Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants

NCT00548054 | Unknown Phase 2 DMC

• 1 other identifier: CH-WC-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the investigators also need to make sure that immune interference does not occur among all the other vaccine antigens given at the same time. Findings from this study will pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).

Conditions

Cholera; Diarrhea; Vibrio Infections

Keywords

cholera; vaccine; Kolkata; West Bengal; India; immunogenicity; safety; infants; expanded programme on immunization

Outcome Measures

Primary Outcomes (2)

• Safety: proportion of subjects with diarrhea

  entire study period

• Immunogenicity: proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline

  14 days after each dose

Secondary Outcomes (8)

• Geometric mean serum vibriocidal titers

  14 days after each dose

• Proportion of subjects with any of the following: a) immediate reactions 30 minutes and up to 3 days after each dose, b) serious adverse events occurring during the trial, c) any adverse event

  entire study period

• Proportion of subjects with ≥ 0.1 mIU/ml of anti-diphtheria toxoid antibodies

  28 days after the third DPT dose

• Proportion of subjects with ≥ 0.1 mIU/ml of anti-tetanus toxoid antibodies

  28 days after the third DPT dose

• For initially seronegative subjects: proportion of subjects with ≥ 15 EU/ml of anti-pertussis IgG and for initially seropositive subjects, proportion with antibody titers equal to or greater than the initial titers prior to vaccination

  28 days after DPT dose

Study Arms (6)

Vaccine Group for Vibriocidal Assay

EXPERIMENTAL

Killed whole cell cholera vaccine bled at day 42 for vibriocidal assay

Biological: Bivalent killed oral cholera vaccine

Vaccine Group for EPI Assay

EXPERIMENTAL

Killed whole cell cholera vaccine bled at day 56 for EPI immunogenicity testing

Biological: Bivalent killed oral cholera vaccine

Placebo Group for Vibriocidal Assay

PLACEBO COMPARATOR

Placebo bled at day 42 for vibriocidal assay

Biological: Killed Escherichia coli K12 placebo

Placebo Group for EPI Assay

PLACEBO COMPARATOR

Placebo bled at day 56 for EPI immunogenicity testing

Biological: Killed Escherichia coli K12 placebo

Vaccine Group for Vibriocidal and Measles Assay

EXPERIMENTAL

Killed whole cell cholera vaccine bled at day 14 and 28 for measles immunogenicity testing

Biological: Bivalent killed oral cholera vaccine

Placebo Group for Vibriocidal and Measles Assay

PLACEBO COMPARATOR

Placebo bled at day 14 and 28 for measles immunogenicity testing

Biological: Killed Escherichia coli K12 placebo

Interventions

Bivalent killed oral cholera vaccine BIOLOGICAL

Oral, 1.5 ml, given 2 times at least 14 days apart

Also known as: Shanchol

Vaccine Group for EPI Assay; Vaccine Group for Vibriocidal Assay; Vaccine Group for Vibriocidal and Measles Assay

Killed Escherichia coli K12 placebo BIOLOGICAL

oral, 1.5 ml per dose

Placebo Group for EPI Assay; Placebo Group for Vibriocidal Assay; Placebo Group for Vibriocidal and Measles Assay

Eligibility Criteria

• Age: 10 Weeks - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged from birth to 2 months who have not received OPV1, DTP1 or HepB2 will be recruited in Kolkata, North 24 Parganas, and South 24 Parganas
• All subjects must satisfy the following criteria at study entry:
• Male or female infants aged from birth to 2 months who the investigator believes will comply with the requirements of the protocol (i.e., available for follow-up visits and specimen collection)
• Written informed consent obtained from their parents/guardians
• Healthy subjects as determined by:
• Medical history
• Physical examination
• Clinical judgment of the investigator
• Healthy infants aged from 9 months to less than 12 months who have not received measles vaccine will be recruited in Kolkata, North 24 Parganas, and South 24 Parganas
• All subjects must satisfy the following criteria at study entry:
• Male or female infants aged from 9 months to less than 12 months who the investigator believes will comply with the requirements of the protocol (i.e., available for follow-up visits and specimen collection)
• Written informed consent obtained from their parents/guardians
• Healthy subjects as determined by:
• Medical history
• Physical examination

You may not qualify if:

• Ongoing serious chronic disease
• Immunocompromising condition or therapy
• Diarrhea (having more frequent watery stools than usual within a 24 hour period) 6 weeks prior to enrollment
• Intake of any anti-diarrheal medicine in the past week
• Irritability, loss of appetite, general ill-feeling or vomiting in the past 24 hours
• Acute disease one week prior to enrollment, with or without fever. Temperature =\>38C (oral) or axillary temperature =\>37.5C warrants deferral of the vaccination pending recovery of the subject
• Receipt of antibiotics in past 14 days
• Receipt of killed oral cholera vaccine
• Receipt of live or killed enteric vaccine in 2 months
• Receipt of DTwP1, OPV1 or Hepatitis B2 vaccines
• One or two episodes of diarrhea lasting for more than 2 weeks in the past 2 months
• One or two episodes of abdominal pain lasting for more than 2 weeks in the past 2 months
• Z-score of \< -2 on the weight for age WHO Child Growth Standards
• Ongoing serious chronic disease
• Immunocompromising condition or therapy

Sponsors & Collaborators

• International Vaccine Institute: lead
• Indian Council of Medical Research: collaborator
• National Institute of Cholera and Enteric Diseases, India: collaborator
• Shantha Biotechnics Limited: collaborator
• Institute of Child Health: collaborator

Study Sites (1)

National Institute of Cholera and Enteric Disease

Kolkata, West Bengal, India

Location

MeSH Terms

Conditions

Cholera; Diarrhea; Vibrio Infections

Interventions

shanchol

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

• Alok K Deb, PhD, MDDS

  National Institute of Cholera and Enteric Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vijayalaxmi Mogasale, MD

CONTACT

82-2-881-1151; vlmogasale@ivi.int

Binod Sah, MBBS, MS

CONTACT

82-2-881-1149; bsah@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2007
• First Posted: October 23, 2007
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 4, 2015

Record last verified: 2015-05

Locations

IN (1)