Other substances

hAd5

candidate vaccine

Phase of research

Potential treatment - pre-clinical evidence

How it helps

Vaccine

Drug status

Experimental

1
 Supporting references
0
 Contradictory references
2
 AI-suggested references
5
 Clinical trials

General information

hAd5 is ImmunityBio’s COVID-19 human adenovirus vaccine candidate. It is the first human adenovirus (Ad5) vaccine designed to deliver both Spike (S) and Nucleocapsid (N) DNA for potential long-lasting humoral and cell-mediated immunity. Currently, it is in the pre-clinical stage of evaluation. 

 

Supporting references

Link Tested on Impact factor Notes Publication date
A Next Generation Bivalent Human Ad5 COVID-19 Vaccine Delivering Both Spike and Nucleocapsid Antigens Elicits Th1 Dominant CD4+, CD8+ T-cell and Neutralizing Antibody Responses
mice Jul/30/2020

AI-suggested references

Link Publication date
Intranasal plus subcutaneous prime vaccination with a dual antigen COVID-19 vaccine elicits T-cell and antibody responses in mice.
Jul/21/2021
Dual-Antigen COVID-19 Vaccine Subcutaneous Prime Delivery With Oral Boosts Protects NHP Against SARS-CoV-2 Challenge
Jun/08/2021

