The investigator-initiated clinical trial, booster vaccination against COVID-19 (KD-414)

ABSTRACT

ConditionCOVID-19
COVID-19;COVID-19

Primary outcome:We will investigate various antibody reactions and cell-mediated immune responses as an exploratory study of immunogenicity, mainly surrogate markers and biomarkers.

CriteriaInclusion criteria Subjects who meet all the inclusion criteria and do not meet any of the exclusion criteria are targeted.

Group who are 20 to under 65 years and finished two intramuscular injections of Pfizer Comirnaty
1. Subjects who are 20 years old or older and under 65 years old at the time of obtaining consent
2. Subjects who have been vaccinated twice with Pfizer Comirnaty intramuscular injection before receiving this investigational drug and 6-12 months have passed since the first vaccine.
3. Subjects with no apparent history of SARS-CoV-2 infection prior to inoculation of this investigational drug
4. Subjects who can obtain written consent

Group who are 65 years or older and finished two intramuscular injections of Pfizer Comirnaty
1. Subjects aged 65 and over at the time of obtaining consent
2. Subjects who have been vaccinated twice with Pfizer Comirnaty intramuscular injection before receiving this investigational drug and 6-12 months have passed since the first vaccine.
3. Subjects with no apparent history of SARS-CoV-2 infection prior to inoculation of this investigational drug
4. Subjects who can obtain written consent

Group who are 20 to under 65 years and finished two intramuscular injections of Takeda/Moderna vaccine
1. Subjects who are 20 years old or older and under 65 years old at the time of obtaining consent
2. Subjects who have been vaccinated twice with Takeda/Moderna vaccine intramuscular injection before receiving this investigational drug and 6-12 months have passed since the first vaccine.
3. Subjects with no apparent history of SARS-CoV-2 infection prior to inoculation of this investigational drug
4. Subjects who can obtain written consent


Group who are 65 years or older and finished two intramuscular injections of Takeda/Moderna vaccine
1. Subjects aged 65 and over at the time of obtaining consent
2. Subjects who have been vaccinated twice with Takeda/Moderna vaccine intramuscular injection before receiving this investigational drug and 6-12 months have passed since the first vaccine.
3. Subjects with no apparent history of SARS-CoV-2 infection prior to inoculation of this investigational drug
4. Subjects who can obtain written consent

Group who have been vaccinated with Pfizer Comirnaty intramuscular injection only once
1. Subjects who are 20 years old or older at the time of obtaining consent
2. Subjects who have been vaccinated once with Pfizer Comirnaty intramuscular injection before receiving this investigational drug and 6-12 months have passed since the vaccine.
3. Subjects with no apparent history of SARS-CoV-2 infection prior to inoculation of this investigational drug
4. Subjects who can obtain written consent


Group who have been vaccinated with Takeda/Moderna vaccine intramuscular injection only once
1. Subjects who are 20 years old or older at the time of obtaining consent
2. Subjects who have been vaccinated once with Takeda/Moderna vaccine intramuscular injection before receiving this investigational drug and 6-12 months have passed since the vaccine.
3. Subjects with no apparent history of SARS-CoV-2 infection prior to inoculation of this investigational drug
4. Subjects who can obtain written consent

Group who have been vaccinated with Pfizer Comirnaty intramuscular injection twice with a history of SARS-CoV-2 infection
1. Those who are 20 years of age or older at the time of obtaining consent
2. Subjects who ha

Exclusion criteria 1.Subjects who tested positive for SARS-CoV-2 by a PCR test at screening,
2.Subjects with COVID-19,
3.Close contact with COVID-19 patients at the time of the inoculation
4.Subjects with a history of administration of anti-SARS-CoV-2 monoclonal antibody within three months before the inoculation of the investigational drug
5.Subjects who have developed anaphylaxis due to a component of the investigational drug (thimerosal)
6.Pregnant women, women who may be pregnant, women who wish to become pregnant by four weeks after the inoculation of the investigational drug, women who are breastfeeding
7.Subjects with progressive ossifying fibrodysplasia
8.Subjects with underlying diseases such as severe cardiovascular disease, kidney disease, liver disease, blood disease, growth disorder, respiratory disease and diabetes etc
9.Subjects who have had the fever (excluding the feeling of heat at the inoculation site) within two days after the vaccination except for the COVID-19 preventive vaccine, and those who have had symptoms suspected of allergies such as a systemic rash (cause) Not applicable if it is confirmed that the ingredient is not contained in the investigational drug)
10.Subjects who have a history of convulsions in the past
11.Subjects having been diagnosed with immunodeficiency or having a close relative with congenital immunodeficiency,
12.Subjects who have experienced documented anaphylaxis caused by an ingredient of the investigational product (thimerosal),
13.Subjects who participated in other clinical trials or clinical trials within 120 days from the date of inoculation of the study drug, or subjects who plan to participate by the end of the follow-up period of this study.
14.Subjects who have received transfusion or a gamma globulin preparation within three months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within six months (180 days), prior to the date of the first dose of study product,
15.Subject who have received any treatments that may affect the immune function within six months (180 days) prior to the date of the first dose of study product, including radiotherapy, immunosuppressants (except for external use), immunosuppressive therapy, antirheumatics, adrenocorticotropic hormones, or corticosteroids (treatment at prednisolone equivalent doses >=2 mg/kg/day for >=14 days, except for external use.),
16.Subjects who are judged by the principal investigator or the sub-investigator as ineligible for the study as a result of the screening test,
17.Subject being otherwise ineligible for this study in the principal investigator's or sub-investigator's opinion.

who have been infected with SARS-CoV-2 at the time of inoculation of this investigational drug for less than three months or more than 24 months have passed.>