NCT05012787 - Safety and Immunogenicity of Adjuvanted SARS-CoV-2 (SCB-2019) Vaccine in Adults With Chronic Immune-Mediated Diseases | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 12, 2021

Primary Completion Date

March 30, 2022

Study Completion Date

May 4, 2022

Conditions

COVID-19

Interventions

BIOLOGICAL

CpG 1018/Alum-adjuvanted SCB-2019 vaccine

Participants will receive 1 intramuscular (IM) injection of 30 microgram (mcg) SCB-2019 with CpG 1018/Alum adjuvant on Day 1 and on Day 22.

BIOLOGICAL

Havrix

Participants will receive Havrix (Hepatitis A vaccine) containing 1440 Enzyme-linked Immunosorbent Assay (ELISA) units (EL.U.) in 1.0 mL dose on Day 1.

OTHER

Placebo; 0.9% saline

Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 22.

Trial Locations (4)

2002

Medical Centre of Edelweiss Medics LLC, Kyiv

3037

Medical Center of Medbud-Clinic LLC, Kyiv

4210

Center of Family Medicine Plus, LLC, Kyiv

21009

Medical Center Salutem LLC, Vinnitsa