Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants
Cholera, Diarrhea, Vibrio Infections
About this trial
This is an interventional prevention trial for Cholera focused on measuring cholera, vaccine, Kolkata, West Bengal, India, immunogenicity, safety, infants, expanded programme on immunization
Eligibility Criteria
Inclusion Criteria, Infants 10 weeks to 6 months of age at Day 0:
- 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
Inclusion Criteria, Infants 9 months to less than 12 months
- 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
- Clinical judgment of the investigator
Exclusion Criteria, Infants 10 weeks to 6 months of age at Day 0:
- 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
Exclusion Criteria, Infants 9 months to less than 12 months:
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Diarrhea (3 or more loose/watery stools within a 24 hour period) 6 weeks prior to enrollment
- Intake of any anti-diarrheal medicine in the past week
- Abdominal pain/cramps, 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 last 4 weeks
- Receipt of measles-containing vaccine (MCV)
- 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
- Disease episode potentially related to measles
- receipt of blood, blood products or a parenteral immunoglobulin preparation in past 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
- Z-score of < -2 on the weight for age WHO Child Growth Standards
Sites / Locations
- National Institute of Cholera and Enteric Disease
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Placebo Comparator
Vaccine Group for Vibriocidal Assay
Vaccine Group for EPI Assay
Placebo Group for Vibriocidal Assay
Placebo Group for EPI Assay
Vaccine Group for Vibriocidal and Measles Assay
Placebo Group for Vibriocidal and Measles Assay
Killed whole cell cholera vaccine bled at day 42 for vibriocidal assay
Killed whole cell cholera vaccine bled at day 56 for EPI immunogenicity testing
Placebo bled at day 42 for vibriocidal assay
Placebo bled at day 56 for EPI immunogenicity testing
Killed whole cell cholera vaccine bled at day 14 and 28 for measles immunogenicity testing
Placebo bled at day 14 and 28 for measles immunogenicity testing