An exploratory single-arm study to evaluate the safety and immunogenicity of KD-414 as a booster vaccination to SARS-CoV-2 in healthy adults
- Conditions
- Prevention of COVID-19
- Registration Number
- JPRN-jRCTs031210388
- Lead Sponsor
- jiie Mugen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 97
1) Participants in the previous study A Survey of Vaccine-Induced COVID-19 antibody Titer to Verify Temporal Changes who received two doses of COVID-19 vaccination and completed antibody titer measurement on Day 29.
2) Subjects who have provided written informed consent; are able to comply with the study protocol for the duration of the study; are able to make themselves available on scheduled study days as specified by the protocol; and are able to report on their health conditions such as symptoms.
1) Have received the third doses of Vaccine against COVID-19 in the past at the time of informed consent,
2)Pregnant or possibly pregnant women, women desiring to become pregnant before completing follow-up examination and breastfeeding women,
3) Patients with progressive ossifying fibrodysplasia,
4) Patients having an underlying disease, such as serious cardiovascular diseases, serious renal diseases, serious hepatic diseases, serious hematological diseases, serious developmental disorders, serious respiratory diseases, serious diabetes mellitus, etc.,
5) Subjects with a history of convulsions,
6) Subjects having been diagnosed with immunodeficiency or having a close relative with congenital immunodeficiency,
7) Subjects possibly being allergic to any ingredient of the study product,
8) Subjects who participated in another clinical trial and have received another investigational product (excluding placebo) within 4 months (120 days) prior to the date of the first dose of study product in this study, or those who plan to participate in another clinical trial during their participation in this study,
9) Subjects who have received transfusion or a gamma globulin preparation within 3 months (90 days), or a bolus therapy (>=200 mg/kg) with a gamma globulin preparation within 6 months (180 days), prior to the date of the first dose of study product,
10) Subject who have received any treatments that may affect the immune function within 6 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.),
11) Subjects who have received live vaccine within 1 month prior to enrollment or inactivated vaccine within 1 week prior to enrollment
12) Subjects who have a history of breakthrough infection if they wish to be vaccinated with study product
13) Subjects who are judged by the principal investigator or the sub investigator as ineligible for the study as a result of the screening test, or Subject being otherwise ineligible for this study in the principal investigator's or sub investigator's opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eutralizing antibody conversion rate at Day 7
- Secondary Outcome Measures
Name Time Method <Immunogenicity><br>1)Neutralizing antibody conversion rate at Day 40<br>2)IgG-S antibody against SARS-CoV-2 at Day 7 and 40<br>3)IgG-N antibody against SARS-CoV-2 at Day 7 and 40<br>4)IgM antibody against SARS-CoV-2 at Day 7 and 40<br>5)Th1 and Th2 against SARS-CoV-2 at Day 7<br>6)SARS-CoV-2 by QuantiFERON at Day 7 and 40<br><br><Efficacy ><br>Incidence of COVID-19 infection until day 40<br><br><Safety><br>1) Percentage of all adverse events, deaths due to adverse events, serious adverse events other than death, important adverse events, and severe (Grade 3 or higher) adverse events that occurred from the time of study drug inoculation to day 40, and their causal relationship to the study drug <br>2) Specified local adverse events<br>3) Specified systemic adverse events<br>4) Unspecified adverse events<br>5) The highest body temperature administration of the study product and 6 days post-injection