CholeraPhase 3NCT02502331
Safety and Immunogenicity of a New Formulation of Euvichol®
A Phase 3 study testing Test Oral Cholera Vaccine and Euvichol® in people with Cholera, run by International Vaccine Institute.
Trial 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 1. Visit 1: Screening and enrollment (1st dosing) 2. Read more about this study
- Who is it for?
- Ages 1 year to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- Test Oral Cholera Vaccine and Euvichol®
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
- 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.
Read the 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.
- Conditions
- Cholera
- Being tested
- Test Oral Cholera Vaccine, Euvichol®
- Keywords
- Oral Cholera Vaccine, immunogenicity, safety
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Oral Cholera VaccineBiological
Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.
Euvichol®Biological
Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Test Oral Cholera Vaccine Receives: Biological: Test Oral Cholera Vaccine |
| comparator group | Active comparator | Euvichol® Receives: Biological: Euvichol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity endpoint for Inaba O1
Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose
Measured: 28 days
Immunogenicity endpoint for Ogawa O1
GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose
Measured: 28 days
Immunogenicity endpoint O139
GMT of Vibriocidal antibodies against serogroup O139 post second dose
Measured: 28 days
Secondary outcomes (2)
Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations.
Measured: 28 days
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- EuBiologics Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Laura Digilio, MD, Principal investigator, International Vaccince Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502331
- Sponsor's protocol ID
- IVI-CHOVI-EUVICHOL
- Status last verified
- Dec 2015
- First submitted
- 14 Jul 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29895500
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02502331
- Acronym / sponsor ID
- IVI-CHOVI-EUVICHOL
- Conditions
- Cholera
- Keywords
- Oral Cholera Vaccine, immunogenicity, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- EuBiologics Co.,Ltd
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Biological: Test Oral Cholera VaccineTest Oral Cholera Vaccine |
| comparator group | Active comparator | Biological: Euvichol®Euvichol® |
Who may qualify
- Ages
- 1 year to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Oral Cholera VaccineThimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd. | Biological | study group |
| Euvichol®Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd. | Biological | comparator group |
Primary outcome
Immunogenicity endpoint for Inaba O1
Time frame: 28 days
Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose
Immunogenicity endpoint for Ogawa O1
Time frame: 28 days
GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose
Immunogenicity endpoint O139
Time frame: 28 days
GMT of Vibriocidal antibodies against serogroup O139 post second dose
2 secondary outcomes
Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations.
Time frame: 28 days
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Derived from this study: PubMed 29895500Russo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Digilio, MD principal investigator
International Vaccince Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test Oral Cholera Vaccine and Euvichol® in people with Cholera, run by International Vaccine Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Digilio, MD (+82-2-881-1363 ext. 363, Laura.Digilio@ivi.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity endpoint for Inaba O1 (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.