Moderna vaccine study

JRCT ID: jRCTs031230490

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy volunteer etc.
• Date of first enrollment: 07/12/2023
• Target sample size: 104
• Study type: Interventional

Intervention(s)

On days of Omicron XBB.1.5 compatible vaccination (Day 1) and Day 2, acetaminophen 300 mg/dose or equivalent placebo (lactose) was orally administered 3 times daily for 2 days.
- Allocation method: Hierarchical block randomization
- Stratification factors: gender (male and female), age (teens, 20s, 30s, 40s, 50s, 60s, 70s)

Outcome(s)

• Primary Outcome: Incidence of local side reactions and/or systemic side reactions occurring within 7 days from the date of vaccination

Secondary Outcome

(1) Incidence of local side reactions occurring within 7 days from the date of vaccination
(1)-1 Incidence of multiple local side reactions
(1)-2 Incidence of individual local side reactions
(1)-3 Incidence of local adverse reactions by severity
(2) Incidence of systemic side reactions occurring within 7 days from the date of vaccination
(2)-1 Incidence of complex systemic adverse reactions
(2)-2 Incidence of individual systemic side reactions
(2)-3 Incidence of systemic adverse reactions by severity
(3) Incidence of side reactions up to 14 days after vaccination (to be reported on the 14th day)
(4) IgG antibody titer 14 days after vaccination
(5) Change in IgG antibody titer from before vaccination (day of vaccination) to 14 days

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Those who meet all of the following selection criteria and who have obtained consent from the person himself/herself.
1) Over 18 years old
2) Gender: Any
3) Eligible for COVID-19 vaccine booster in accordance with the instructions of the Ministry of Health, Labor and Welfare
4) Healthy or stable chronic condition without major changes in treatment or hospitalization over the past 6 weeks
5) Those who can agree to contraception in order to take drugs on the day of COVID-19 vaccination and the day after that

Exclude criteria

Those who meet even one of the following exclusion criteria will be excluded from the target.
(1) Persons who have not received mRNA or COVID-19 vaccine
(2) Persons who have taken antipyretic analgesics or acetaminophen within 24 hours prior to booster vaccination
(3) Patients with a contraindication or history of severe adverse reaction to mRNA or COVID-19 vaccine
(4) Allergy or intolerance to acetaminophen
5) Patients on chronic treatment with NSAIDs
6) Patients with peptic ulcer
(7) Patients with aspirin asthma or with a history of aspirin asthma
(8) Patients with severe cardiac dysfunction
(9) Patients with a history of immunodeficiency (including but not limited to CD4 count below 200, progressive hypogammaglobulinemia, CVID)
(10) Patients with a history of systemic steroid therapy, active treatment with immunosuppressive agents including DMAR, small molecule drugs used to suppress immune response, biologics, or human blood products in the past 12 months
(11) Persons with serious renal disease
(12) Persons with serious liver disease
(13) Pregnant or lactating mothers
(14) Persons deemed unsuitable as subjects by the doctor in charge of conducting the research

Related Information

• Primary Sponsor: Kobashi Hiroe
• Secondary Sponsor: Takao Hiroyuki,Allm Inc.