CompletedNCT04760236Updated Jun 22, 2023

Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™

A Phase 3 interventional study of Oral Cholera Vaccine Simplified (OCV-S) and Shanchol™ in Cholera, sponsored by International Vaccine Institute. Completed at 4 sites in Nepal. Open to participants aged 1 Year to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by International Vaccine Institute · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 2,530
Allocation: Randomized
Ages: 1 Year to 40 Years
Sex: All

Study summary

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™.

Conditions studied

Cholera

Browse trials for

Cholera 74

Who can participate

Ages eligible: 1 Year to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2,530 participants (actual)

Study arms

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.
Biological: Oral Cholera Vaccine Simplified (OCV-S)
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.
Biological: Oral Cholera Vaccine Simplified (OCV-S)
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.
Biological: Oral Cholera Vaccine Simplified (OCV-S)
Active comparator
Shanchol™ group
Participants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.
Biological: Shanchol™

Interventions

BiologicalOral Cholera Vaccine Simplified (OCV-S)
* Manufacturer: EuBiologics Co., Ltd. * Oral administration
BiologicalShanchol™
* Manufacturer: Shantha Biotechnics * Oral administration

What researchers measure

Primary outcomes

Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
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
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Vaccine Safety profile
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
Time frame: As in Description

Secondary outcomes

Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT for all ages
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

Other outcomes

The equivalence of immunogenicity in 3 lots as measured by seroconversion rates
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
Time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Vibriocidal antibody responses
Seroconversion rate and GMT of vibriocidal antibody responses 2 weeks after first dose for all ages and for each age stratum
Time frame: 2 weeks after first dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

Study locations

4 sites

Nepalgunj medical college
Banke, City- Nepalgunj, Nepal
B.P.Koirala Institute of Health Sciences
Rautahat, Dharan, Nepal
Dhulikhel Hospital
Kavre, Dhulikhel, Nepal
Kanti Children's Hospital
Kathmandu, Sukedhara 44600, Nepal

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT04760236
Lead sponsor: International Vaccine Institute
Collaborators: EuBiologics Co.,Ltd
Responsible party: Sponsor
First posted: Feb 18, 2021
Start date: Oct 6, 2021
Primary completion: Dec 22, 2022
Completion: Mar 21, 2023
Last update: Jun 22, 2023

Study contacts

Julia Lynch, MD

principal investigator · International Vaccine Institution

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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