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

Primary Purpose

Cholera

Status
Completed
Phase
Phase 3
Locations
Nepal
Study Type
Interventional
Intervention
Oral Cholera Vaccine Simplified (OCV-S)
Shanchol™
Sponsored by
International Vaccine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholera

Eligibility Criteria

1 Year - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nepalgunj medical college
  • B.P.Koirala Institute of Health Sciences
  • Dhulikhel Hospital
  • Kanti Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

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™ group

Arm Description

Participants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0-2 week schedule.

Participants (n=330) aged 18-40 years old will received OCV-S (Lot 2) according to 0-2 week schedule.

Participants (n=935) aged 1-40 years old will received OCV-S (Lot 3) according to 0-2 week schedule.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
January 13, 2021
Last Updated
June 20, 2023
Sponsor
International Vaccine Institute
Collaborators
EuBiologics Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04760236
Brief Title
Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Vaccine Institute
Collaborators
EuBiologics Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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™.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)
Arm Type
Experimental
Arm Description
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0-2 week schedule.
Arm Title
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)
Arm Type
Experimental
Arm Description
Participants (n=330) aged 18-40 years old will received OCV-S (Lot 2) according to 0-2 week schedule.
Arm Title
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)
Arm Type
Experimental
Arm Description
Participants (n=935) aged 1-40 years old will received OCV-S (Lot 3) according to 0-2 week schedule.
Arm Title
Shanchol™ group
Arm Type
Active Comparator
Arm Description
Participants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.
Intervention Type
Biological
Intervention Name(s)
Oral Cholera Vaccine Simplified (OCV-S)
Intervention Description
Manufacturer: EuBiologics Co., Ltd. Oral administration
Intervention Type
Biological
Intervention Name(s)
Shanchol™
Intervention Description
Manufacturer: Shantha Biotechnics Oral administration
Primary Outcome Measure Information:
Title
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
Description
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™
Title
Vaccine Safety profile
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
Time Frame
As in Description
Secondary Outcome Measure Information:
Title
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT for all ages
Description
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™
Title
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
Description
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™
Title
Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT in each age stratum
Description
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™
Title
The equivalence of immunogenicity in 3 lots as measured by GMT
Description
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 Pre-specified Outcome Measures:
Title
The equivalence of immunogenicity in 3 lots as measured by seroconversion rates
Description
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™
Title
Vibriocidal antibody responses
Description
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™

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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Lynch, MD
Organizational Affiliation
International Vaccine Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepalgunj medical college
City
Banke
State/Province
City- Nepalgunj
Country
Nepal
Facility Name
B.P.Koirala Institute of Health Sciences
City
Rautahat
State/Province
Dharan
Country
Nepal
Facility Name
Dhulikhel Hospital
City
Kavre
State/Province
Dhulikhel
Country
Nepal
Facility Name
Kanti Children's Hospital
City
Kathmandu
State/Province
Sukedhara
ZIP/Postal Code
44600
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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