Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure
Latest Information Update: 22 Dec 2023
At a glance
- Drugs INO 4800 (Primary)
- Indications COVID 2019 infections
- Focus Pharmacodynamics; Registrational; Therapeutic Use
- Acronyms INNOVATE
- Sponsors Inovio Pharmaceuticals
- 11 Oct 2022 Status changed from active, no longer recruiting to discontinued.
- 09 Jun 2022 Planned End Date changed from 1 Jan 2023 to 1 Feb 2023.
- 09 Jun 2022 Planned primary completion date changed from 1 Jan 2023 to 1 Feb 2023.
Most Recent Events
Trial Overview
Purpose
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
Comments
According to an Inovio Pharmaceuticals media release, Company plans to file preliminary Phase 2 results and device data with the U.S. Food and Drug Administration (FDA).
According to an Inovio Pharmaceuticals media release, given the increasing availability of vaccines authorized for emergency use, the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, will discontinue funding for the Phase 3 segment of the trial, while continuing to fund the completion of phase 2 segment.
Primary Endpoints
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay
time_frame: Baseline up to Day 393
Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
time_frame: Baseline up to Day 393
Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease
time_frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)
Other Endpoints
Phase 2 and 3: Percentage of Participants With Solicited Injection Site Reactions
description: Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (Food and Drug Administration [FDA] Guidance for Industry, September 2007). Participants were provided a diary to record the solicited injection site reactions. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection. The solicited injection site reactions were recorded for 7 days after each dose. time_frame: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)
Phase 2 and 3: Percentage of Participants With Unsolicited Injection Site Reactions
description: Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' FDA Guidance for Industry, September 2007. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were reported. Injection site reactions were evaluated starting 30 minutes following the injection. Unsolicited injection site reactions were recorded for up to 28 days after administration of dose 2. time_frame: From first dose of study drug up to Day 56
Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs)
description: An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were provided a diary to record the solicited systemic AEs. The solicited AEs were recorded for 7 days after each dose. time_frame: 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35)
Phase 2 and 3: Percentage of Participants With Unsolicited AEs
description: An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs were recorded for up to 28 days after administration of dose 2. time_frame: From first dose of study drug up to Day 56
Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)
description: An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly or birth defect. time_frame: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126
Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)
description: An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. time_frame: Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126
Phase 3: Number of Participants With Death From All Causes
time_frame: Baseline up to Day 126
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Non-Severe COVID-19 Disease
description: The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. The case definition for non-severe COVID-19 was participants with confirmed COVID-19, and which did not meet the case definition of severe COVID-19. time_frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Severe COVID-19 Disease
description: The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. time_frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Death From COVID-19 Disease
time_frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Percentage of Participants (SARS-CoV-2 Seropositive at Baseline) With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease
description: Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with prior exposure to COVID-19 at baseline were considered for the analysis. time_frame: From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126)
Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay
description: Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 were measured using ELISpot. time_frame: Baseline up to Day 126
Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay
description: The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. time_frame: Baseline up to Day 126 [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | prevention | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04642638 | Interferon Gamma (IFNg) | Outcome Measure |
| T-cell surface antigen CD4 | Eligibility Criteria |
Subjects
- Subject Type patients
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Number
Planned: 7517
Actual: 1307
- Sex male & female
- Age Group ≥ 18 years; adult
Patient Inclusion Criteria
Key - Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings. - Phase 2 only: Screening laboratory results within normal limits for testing laboratory or are deemed not clinically significant by the Investigator. - Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from Screening until 3 months following last dose (Phase 2) or until last dose (Phase 3). Key
