COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031210503

Minako Kono

dctsm@ims.u-tokyo.ac.jp

2021-12-21

Recruiting

nonRCT

Non-randomized

Single group assignment

Open label

unclear

Prevention

<Group 1> Group who are 20 to under 65 years and finished two intramuscular injections of Pfizer Comirnaty1. Subjects who are 20 years old or older and under 65 years old at the time of obtaining consent2. 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 drug4. Subjects who can obtain written consent<Group 2> Group who are 65 years or older and finished two intramuscular injections of Pfizer Comirnaty1. Subjects aged 65 and over at the time of obtaining consent2. 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 drug4. Subjects who can obtain written consent<Group 3> Group who are 20 to under 65 years and finished two intramuscular injections of Takeda/Moderna vaccine1. Subjects who are 20 years old or older and under 65 years old at the time of obtaining consent2. 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 drug4. Subjects who can obtain written consent<Group 4> Group who are 65 years or older and finished two intramuscular injections of Takeda/Moderna vaccine1. Subjects aged 65 and over at the time of obtaining consent2. 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 drug4. Subjects who can obtain written consent<Group 5-1> Group who have been vaccinated with Pfizer Comirnaty intramuscular injection only once1. Subjects who are 20 years old or older at the time of obtaining consent2. 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 drug4. Subjects who can obtain written consent<Group 5-2> Group who have been vaccinated with Takeda/Moderna vaccine intramuscular injection only once1. Subjects who are 20 years old or older at the time of obtaining consent2. 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 drug4. Subjects who can obtain written consent<Group 6-1> 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 consent2. Subjects who have been vaccinated twice with Pfizer Comirnaty intramuscular injection have been vaccinated for 6 to 12 mon

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 inoculation4.Subjects with a history of administration of anti-SARS-CoV-2 monoclonal antibody within three months before the inoculation of the investigational drug5.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 breastfeeding7.Subjects with progressive ossifying fibrodysplasia8.Subjects with underlying diseases such as severe cardiovascular disease, kidney disease, liver disease, blood disease, growth disorder, respiratory disease and diabetes etc9.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 past11.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.<Subjects 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.>

1

Koga Michiko

20

100

Japan

Healthy volunteers

N/A

160

[Safety and tolerance]Percentage of subjects who reported any adverse event even onceFrequency of each adverse event item after codingPercentage of subjects who reported the relevant adverse event even once by gradeSummary statistics for safety-related inspection items[Immunogenicity] Geometric mean of neutralizing antibody titers of each group against SARS-CoV-2 at four weeks after the investigational drug; and geometric mean fold rise of neutralizing antibody titers of each group against SARS-CoV-2 after the investigational drug compared to the titer before the first vaccination

Phase 1

[{"arm_notes": "IM;group 1 20-65 yo Comirnaty twice;group 2 >=65 yo Comirnaty twice;group 3 20-65 yo Takeda/Moderna twice;group 4 >=65 yo Takeda/Moderna twice;group 5 Comirnaty once; group 6 Takeda/Moderna once;group 7 Comirnaty twice + history of infection 3 to 24 months before; group 8 Takeda/Moderna twice + history of infection 3 to 24 months before", "treatment_id": 703, "treatment_name": "Kd-414", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]