- inactivated vaccine in healthy adults taken between ages 18-59 years
- randomized double-blind and placebo controlled trial 
- purpose was to evaluate the immunogenicity and safety of a SARS-CoV-2 inactivated vaccine
- evaluation for optimal dose

San Jose State University

- Sinovac Vaccine is also known as CoronaVac SARS-CoV-2 Vaccine
- this is an inactivated pathogen it differs from how the other rival vaccine candidates are made using either DNA or RNA
- virus is grown in cultures and then inactivated it
- typically takes longer than other vaccines to develop

- Introduction 
- Methods
- Results
- Conclusion

 Sinovac Vaccine

Yan-Jun Zhang, Gang Zeng, Hong-Xing Pan, Chang-Gui Li, Biao Kan, Ya-Ling Hu, Hai-Yan Mao, Qian-Qian Xin, Kai Chu, Wei-Xiao Han, Zhen Chen, Rong Tang, Wei-Dong Yin, Xin Chen, Xue-Jie Gong, Chuan Qin, Yuan-Sheng Hu, Xiao-Yong Liu, Guo-Liang Cui, Cong-Bing Jiang, Heng-Ming Zhang, Jing-Xin Li, Min-Nan Yang, Xiao-Juan Lian, Yan Song, Jin-Xing Lu, Xiang-Xi Wang, Miao Xu, Qiang Gao, Feng-Cai Zhu
medRxiv 2020.07.31.20161216; doi: https://doi.org/10.1101/2020.07.31.20161216

Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 years: Report of the Randomized, Double-blind, and Placebo-controlled Phase 2 Clinical Trial

Introduction to Phase 2 Clinical Trial of Sinovac

- 600 healthy adults in the age ranges 18-59 were taken into this study
- each adult was assigned at random to receive two injections of different dosages
- dose of 3 μg/0.5 mL or 6 μg /0.5mL
- placebo day 0-14  or 0-28
- data collected after 7 or 28 days
- blood samples were also taken for antibody assay

Methods of Phase 2 Clinical Trial for Sinovac

- vaccine was well-tolerated
- no dosage safety concerns
- adverse reaction were mild in severity
- most reported symptom was pain at the injection site
- overall it showed good immunogencity

Results of the Phase 2 Clinical Trial for Sinovac

- safety and immunogenicity was seen in both schedules and both dosages 
- successful trial and support to conduct phase 3 trial 

Conclusion for Phase 2 Clinical Trial of Sinovac

Safety Profile:
- Two-dose series was well tolerated with no dose-safety concerns
- Adverse reactions were mild, and most commonly reported was pain at injection site

Method:
- Randomized and double-blind, placebo-controlled
- Consisted of 600 participants; all healthy adults with ages ranging from 18-59
- Two-dose series of 0.5 mL, 0.6 mL, or placebo

Performance:
- The smaller dose (0.5 mL), had 92.4% seroconversion after 2 weeks, and 97.4% after 4 weeks
- Antigen binding antibody levels ranged from 23.8 to 65.4 after 28 days depending on dosage and schedule


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