NCT04760236

Brief 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™.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,530

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.2 years

First QC Date

January 13, 2021

Last Update Submit

June 20, 2023

Conditions

Cholera

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    As in Description

Secondary Outcomes (4)

  • Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT 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

    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

    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

    2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

Other Outcomes (2)

  • The equivalence of immunogenicity in 3 lots as measured by seroconversion rates

    2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

  • Vibriocidal antibody responses

    2 weeks after first dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

Study Arms (4)

Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)

EXPERIMENTAL

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)

Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)

EXPERIMENTAL

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)

Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)

EXPERIMENTAL

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)

Shanchol™ group

ACTIVE COMPARATOR

Participants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.

Biological: Shanchol™

Interventions

Oral Cholera Vaccine Simplified (OCV-S)BIOLOGICAL

* Manufacturer: EuBiologics Co., Ltd. * Oral administration

Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)
Shanchol™BIOLOGICAL

* Manufacturer: Shantha Biotechnics * Oral administration

Shanchol™ group

Eligibility Criteria

Age1 Year - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nepalgunj medical college

Bānke, City- Nepalgunj, Nepal

Location

B.P.Koirala Institute of Health Sciences

Rautahat, Dharan, Nepal

Location

Dhulikhel Hospital

Kavre, Dhulikhel, Nepal

Location

Kanti Children's Hospital

Kathmandu, Sukedhara, 44600, Nepal

Location

Related Publications (1)

  • Song KR, Chapagain RH, Tamrakar D, Shrestha R, Kanodia P, Chaudhary S, Wartel TA, Yang JS, Kim DR, Lee J, Park EL, Cho H, Lee J, Thaisrivichai P, Vemula S, Kim BM, Gupta B, Saluja T, Pansuriya RK, Ganapathy R, Baik YO, Lee YJ, Jeon S, Park Y, Her HL, Park Y, Lynch JA. Safety and immunogenicity of the Euvichol-S oral cholera vaccine for prevention of Vibrio cholerae O1 infection in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial. Lancet Glob Health. 2024 May;12(5):e826-e837. doi: 10.1016/S2214-109X(24)00059-7.

    PMID: 38614631DERIVED

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Julia Lynch, MD

    International Vaccine Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

February 18, 2021

Study Start

October 6, 2021

Primary Completion

December 22, 2022

Study Completion

March 21, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

NE(4)