Adults 18 to 50, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Medically Attended Adverse Events (MAAE)Primary· From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 1 week post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
0
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
0
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
0
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
1
Number of Participants With Solicited Local Reactogenicity AEsPrimary· From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
9
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
5
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
7
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
2
Number of Participants With Solicited Systemic Reactogenicity AEsPrimary· From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
6
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
5
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
6
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
4
Number of Participants With Unsolicited AEsPrimary· From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 1 week post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
3
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
4
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
2
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
4
Number of Participants With Medically Attended Adverse Events (MAAE)Primary· From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 30 days post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
1
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
3
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
1
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
2
Number of Participants With Unsolicited AEsPrimary· From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 30 days post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
4
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
7
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
3
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
5
Number of Participants With Medically Attended Adverse Events (MAAE)Primary· From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with MAAEs through 6 months post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
2
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
3
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
2
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
4
Number of Participants With Unsolicited AEsPrimary· From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.
Number of Participants with unsolicited AEs through 6 months post final vaccine administration
Group
Value
95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose
5
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
9
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose
4
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose
6
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited AEs: From first dose to 1 week post final vaccine; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. Unsolicited AEs: From first dose to 30 days post final vaccine; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. Medically Attended AEs and Serious AEs: From first dose to 6 months post final vaccine; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. SAEs related to treatment were reported any time, up to 1 year..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04591717 — COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ImmunityBio, Inc.
Last refreshed: 15 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04710303.