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Virus Therapy

hAd5-S-Fusion+N-ETSD vaccine for COVID-19

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 day 387
Awards & highlights

Study Summary

This trial is designed to assess the safety and effectiveness of a new vaccine for adults.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 387
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 387 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
+16 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyExperimental Treatment1 Intervention
Cohort 3d: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on days 15 and 29
Group II: Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyExperimental Treatment1 Intervention
Cohort 3c: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22
Group III: Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyExperimental Treatment1 Intervention
Cohort 3b: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; no vaccine on day 22
Group IV: Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC and 0.5 mL of hAd5-S-Fusion+N-ETSD sublinguallyExperimental Treatment1 Intervention
Cohort 3a: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 1; 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) and 0.5 mL of hAd5-S-Fusion+N-ETSD sublingually (5 × 10e10 VP/dose) on day 22
Group V: Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SCExperimental Treatment1 Intervention
Cohort 2: 1.0 mL of hAd5-S-Fusion+N-ETSD SC (1 × 10e11 VP/dose) on days 1 and 22
Group VI: Cohort 1: 0.5 mL of hAd5-S-Fusion+N-ETSD SCExperimental Treatment1 Intervention
0.5 mL of hAd5-S-Fusion+N-ETSD SC (5 × 10e10 VP/dose) on days 1 and 22
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hAd5-S-Fusion+N-ETSD vaccine
2020
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
5,102 Total Patients Enrolled
8 Trials studying COVID-19
322 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Hoag Memorial Hospital Presbyterian
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
2020. "COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04591717.
~8 spots leftby Apr 2025
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