COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post final vaccine

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 of MAAEs

Incidence of Serious AEs

Incidence of Solicited Local Reactogenicity AEs

+3 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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) were 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) were 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) were 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) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).

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