Ad5-Covid-S/N
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- LARVOL DELTA
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November 15, 2024
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
(clinicaltrials.gov)
- P1 | N=41 | Completed | Sponsor: ImmunityBio, Inc. | Active, not recruiting ➔ Completed | Phase classification: P1b ➔ P1
Phase classification • Trial completion • Infectious Disease • Novel Coronavirus Disease
October 15, 2024
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
(clinicaltrials.gov)
- P1 | N=28 | Terminated | Sponsor: ImmunityBio, Inc. | Phase classification: P1b ➔ P1 | Active, not recruiting ➔ Terminated; The study was terminated early due to low enrollment.
Phase classification • Trial termination • Infectious Disease • Novel Coronavirus Disease
June 07, 2024
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
(clinicaltrials.gov)
- P2/3 | N=35 | Terminated | Sponsor: ImmunityBio, Inc. | Completed ➔ Terminated; There were no participants enrolled into Phase 3 portion of the study because the study was prematurely terminated.
Trial termination • Infectious Disease • Novel Coronavirus Disease
September 28, 2023
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
(clinicaltrials.gov)
- P1b | N=35 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Nov 2022 ➔ Nov 2023 | Trial primary completion date: Nov 2022 ➔ Sep 2023
Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease
September 01, 2023
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELLVACCINE TRIAL
(clinicaltrials.gov)
- P2/3 | N=35 | Completed | Sponsor: ImmunityBio, Inc.
New P2/3 trial • Infectious Disease • Novel Coronavirus Disease
February 28, 2023
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
(clinicaltrials.gov)
- P1b | N=34 | Completed | Sponsor: ImmunityBio, Inc. | Active, not recruiting ➔ Completed | Trial primary completion date: Nov 2022 ➔ Apr 2022
Trial completion • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
September 16, 2022
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
(clinicaltrials.gov)
- P1b | N=35 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2022 ➔ Nov 2022 | Trial primary completion date: Apr 2022 ➔ Nov 2022
Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease
March 29, 2022
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
(clinicaltrials.gov)
- P1b | N=34 | Active, not recruiting | Sponsor: ImmunityBio, Inc. | Trial completion date: Nov 2021 ➔ Nov 2022 | Trial primary completion date: Nov 2021 ➔ Nov 2022
Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
January 04, 2022
COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
(clinicaltrials.gov)
- P1/2; N=0; Withdrawn; Sponsor: ImmunityBio, Inc.; N=540 ➔ 0; Not yet recruiting ➔ Withdrawn
Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • IFNG
January 04, 2022
COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
(clinicaltrials.gov)
- P1/2; N=0; Withdrawn; Sponsor: ImmunityBio, Inc.; N=540 ➔ 0; Not yet recruiting ➔ Withdrawn
Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • IFNG
December 03, 2021
COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
(clinicaltrials.gov)
- P1/2; N=540; Not yet recruiting; Sponsor: ImmunityBio, Inc.; Initiation date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Sep 2021 ➔ Mar 2022
Clinical • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • IFNG
December 03, 2021
COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
(clinicaltrials.gov)
- P1/2; N=540; Not yet recruiting; Sponsor: ImmunityBio, Inc.; Initiation date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Sep 2021 ➔ Mar 2022
Clinical • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • IFNG
July 20, 2021
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
(clinicaltrials.gov)
- P1b; N=26; Active, not recruiting; Sponsor: ImmunityBio, Inc.; Recruiting ➔ Active, not recruiting; N=65 ➔ 26
Clinical • Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
July 20, 2021
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
(clinicaltrials.gov)
- P1b; N=34; Active, not recruiting; Sponsor: ImmunityBio, Inc.; Recruiting ➔ Active, not recruiting; N=60 ➔ 34
Clinical • Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
April 14, 2021
COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
(clinicaltrials.gov)
- P1/2; N=540; Not yet recruiting; Sponsor: ImmunityBio, Inc.
New P1/2 trial • Infectious Disease • Novel Coronavirus Disease
April 13, 2021
COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines
(clinicaltrials.gov)
- P1/2; N=540; Recruiting; Sponsor: ImmunityBio, Inc.
