- 380 people enrolled in cohort 1a (377 vaccinated) 
- 25 were enrolled in cohort 1b
- Seven (1.7%) participants were positive for SARS-CoV-2 at screening
- 405 were enrolled in cohort 3 (403 vaccinated)

Ad26.COV2.S Phase 1/2 Study Results - Study Participants

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

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

- Study Participants
- Vaccine Safety and Reactogenicity of Ad26.COV2.S
- Immunogenicity of Ad26.COV2.S

Bowdoin College

- Investigates the Safety and Immunogenicity of the Ad26.COV2.S vaccine in 3 cohorts of people.
- Administered at dose levels of 5x10^10 or 1x10^11 either as single dose or two doses spaced by 56 days.
- Measured S specific antibodies by ELISA, neutralizing titers by wtVNA and CD4+ Th1 and Th2 and CD8+ immune responses by ICS.
- Concluded that the safety profile and immunogenicity after one dose at the lower dosage were sufficient as a potentially protective vaccine and therefore moved to phase 3 testing. 

- Methods
- Results 
- Discussion

Ad26.COV2.S Phase 1/2a Study Interim Publication

Sadoff, J., Gars, M. L., Shukarev, G., Heerwegh, D., Truyers, C., Groot, A. M., . . . Schuitemaker, H. (2020). Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: Interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv. doi:10.1101/2020.09.23.20199604

Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial

Study Design and Participants
- Multicenter, randomized, double-blind, placebo-controlled trial
- Evaluating safety, reactogenicity and immunogenicity of Ad26.COV2.S at intramuscularly at doses 5x10^10 or 1x10^11 vp 
-Single dose or two-dose schedules 8 weeks apart
- Cohort 1a &1b of adults aged 18-55 and Cohort 3 adults > 65 years old
Randomization and Blinding
- Patients randomly assigned to either one dose or two dose schedule with all possible combinations of high dose, low dose and placebo
-Sponsor and Statisticians group-unblinded for interim analysis after 29 day visit.
Procedures
- S-specific binding bodies were measured by ELISA
- SARS-COV2 neutralizing antibody tigers measured in microneutralization wtVNA
- SARS-COV2 S-specific T cell responses were measured by ICS
Statistical Methods


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