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.

to determine the immunogenicity and safety of COVID-19 recombinant receptor binding domain (RBD) protein vaccine in healthy population

Clinical trial with control group with parallel groups, double-blind, randomized, phase two on 300 volunteers

This double-blind study (volunteers and outcome assessors) with placebo will be performed on 300 healthy volunteers at Baqiyatallah Hospital in Tehran, Shahid Soleimani Clinical Trial Center . Candidates received a random dose of 80 micrograms of vaccine or placebo, received the vaccine on days 0, 21 and 35, and were followed up until day 49 for side effects, humoral and cellular immunity. All people will be followed up for a long time after the end of the study until day 360.

Healthy 18-40 years, the ability to understand the study, signing the informed consent, not being pregnant, Main exclusion criteria: Positive PCR test, symptoms consistent with COVID-19, history of COVID-19 disease in the last month, abnormal paraclinical findings, history of allergy to the vaccine, neurologic disease, immunodeficiency, coagulopathy, psychiatric and other chronic diseases, Receiving live vaccine in one month or other vaccines in 14 days before inoculation

Participants are randomly assigned to the following groups: 1- Receiving the recombinant vaccine (80 micrograms) intramuscularly (deltoid muscle) on days 0, 21 and 35 (240 people) 2- Receiving placebo (buffer + adjuvant) intramuscularly (deltoid muscle) on days 0, 21 and 35 (60 people)

The titer of antibody (RBD), the occurrence of SARS-COV-2 infection, measurement of cellular immunity. occurrence of any side effects after injection, during 7, 125 days, and a year.

The randomization process in this study will be done in one step and a random chain will be created. For this purpose, 72 random block sequences with size 5 are produced so that for every 4 volunteers receiving active vaccine, 1 volunteer will receive a placebo.

Each dose of vaccine is packaged separately and has an identification number. Vaccine boxes and placebo are offered in exactly the same appearance and packaging, which will blind the participants, researchers and outcome assessors. After using the vaccine, the abbreviation of the study participant and the date of vaccination are written in the outer packaging box and the activity label is recorded on the main sheet. Personnel check all information before injection. During the study, all outer packing boxes will be archived and maintained.

No plans to release patient data

Data will be available to regulatory bodies and the ethics committee

The protocol and results will become available to the public after completion of the study.

The regulatory body and the ethics committee will have access to the study data. The monitoring team will have access to the study data during the conduct. DSMB will have access to the study data and results in predefined timelines and decides about the continuation of the study.

With the permission of the sponsor and the approval of regulatory

The study sponsor is responding to this request

Relevant applications will be provided to the requesting researcher in the form of a joint project after review and approval by the relevant authorities. Normally between 3 to 5 working days