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Virus Therapy

hAd5-S-Fusion+N-ETSD vaccine for Coronavirus

Phase 1 & 2
Waitlist Available
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post final vaccine administration
Awards & highlights
No Placebo-Only Group

Summary

This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous and oral (capsule) administration.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post final vaccine administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post final vaccine administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs
Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs
Phase 1 Safety: Incidence and severity of unsolicited AEs
+7 more
Secondary study objectives
Phase 1 Cellular Immunogenicity: T cell activity
Antibodies, Phospho-Specific
Phase 1 Humoral Immunogenicity: GMT of neutralizing antibody
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental: Cohort 2: hAd5-S-Fusion+N-ETSD Subcutaneous and OralExperimental Treatment1 Intervention
Cohort 2 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous and 1 × 10e10 IU/dose Oral on Day 1
Group II: Experimental: Cohort 1: hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose SubcutaneousExperimental Treatment1 Intervention
Cohort 1 (n=20): hAd5-S-Fusion+N-ETSD at 5 × 10e10 IU/dose Subcutaneous on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hAd5-S-Fusion+N-ETSD vaccine
2020
Completed Phase 1
~40

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
66 Previous Clinical Trials
4,759 Total Patients Enrolled
~0 spots leftby Oct 2025
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