Sinovac’s Study Design & Details

Background: CoronaVac (formerly PiCoVacc) is a formalin-inactivated and alum-adjuvanted candidate vaccine. Results from animal studies showed “partial or complete protection in macaques” exposed to SARS-CoV-2, according to a paper published by researchers in the journal Science.

 

Study Design:

A Phase 1/2 trial enrolled 743 healthy volunteers (18-59 years old) who received two different dosages of the vaccine or placebo. There were 143 participants in Phase 1 (NCT04352608) and 600 participants in Phase 2 (NCT04383574).

 

Outcomes:

Results from the Phase 1/2 trials published in the pre-print server medRxiv indicate the vaccine has good safety and immunogenicity, with 92.4% of participants receiving the 3 μg dose on a 0-14 day schedule and 97.4% of individuals receiving the dose on a 0-28 day schedule achieving seroconversion.

 

Status:

Sinovac said a Phase 3 trial in collaboration with Instituto Butantan in Brazil is underway, and the company plans to enroll around 9,000 patients in the healthcare industry.


Source: http://www.sinovac.com/



This is for informational purposes only. You should consult your clinical textbook for advising your patients.