Study design

Randomized Controlled Trial

Study population and setting

This is a Phase I, interventional trial of a COVID-19/artificial antigen presenting cell (aAPC) vaccine,that is taking place at Shenzen Geno-Immune Medical Institute in collaboration with Shenzen Second and Third People’s Hospitals in Shenzen, China. It began on February 15th, 2020 and is currently recruiting. This trial has an estimated enrollment of 100 participants who meet the following criteria: healthy or COVID-19 positive, between 6 months and 80 years of age, white blood cells ≥ 3,500/μl, lymphocytes ≥ 750/μl, HIV, HBV, HCV, and TB negative, and the interval between onset of symptoms and randomization is within 7 days for participants who are COVID-19 positive. The COVID-19 positive patients are included to test if the vaccine could possibly be used as a therapeutic vaccine.

Study participants receive 5×10^6 aAPCs via subcutaneous injection at 0, 14, and 28 days post-randomization. Peripheral blood samples are collected for analysis at 0, 14, 21, 28, and 60 days post-randomization.

The vaccine is comprised of aAPCs that are inactivated so that they cannot proliferate. Primary outcomes include frequency of vaccine events (ex. Fever, rash, abnormal heart function), frequency of serious vaccine events, and the proportion of subjects with a positive T-cell response against SARS-CoV-2 antigens. Secondary endpoints also include tracking the need for mechanical ventilation, vaccine related deaths, clinical improvement, and lung injury in the COVID-19 patients who are vaccinated.

Summary of Main Findings

N/A, study is incomplete

Study Strengths

N/A, study is incomplete

Limitations

N/A, study is incomplete

Value added

Though this is a relatively small trial (n = ~100), it is one of the first test a vaccine using aAPCs to increase immunity to COVID-19.