherapeutics: collaborator
• Vaccine Technologies Inc.: collaborator

Study Sites (2)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Christian Medical College

Vellore, India

Location

MeSH Terms

Conditions

Cholera; Diarrhea; Vibrio Infections

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

• John Clemens, MD

  International Vaccine Insititute

  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: February 19, 2008
• First Posted: February 28, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

IN (1); BA (1)