10.06.2020 16:04:48
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Johnson & Johnson To Begin First-in-human Trial Of COVID-19 Vaccine Candidate In July
(RTTNews) - Johnson & Johnson (JNJ) has accelerated the initiation of its phase 1/2a first-in-human clinical trial of COVID-19 Vaccine Candidate, Ad26.COV2-S, recombinant. The trial is now anticipated to begin in the second half of July. Previously, it was scheduled to begin in September. The randomized, double-blind, placebo-controlled study will evaluate the safety, reactogenicity, and immunogenicity of the investigational SARS-CoV-2 vaccine in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.
The company is also in discussions with the National Institutes of Allergy and Infectious Diseases to start the phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending outcome of phase 1 studies and approval of regulators.
Johnson & Johnson's efforts to expedite development of a SARS-CoV-2 vaccine are supported by a collaboration between Pharmaceutical Companies and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
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