Phase I of clinical trial
The Covid-19 inactivated vaccine Phase I clinical study, produced by this company, started on Feb 2021, after receiving approvals of Iran Food and Drug Administration (IFDA)and the National Ethics Committee. In this study, 56 volunteers were enrolled in the study by predictions in statistical calculations. The trial protocol summary can be found in the link https://www.irct.ir/trial/52701 in both English and Persian languages. This study is randomized double-blind which means that the vaccines and placebo were labeled by defined code, and both participants and the medical staff will not be aware of received product until the end of the 28th day. Also, participants were assigned to mentioned sub-groups randomly without prior knowledge according to the randomization codes prepared by the Iran Food and Drug Administration (IFDA)in advance.
In this phase, 2 different doses of vaccine against placebo were evaluated by two separated injections on days 0 and 14. The results of immunity and immunogenicity of the experimental vaccine have been presented to MOH on March 2021. According to obtained results, one of doses selected and phase II/III clinical trial started.
Phase II/III of clinical trial
Clinical study of inactivated experimental vaccine Covid-19 produced by Shifa pharmed Industries Group were performed as randomized double-blind method after getting approvals by the Iran Food and Drug Administration (IFDA)and the National Ethics and Registration Committee in IRCT platform, first in Tehran (for phase II) with 280 participants and nationwide (Phase III) by 2000۰ participants. In phase II of this trial, two frequencies in injection (days 0 and 21 and days 0 and 28) will be examined and one of these strategies will be selected and used in phase III. All participants will receive their inoculations in selected timeline from previous studies.
Animal studies were conducted on mice, rabbits, piglets and monkeys to evaluate the safety, find the number of injecting doses and the effectiveness of vaccine. The vaccine challenge trail was also performed in mice and monkeys, which is summarized in following table. The full report has been submitted to the Iran Food and Drug Administration (IFDA)and its article is being written for submitting in prestigious scientific journals.
According to the preclinical results, inactivated experimental Covid-19 vaccine, shows acceptable safety and immunogenicity (immunogenicity).
Produced vaccine by Shifa Pharmed Industries Group, is based on inactivated Covid-19 virus (killed).
Production process perform in a sterile environment and proliferate under Level 3 of Biosafety conditions, inactivated by suitable substance, purified on special chromatographic column, formulated, and finally prepared as 0.5 ml suspension in sterile vials for intramuscular injection use.
Following the approval of physicochemical tests, safety and immunogenicity studies in animal models, the Covid-19 vaccine is currently undergoing clinical trials in humans under the supervision of the Ministry of Health, the Iran Food and Drug Administration (IFDA), and the National Ethics Committee. Filled vials should be stored at 2 to 8 ° C without freezing.
The summary of the clinical trials in different phases is as follow: