- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760236
Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
June 20, 2023 updated by: International Vaccine Institute
Phase III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of OCV-S Compared to Shanchol™ in 1 to 40 Years Old Healthy Nepalese Participants
This study is to evaluate immune non-inferiority, safety and lot-to-lot consistency of OCV-S compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants.
The investigators hypothesize that the simplified formulation is able to induce non-inferior immunogenicity compared to licensed OCV, Shanchol™.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2530
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rok K Song, MD
- Phone Number: +82-2-8811-228
- Email: katerina.song@ivi.int
Study Contact Backup
- Name: Anh Wartel, MD
- Phone Number: +82-2-8811-274
- Email: anh.wartel@ivi.int
Study Locations
-
-
City- Nepalgunj
-
Banke, City- Nepalgunj, Nepal
- Nepalgunj medical college
-
-
Dharan
-
Rautahat, Dharan, Nepal
- B.P.Koirala Institute of Health Sciences
-
-
Dhulikhel
-
Kavre, Dhulikhel, Nepal
- Dhulikhel Hospital
-
-
Sukedhara
-
Kathmandu, Sukedhara, Nepal, 44600
- Kanti Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 40 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy participants 1 to 40 years of age at enrollment
- Participants/Parent(s)/Legally authorized representative (LAR) willing to provide written informed consent to participate study voluntarily
- Participants/Parent(s)/LAR who can be followed up during the study period and can comply with the study requirements
Exclusion Criteria:
- Known history of hypersensitivity reactions to other preventive vaccines
- Severe chronic diseases or medical conditions based on the medical judgment of the investigator. In particular, a participant with a) chronic infection such as tuberculosis, or sequel of poliomyelitis, b) known history of immune function disorders, c) chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days)/cytotoxic drugs/immunosuppressants within past 6 weeks, d) active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease-free for 5 years, e) Congestive heart failure, f) myocardial infarction within the previous 6 months, g) known HIV-infected patients, h) neurological and/or psychiatric disorder, or i) known history of uncontrolled coagulopathy or blood disorders
- Participant who planned to or has received other vaccines from 1 month prior to test vaccination excluding a public health vaccination campaign due to an outbreak
- Participant concomitantly enrolled or scheduled to be enrolled in another trial
- Receipt of blood or blood-derived products in the past 3 months
- Participant who has previously received a cholera vaccine
- Any female participant who is lactating, pregnant or planning for pregnancy during study period
- Participants planning to move from the study area before the end of study period
- Employees or the family members of the OCV-S study sites
Temporary Contraindication:
Should a participant have one of the conditions/situations listed below, the Investigator will postpone primary or subsequent vaccination until the condition/situation is resolved.
- Febrile illness (axillary temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination or planned vaccination, according to Investigator's judgment.
- Gastrointestinal symptoms including nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
- Administration of antidiarrheal drugs or antibiotics to treat diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation
Diarrhea occurring up to 1 week within 6 months prior to study initiation.
- Lactation: Breastfeeding women will not be enrolled. Should a female participant decide to breastfeed during the vaccination period, she will be excluded from further vaccination, but will be followed for safety until the end of the study
- Pregnancy Test is necessary for all married female participants of childbearing age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0-2 week schedule.
|
|
Experimental: Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 2) according to 0-2 week schedule.
|
|
Experimental: Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)
Participants (n=935) aged 1-40 years old will received OCV-S (Lot 3) according to 0-2 week schedule.
|
|
Active Comparator: Shanchol™ group
Participants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
Time Frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ for all ages
|
2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Vaccine Safety profile
Time Frame: As in Description
|
Frequency of solicited adverse events within 7 days post vaccination, unsolicited adverse events within 28 days post vaccination, Serious Adverse Events (SAEs) after each dose during the entire study period in all ages and in each age stratum
|
As in Description
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT for all ages
Time Frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Geometric Mean Titer (GMT) of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ for all ages
|
2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rate in each age stratum
Time Frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ in each age stratum
|
2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT in each age stratum
Time Frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Geometric Mean Titer of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™ in each age stratum
|
2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
The equivalence of immunogenicity in 3 lots as measured by GMT
Time Frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Geometric Mean Titer of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of 3 lots of OCV-S in adults
|
2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The equivalence of immunogenicity in 3 lots as measured by seroconversion rates
Time Frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of 3 lots of OCV-S in adults
|
2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Vibriocidal antibody responses
Time Frame: 2 weeks after first dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Seroconversion rate and GMT of vibriocidal antibody responses 2 weeks after first dose for all ages and for each age stratum
|
2 weeks after first dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Lynch, MD, International Vaccine Institution
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2021
Primary Completion (Actual)
December 22, 2022
Study Completion (Actual)
March 21, 2023
Study Registration Dates
First Submitted
January 13, 2021
First Submitted That Met QC Criteria
February 15, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVI OCV-S
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cholera
-
Johns Hopkins Bloomberg School of Public HealthBill and Melinda Gates Foundation; Meilleur Accès aux Soins de Santé (M.A....CompletedCholera Vaccination Reaction | Adverse Reaction to Cholera VaccineCameroon
-
Brigham and Women's HospitalRecruitingCholera | Cholera Vaccine ToxicityUnited States
-
Bavarian NordicEmergent BioSolutionsCompleted
-
International Vaccine InstituteMassachusetts General Hospital; EuBiologics Co.,LtdRecruitingCholera Vaccination ReactionKorea, Republic of
-
Jiangsu Province Centers for Disease Control and...CompletedSafety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules)
-
University of Maryland, BaltimoreRecruitingTyphoid and/or Cholera VaccinationUnited States
-
Bharat Biotech International LimitedRecruiting
-
Bavarian NordicEmergent BioSolutionsCompletedCholeraUnited States, Australia
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on Oral Cholera Vaccine Simplified (OCV-S)
-
International Centre for Diarrhoeal Disease Research...Centers for Disease Control and PreventionNot yet recruitingMeasles | Rubella | Cholera | Typhoid
-
International Vaccine InstituteGöteborg University; National Institute of Hygiene and Epidemiology, VietnamCompleted
-
Bavarian NordicEmergent BioSolutionsCompleted
-
Johns Hopkins Bloomberg School of Public HealthCompletedCholera | Vibrio Cholerae InfectionZambia
-
International Vaccine InstituteEuBiologics Co.,LtdUnknown
-
Sachin DesaiIndian Council of Medical Research; National Institute of Cholera and Enteric...Completed
-
International Centre for Diarrhoeal Disease Research...Stanford University; Centers for Disease Control and PreventionRecruitingVaccine ReactionBangladesh
-
Johns Hopkins Bloomberg School of Public HealthBill and Melinda Gates Foundation; Meilleur Accès aux Soins de Santé (M.A....CompletedCholera Vaccination Reaction | Adverse Reaction to Cholera VaccineCameroon
-
Jiangsu Province Centers for Disease Control and...CompletedSafety of the Oral O1 / O139 Cholera Vaccine (Enteric Capsules)
-
International Vaccine InstituteIndian Council of Medical Research; National Institute of Cholera and Enteric... and other collaboratorsCompletedCholera | Diarrhoea | Vibrio InfectionIndia