Methods for the Inactivated Whole Virus Vaccine by Wuhan Institute of Biological Products Phase I and II Trials
Study Design and Participants: - Trials conducted in Henan Province, China - Double-blind, randomized, placebo-controlled Phase I and Phase II trials - Participants: aged 18 to 59 years, no history of SARS-CoV (on-site inquiry) or SARS-CoV-2 (serological and nucleic acid test) - Phase I Design: 96 participants, 3 vaccine dose groups (low 2.5 μg, medium 5 μg, and high 10 μg antigen protein content per dose) and a control group (received aluminum hydroxide adjuvant only), ratio of vaccine to placebo was 3:1, received intramuscular injections on days 0, 28, and 56. - Phase II Design: 224 participants, 2 schedule groups that both received the 5 μg vaccine (days 0 and 14, and days 0 and 21), the vaccine to placebo ratio was 3:1. - Sequential enrollment and sentinel data were used to keep the participants safe. The low dose in Phase I was used first and monitored for 7 days for adverse reactions. The medium dose group only received vaccines if there were no vaccine-related reactions in those 7 days, and the same procedure was followed for the high dose group and the phase II medium dose vaccinations.
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SARS-CoV-2 (COVID-19)
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Results for the Inactivated Whole Virus vaccine by Wuhan Institute of Biological Products Phase II Trial
Discussion for the Inactivated Whole Virus Vaccine by Wuhan Institute of Biological Products
Methods for the Inactivated Whole Virus Vaccine by Wuhan Institute of Biological Products Phase I and II Trials