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NCT04710303

COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults

Completed Phase 1 Results posted Last updated 15 November 2024
What this trial tests

Phase 1 trial testing hAd5-S-Fusion+N-ETSD vaccine in Covid19 in 41 participants. Completed in 2 August 2022.

Timeline
2 March 2021
Primary endpoint
2 August 2022
2 August 2022

Quick facts

Lead sponsorImmunityBio, Inc.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment41
Start date2 March 2021
Primary completion2 August 2022
Estimated completion2 August 2022
Sites1 location across South Africa

Drugs / interventions tested

Conditions studied

Sponsor

ImmunityBio, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Medically Attended Adverse Events (MAAE) Primary · 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

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose0
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose0
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose0
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose1
Number of Participants With Solicited Local Reactogenicity AEs Primary · 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

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose9
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose5
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose7
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose2
Number of Participants With Solicited Systemic Reactogenicity AEs Primary · 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

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose6
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose5
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose6
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose4
Number of Participants With Unsolicited AEs Primary · 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

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose3
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose4
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose2
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose4
Number of Participants With Medically Attended Adverse Events (MAAE) Primary · From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.

Number of Participants with MAAEs through 30 days post final vaccine administration

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose1
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose3
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose1
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose2
Number of Participants With Unsolicited AEs Primary · From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6.

Number of Participants with unsolicited AEs through 30 days post final vaccine administration

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose4
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose7
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose3
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose5
Number of Participants With Medically Attended Adverse Events (MAAE) Primary · From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.

Number of Participants with MAAEs through 6 months post final vaccine administration

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose2
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose3
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose2
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose4
Number of Participants With Unsolicited AEs Primary · From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6.

Number of Participants with unsolicited AEs through 6 months post final vaccine administration

GroupValue95% CI
Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose5
Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose9
Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose4
Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose6

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs: From first dose to 1 week post final vaccine; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. Unsolicited AEs: From first dose to 30 days post final vaccine; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. Medically Attended AEs and Serious AEs: From first dose to 6 months post final vaccine; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. SAEs related to treatment were reported any time, up to 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: Cohort 1
Serious: 0/10 (0%)
Deaths: 0/10
Group 1: Cohort 2
Serious: 0/11 (0%)
Deaths: 0/11
Group 1: Cohort 3
Serious: 0/10 (0%)
Deaths: 0/10
Group 1: Cohort 6
Serious: 0/10 (0%)
Deaths: 0/10
Group 2: Cohort 1
Serious: 0/10 (0%)
Deaths: 0/10
Group 2: Cohort 2
Serious: 0/11 (0%)
Deaths: 0/11
Group 2: Cohort 3
Serious: 0/10 (0%)
Deaths: 0/10
Group 2: Cohort 6
Serious: 0/10 (0%)
Deaths: 0/10
Group 3: Cohort 1
Serious: 0/10 (0%)
Deaths: 0/10
Group 3: Cohort 2
Serious: 0/11 (0%)
Deaths: 0/11
Group 3: Cohort 3
Serious: 0/10 (0%)
Deaths: 0/10
Group 3: Cohort 6
Serious: 0/10 (0%)
Deaths: 0/10
Group 4: Cohort 1
Serious: 0/10 (0%)
Deaths: 0/10
Group 4: Cohort 2
Serious: 0/11 (0%)
Deaths: 0/11
Group 4: Cohort 3
Serious: 0/10 (0%)
Deaths: 0/10
Group 4: Cohort 6
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (47 terms — click to expand)

