Lebanon Valley College

- Safety Outcomes 
- Immunogenicity Outcomes 

Results for the Inactivated Whole Virus vaccine by Wuhan Institute of Biological Products Phase II Trial 

Xia, S., Duan, K., Zhang, Y., Zhao, D., Zhang, H., Xie, Z., Li, X., Peng, C., Zhang, Y., Zhang, W., Yang, Y., Chen, W., Gao, X., You, W., Wang, X., Wang, Z., Shi, Z., Wang, Y., Yang, X., … Yang, X. (2020). Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA, 324(10), 951–960. https://doi.org/10.1001/jama.2020.15543

Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials

In the phase 2 trial, the percentage of people who reported adverse outcomes in each dose section were:

- medium dose at days 0 and 14: 6% 

- alum only at days 0 and 14: 14.3%

- medium does at days 0 and 21: 19% 

- alum only at days 0 and 21: 17.9%

Most common adverse reactions: injection site pain was the most common and fever was the second most common.

All adverse reactions were only reported within the first seven days of injection. (No adverse reactions reported within days 8 to 28.)

Safety Outcomes for the Inactivated Whole Virus Vaccine by Wuhan Institute of Biological Products Phase II Trial 

Effectiveness of immunogenicity was assessed by measuring the geometric mean titer of neutralizing antibody to live SARS-CoV-2, and the geometric mean titer of specific IgG antibody to whole SARS-CoV-2 antigen. 
- Neutralizing Antibody Outcomes
- Specific IgG Antibody Outcomes

Immunogenicity Outcomes for the Inactivated Whole Virus Vaccine by Wuhan Institute of Biological Products Phase II Trial

Figure 3. Antibody Responses 14 Days After the Second Dose in the Phase 2 Trial

Safety Profile:
- 7 days after injection, 15% of participants reported adverse reactions (6 or 25% in the high dose in phase 1, and 16 or 19% in medium dose at days 0-21 in phase 2 had the most adverse reactions)
- Most common adverse reaction was injection site pain, then fever
- All reactions were mild and did not require treatment

Method:
- Randomized and placebo-controlled; adults aged 18-59 (with no positive COVID-19 result)
- Phase 1: 96 healthy adults were assigned to aluminum hydroxide only or low, medium, and high doses of the vaccine
- Phase 2: 224 healthy adults were given either aluminum hydroxide only, or 5 microgram/dose of the vaccine in two groups (days 1-14 or 1-21)

Performance:
- Geometric mean titer of phase 1 at 14 days post-injection: 316 in low-dose, 206 in medium-dose, and 297 in high-dose
- GMT of phase 2 using medium dose: 121 (injections received on days 0 and 14) and 247 (injections received on days 0 and 21)
- Seroconversion: 95.8% in medium-dose group in phase 1; 97.6% in two phase two groups; none in aluminum hydroxide only group


Learn Before

Related