A Phase 3, Randomized, Double-Blind, Active-Controlled, Confirmatory Study to Compare the Immunogenicity, Efficacy, and Safety of KD-414 Vaccine and Vaxzevria Vaccine in Adults Aged 18 to 40 Years Old (COVID-19)

JRCT ID: jRCT2031210679

Registered date:18/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of COVID-19 infection
• Date of first enrollment: 30/04/2022
• Target sample size: 1500
• Countries of recruitment: Philippines,Japan
• Study type: Interventional

Intervention(s)

KD-414 is an inactivated whole-particle vaccine containing purified inactivated SARS CoV 2 cultured in Vero cells derived from African green monkey kidney cells, with aluminum hydroxide as adjuvant. Each KD-414 vaccine contains inactivated SARS-CoV-2 and excipients. Subjects randomly assigned to receive KD-414 will be vaccinated on Days 1, 29, and 120. The vaccine will be administered by IM injection into the deltoid muscle.
Vaxzevria vaccine is a monovalent vaccine composed of a single recombinant, replication deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. Vaxzevria vaccine contains recombinant ChAdOx1-S. Subjects randomly assigned to receive Vaxzevria will be vaccinated on Days 1 and 29. On Day 120, normal saline will be administered. The vaccine and normal saline will be administered by IM injection into the deltoid muscle.

Outcome(s)

• Primary Outcome: Geometric mean titer of serum neutralizing antibody against SARS-CoV-2 at 28 days after the third dose of KD-414 (Day 148) as compared with that at 28 days after the second dose of Vaxzevria (Day 57).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Both

Include criteria

1. Is capable of understanding the written informed consent, provides signed informed consent, and agrees to comply with protocol requirements.
2. Is aged 18 to 40 years old.
3. Is healthy or medically stable as determined by investigator judgment based on medical history, physical examination, and vital signs. Medically stable condition is defined as any chronic medical disease or condition that has not required a change in medication or surgical intervention or resulted in hospitalization or medically attended events within 6 months prior to screening.

Exclude criteria

1. Has a current diagnosis or a history of laboratory confirmed SARS-CoV-2.
2. Has close contacts with person(s) with COVID-19 within 14 days of the first dose of study vaccine (based on the interview with subject).
3. Has been infected with HIV..
4. Has received any prior vaccines against COVID-19.
5. Has experienced documented anaphylaxis caused by an ingredient of study vaccine.

Related Information

• Primary Sponsor: Fushimi Hideki
• Source(s) of Monetary Support: AMED,MHLW