Clinical trial NCT04760236: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholera
Lead sponsor: International Vaccine Institute
Sponsor class: OTHER
Collaborators: name: EuBiologics Co.,Ltd
First posted: 2021-02-18
Enrollment: 2530
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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™.


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.

Primary outcomes:
measure: Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by seroconversion rates for all ages
timeFrame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
measure: Vaccine Safety profile
timeFrame: As in Description
Secondary outcomes:
measure: Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT for all ages
timeFrame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
measure: 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
timeFrame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
measure: Immune non-inferiority of OCV-S compared to Shanchol™ (i.e., one lot of OCV-S) as measured by GMT in each age stratum
timeFrame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
measure: The equivalence of immunogenicity in 3 lots as measured by GMT
timeFrame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Other outcomes:
measure: The equivalence of immunogenicity in 3 lots as measured by seroconversion rates
timeFrame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
measure: Vibriocidal antibody responses
timeFrame: 2 weeks after first dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™
Locations:
city: Banke
country: Nepal
facility: Nepalgunj medical college
state: City- Nepalgunj
city: Rautahat
country: Nepal
facility: B.P.Koirala Institute of Health Sciences
state: Dharan
city: Kavre
country: Nepal
facility: Dhulikhel Hospital
state: Dhulikhel
city: Kathmandu
country: Nepal
facility: Kanti Children's Hospital
state: Sukedhara
Study officials:
affiliation: International Vaccine Institution
name: Julia Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References: