Smith College

- location:

single center in Wuhan, China

- participation eligibility: 

age: 18 years or older, HIV-negative, previous SARS-CoV-2 infection-free, axillary temp: 37.0 deg C or less, BMI: 18.5-30.0, general good health, no pregnant/breastfeeding women, no people with mental disease, allergies, cardiovascular disease, other chronic illnesses

- randomized, double-blinded, placebo-controlled

1 x 10^11, 5x10^10 viral particles per mL, placebo were randomized at 2:1:1 ratio

- procedure:

single injection, IM, arm, participants monitored (blood samples collected for antibody responses) for 30 mins, follow-up within 14 days, 28 days, and 6 months, self-reported serious effects, detection limit for RBD = 1:40, for neutralizing antibody to live SARS-CoV-2 virus and a pesudovirus = 1:8 and 1:10, respectively, expression of IFN detected by enzyme-linked immunospot (ELISpot) assay

(see children nodes for more information)

Methods - Study on immunogenicity and safety of Ad5-vectored COVID-19 vaccine in larger population

Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. doi: 10.1016/S0140-6736(20)31605-6.

https://reader.elsevier.com/reader/sd/pii/S0140673620316056?token=97B865EF00C0E8CED18EB943DA8BC3625887370F6AD86C661591D78080B9D0ADF7A2E0703365A9D821BE21A8F2E5D70E

Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial

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