Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
A Phase 1, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study to Assess the Safety and Immunogenicity of an Investigational Non-Replicating Rotavirus Vaccine (MT-5625) in Healthy Adults, Toddlers and Infants
1 other identifier
interventional
110
2 countries
2
Brief Summary
A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged 18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jul 2018
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedStudy Start
First participant enrolled
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2019
CompletedAugust 6, 2019
August 1, 2019
12 months
April 15, 2018
August 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects with local reactions and reactogenicity events.
Within 7 days after each vaccination
Proportion of subjects reporting adverse events.
Within 28 days after each vaccination
Secondary Outcomes (4)
Proportion of subjects with anti-MT-5625 IgG seroresponses
Day 28 after each vaccination
Proportion of subjects with neutralizing antibody responses
Day 28 after each vaccination
Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.
Day 28 after each vaccination
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.
Day 28 after each vaccination
Study Arms (8)
Adult MT-5625 middle dose
EXPERIMENTALAdult receiving intramuscular injection with either middle dose of MT-5625 or placebo
Adult MT-5625 high dose
EXPERIMENTALAdult receiving intramuscular injection with either high dose of MT-5625 or placebo
Toddler MT-5625 middle dose
EXPERIMENTALToddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
Toddler MT-5625 high dose
EXPERIMENTALToddler receiving intramuscular injection with either high dose of MT-5625 or placebo
Infant MT-5625 low dose
EXPERIMENTALInfant receiving intramuscular injection with either low dose of MT-5625 or placebo
Infant MT-5625 middle dose
EXPERIMENTALInfant receiving intramuscular injection with either middle dose of MT-5625 or placebo
Infant MT-5625 high dose
EXPERIMENTALInfant receiving intramuscular injection with either high dose of MT-5625 or placebo
Rotarix
ACTIVE COMPARATORInfant receiving oral administration with Rotarix
Interventions
Intramuscular injection
Intramuscular injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- Healthy male or female adults/toddlers/infants as established by medical history and clinical examination before entering the study
- Adults aged \>18 and \< 35, toddlers aged \>12 and \< 24 months, and infants aged \> 6 and \< 10 weeks at the time of enrollment
- Subject (or Parent/Legal Guardian) willing and able to give written informed consent after the nature of the study has been explained
- Subject (or Parent/Legal Guardian) willing to comply with the study restrictions and study schedule and to remain in the area for the study duration
- Females of potential childbearing must not be pregnant or breastfeeding and willing to use adequate method of contraception during the trial
You may not qualify if:
- ALL SUBJECTS
- Presence of fever or other acute illness
- Concurrent participation in another clinical trial or receipt of an investigational product during the 30 days prior to randomization
- Suspected or known impairment of immune function
- Known sensitivity to any components of the study vaccine
- History of anaphylactic reaction
- Receipt of immunoglobulin therapy or blood products in last 6 months
- History of chronic immunosuppressive medications (with the exception of inhaled or topical steroids)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- ADULTS ONLY
- Have received any vaccine within 4 weeks prior to randomization
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
- Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
- Have any contraindications to parenteral injections ( eg history of bleeding disorder)
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Investigational center
Adelaide, Australia
Investigational center
Johannesburg, South Africa
Related Publications (1)
Kurokawa N, Robinson MK, Bernard C, Kawaguchi Y, Koujin Y, Koen A, Madhi S, Polasek TM, McNeal M, Dargis M, Couture MM, Trepanier S, Forrest BD, Tsutsui N. Safety and immunogenicity of a plant-derived rotavirus-like particle vaccine in adults, toddlers and infants. Vaccine. 2021 Sep 15;39(39):5513-5523. doi: 10.1016/j.vaccine.2021.08.052. Epub 2021 Aug 25.
PMID: 34454786DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
General Manager
Tanabe Pharma Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2018
First Posted
April 25, 2018
Study Start
July 3, 2018
Primary Completion
June 28, 2019
Study Completion
June 28, 2019
Last Updated
August 6, 2019
Record last verified: 2019-08