Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants
NCT ID: NCT00548054
Last Updated: 2015-05-04
Study Results
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Basic Information
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UNKNOWN
PHASE2
300 participants
INTERVENTIONAL
2015-12-31
2016-12-31
Brief Summary
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Detailed Description
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A monovalent (anti-O1) oral killed cholera vaccine with a B-subunit was developed by Professor Jan Holmgren in Sweden and is now licensed to a pharmaceutical company in the United Kingdom. The technology for this vaccine was transferred to Vietnamese scientists at the National Institute of Hygiene and Epidemiology in Hanoi in the mid-1980s.
The Vietnamese developed a bivalent vaccine, with killed 0139 cells and without the B-subunit. Since licensure, more than 9 million doses have been given without any report of serious adverse events.
The vaccine has been reformulated in order to internationalize the vaccine. Phase II trials of this vaccine in Son La, Vietnam and Kolkata, India have found the vaccine to be safe with no serious adverse reactions associated with the vaccine. A phase III study of the reformulated vaccine is ongoing in Kolkata, India.
The youngest person the vaccine has been administered to was a 1 year old. Previous studies with the B-subunit containing killed whole cell vaccine was found to be safe among infants as young as 6 months eliciting significant vibriocidal responses among 53% of vaccinees. However, no data is available regarding the use of the bivalent whole cell killed oral vaccine in infants.
Due to the higher risk of cholera among infants, the possibility of introducing cholera vaccine as part of the expanded programme on immunization (EPI) needs to be investigated.
Data regarding the safety and immunogenicity of the reformulated bivalent killed whole cell vaccine among infants needs to be gathered in order to pave the way for the possible use of this vaccine in cholera-endemic areas where infants and children are most at risk. Furthermore, there is no data regarding the concomitant use of this vaccine with other EPI vaccines given to young infants such as Diphtheria-Tetanus-whole cell Pertussis (DTwP), Oral Polio Vaccine (OPV) Hepatitis B and Measles vaccines. It would be important to determine if interference exists between the killed whole cell vaccine and other antigens included in the regular EPI schedule. Providing the killed whole cell vaccine in the context of the EPI will make it easier to introduce cholera vaccines in areas which are cholera-endemic.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
QUADRUPLE
Study Groups
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Vaccine Group for Vibriocidal Assay
Killed whole cell cholera vaccine bled at day 42 for vibriocidal assay
Bivalent killed oral cholera vaccine
Oral, 1.5 ml, given 2 times at least 14 days apart
Vaccine Group for EPI Assay
Killed whole cell cholera vaccine bled at day 56 for EPI immunogenicity testing
Bivalent killed oral cholera vaccine
Oral, 1.5 ml, given 2 times at least 14 days apart
Placebo Group for Vibriocidal Assay
Placebo bled at day 42 for vibriocidal assay
Killed Escherichia coli K12 placebo
oral, 1.5 ml per dose
Placebo Group for EPI Assay
Placebo bled at day 56 for EPI immunogenicity testing
Killed Escherichia coli K12 placebo
oral, 1.5 ml per dose
Vaccine Group for Vibriocidal and Measles Assay
Killed whole cell cholera vaccine bled at day 14 and 28 for measles immunogenicity testing
Bivalent killed oral cholera vaccine
Oral, 1.5 ml, given 2 times at least 14 days apart
Placebo Group for Vibriocidal and Measles Assay
Placebo bled at day 14 and 28 for measles immunogenicity testing
Killed Escherichia coli K12 placebo
oral, 1.5 ml per dose
Interventions
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Bivalent killed oral cholera vaccine
Oral, 1.5 ml, given 2 times at least 14 days apart
Killed Escherichia coli K12 placebo
oral, 1.5 ml per dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All subjects must satisfy the following criteria at study entry:
1. 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)
2. Written informed consent obtained from their parents/guardians
3. 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:
1. 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)
2. Written informed consent obtained from their parents/guardians
3. Healthy subjects as determined by:
* Medical history
* Physical examination
* Clinical judgment of the investigator
Exclusion Criteria
2. Immunocompromising condition or therapy
3. Diarrhea (having more frequent watery stools than usual within a 24 hour period) 6 weeks prior to enrollment
4. Intake of any anti-diarrheal medicine in the past week
5. Irritability, loss of appetite, general ill-feeling or vomiting in the past 24 hours
6. 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
7. Receipt of antibiotics in past 14 days
8. Receipt of killed oral cholera vaccine
9. Receipt of live or killed enteric vaccine in 2 months
10. Receipt of DTwP1, OPV1 or Hepatitis B2 vaccines
11. One or two episodes of diarrhea lasting for more than 2 weeks in the past 2 months
12. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 2 months
13. Z-score of \< -2 on the weight for age WHO Child Growth Standards
1. Ongoing serious chronic disease
2. Immunocompromising condition or therapy
3. Diarrhea (3 or more loose/watery stools within a 24 hour period) 6 weeks prior to enrollment
4. Intake of any anti-diarrheal medicine in the past week
5. Abdominal pain/cramps, loss of appetite, general ill-feeling or vomiting in the past 24 hours
6. 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
7. Receipt of antibiotics in past 14 days
8. Receipt of killed oral cholera vaccine
9. Receipt of live or killed enteric vaccine in last 4 weeks
10. Receipt of measles-containing vaccine (MCV)
11. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
12. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
13. Disease episode potentially related to measles
14. receipt of blood, blood products or a parenteral immunoglobulin preparation in past 3 months
15. History of anaphylaxis, any serious vaccine reaction, allergy to eggs, egg products or to any measles vaccine component
16. Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
17. Z-score of \< -2 on the weight for age WHO Child Growth Standards
10 Weeks
11 Months
ALL
Yes
Sponsors
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Indian Council of Medical Research
OTHER_GOV
National Institute of Cholera and Enteric Diseases, India
OTHER
Shantha Biotechnics Limited
INDUSTRY
Institute of Child Health
OTHER
International Vaccine Institute
OTHER
Responsible Party
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Principal Investigators
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Alok K Deb, PhD, MDDS
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cholera and Enteric Disease
Locations
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National Institute of Cholera and Enteric Disease
Kolkata, West Bengal, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CH-WC-01
Identifier Type: -
Identifier Source: org_study_id
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