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

NCT ID: NCT04760236

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2023-03-21

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™.

Conditions

Cholera

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral Cholera Vaccine Simplified (OCV-S)

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Oral Cholera Vaccine Simplified (OCV-S)

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

Oral Cholera Vaccine Simplified (OCV-S)

Intervention Type: BIOLOGICAL

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

Shanchol™ group

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

Group Type: ACTIVE_COMPARATOR

Shanchol™

Intervention Type: BIOLOGICAL

• Manufacturer: Shantha Biotechnics
• Oral administration

Interventions

Oral Cholera Vaccine Simplified (OCV-S)

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

Intervention Type: BIOLOGICAL

Shanchol™

• Manufacturer: Shantha Biotechnics
• Oral administration

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EuBiologics Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

International Vaccine Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

International Vaccine Institution

Locations

Nepalgunj medical college

Bānke, City- Nepalgunj, Nepal

B.P.Koirala Institute of Health Sciences

Rautahat, Dharan, Nepal

Dhulikhel Hospital

Kavre, Dhulikhel, Nepal

Kanti Children's Hospital

Kathmandu, Sukedhara, Nepal

Countries

Nepal

References

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.

Reference Type: DERIVED

PMID: 38614631 (View on PubMed)

Other Identifiers

IVI OCV-S

Identifier Type: -

Identifier Source: org_study_id