New P1/2 trial • Infectious Disease • Novel Coronavirus Disease
February 12, 2021
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
(clinicaltrials.gov)
- P1b; N=60; Recruiting; Sponsor: ImmunityBio, Inc.; N=35 ➔ 60
Clinical • Enrollment change • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
October 19, 2020
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
(clinicaltrials.gov)
- P1b; N=35; Not yet recruiting; Sponsor: ImmunityBio, Inc.
Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
March 15, 2021
ImmunityBio (IBRX) Announces Positive Interim Phase I Safety Data of hAd5 T-Cell COVID-19 Vaccine Candidate in Oral and Sublingual Formulations
(Streetinsider.com)
- P1b, N=60; NCT04591717; P1, N=65; NCT04732468; Sponsor: ImmunityBio, Inc.; "...it has met the safety requirements for the first 12 participants in its Phase Ib human adenovirus (hAd5)-based T-cell COVID-19 vaccine trials in sublingual and oral formulations. The independent Safety Review Committee recommended the study continue with no modifications to the trial design....Six participants have been dosed in each trial to date and the trial is anticipated to be fully enrolled in Q2...hAd5-COVID-19 T-cell vaccine candidate is completely protective in non-human primates against high SARS-CoV-2 titer exposures."
DSMB • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease
March 08, 2021
ImmunityBio and NantKwest Begin Dosing Participants in Global Trials for Novel COVID-19 Vaccine; Subcutaneous Route in South Africa, Oral and Sublingual in the U.S.
(Businesswire)
- "...first cohorts of their South Africa and U.S. COVID-19 vaccine trials have received their initial doses...In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation. The Phase I trial in Cape Town, South Africa is using subcutaneous administration and nine participants have been dosed to date. It is expected to be followed by sublingual delivery and room temperature-stable oral capsule trials. The two U.S. Phase Ib trials are studying a combination of subcutaneous/sublingual and subcutaneous/oral formulations; six participants have been dosed in each trial to date....The capsule and sublingual formulations protocol will be evaluated in a follow-on trial....Based on the findings of these trials, the optimal combination of administration route and dose will be determined and entered into the Phase II/III design."
Trial status • Infectious Disease • Novel Coronavirus Disease
March 05, 2021
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults
(clinicaltrials.gov)
- P1b; N=35; Recruiting; Sponsor: ImmunityBio, Inc.; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease
March 05, 2021
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
(clinicaltrials.gov)
- P1b; N=65; Recruiting; Sponsor: ImmunityBio, Inc.; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8
February 11, 2021
ImmunityBio and NantKwest Announce FDA Authorization to Study hAd5 T-Cell COVID-19 Vaccine for Combination of Subcutaneous, Oral and Sublingual Boost to Induce T-Cell, Mucosal, and Antibody Immunity
(Businesswire)
- "ImmunityBio, Inc....announced they have received FDA authorization to expand Phase I testing...The FDA authorized the expansion of a currently active multi-cohort trial of the subcutaneous version of the vaccine...The FDA also authorized a second Phase I study that will examine the addition of an oral boost to the subcutaneous prime administration....Both oral and sublingual trials are anticipated to begin this month and will be conducted at two sites in California. Based on the findings of these trials...the optimal combination of route of administration and dose will be determined and entered into the Phase 2 / 3 design."
Trial initiation date • Trial status • Infectious Disease • Novel Coronavirus Disease
February 01, 2021
COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA
(clinicaltrials.gov)
- P1b; N=65; Not yet recruiting; Sponsor: ImmunityBio, Inc.
Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease
January 19, 2021
ImmunityBio Announces Phase I Trial of COVID-19 Vaccine Candidate in South Africa as New Variants of SARS-CoV-2 Spread
(Businesswire)
- "ImmunityBio, Inc....announced it has received authorization from the South Africa Health Products Regulatory Authority (SAHPRA) to begin a Phase I clinical trial of its hAd5 T-cell vaccine, the company’s novel COVID-19 vaccine candidate, which will be administered subcutaneously....This novel vaccine candidate is delivered subcutaneously and via a room-temperature oral capsule formulation and has the potential to serve as a universal T-cell boost to current vaccines or address mutations where other vaccines might fail, including the 501Y.V2 variant..."
New P1 trial • Infectious Disease • Novel Coronavirus Disease
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