ReactionSystemGroup 1: Cohort 1Group 1: Cohort 2Group 1: Cohort 3Group 1: Cohort 6Group 2: Cohort 1Group 2: Cohort 2Group 2: Cohort 3Group 2: Cohort 6Group 3: Cohort 1Group 3: Cohort 2Group 3: Cohort 3Group 3: Cohort 6Group 4: Cohort 1Group 4: Cohort 2Group 4: Cohort 3Group 4: Cohort 6
Injection site pruritusGeneral disorders
Injection site painGeneral disorders
Injection site reactionGeneral disorders
HeadacheNervous system disorders
FatigueGeneral disorders
MyalgiaMusculoskeletal and connective tissue disorders
Injection site swellingGeneral disorders
Injection site erythemaGeneral disorders
ChillsGeneral disorders
DiarrhoeaGastrointestinal disorders
Abdominal painGastrointestinal disorders
NauseaGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
COVID-19Infections and infestations
Influenza like illnessGeneral disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
RhinalgiaRespiratory, thoracic and mediastinal disorders
Abdominal discomfortGastrointestinal disorders
BronchitisInfections and infestations
GastroenteritisInfections and infestations
HIV infectionInfections and infestations
ImpetigoInfections and infestations
Oral herpesInfections and infestations
Subcutaneous abscessInfections and infestations
Upper respiratory tract infectionInfections and infestations
Skin lacerationInjury, poisoning and procedural complications
Thermal burnInjury, poisoning and procedural complications
Neck painMusculoskeletal and connective tissue disorders
Vaginal dischargeReproductive system and breast disorders
PhlebitisVascular disorders
Asymptomatic COVID-19Infections and infestations
Nasal drynessRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
RhinorrhoeaRespiratory, thoracic and mediastinal disorders
Injection site bruisingGeneral disorders
MalaiseGeneral disorders
PyrexiaGeneral disorders
NeutropeniaBlood and lymphatic system disorders
LeukocytosisBlood and lymphatic system disorders

Data from ClinicalTrials.gov NCT04710303 adverse events section.

Sponsor's own description

This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
    Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
  2. COVID-19 vaccine access in Africa: Global distribution, vaccine platforms, and challenges ahead.
    Massinga Loembé M, Nkengasong JN. · · 2021 · cited 76× · PMID 34260880 · DOI 10.1016/j.immuni.2021.06.017
  3. Oral and intranasal vaccines against SARS-CoV-2: Current progress, prospects, advantages, and challenges.
    Kar S, Devnath P, Emran TB, Tallei TE, et al · · 2022 · cited 34× · PMID 35349752 · DOI 10.1002/iid3.604
  4. Pharmaceutical Aspects and Clinical Evaluation of COVID-19 Vaccines.
    Hofman K, Shenoy GN, Chak V, Balu-Iyer SV. · · 2021 · cited 15× · PMID 33929280 · DOI 10.1080/08820139.2021.1904977
  5. Adenovirus vector-based vaccines as forefront approaches in fighting the battle against flaviviruses.
    Shoushtari M, Roohvand F, Salehi-Vaziri M, Arashkia A, et al · · 2022 · cited 13× · PMID 35714271 · DOI 10.1080/21645515.2022.2079323
  6. Advances in Pathogenesis, Progression, Potential Targets and Targeted Therapeutic Strategies in SARS-CoV-2-Induced COVID-19.
    Zhou H, Ni WJ, Huang W, Wang Z, et al · · 2022 · cited 12× · PMID 35450063 · DOI 10.3389/fimmu.2022.834942
  7. A comprehensive overview of vaccines developed for pandemic viral pathogens over the past two decades including those in clinical trials for the current novel SARS-CoV-2.
    Damodharan K, Arumugam GS, Ganesan S, Doble M, et al · · 2021 · cited 7× · PMID 35479882 · DOI 10.1039/d0ra09668g
  8. Clinical progress of therapeutics and vaccines: Rising hope against COVID-19 treatment.
    Bandaru R, Rout SR, Kamble OS, Samal SK, et al · · 2022 · cited 4× · PMID 35437418 · DOI 10.1016/j.procbio.2022.04.011

Verify or expand the search:

Other trials of hAd5-S-Fusion+N-ETSD vaccine

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other ImmunityBio, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04710303.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing