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Ad26.COV2.S Phase 1/2a Study Results - Vaccine Safety and Reactogenicity of Ad26.COV2.S

Local AEs - Cohort 1a & 1b:

  • 72% of participants reported solicited adverse effects
  • Solicited local AES were reported in 58% of participants - mostly grade 1/2, most frequent AE was injection site pain
  • Three participants Reported grade 3 pain Systemic AEs - Cohort 1a & 1b:
  • 64% of participants reported systemic AEs, mostly grade 1/grade 2
  • 11% reported grade 3 systemic AES -Most common was fatigue, headache and myalgia
  • Fevers occurred in 19% of participants, grade 3 fevers in 5% of participants Local AEs - Cohort 3:
  • 27% of participants reported local AEs - mostly grade 1/2
  • One participant reported grade 3 swelling and erythema Systemic AEs - Cohort 3:
  • 14% of participants reported grade1 or 2 fevers, no grade 3 Overall
  • No grade 4 AEs, no participant discontinued do to AE
  • two SAEs - one hypotension to vaccine related, one hospitalization of fever vaccine related but recovered within 12 hours

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Updated 2020-10-16

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SARS-CoV-2 (COVID-19)

Biomedical engineering

Biomedical Sciences