Patient Exclusion Criteria
- Acute febrile illness with temperature higher than or equal to 100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat). - Positive serologic or molecular (Reverse transcription polymerase chain reaction (RT-PCR)) test for SARS-CoV-2 at Screening (this criterion applies to all Phase 2 participants and only applies after approximately 402 participants positive for SARS-CoV-2 serologic test are randomized in the Phase 3 segment of the study). - Pregnant or breastfeeding or intending to become pregnant or intending to father children within the projected duration of the trial starting from the Screening visit until 3 months following the last dose (Phase 2) or until last dose (Phase 3). - Known history of uncontrolled human immunodeficiency virus (HIV) based on clusters of differentiation (CD4) count less than 200 cells per cubic millimeter (/mm^3) or a detectable viral load within the past 3 months. - Is currently participating or has participated in a study with an investigational product within 30 days preceding Day 0. - Previous or planned receipt of an investigational (including Emergency Use Authorization (EUA) or local equivalent authorization) or licensed vaccine for prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS) (documented receipt of placebo in previous trial would be permissible for trial eligibility). - Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease) requiring significant changes in therapy or hospitalization for worsening disease during the 6 weeks prior to enrolment. - Immunosuppression as a result of underlying illness or treatment. - Lack of acceptable sites available for ID injection and EP. - Blood donation or transfusion within 1 month prior to Day 0. - Reported alcohol or substance abuse or dependence, or illicit drug use (excluding marijuana use). - Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04642638 | ClinicalTrials.gov: US National Institutes of Health |
| COVID19-311 | - |
| INNOVATE | - |
| WHO-UTN-U1111-1266-9952 | - |
Organisations
- Sponsors Inovio Pharmaceuticals
- Affiliations Advaccine (Suzhou) Biopharmaceuticals; Inovio Pharmaceuticals
Trial Dates
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Initiation Dates
Planned : 01 Nov 2020
Actual : 30 Nov 2020
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Primary Completion Dates
Planned : 01 Feb 2023
Actual : 13 Sep 2022
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End Dates
Planned : 01 Feb 2023
Actual : 13 Sep 2022
Other Details
- Design double-blind; multicentre; prospective; randomised; sequential
- Phase of Trial Phase II/III
- Location Brazil; Colombia; India; Mexico; Philippines; Thailand; USA
- Focus Pharmacodynamics; Registrational; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| INO 4800Primary Drug | Intradermal | Injection |
Phase 2: INO-4800 Dose Group 1
Participants received one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Drug: INO-4800 (INO-4800 was administered ID on Day 0 and Day 28.) Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.)
Phase 2: INO-4800 Dose Group 2
Participants received two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Drug: INO-4800 (INO-4800 was administered ID on Day 0 and Day 28.) Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.)
Phase 3: INO-4800 Dose Group (2.0mg per dosing visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Drug: INO-4800 (INO-4800 was administered ID on Day 0 and Day 28.) Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.)
Phase 2: Placebo Dose Group 1
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Drug: Placebo (Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.) Other Name: SSC-0001, Placebo for INO-4800 Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.)
Phase 2: Placebo Dose Group 2
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Drug: Placebo (Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.) Other Name: SSC-0001, Placebo for INO-4800 Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.)
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. Drug: Placebo (Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.) Other Name: SSC-0001, Placebo for INO-4800 Device: CELLECTRA® 2000 (EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.)
Results
Adverse events
Treatment with INO 4800 was safe and generally well tolerated, in participants (n=401), for the prevention of COVID-2019 infections, in the phase I and phase II/III INNOVATE trials. Participants in the phase I trial received 0.5mg, 1.0mg or 2.0mg intradermally (ID) followed by electroporation (EP) at days 0 and 28. An optional booster dose was administered >6 months post-dose 2. The phase II trial further compared the 1.0mg and 2.0mg doses against placebo, randomized at a 3:3:1:1 ratio. The majority of adverse events (AEs) related to INO 4800 across both trials were mild in severity and did not increase in frequency with age and subsequent doses [2] .
Results from the phase II segment of a phase II/III INNOVATE trial showed that INO 4800 was safe and well-tolerated in the participants (n=400). The majority of adverse events (AEs) were grade 1 and grade 2 in severity and was not reported to increase in frequency with the second dose. The number of participants experiencing each of the most common AEs did not differ between the two dosing groups [3] .
Immunogenicity
Treatment with INO 4800 showed good pharmacokinetics, in participants (n=401), for the prevention of COVID-2019 infections, in the phase I and phase II/III INNOVATE trials. Participants in the phase I trial received 0.5mg, 1.0mg or 2.0mg intradermally (ID) followed by electroporation (EP) at days 0 and 28. An optional booster dose was administered >6 months post-dose 2. The phase II trial further compared the 1.0mg and 2.0mg doses against placebo, randomized at a 3:3:1:1 ratio. In phase I trial, 78% (14/18) and 84% (16/19) of participants generated neutralising antibody responses with geometric mean titers (GMTs) of 17.4 (95%CI 8.3, 36.5) and 62.3 (95% CI 36.4, 106.7) in the 1.0 and 2.0 groups, respectively. By week 8, 74% (14/19) and 100% (19/19) participants generated T cell responses by Th1- associated IFNγ ELISPOT assay. Following a booster dose, neutralising GMTs rose to 82.2 (95% CI 38.2, 176.9) and 124.7 (95% CI 62.8, 247.7) in the 1.0mg and 2.0mg groups, respectively, demonstrating the ability of INO 4800 to boost. In the phase II study, neutralising antibody responses demonstrated GMTs of 93.6 (95%CI 77.3, 113.4) in the 1.0mg dose group and 150.6 (95%CI 123.8, 183.1) in the 2.0mg dose group. The candidate showed the induction of both humoral and cellular immune responses. In addition to eliciting neutralising antibodies, INO 4800 also induced T cell immune responses as demonstrated by IFNγ ELISpot. As a homologous booster, INO 4800, when administered 6-10.5 months following the primary series, resulted in an increased immune response without increase in reactogenicity. The 2.0mg dose was selected for phase III evaluation [2] .
Results from the phase II segment of a phase II/II INNOVATE trial showed that the geometric mean fold rise (GMFR) of binding and neutralizing antibody levels in patients (n=400) resulting from INO 4800 were significantly greater in the 2.0 mg dose group versus the 1.0 mg dose group. The T cell immune responses measured by the ELISpot assay were also higher in the 2.0 mg dose group compared to the 1.0 mg dose group [3] .
Publications
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Tebas P, Agnes J, Giffear M, Kraynyak KA, Blackwood E, Amante D, et al. Safety and Immunogenicity of INO-4800, a COVID-19 DNA Vaccine as a Primary Series and Booster. IDW-2021 2021; abstr. 571.
Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S387/6450012 -
Inovio Pharmaceuticals. INOVIO Announces Positive Data from Phase 2 Segment of Clinical Trial Evaluating INO-4800, its COVID-19 DNA Vaccine. Media-Rel 2021;.
Media Release
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Carlos Alberto García | Unidad de Medicina Especializada SMA | Mexico |
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Inovio Call Center
(267) 440-4237 clinical.trials@inovio.com
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| Isabel Montserrat Alvarado | BRCR Global Mexico | Mexico |
| Jose Colmenares | Inovio Pharmaceuticals |
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| Mammen P. Mammen Jr, M.D., FACP, FIDSA | Inovio Pharmaceuticals |
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| Roselia Ramirez | SMIQ, S. de R. L. de C.V. | Mexico |
Centres
| Centre Name | Location | Trial Centre Country |
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| Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. |
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| Advanced Clinical Research | West Jordan, Utah | USA |
| AMR Kansas City | Kansas City, Missouri | USA |
| AMR Lexington | Lexington, Kentucky | USA |
| AMR South Florida | Coral Gables, Florida | USA |
| AMR Tempe | Tempe, Arizona | USA |
| AMR, Clinical Research Consortium- Las Vegas | Las Vegas, Nevada | USA |
| Ascension St. John Hospital | Detroit, Michigan | USA |
| Asian Hospital & Medical Center | Muntinlupa, Metro Manila | Philippines |
| Bluecare Salud S A S Sede Centro Medico Integral Chico Medplus CRI | Bogotá, Bogotá, D. C. | Colombia |
| BRCR Global Mexico | Guadalajara, Jalisco | Mexico |
| Central Phoenix Synexus Clinical Research | Phoenix, Arizona | USA |
| Centro de Investigacion Medico Asistencial S.A.S | Barranquilla, Atlántico | Colombia |
| CEPES Centro de Pesquisa Multidisciplinar - Faculdade de Medicina do ABC (FMABC) | Santo André, São Paulo | Brazil |
| Clinica de la Costa LTDA | Barranquilla, Atlántico | Colombia |
| Clinical Research Trials of Florida, Inc | Tampa, Florida | USA |
| Corazon IPS S.A.S | Barranquilla, Atlántico | Colombia |
| DM Clinical Research | Tomball, Texas | USA |
| IBPCLIN - Instituto Brasil de Pesquisa Clínica AS | Rio De Janeiro | Brazil |
| Inovio Pharmaceuticals |
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| Inovio Pharmaceuticals |
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| Ips Centro Cientifico Asistencial Sas | Barranquilla, Atlántico | Colombia |
| Las Pinas Doctors Hospital | Las Piñas, Metro Manila | Philippines |
| Lobus Centro de Pesquisa Clinica LTDA | Volta Redonda, Rio De Janeiro | Brazil |
| Lung Center of the Philippines, clinical research Facility building | Quezon City, Metro Manila | Philippines |
| Mary Johnston Hospital | Tondò, Manila | Philippines |
| Optimal Research, LLC | San Diego, California | USA |
| Philippine General Hospital | Ermita, Metro Manila | Philippines |
| Riverside Medical Center Inc. | Bacolod City, Negros Occidental | Philippines |
| SMIQ, S. de R. L. de C.V. | Querétaro | Mexico |
| Synexus Clinical Research US, Inc - Phoenix Southeast | Chandler, Arizona | USA |
| Tekton Research | San Antonio, Texas | USA |
| Thomas Jefferson University | Philadelphia, Pennsylvania | USA |
| Unidad de Medicina Especializada SMA | San Juan del Río, Querétaro | Mexico |
| University of Pennsylvania | Philadelphia, Pennsylvania | USA |
| Walter Reed Army Institute of Research | Silver Spring, Maryland | USA |
| West Visayas State University Medical Center | Iloilo City, Iloilo | Philippines |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 22 Dec 2023 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 22 Dec 2023 |
| 11 Oct 2022 | Status change - discontinued | Status changed from active, no longer recruiting to discontinued. Updated 17 Oct 2022 |
| 09 Jun 2022 | Completion date | Planned End Date changed from 1 Jan 2023 to 1 Feb 2023. Updated 15 Jun 2022 |
| 09 Jun 2022 | Other trial event | Planned primary completion date changed from 1 Jan 2023 to 1 Feb 2023. Updated 15 Jun 2022 |
| 09 Jun 2022 | Status change - active, no longer recruiting | Status changed from suspended to active, no longer recruiting. Updated 15 Jun 2022 |
| 10 May 2022 | Other trial event | According to an AccInovio Pharmaceuticals media release, company has decided to prioritize its COVID-19 efforts to advance its heterologous booster strategy. In so doing, the company will discontinue this trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases1, which would necessitate an increase in trial size and costs for INNOVATE. The heterologous booster market offers greater opportunities as the world enter the endemic phase of COVID-19. Updated 17 May 2022 |
| 01 Mar 2022 | Other trial event | According to an Inovio Pharmaceuticals media release, interim efficacy data from INNOVATE will therefore not be available in the first half of 2022 as previously expected. Updated 08 Mar 2022 |
| 01 Mar 2022 | Status change - suspended | According to an Inovio Pharmaceuticals media release, status changed from recruiting to suspended. Updated 08 Mar 2022 |
| 01 Mar 2022 | Other trial event | According to an Inovio Pharmaceuticals media release, in addition, to reflect the potential impact of the Omicron variant on INNOVATE, the Data Safety Monitoring Board (DSMB) recommended that INOVIO pause enrollment of new participants in the global Phase 3 clinical trial of INO-4800 in order to update the Informed Consent Form and Investigator Brochure. Updated 08 Mar 2022 |
| 01 Mar 2022 | Other trial event | According to an Inovio Pharmaceuticals media release, company plans to seek regulatory approval to amend the primary endpoint of INNOVATE from prevention of virologically confirmed COVID-19 disease to prevention of severe disease due to COVID-19. The Company believes INO-4800's ability to generate T cell responses could be critical in meeting the proposed amended primary endpoint. Updated 08 Mar 2022 |
| 15 Nov 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, phase 3 segment has received regulatory approvals to begin in Colombia, Mexico, Brazil, Philippines, India, Thailand and the United States. Updated 30 Nov 2021 |
| 09 Nov 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, the dosing for INNOVATE Phase 3 segment is underway and the company aims to have interim efficacy data in the first half 2022. Updated 22 Nov 2021 |
| 09 Nov 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) provided authorization to proceed for INOVIO INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. The FDA has lifted the partial clinical hold following the FDAs review of additional non-clinical, clinical, and device information provided by INOVIO. Updated 21 Nov 2021 |
