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CholeraPhase 3NCT04760236

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

A Phase 3 study testing Oral Cholera Vaccine Simplified (OCV-S) and Shanchol™ in people with Cholera, run by International Vaccine Institute at 4 sites in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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™. Read more about this study

Who is it for?
Ages 1 year to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cholera
What is being tested?
Oral Cholera Vaccine Simplified (OCV-S) and Shanchol™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,530 participants
Where
4 sitesNepal
Study dates
6 Oct 2021to 21 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 locations and contacts

4 sites in 1 country.

Nepal4 sites

  • Nepalgunj medical college

    Bānke, City- Nepalgunj

  • Kanti Children's Hospital

    Kathmandu, Sukedhara, 44600

  • Dhulikhel Hospital

    Kavre, Dhulikhel

  • B.P.Koirala Institute of Health Sciences

    Rautahat, Dharan

Other trials in Nepal

About this study

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

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
Being tested
Oral Cholera Vaccine Simplified (OCV-S), Shanchol™
Medical subject headings
Cholera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Cholera Vaccine Simplified (OCV-S)Biological

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

  • Shanchol™Biological

    • Manufacturer: Shantha Biotechnics
    • Oral administration
Study groups in NCT04760236
Study groupRoleWhat they receive
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 1)ExperimentalParticipants (n=330) aged 18-40 years old will received OCV-S (Lot 1) according to 0-2 week schedule.
Receives: Biological: Oral Cholera Vaccine Simplified (OCV-S)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 2)ExperimentalParticipants (n=330) aged 18-40 years old will received OCV-S (Lot 2) according to 0-2 week schedule.
Receives: Biological: Oral Cholera Vaccine Simplified (OCV-S)
Oral Cholera Vaccine-Simplified (OCV-S) group (Lot 3)ExperimentalParticipants (n=935) aged 1-40 years old will received OCV-S (Lot 3) according to 0-2 week schedule.
Receives: Biological: Oral Cholera Vaccine Simplified (OCV-S)
Shanchol™ groupActive comparatorParticipants (n=935) aged 1-40 years old will received Shanchol™ according to 0-2 week schedule.
Receives: Biological: Shanchol™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

  2. 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

    Measured: As in Description

Secondary outcomes (4)

  1. 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

    Measured: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

  2. 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

    Measured: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

  3. 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

    Measured: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

  4. 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

    Measured: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start6 Oct 2021
  3. Primary completion22 Dec 2022
  4. Study completion21 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,530 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04760236
Sponsor's protocol ID
IVI OCV-S
Status last verified
Jun 2023
First submitted
13 Jan 2021
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38614631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oral Cholera Vaccine Simplified (OCV-S) and Shanchol™ in people with Cholera, run by International Vaccine Institute at 4 sites in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 2 weeks after second dose of either OCV-S (i.e., one lot of OCV-S) or Shanchol™). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04760236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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