Biomarker research of DAICHIRONA

JRCT ID: jRCTs031240519

Registered date:03/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Health adults
• Date of first enrollment: 20/12/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): DAICHIRONA INTRAMUSCULAR INJECTION (antigenic strain: SARS-CoV-2 omicron strain JN.1 strain) once intramuscularly inoculated with 0.6 mL.

Outcome(s)

• Primary Outcome: Cytokine and chemokine productions from cultured PBMCs after DAICHIRONA stimulation by specific side effects categories after intramuscular injection and by severity category

Secondary Outcome

<Exploratory evaluations>
-Cytokine and chemokine productions from cultured PBMCs after coronavirus (SARS-CoV-2) RNA vaccine-stimulation*1.
-Cytokine and chemokine productions from cultured PBMCs after stimulating other coronavirus (SARS-CoV-2) RNA vaccines*2 by specific side effects categories and severity categories after intramuscular injection of DAICHIRONA
-Anti SARS-CoV-2 Receptor-Binding Domain (RBD) antibody titers in blood before and after intramuscular injection of DAICHIRONA, changes and pre-and post-inoculation ratios.
-Anti SARS-CoV-2 RBD antibody titers (at each time point and pre-to post-vaccination) by specific side effects categories and by severity categories after intramuscular injection of DAICHIRONA
-Relationship between anti SARS-CoV-2 RBD antibody titers before and after intramuscular injection of DAICHIRONA and cytokine/chemokine productions from cultured PBMC after intramuscular stimulation of DAICHIRONA
<Safety evaluations>
-Evaluation by specific side effects classification and severity classification after intramuscular injection of DAICHIRONA
-Evaluation of adverse events/ side effects

*1: DAICHIRONA; COMIRNATY; Spikevax
*2: COMIRNATY; Spikevax

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

1.Healthy adults aged between 18 to 64 years at the time of informed consent
2.Persons previously vaccinated against coronavirus (SARS-CoV-2) mRNA vaccine
3.Persons who are concluded to be eligible for vaccination with DAICHIRONA by the principal investigator, etc. from the preliminary medical examination
4.Persons who have voluntarily given written informed consent to participate in this study

Exclude criteria

1.Persons presenting with fever.
2.Persons who have serious acute illness at the time of obtaining informed consent.
3.Persons with a history of severe hypersensitivity to coronavirus (SARS-CoV-2) mRNA vaccine components.
4.Persons who had vaccinated against coronavirus (SARS-CoV-2) mRNA vaccine within 3 months before the date of informed consent.
5.Persons with a history of coronavirus infection within 6 months before the date of informed consent.
6.Persons aged between 60 to 64 years who are eligible for regular vaccination against corona virus infections.
7.Persons who fall under prohibited concomitant medications and prohibited concomitant therapies.
8.Persons who have experienced shock or anaphylaxis due to food, drugs, vaccines, etc.
9.Persons with a history of Guillain-Barre syndrome.
10.A person who falls under any of the followings or who is concluded by the principal investigator, etc. may have a problem with ensuring safety
- Individuals with thrombocytopenia or coagulopathy
- Individuals on anticoagulation therapy
- Individuals with a previous diagnosis of immunodeficiency and relatives with hereditary immunodeficiency disorder.
-Individuals with underlying diseases such as cardiovascular disease, kidney disease, liver disease, hematologic disease, or growth disorder
- Individuals with renal or hepatic dysfunction
- Individuals who have experienced pyrexia or a history of symptoms of allergy such as generalized rash within 2 days of vaccination.
-Individuals with a history of convulsions
-Individuals who may be allergic to mRNA vaccine components.
11.Persons who wish to become pregnant, is pregnant, is breastfeeding, or possibly is pregnant.
12.Others who are concluded as unfit for this study by the principal investigator, etc.

Related Information

• Primary Sponsor: Kijima Takashi
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd.