Safety and Immunogenicity of a New Formulation of Euvichol®

NCT02502331 | Unknown Phase 3

• 1 other identifier: IVI-CHOVI-EUVICHOL
• Study Type: interventional
• Target: 442
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Number of doses and intervals: Two doses, 2 weeks apart
• Method of administration: Oral administration
• Volume of vaccine to be administered: 1.5 mL/dose
• Observational period: 4 weeks (2 weeks after each dose)
• Number of visits: 3 visits
• Visit 1: Screening and enrollment (1st dosing)
• Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)
• Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This study will be carried out in healthy adults and children, at two sites, enrollment will be competitive between the sites. Subjects will be stratified according to age into adults (18\~40 years of age) and children (1\~17 years of age). According to the pre-generated randomization list, the participants will be randomized to the test or comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, blood sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the participants will be observed for 30 minutes post vaccination and instructed to record solicited adverse events that occur up to 6 days after vaccination on the participant diary card.

Conditions

Cholera

Keywords

Oral Cholera Vaccine; immunogenicity; safety

Outcome Measures

Primary Outcomes (3)

• Immunogenicity endpoint for Inaba O1

  Geometric Mean Titer (GMT) of Vibriocidal antibodies against Inaba serogroup O1 post second dose

  28 days

• Immunogenicity endpoint for Ogawa O1

  GMTof Vibriocidal antibodies against Ogawa serogroup O1 post second dose

  28 days

• Immunogenicity endpoint O139

  GMT of Vibriocidal antibodies against serogroup O139 post second dose

  28 days

Secondary Outcomes (2)

• Proportion of participants showing seroconversion against Inaba serogroup O1, Ogawa serogroup O1and serogroup O139 post vaccinations.

  28 days

• Seroconversion is defined as 4-fold rise in vibriocidal antibody titer at Visit 3 two weeks after the second dose, compared to baseline titers, measured at Visit 1 prior to vaccination.

  28 days

Study Arms (2)

study group

EXPERIMENTAL

Test Oral Cholera Vaccine

Biological: Test Oral Cholera Vaccine

comparator group

ACTIVE COMPARATOR

Euvichol®

Biological: Euvichol®

Interventions

Test Oral Cholera Vaccine BIOLOGICAL

Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.

study group

Euvichol® BIOLOGICAL

Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.

comparator group

Eligibility Criteria

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

You may qualify if:

• Subject willing to provide written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
• Individuals aged 1 - 40 years.
• An individual who can be followed up during the study period and is capable of complying with the study requirements

You may not qualify if:

• Known history of hypersensitivity reactions to other preventive vaccines.
• Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (\> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic drugs or other immunosuppressants.
• Severe chronic diseases, based on the judgment of the investigator.
• ℃ or higher body temperature measured prior to investigational product dosing.
• Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
• Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhoea within 1 week prior to study initiation.
• Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.
• Other vaccination within 1 week prior to study initiation or planned vaccination during the study, except for tetanus toxoid vaccine.
• Participation in another clinical trial with investigational product dosing within 1 month prior to study initiation.
• Pregnant or lactating women, women of reproductive age planning pregnancy and/or lactation before the end of the study period.
• An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator
• History of cholera vaccinations or history of cholera.
• History of alcohol or substance abuse
• Participant planning to move from the study area before the end of study period.

Sponsors & Collaborators

• International Vaccine Institute: lead
• EuBiologics Co.,Ltd: collaborator

Related Publications (1)

• Russo P, Ligsay AD, Olveda R, Choi SK, Kim DR, Park JY, Park JY, Syed KA, Dey A, Kim YH, Lee SH, Kim J, Chon Y, Digilio L, Kim CW, Excler JL. A randomized, observer-blinded, equivalence trial comparing two variations of Euvichol(R), a bivalent killed whole-cell oral cholera vaccine, in healthy adults and children in the Philippines. Vaccine. 2018 Jul 5;36(29):4317-4324. doi: 10.1016/j.vaccine.2018.05.102. Epub 2018 Jun 9.

  PMID: 29895500 DERIVED

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Digilio, MD

  International Vaccince Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Digilio, MD

CONTACT

+82-2-881-1363; Laura.Digilio@ivi.int

Sung Hee Lee, Msc

CONTACT

+82-2-881-1431; sungheelee@ivi.int

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 20, 2015
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 17, 2015

Record last verified: 2015-12