Clinical trials

ID Title Status Phase Start date Completion date
NCT04710303 COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults Recruiting Phase 1 Mar/02/2021 Apr/01/2022
  • Alternative id - AW_001_ProVIVA-SA-1
  • Interventions - Biological: hAd5-S-Fusion+N-ETSD vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Khayelitsha Clinical Research Site, Khayelitsha, South Africa
  • Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 35
  • Age - 18 Years to 50 Years   (Adult)
  • Outcome measures - Incidence of MAAEs and SAEs|Incidence and severity of solicited local reactogenicity AEs|Incidence and severity of solicited systemic reactogenicity AEs|Incidence and severity of unsolicited AEs|Incidence of changes of laboratory safety examinations|Vital Sign - Temperature|Vital Sign - Heart rate|Vital Sign - Blood Pressure|Vital Sign - Respiratory Rate|GMFR in IgG titer|GMT of S-specific, RBD-specific, and N-specific antibodies|Percentage of participants who seroconverted|GMFR in neutralizing antibody|GMT of neutralizing antibody|Seroconversion rate of neutralizing antibody|New HIV infections in vaccine recipients
NCT04845191 COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines Withdrawn Phase 1|Phase 2 Dec/01/2021 Aug/01/2022
  • Alternative id - COVID-4.009
  • Interventions - Biological: hAd5-S-Fusion+N-ETSD vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Phase 1 Safety: Incidence of MAAEs and SAEs|Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs|Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs|Phase 1 Safety: Incidence and severity of unsolicited AEs|Phase 1 Safety: Incidence of changes of laboratory safety examinations|Phase 1 Safety: Vital Sign - Temperature|Phase 1 Safety: Vital Sign - Heart Rate|Phase 1 Safety: Vital Sign - Blood Pressure|Phase 1 Safety: Vital Sign - Respiratory Rate|Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells|Phase 1 Humoral Immunogenicity: GMT of S-specific and N-specific antibodies|Phase 1 Humoral Immunogenicity: GMT of neutralizing antibody|Phase 1 Mucosal Immunogenicity: GMT of IgA antibody levels|Phase 1 Cellular Immunogenicity: T cell activity|Phase 2 Efficacy: Incidence and severity of COVID-19 ≥14 days after vaccination|Phase 2 Efficacy: Mean SARS-CoV-2 viral load|Phase 2 Efficacy: Humoral Immunogenicity - GMT of S-specific and N-specific antibodies|Phase 2 Efficacy: Humoral Immunogenicity - GMT of neutralizing antibody|Phase 2 Efficacy: Mucosal Immunogenicity - GMT of IgA antibody levels|Phase 2 Efficacy: Cellular Immunogenicity - T cell activity|Phase 2 Safety: Incidence of MAAEs and SAEs|Phase 2 Safety: Incidence and severity of solicited local reactogenicity AEs|Phase 2 Safety: Incidence and severity of solicited systemic reactogenicity AEs|Phase 2 Safety: Incidence and severity of unsolicited AEs|Phase 2 Safety: Incidence of changes of laboratory safety examinations|Phase 2 Safety: Vital Sign - Temperature|Phase 2 Safety: Vital Sign - Heart rate|Phase 2 Safety: Vital Sign - Blood Pressure|Phase 2 Safety: Vital Sign - Respiratory rate
NCT04732468 COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA Active, not recruiting Phase 1 Feb/24/2021 Apr/01/2022
  • Alternative id - COVID-4.005
  • Interventions - Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)|Drug: hAd5-SFusion+ N-ETSD (Oral capsule)
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Chan Soon - Shiong Institute for Medicine, El Segundo, California, United States|Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
  • Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 26
  • Age - 18 Years to 55 Years   (Adult)
  • Outcome measures - Incidence of MAAEs and SAEs|Incidence and severity of solicited local reactogenicity AEs|Incidence and severity of solicited systemic reactogenicity AEs|Incidence and severity of unsolicited AEs|Incidence of changes of laboratory safety examinations|Vital Sign - Temperature|Vital Sign - Heart rate|Vital Sign - Blood Pressure|Vital Sign - Respiratory Rate|GMFR in IgG titer|GMT of S-specific, RBD-specific, and N-specific antibodies|Percentage of subjects who seroconverted|GMFR in neutralizing antibody|GMT of neutralizing antibody|Seroconversion rate of neutralizing antibody|CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein|CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
NCT04843722 COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines Withdrawn Phase 1|Phase 2 Dec/01/2021 Aug/01/2022
  • Alternative id - COVID-4.006
  • Interventions - Biological: hAd5-S-Fusion+N-ETSD vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations -
  • Study designs - Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 0
  • Age - 18 Years to 80 Years   (Adult, Older Adult)
  • Outcome measures - Phase 1 Safety: Incidence of MAAEs and SAEs|Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs|Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs|Phase 1 Safety: Incidence and severity of unsolicited AEs|Phase 1 Safety: Incidence of changes of laboratory safety examinations|Phase 1 Safety: Vital Sign - Temperature|Phase 1 Safety: Vital Sign - Heart Rate|Phase 1 Safety: Vital Sign - Blood Pressure|Phase 1 Safety: Vital Sign - Respiratory Rate|Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells|Phase 1 Humoral Immunogenicity: GMT of S-specific and N-specific antibodies|Phase 1 Humoral Immunogenicity: GMT of neutralizing antibody|Phase 1 Mucosal Immunogenicity: GMT of IgA antibody levels|Phase 1 Cellular Immunogenicity: T cell activity|Phase 2 Efficacy: Incidence and severity of COVID-19 ≥14 days after vaccination|Phase 2 Efficacy: Mean SARS-CoV-2 viral load|Phase 2 Efficacy: Humoral Immunogenicity - GMT of S-specific and N-specific antibodies|Phase 2 Efficacy: Humoral Immunogenicity - GMT of neutralizing antibody|Phase 2 Efficacy: Mucosal Immunogenicity - GMT of IgA antibody levels|Phase 2 Efficacy: Cellular Immunogenicity - T cell activity|Phase 2 Safety: Incidence of MAAEs and SAEs|Phase 2 Safety: Incidence and severity of solicited local reactogenicity AEs|Phase 2 Safety: Incidence and severity of solicited systemic reactogenicity AEs|Phase 2 Safety: Incidence and severity of unsolicited AEs|Phase 2 Safety: Incidence of changes of laboratory safety examinations|Phase 2 Safety: Vital Sign - Temperature|Phase 2 Safety: Vital Sign - Heart rate|Phase 2 Safety: Vital Sign - Blood Pressure|Phase 2 Safety: Vital Sign - Respiratory rate
NCT04591717 COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers Active, not recruiting Phase 1 Oct/19/2020 Nov/19/2021
  • Alternative id - QUILT-COVID-19-hAd5-Vaccine
  • Interventions - Biological: hAd5-S-Fusion+N-ETSD vaccine
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Chan Soon - Shiong Institute for Medicine, El Segundo, California, United States|Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
  • Study designs - Allocation: Non-Randomized|Intervention Model: Sequential Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
  • Enrollment - 34
  • Age - 18 Years to 55 Years   (Adult)
  • Outcome measures - Incidence of MAAEs and SAEs|Incidence and severity of solicited local reactogenicity AEs|Incidence and severity of solicited systemic reactogenicity AEs|Incidence and severity of unsolicited AEs|Incidence of abnormal changes of laboratory safety examinations|Vital Signs - Fever|Vital Signs - Tachycardia|Vital Signs - Bradycardia|Vital Signs - Hypertension|Vital Signs - Hypotension|Vital Signs - Respiratory Rate|GMFR in IgG titer|GMT of S-specific, RBD-specific, and N-specific antibodies against 2019 novel coronavirus|Percentage of subjects who seroconverted|GMFR in neutralizing antibody|GMT|Seroconversion rate of neutralizing antibody|CD8+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein|CD4+ T-Cell activity against SARS-CoV-2 S protein, RBD, and N protein
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