| 03 Nov 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, company has received authorization from India's Central Drugs Standard Control Organization (CDSCO)'s Drug Controller General of India (DCGI) to proceed with the Phase 3 segment of this trial. Phase 3 segment builds upon the Phase 2 segment, which was conducted in the U.S. Updated 11 Nov 2021 |
| 21 Oct 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, the signing of a non-binding memorandum of understanding (MOU) with Colombia's Ministry of Health and Social Protection.The framework of the planned collaboration builds on company recently announced authorization to proceed in Colombia with the Phase 3 segment of this study. Updated 26 Oct 2021 |
| 18 Oct 2021 | Other trial event | Planned number of patients changed from 6578 to 7517. Updated 28 Oct 2021 |
| 18 Oct 2021 | Completion date | Planned End Date changed from 1 Sep 2022 to 1 Jan 2023. Updated 28 Oct 2021 |
| 18 Oct 2021 | Other trial event | Planned primary completion date changed from 1 Sep 2022 to 1 Jan 2023. Updated 28 Oct 2021 |
| 11 Oct 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, the company is working with partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the INNOVATE Phase 3 segment in multiple countries, with a focus on countries in Latin America, Asia, and Africa. The company recently announced that it has received regulatory authorization to proceed in Brazil, Philippines, and Mexico. Updated 13 Oct 2021 |
| 11 Oct 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, the company announced that it has received authorization from Colombias INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or the National Food and Drug Surveillance Institute), to conduct the Phase 3 segment of this study in Colombia. Updated 13 Oct 2021 |
| 03 Oct 2021 | Results | Results presented at the IDWeek 2021 Updated 05 Feb 2022 |
| 09 Sep 2021 | Biomarker Update | Biomarkers information updated Updated 17 Sep 2021 |
| 26 Aug 2021 | Status change - recruiting | Status changed from active, no longer recruiting to recruiting, according to an Inovio Pharmaceuticals media release. Updated 30 Aug 2021 |
| 26 Aug 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, it has received regulatory authorization from Brazil's ANVISA (Agencia Nacional de Vigilancia Sanitaria), the national health regulatory agency of Brazil, to initiate the global Phase 3 segment of his trial. Updated 30 Aug 2021 |
| 08 Jun 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, the companies will evaluate the safety and efficacy of INO-4800 in a two-dose regimen (2.0 mg), administered one month apart, in a two-to-one randomization in subjects 18 years and older across several countries, primarily in Latin America and Asia Updated 15 Jun 2021 |
| 10 May 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, Company plans to file preliminary Phase 2 results and device data with the U.S. Food and Drug Administration (FDA). Updated 13 May 2021 |
| 10 May 2021 | Results | According to an Inovio Pharmaceuticals media release, result has been published as a pre-print in MedRxiv. Updated 13 May 2021 |
| 10 May 2021 | Results | Phase 2 results presented in the Inovio Pharmaceuticals Media Release. Updated 13 May 2021 |
| 23 Apr 2021 | Other trial event | According to an Inovio Pharmaceuticals media release, given the increasing availability of vaccines authorized for emergency use, the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency, will discontinue funding for the Phase 3 segment of the trial, while continuing to fund the completion of phase 2 segment. Updated 30 Apr 2021 |
| 19 Feb 2021 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 23 Feb 2021 |
| 07 Dec 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, first patient has been dosed in the trial. The company plans to fully enroll the Phase 2 segment of the trial by the end of this month. Updated 13 Dec 2020 |
| 03 Dec 2020 | Other trial event | New source identified and integrated: (ClinicalTrials.gov: US National Institutes of Health: NCT04642638). Updated 03 Dec 2020 |
