Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR202110626944896 Date of Approval: 14/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
Official scientific title 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
Brief summary describing the background and objectives of the trial 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.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/12/2021
Actual trial start date 30/11/2020
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 7116
Actual target sample size (number of participants) 0
Recruitment status Withdrawn
Publication URL
Secondary Ids Issuing authority/Trial register
INNOVATE Inovio Pharmaceuticals
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group INO 4800 Dose Once on Day 0 and Day 28. Day 0 and Day 28 INO-4800 will be administered intradermal injection on Day 0 and Day 28. Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28. 4744
Control Group Placebo Once on Day 0 and Day 28. Day 0 and Day 28 Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28. EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28. 2372 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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). 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. 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 HIV based on a 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. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 11/10/2021 Comite de Protection Des Personnes Du Nord
Ethics Committee Address
Street address City Postal code Country
Institut Pasteur de Tunis 13, Tunis,Place Pasteur, Tunis Belvédère 74 1 1002 Tunisia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 08/11/2021 National Ethics Committee Rwanda
Ethics Committee Address
Street address City Postal code Country
Ministry of Health, P.O. Box. 84 Kigali 00000 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay Baseline up to Day 393
Primary Outcome Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay Baseline up to Day 393
Primary Outcome Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393
Secondary Outcome Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions From time of consent up to 28 days post-dose 2 up to Day 56
Secondary Outcome Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs) From time of consent up to 28 days post-dose 2 up to Day 56
Secondary Outcome Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs) Baseline up to Day 393
Secondary Outcome Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs) Baseline up to Day 393
Secondary Outcome Phase 3: Percentage of Participants With Death From All Causes Phase 3: Percentage of Participants With Death From All Causes
Secondary Outcome Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Non-Severe COVID-19 Disease From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393
Secondary Outcome Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Severe COVID-19 Disease From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393
Secondary Outcome Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Death From COVID-19 Disease From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393
Secondary Outcome Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393
Secondary Outcome Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay Baseline up to Day 393
Secondary Outcome Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay Baseline up to Day 393
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Center for Family Health Research KK 19 Av, No. 57, Kicukiro Kigali 780 Rwanda
Rinda Ubuzima research centre KG 11 Avenue No 47 P.O Box 4560 Kigali 4560 Rwanda
Hopital Militaire de Tunis 1008 Montfleury Tunis 1008 Tunisia
Hopital Militaire de Sfax Express Rocade Nr 11, Thyna Sfax 3029 Tunisia
Hospital Fattouma Bourguiba Rue du 1er juin 1955 Monastir 5000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Inovio Pharmaceuticals Inc. 660 W Germantown Pike, Ste 110 Plymouth Meeting 19462 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Inovio Pharmaceuticals Inc. 660 W. Germantown Pike, Ste 110 Plymouth Meeting 19462 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faida Ajili faida1977@yahoo.fr 0021698631188 Hopital Militaire de Tunis, Montfleury 1008
City Postal code Country Position/Affiliation
Tunis 00000 Tunisia Military Hospital instruction of Tunis
Role Name Email Phone Street address
Public Enquiries Inovio Call Center clinical.trials@inovio.com 12674404237 660 W Germantown Pike, Ste 110
City Postal code Country Position/Affiliation
Plymouth Meeting 19462 United States of America Inovio
Role Name Email Phone Street address
Scientific Enquiries Inovio Call Center clinical.trials@inovio.com 12674404237 660 W Germantown Pike, Ste 110
City Postal code Country Position/Affiliation
Plymouth Meeting 19462 United States of America Inovio
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request. Informed Consent Form,Study Protocol Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study. Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/10/2021 This is the device used along with the intervention; the group is assigned to the intervention, not the device. Experimental Group, Device CELLECTRA 2000, Once on Day 0 and Day 28., Day 0 and Day 28, Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28., 0,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/10/2021 This is the device used along with the intervention; the group is assigned to the intervention, not the device. Experimental Group, Device CELLECTRA 2000, Once on Day 0 and Day 28., Day 0 and Day 28, EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28., 2372, Experimental Group, Device CELLECTRA 2000, Once on Day 0 and Day 28., Day 0 and Day 28, EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28., 0,
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 12/10/2021 Anticipated start of trial pending ethics approval. 01 Nov 2020 01 Dec 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 12/10/2021 Trial was started in the US but is pending ethics approval for PACTR. 20 Nov 2020
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/10/2021 Update intervention name. Experimental Group, INO 4800 Dose , Once on Day 0 and Day 28., Day 0 and Day 28, INO-4800 will be administered intradermal injection on Day 0 and Day 28. Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28. , 4744,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/10/2021 Update intervention. Control Group, Placebo , Once on Day 0 and Day 28., Day 0 and Day 28, Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28. , 2372, Placebo Control Group, Placebo , Once on Day 0 and Day 28., Day 0 and Day 28, Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28. EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28. , 2372, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 31/01/2022 Updated start date 30 Nov 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 31/01/2022 Study has started Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 07/06/2022 Updated per amendment 31 Jan 2023 28 Feb 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/06/2022 Updated per amendment Recruiting Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/06/2022 Updated status due to study changes. Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/06/2022 Updated status due to study changes. Recruiting Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 07/06/2022 added missing text 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 HIV based on a 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 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. 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 HIV based on a 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.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/06/2022 Updates to outcome measure text Secondary Outcome, Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease, From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393 Secondary Outcome, Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease , From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/06/2022 Study status update Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/06/2022 Study status update Recruiting Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 10/06/2022 Study cancelled in these countries Active, not recruiting Withdrawn
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 10/06/2022 Study withdrawn 0