Clinical trial of Noora vaccine

A double-blind, randomized, placebo-controlled Phase II clinical trial to evaluate the immunogenicity and safety of covid-19 recombinant RBD protein vaccine (80 microgram) of Plasma Darman Sarve Sepid Co. in healthy population.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210620051639N2

Enrollment

300

Registered

2021-10-11

Start date

2021-10-12

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 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,

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
Local adverse event (s) (pain, redness, stiffness, swelling, skin rash, burning and itching). Timepoint: 30 min to 7 days after injection. Method of measurement: close monitoring.;Adverse systemic events (fever, headache, chills, diarrhea, vomiting, muscle aches, joint pain, shortness of breath, fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Adverse laboratory event (s) (biochemical or hematological) based on FDA scoring. Timepoint: in day 49 after vaccination. Method of measurement: based on FDA score.;Any serious adverse event, medically attended adverse event, or adverse event of interest. Timepoint: 0-125 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.	—

Measure

Time frame

Local adverse event (s) (pain, redness, stiffness, swelling, skin rash, burning and itching). Timepoint: 30 min to 7 days after injection. Method of measurement: close monitoring.;Adverse systemic events (fever, headache, chills, diarrhea, vomiting, muscle aches, joint pain, shortness of breath, fatigue, allergic reactions, etc.) based on the severity, duration and maximum severity of the complication. Timepoint: 0-7 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.;Adverse laboratory event (s) (biochemical or hematological) based on FDA scoring. Timepoint: in day 49 after vaccination. Method of measurement: based on FDA score.;Any serious adverse event, medically attended adverse event, or adverse event of interest. Timepoint: 0-125 days after each injection. Method of measurement: Examination, history, and report of the study participant based on the Vaccine Adverse Event Reporting System.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hassan Abolghasemi

Bagheiat-allah University of Medical Sciences

H.abolghasemi.ha@gmail.com+98 21 8216 2440

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026