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

International Vaccine Institute (IVI)

Status and phase: Completed; Phase 3

Conditions: Cholera

Treatments: Biological: Shanchol™; Biological: Oral Cholera Vaccine Simplified (OCV-S)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04760236

IVI OCV-S

Details and patient eligibility

About

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™.

Enrollment: 2,530 patients

Sex: All

Ages: 1 to 40 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,530 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: Oral Cholera Vaccine Simplified (OCV-S)

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

Experimental group

Description:

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

Treatment:

Biological: Oral Cholera Vaccine Simplified (OCV-S)

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

Experimental group

Description:

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

Treatment:

Biological: Oral Cholera Vaccine Simplified (OCV-S)

Shanchol™ group

Active Comparator group

Description:

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

Treatment:

Biological: Shanchol™