Immune Response to a Delayed Second Dose of Oral Cholera Vaccine

NCT05453253 | Unknown Phase 4 DMC

• 1 other identifier: OCV_DelayedProtocol
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

Immune response to a delayed second dose of oral cholera vaccine A randomized, controlled, non-inferiority immunogenicity trial in Conakry, The Republic of Guinea

Conditions

Cholera; Vibrio Cholerae Infection

Keywords

Delayed vaccine; Cholera; non-inferiority

Outcome Measures

Primary Outcomes (1)

• Serum vibriocidal antibody specific to V. cholerae O1, Inaba, Ogawa and O139 strains

  Serum vibriocidal antibody Geometric Mean Titre (GMT)

  14 days after the administration of the second vaccine dose

Secondary Outcomes (6)

• Serum vibriocidal antibody specific to V. cholerae O1, Inaba, Ogawa and O139 strains

  Just before and 14 days after administration of the first dose and and just before the second OCV dose

• Serum vibriocidal anti-OSP IgA, IgG, IgM

  Just before and 14 days after administration of the first and the second OCV dose

• Anti-CtxB immunoglobulines

  Just before and 14 days after administration of the first and the second OCV dose

• Immediate Adverse Events (IAEs) (Safety)

  Up to 30 minutes after each OCV dose

• Adverse events (AEs) (Safety)

  Until 14 days after the administration of the first and the second OCV dose

Other Outcomes (3)

• Serum vibriocidal antibody specific to V. cholerae O1, Inaba, Ogawa and O139 strains

  In a subgroup of participants: At 4, 7, 28 and 180 days after administration of the first and the second OCV dose

• Serum vibriocidal anti-OSP IgA, IgG, IgM

  In a subgroup of participants: At 4, 7, 28 and 180 days after administration of the first and the second OCV dose

• Anti-CtxB immunoglobulines

  In a subgroup of participants: At 4, 7, 28 and 180 days after administration of the first and the second OCV dose

Study Arms (3)

interventional 6 months interval between OCV doses

EXPERIMENTAL

This intervention arm will modify the recommended interval for administration of the second Euvichol-Plus®, which will be extended to 6 months.

Biological: Delayed second dose of oral cholera vaccine, Euvichol-Plus

interventional 12 months interval between OCV doses

EXPERIMENTAL

This intervention arm will modify the recommended interval for administration of the second Euvichol-Plus®, which will be extended to 12 months.

Biological: Delayed second dose of oral cholera vaccine, Euvichol-Plus

control arm (standard 14-day interval)

ACTIVE COMPARATOR

Participants will receive the oral cholera vaccine, Euvichol-Plus®, according to the manufacturer instructions: 2 doses two weeks apart.

Biological: Oral cholera vaccine, Euvichol-Plus, according to manufacturer notice

Interventions

Delayed second dose of oral cholera vaccine, Euvichol-Plus BIOLOGICAL

The intervention arms (6 and 12 months) will modify the recommended interval for administration of the second vaccine dose, which will be extended to 6 and 12 months according to the intervention arm.

interventional 12 months interval between OCV doses; interventional 6 months interval between OCV doses

Oral cholera vaccine, Euvichol-Plus, according to manufacturer notice BIOLOGICAL

Euvichol-Plus, a WHO prequalified oral cholera vaccine, contains modified killed whole cell vaccine of formalin killed Vibrio cholerae strains of O1 Inaba, O1 Ogawa and O139. In the control arm, participants will receive the Euvichol-Plus following the manufacturer recommendations: two doses administered orally 14 days apart for individuals aged ≥1 year.

control arm (standard 14-day interval)

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any healthy individual ≥ 1 year-old and younger than 40 years old , eligible for OCV vaccination (not suffering from a medical condition that contraindicates vaccination, i.e. any acute illness, including acute gastrointestinal illness or acute febrile illness).
• Living in the study area with no plan to move away over the study period (up to 18 months).
• Who provided written informed consent or whose representative (mother, father or main caretaker) provided written informed consent in case of individuals younger than 18 years. A written assent will also be obtained from adolescents (10-17 years)
• An individual who (or whose mother, father or main caretaker) is, based on the judgment of the investigator, capable of complying with the study requirements.

You may not qualify if:

• Known history of hypersensitivity reactions to other vaccines.
• Individual acutely ill or with signs of infection at the time of enrolment (e.g. fever \> 38⁰C)
• Gastrointestinal symptoms including nausea, vomiting, diarrhea, or decreased appetite within 24 hours prior to study initiation .
• Diarrhea, administration of antidiarrheal drugs or antibiotics to treat diarrhea or abdominal pain either lasting 2 weeks or longer within 6 months prior to study initiation, or occurring during the week before study initiation.
• Other vaccination within 1 week prior to study initiation or planned vaccination during the following month after vaccine intake .
• Participation in another trial with investigational product within 1 month prior to study initiation.
• Pregnant (as determined by a urine test on the day of each vaccination) or lactating women, women of reproductive age planning pregnancy before the end of the study period (up to minimum 18 months).
• An individual thought to have difficulty participating in the study due to other reasons (such as mental disorders, alcohol or drug intoxication), based on the judgment of the investigator.
• History of cholera vaccination or history of cholera as diagnosed by a medical person in a health facility (with or without laboratory confirmation).
• Severe chronic diseases or medical conditions, based on the medical judgment of the investigator, such as known low hemoglobin level or symptomatic anemia, severe acute malnutrition, chronic infection (e.g. tuberculosis), sequel of poliomyelitis, immunodeficiency due to symptomatic HIV/AIDS.
• Thrombocytopenia or bleeding disorders or other known contraindication to venipuncture. Severe medical condition that contraindicates vaccination. In particular, a) known history of immune function disorders; or b) current use of steroids cytotoxic drugs, immunosuppressant, immune modifying drug, Prednisolone, Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus; or c) known 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 patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years; or d) known uncompensated NYHA Class 3 or 4 congestive heart failure; or e) known myocardial infarction within the previous 6 months; or f) known neurological and/or psychiatric disorder.

Sponsors & Collaborators

• Epicentre: lead
• Ministry of Health, Guinea: collaborator
• Massachusetts General Hospital: collaborator
• Médecins Sans Frontières, Belgium: collaborator

Study Sites (1)

Dixinn

Conakry, Guinea

Location

MeSH Terms

Conditions

Cholera

Interventions

Cholera Vaccines

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Considering 20% loss of follow-up and sampling failures at 14 days post 2nd OCV, the aim is to enroll 152 participants per arm for the analysis. Thus 456 (3\*152) participants will be recruited. Also, participants with a blood sampling failure at baseline (pre-1st OCV) will be replaced and withdrawn before randomization. Thus 456 (3\*152) participants with an appropriate blood sample at baseline will be randomisedecruited.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 12, 2022
• Study Start: July 20, 2022
• Primary Completion: February 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

GU (1)