| 01 Dec 2020 | Status change - recruiting | Status changed to recruiting. Updated 10 Dec 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the phase 2 segment of the trial is expected to enroll approximately 400 participants, in order to confirm the dose (s) for the subsequent efficacy evaluation planned for the Phase 3 segment.The Phase 3 segment will be case-driven with the final number of enrollees to be determined by the incidence of COVID-19 during the Phase 3 segment. Updated 30 Nov 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company intends to work diligently to ensure diversity in enrollment, targeting specific populations that are working or residing in environments with high infection rates and/or areas where there is greater risk of exposure to SARS-CoV-2, for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings. Updated 30 Nov 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the lead Principal Investigator for this trial is Dr. Pablo Tebas, Professor of Medicine at the Hospital of the University of Pennsylvania. Updated 30 Nov 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the FDAs authorization to proceed with the phase 2 segment is based on its review of INOVIOs non-clinical data, device information and interim Phase 1 safety and immunogenicity data as well as its design and plans for the Phase 2 and Phase 3 segments of this planned clinical trial. Updated 30 Nov 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the Phase 3 segment of this trial remains on partial clinical hold until INOVIO satisfactorily resolves the FDAs remaining questions related to the CELLECTRA 2000 device that will be used to deliver INO-4800 directly into the skin. The company plans to resolve the remaining device questions during the conduct of Phase 2 segment and prior to the start of the Phase 3 segment of the trial. Updated 30 Nov 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, this trial will be funded by the U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Defense Health Agency (DHA). Updated 30 Nov 2020 |
| 16 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with the Phase 2 segment of this planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate. Updated 30 Nov 2020 |
| 09 Nov 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company has responded to the United States Food & Drug Administration (FDA) to address the questions related to the partial clinical hold on INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800. Updated 23 Nov 2020 |
| 28 Sep 2020 | Status change - suspended | Status changed from planning to suspended, according to an Inovio Pharmaceuticals media release. Updated 29 Sep 2020 |
| 28 Sep 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, this partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification. In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development. INOVIO and its partners are continuing to prepare for this trial, following resolution of the FDA. Updated 29 Sep 2020 |
| 28 Sep 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, until the FDA questions have been satisfactorily addressed, this study is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed. Updated 29 Sep 2020 |
| 28 Sep 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial. Updated 29 Sep 2020 |
| 10 Aug 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company plans to start this trial in September. Updated 13 Aug 2020 |
| 30 Jun 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company plans to initiate this study in this summer upon regulatory concurrence. Updated 05 Jul 2020 |
| 20 May 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, this study is anticipated to start in July/August pending regulatory approval. Updated 24 May 2020 |
| 30 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, INOVIO plans to produce one million doses of INO-4800 by the end of 2020. Updated 08 May 2020 |
| 30 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, INOVIO today announced that it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIOs investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. (NCT04336410) for COVID-19 and could potentially advance to Phase 2/3 efficacy trial (CT profile 320589) this summer. Updated 08 May 2020 |
| 08 Apr 2020 | New trial record | New trial record Updated 08 Apr 2020 |
| 06 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, upon attaining initial safety and immunogenicity data from Phase 1 studies, the company plans to advance INO-4800 to Phase 2 efficacy studies as rapidly as possible. Updated 08 Apr 2020 |
Table of Contents
References
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
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