Trial of Johnson & Johnson COVID-19 vaccine shows promising early results

14 January, 2021

Results from a Phase 1-2a clinical trial of the Johnson & Johnson COVID-19 vaccine candidate, Ad26.COV2.S, have been published in the New England Journal of Medicine. The vaccine was accelerated into human trials in late-July 2020, across locations in the United States and Belgium.

Over 400 people aged 18-55 years were enrolled in cohort 1, with over 400 additional people aged over 65 years enrolled into the cohort 3. (Cohort 2, which examined longer-term data of a single dose, began in November 2020 and results are not provided in the paper.)

Participants were split into five groups and given vaccines as a; low dose followed by low dose, low dose followed by placebo, high dose followed by high dose, high dose followed by placebo, or placebo followed by placebo. Side effects reported include pain at the injection site, fever, fatigue, headache and muscle aches.

The authors found “the Ad26.COV2.S vaccine had an acceptable safety and reactogenicity profile and was immunogenic after a single vaccination with either the low or high dose.” Over 90% of participants across both age groups and all doses had high levels of antibodies 29 days after the first dose, which increased to 100% after 57 days. Antibodies were sustained until at least day 71 in the younger age group.

Phase 3 trials are underway to evaluate efficacy of a single dose vs two shots of a lower doses.

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