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hAd5-S-Fusion+N-ETSD vaccine

Phase 1

Covid19 | Monoclonal antibody | Infectious Disease |ImmunityBio, Inc.|Last Updated: Nov 15, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04710303COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African AdultsPHASE1 COMPLETED 41 — — Mar 2, 2021Aug 2, 2022Nov 15, 20241 South Africa
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Study Endpoints
Primary Endpoints
Number of Participants With Medically Attended Adverse Events (MAAE)
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

Number of Participants With Solicited Local Reactogenicity AEs
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

Number of Participants With Solicited Systemic Reactogenicity AEs
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

Number of Participants With Unsolicited AEs
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

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per doseEXPERIMENTALhAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22
Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per doseEXPERIMENTALhAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per doseEXPERIMENTALhAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per doseEXPERIMENTALhAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1
Interventions
NameTypeDescription
hAd5-S-Fusion+N-ETSD vaccineBIOLOGICALThe hAd5-S-Fusion+N-ETSD vaccine is a hAd5 \[E1-, E2b-, E3-\] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria 1. Adults, age 18 - 50 years, inclusive, at time of first study vaccination. 2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Agrees to the collection of bio...

Countries:South Africa
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