Back to resultsSafety and Immunogenicity of a New Formulation of Euvichol®
Primary Purpose
Cholera
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Test Oral Cholera Vaccine
Euvichol®
Sponsored by
About this trial
This is an interventional prevention trial for Cholera focused on measuring Oral Cholera Vaccine, immunogenicity, safety
Eligibility Criteria
Inclusion Criteria:
- Subject willing to provide written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
- Individuals aged 1 - 40 years.
- An individual who can be followed up during the study period and is capable of complying with the study requirements
Exclusion Criteria:
- Known history of hypersensitivity reactions to other preventive vaccines.
- Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic drugs or other immunosuppressants.
- Severe chronic diseases, based on the judgment of the investigator.
- 38℃ or higher body temperature measured prior to investigational product dosing.
- Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
- Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhoea within 1 week prior to study initiation.
- Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
- Other vaccination within 1 week prior to study initiation or planned vaccination during the study, except for tetanus toxoid vaccine.
- Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
- Pregnant or lactating women, women of reproductive age planning pregnancy and/or lactation before the end of the study period.
- An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
- History of cholera vaccinations or history of cholera.
- History of alcohol or substance abuse
- Participant planning to move from the study area before the end of study period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
comparator group
Arm Description
Test Oral Cholera Vaccine
Euvichol®
Outcomes
Primary Outcome Measures
Immunogenicity endpoint for Inaba O1
Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose
Immunogenicity endpoint for Ogawa O1
GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose
Immunogenicity endpoint O139
GMT of Vibriocidal antibodies against serogroup O139 post second dose
Secondary Outcome Measures
Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations.
Seroconversion is defined as 4-fold rise in vibriocidal antibody titer at Visit 3 two weeks after the second dose, compared to baseline titers, measured at Visit 1 prior to vaccination.
Full Information
NCT ID
NCT02502331
First Posted
July 14, 2015
Last Updated
December 15, 2015
Sponsor
International Vaccine Institute
Collaborators
EuBiologics Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02502331
Brief Title
Safety and Immunogenicity of a New Formulation of Euvichol®
Official Title
A Randomized, Observer Blinded, Controlled Trial to Evaluate the Safety and Immunogenicity of a New Formulation of Euvichol® (Killed Bivalent Whole Cell Oral Cholera Vaccine Manufactured by EuBiologics Co. Ltd.) in Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Vaccine Institute
Collaborators
EuBiologics Co.,Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Number of doses and intervals: Two doses, 2 weeks apart
Method of administration: Oral administration
Volume of vaccine to be administered: 1.5 mL/dose
Observational period: 4 weeks (2 weeks after each dose)
Number of visits: 3 visits
Visit 1: Screening and enrollment (1st dosing)
Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)
Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This study will be carried out in healthy adults and children, at two sites, enrollment will be competitive between the sites. Subjects will be stratified according to age into adults (18~40 years of age) and children (1~17 years of age). According to the pre-generated randomization list, the participants will be randomized to the test or comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, blood sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the participants will be observed for 30 minutes post vaccination and instructed to record solicited adverse events that occur up to 6 days after vaccination on the participant diary card.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator will remain blinded and will not handle the investigational product.
Detailed Description
Primary immunogenicity endpoint
Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose
GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose
GMT of Vibriocidal antibodies against serogroup O139 post second dose
Secondary immunogenicity endpoints
Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations
Seroconversion is defined as 4-fold rise in vibriocidal antibody titer at Visit 3 two weeks after the second dose, compared to baseline titers, measured at Visit 1 prior to vaccination.
Proportion of participants with:
Immediate reactions within 30 minutes after each dose of vaccination.
Solicited systemic Adverse Events: nausea/vomiting, diarrhea, headache, fatigue, myalgia, fever, and anorexia/loss of appetite within 7 days after each vaccination.
Diarrhea is defined as having 3 or more loose/watery stools within a 24-hour period or at least 1 bloody loose stool or any number of loose stools with signs of dehydration.
Fever is defined as having an axillary temperature of 38 ℃
Unsolicited Adverse Events and Serious Adverse Events occurring 14 days following each vaccination, as reported by participants Measurement of Geometric Mean Titer of vibriocidal antibodies post vaccination, Ratio ofGeometric Mean Titer of vibriocidal antibodies post vaccination of Test vaccine' compared with 'Comparator vaccine'.
Expected outcome: Statistical equivalence of the two vaccines.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera
Keywords
Oral Cholera Vaccine, immunogenicity, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
442 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Test Oral Cholera Vaccine
Arm Title
comparator group
Arm Type
Active Comparator
Arm Description
Euvichol®
Intervention Type
Biological
Intervention Name(s)
Test Oral Cholera Vaccine
Intervention Description
Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.
Intervention Type
Biological
Intervention Name(s)
Euvichol®
Intervention Description
Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.
Primary Outcome Measure Information:
Title
Immunogenicity endpoint for Inaba O1
Description
Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose
Time Frame
28 days
Title
Immunogenicity endpoint for Ogawa O1
Description
GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose
Time Frame
28 days
Title
Immunogenicity endpoint O139
Description
GMT of Vibriocidal antibodies against serogroup O139 post second dose
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations.
Time Frame
28 days
Title
Seroconversion is defined as 4-fold rise in vibriocidal antibody titer at Visit 3 two weeks after the second dose, compared to baseline titers, measured at Visit 1 prior to vaccination.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject willing to provide written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
Individuals aged 1 - 40 years.
An individual who can be followed up during the study period and is capable of complying with the study requirements
Exclusion Criteria:
Known history of hypersensitivity reactions to other preventive vaccines.
Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic drugs or other immunosuppressants.
Severe chronic diseases, based on the judgment of the investigator.
38℃ or higher body temperature measured prior to investigational product dosing.
Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhoea within 1 week prior to study initiation.
Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
Other vaccination within 1 week prior to study initiation or planned vaccination during the study, except for tetanus toxoid vaccine.
Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
Pregnant or lactating women, women of reproductive age planning pregnancy and/or lactation before the end of the study period.
An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
History of cholera vaccinations or history of cholera.
History of alcohol or substance abuse
Participant planning to move from the study area before the end of study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Digilio, MD
Phone
+82-2-881-1363
Ext
363
Email
Laura.Digilio@ivi.int
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Hee Lee, Msc
Phone
+82-2-881-1431
Ext
431
Email
sungheelee@ivi.int
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Digilio, MD
Organizational Affiliation
International Vaccince Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
29895500
Citation
Russo P, Ligsay AD, Olveda R, Choi SK, Kim DR, Park JY, Park JY, Syed KA, Dey A, Kim YH, Lee SH, Kim J, Chon Y, Digilio L, Kim CW, Excler JL. A randomized, observer-blinded, equivalence trial comparing two variations of Euvichol(R), a bivalent killed whole-cell oral cholera vaccine, in healthy adults and children in the Philippines. Vaccine. 2018 Jul 5;36(29):4317-4324. doi: 10.1016/j.vaccine.2018.05.102. Epub 2018 Jun 9.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity of a New Formulation of Euvichol®
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