A Phase 1, Randomized, Double-blind, Multi-center, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent VLP Vaccine in Healthy Japanese Infants 5 Months of Age at First Trial Vaccine Administration

JRCT ID: jRCT2051230076

Registered date:25/07/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of norovirus-associated acute gastroenteritis.
• Date of first enrollment: 18/08/2023
• Target sample size: 21
• Study type: Interventional
• Intervention(s): 0.5 mL of HIL-214 or Placebo is injected twice at an interval of 4 to 8 weeks by the intramuscular (IM) route (anterolateral thigh).

Outcome(s)

Primary Outcome

Occurrence and intensity of solicited local reactions up to 7 days after each dose of trial vaccine.
Occurrence, intensity, and relationship of solicited systemic AEs up to 7 days after each dose of trial vaccine.
Occurrence, intensity, and relationship of unsolicited AEs up to 28 days after each dose of trial vaccine.
Occurrence, intensity, and relationship of AEs leading to withdrawal of trial vaccine up to 56 days post-dose 1.

Secondary Outcome

Occurrence, intensity, and relationship of AEs leading to withdrawal from the trial, SAEs and MAAEs throughout the entire trial period
At baseline, pre-dose 2, 28-days post-dose 2 and 6-months post-dose 2:
(1)HBGA blocking antibody titers.
(2)Pan-Ig antibody titers.

Key inclusion & exclusion criteria

• Age minimum: >= 4month 2weeks old
• Age maximum: <= 5month 2weeks old
• Gender: Both

Include criteria

Male or female subject aged 5 months (-14/+14 days).
Infants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
The subjects legally acceptable representative (LAR) signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
The subjects LAR is willing and able to comply with trial procedures and is available for the duration of follow-up.

Exclude criteria

Clinically significant abnormality in growth by length/height, weight, or head circumference (according to national guidelines).
Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
Chronic use of oral corticosteroids (equivalent to 20 mg/day prednisolone for >=12 weeks / >=2 mg/kg body weight /day for >=2 weeks) within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
Use of parenteral corticosteroids (equivalent to 20 mg/day prednisolone for >=12 weeks / >=2 mg/kg body weight /day for >=2 weeks. Use of inhaled, intranasal or topical corticosteroid is allowed) within 60 days prior to Visit 1.
Receipt of immunostimulants within 60 days prior to Visit 1.
Receipt of parenteral, epidural or intra-articular immunoglobulin (Ig) preparations, blood products, and/or plasma derivatives within 90 days prior to Visit 1 or planned during the full duration of the trial.
Receipt of immunosuppressive therapy prior to Visit 1.
Known hypersensitivity or allergy to any of the trial vaccine components (including excipients).
Any clinically significant active infection (as assessed by the investigator) or temperature >= 38.0 C (>100.4 F), regardless of method used, within 3 days prior to intended trial vaccine administration.
Gastroenteritis within 7 days before planned dosing (can warrant delay of trial vaccine administration).
History of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial.
Abnormalities of splenic or thymic function.
Known or suspected impairment/alteration of immune function.
Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Receipt or scheduled receipt of any other approved or authorized vaccines within 14 days (for all non-live vaccines or oral live vaccines) or 28 days (for parenteral live vaccines) before or after trial vaccine administration.
Participation in any clinical trial with another investigational product 30 days prior to first trial visit or intention to participate in another clinical trial at any time during the conduct of this trial.
Seropositive for, or in evaluation for, possible human immunodeficiency virus infection.
Hepatitis B or C infection.
Any heritable immunodeficiency or autoimmune disease.
Subjects LAR or subjects first-degree relatives involved in the trial conduct.

Related Information

• Primary Sponsor: Takahashi Kazuma