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Virus Therapy

hAd5-S-Fusion+N-ETSD (Suspension for injection) for Coronavirus

Phase 1
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post final vaccine
Awards & highlights

Summary

This trial tests a new treatment in injection and pill form on healthy adults to see if it safely boosts the immune system to fight diseases.

Eligible Conditions
  • Coronavirus

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of solicited local reactogenicity AEs
Incidence and severity of solicited systemic reactogenicity AEs
Incidence and severity of unsolicited AEs
+6 more
Secondary study objectives
CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
GMFR in IgG titer
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)Experimental Treatment2 Interventions
For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) will be administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).
Group II: Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)Experimental Treatment1 Intervention
For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) will be administered on days 1 (prime) and on day 22 (boost).
Group III: Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)Experimental Treatment2 Interventions
For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).
Group IV: Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)Experimental Treatment2 Interventions
For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).

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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
4,731 Total Patients Enrolled
~6 spots leftby Sep 2025
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