Clinical trial of Noora vaccine

ABSTRACT

ConditionCOVID-19.
U07.1 COVID-19, virus identified;U07.1

InterventionIntervention 1 Intervention group receiving 80 micrograms of RBD protein recombinant SARS-CoV-2 vaccine in days 0, 21, and 35; intramuscular (deltoid muscle). Intervention 2 Control group the placebo group will receive an intramuscular injection (in the deltoid muscle) consisting of buffer and adjuvant only, on days 0, 21, and 35.

Primary outcome:IgG antibody against Receptor Binding Domain (RBD) protein. Timepoint in days 0, 35, 49, 125, 215 after injection of the first dose of vaccine. Method of measurement based on ELISA method and seroconversion rate (proportion of individuals with at least twofold and fourfold increases) and Geometric Mean Titer (GMT).;Cellular immunity response against recombinant vaccine RBD protein. Timepoint in days 0 and 49 after injection of the first dose. Method of measurement determining Th1 or Th2 dominance based on levels of IL-4? IL-10? IL-12? ? INF? with ELISA measurement, and levels of CD3? CD4? CD8 with INF? based on flow cytometry measurement.;Measurement of neutralizing Antibody based on virus neutralizing test (VNT). Timepoint in day 49 after injection of the first dose. Method of measurement Based on the cell culture and inhibition of virus entry (Neutralizing titer).

CriteriaInclusion criteria Healthy persons, 18-40 years old,
Without uncontrolled underlying disease

Exclusion criteria History of Covid-19 disease in the past month, positive coronavirus PCR test, uncontrolled underlying disease, T Important surgical history, receiving corona vaccine