NIPH Clinical Trials Search

Evaluation of the safety and immunogenicity of a new corona vaccine (Kost aive) in the elderly.(KOSTAIVE study)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Prevention of COVID-19
Date of first enrollment	14/10/2025
Target sample size	300
Countries of recruitment
Study type	Interventional
Intervention(s)	The research drug will be administered as a routine vaccination with the novel corona vaccine. After consent is obtained, the prescribed observations, tests, etc. will be performed at each observation point.

Outcome(s)

Primary Outcome

Specific adverse events (specific local adverse events and specific systemic adverse events) occurring after the research drug inoculation (Day 1) through Day 7, and unspecified adverse events occurring after the research drug inoculation (Day1) through Day 29.

Secondary Outcome

[Safety] (1) Symptoms of concern that occurred from after inoculation (Day 1) to Day 7 (2)Serious adverse events other than death, death due to adverse events, medically significant adverse events, noteworthy adverse events, adverse events leading to discontinuation/ dropout that occur red from after study drug inoculation (Day 1) to Day 361 (3)Days to onset and duration of specified adverse events and unspecified adverse events (4) Body temperature before and after inoculation (Day 1) to Day 7 of the study drug [Immunogenicity] (1) Geometric mean titer (GMT) against SARS-CoV-2 (Omicron XEC strain) at Day 29 (2) Neutralizing antibody response rate (SRR) against SARS-CoV-2 (Omicron XEC strain) on Day 29 (3) GMT against SARS-CoV-2 (Omicron XEC strain) at Day 1, Day 29, Day 61, Day 91, Day 181 and Day 361 (4) Trends in SRR against SARS-CoV-2 (omicron XEC strains) on Day 29, Day 61, Day 91, Day 181 and Day 361 (5) Geometric mean fold increase in neutralizing antibody titer (GMFR) against Day 1 for SARS-CoV-2 (Omicron XEC strain) at Day 29, Day 61, Day 91, Day 181 and Day 361 [Efficacy] (1) Incidence of novel coronavirus infection (COVID-19) from Day 8 to the completion of follow-up (Day 361) (2) Incidence of severe COVID-19 from Day 8 to the completion of follow-up (Day 361)

Key inclusion & exclusion criteria

Age minimum	>= 65age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Persons who, at the time of obtaining consent, meet the conditions of routine inoculators of the new corona vaccine who are 65 years of age or older (including persons 60 years of age or older with heart, kidney, or respiratory impairment that severely limits their personal lives or persons with immune dysfunction caused by the human immunod eficiency virus that makes daily living almost impossible) and who are eligible to receive the research drug (Costaive for intramuscular injection) who are eligible for observation and examination for 1 year after vaccination. 2) Persons who can prove a history of vaccination with the novel corona vaccine. 3) If the subject has a history of novel coronavirus infection, the time of infection must be identifiable and at least one month must have elapsed since the last novel coronavirus infection. 4) Patients who have been vaccinated against novel coronavirus for at least 3 months since their last vaccination against novel coronavirus. 5) Persons who can give written consent.
Exclude criteria	1) Persons who are judged by the Principal Investigator to be ineligible as research subjects.