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

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Brief Title

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

Official Title

A Phase III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to ShancholTM in 1 to 40 Years Old Healthy Nepalese Participants

Brief Summary

      The investigators plan to study 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 with non-simplified, licensed OCV.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages

Secondary Outcome

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

Condition

Cholera

Intervention

Oral Cholera Vaccine Simplified (OCV-S)

Study Arms / Comparison Groups

 Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)
Description:  Participants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0.2-week schedule.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

2530

Start Date

October 6, 2021

Completion Date

January 21, 2023

Primary Completion Date

October 21, 2022

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.
      

Gender

All

Ages

1 Year - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Julia Lynch, MD, +82-2-8811-228, [email protected]

Location Countries

Nepal

Location Countries

Nepal

Administrative Informations


NCT ID

NCT04760236

Organization ID

IVI OCV-S


Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 EuBiologics Co.,Ltd

Study Sponsor

Julia Lynch, MD, Principal Investigator, International Vaccine Institution


Verification Date

October 2021