Investigator-initiated clinical trial, phase I trial, and accompanying st udies investigating the safety and immunogenicity of booster vaccination against COVID-19 (KD-414)

Koga Michiko0 sites160 target enrollmentDecember 26, 2021

ConditionsCOVID-19

Overview

No summary available.

Registry

who.int

Start Date

December 26, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Koga Michiko

•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

•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