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: pactr.samrc.ac.za
Trial no.: PACTR202206666476182 Date of Approval: 29/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers
Official scientific title Phase 1 Open Label, Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Intradermal Booster Dose of INO-4800 Alone or in Combination With INO-9112 Followed by Electroporation, in Adults Who Completed a Primary Immunization Series Against SARS-CoV-2 With mRNA Vaccines
Brief summary describing the background and objectives of the trial This is a randomized, open label, phase 1 clinical trial of an intra-dermal booster dose of INO-4800 alone or in combination with INO-9112 followed by electroporation (EP) among healthy adults at least 18 years of age, who previously completed their primary series with mRNA vaccines against SARS-CoV-2 within 6-12 months prior to the booster dose.
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 Coronavirus Infection
Purpose of the trial Prevention
Anticipated trial start date 31/08/2022
Actual trial start date
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 0
Recruitment status Withdrawn
Publication URL
Secondary Ids Issuing authority/Trial register
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group INO4800 followed by EP administered INO-4800 will be given at 0.8 or 1.6 mg. at least 6 months but no more than 12 months INO-4800 will be given at 0.8 or 1.6 mg for at least 6 months but no more than 12 months following the completion of a primary vaccination. Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800. 40
Control Group INO9112 followed by EP administered at Day 0 INO-9112 will be given in at various doses (dose of 0, 0.05, 0.10, 0.20 or 0.40 mg) in combination with INO-4800. for at least 6 months but no more than 12 months INO-9112 will be given in at various doses (dose of 0, 0.05, 0.10, 0.20 or 0.40 mg) in combination with INO-4800. Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800. 120 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy men and non-pregnant women at least 18 years of age; Able and willing to comply with all study procedures; Screening laboratory results within normal limits or deemed not clinically significant by the Investigator; Received full primary series doses of an approved or authorized mRNA vaccine at least 6 months but no more than 12 months prior to INO-4800 booster dose. Must meet one of the following criteria with respect to reproductive capacity: Women who are post-menopausal as defined by reported spontaneous amenorrhea for ≥ 12 months; Surgically sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrollment; Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until Day 28 post booster dose. Acute febrile illness with temperature >100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat) within the prior 72 hours; Positive SARs-CoV-2 PCR test, if results are available prior to dosing; Pregnant or breastfeeding, or intending to become pregnant or intending to father children within the projected duration of the study starting from the Screening visit until Day 28 post booster dose; Positive pregnancy test during screening or immediately prior to booster dose; Positive HIV rapid test, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody at Screening; Is currently participating or has participated in a study with an IP within 30 days preceding Day 0 (documented receipt of placebo in a previous study would be permissible for study eligibility); Currently participating in another study with an investigational product during the conduct of this study; Previous or planned receipt of any COVID-19 booster vaccine during the trial period Medical conditions as follows: Respiratory diseases History of hypersensitivity or severe allergic reaction Uncontrolled hypertension Uncontrolled diabetes mellitus Malignancy within the past 2 years, with the exception of superficial skin History of cardiovascular History of seizures within the past 2 years Underlying immunosuppressive illness Lack of acceptable sites for ID injection and EP Blood donation or transfusion within 1 month prior to Day 0; Reported alcohol or substance abuse/dependence or illicit drug use within the past year; Any non-study vaccine (e.g., influenza vaccine) within 2 weeks prior to the dose of IP. 80 and over: 80+ Year,Adolescent: 13 Year-18 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 07/07/2022 Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
P. O. Box LG581 Legon 00000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) Baseline up to Day 7
Primary Outcome Percentage of Participants with Adverse Events (AEs) Baseline up to Day 28
Primary Outcome Percentage of Participants with Serious Adverse Events (SAEs) Baseline up to week 52
Primary Outcome Percentage of Participants with Adverse Events of Special Interest (AESIs) Baseline up to week 52
Primary Outcome Percentage of Participants with Incidence of medically attended AEs (MAAEs) Baseline up to week 52
Primary Outcome Percentage of Participants with Change in SARS-CoV-2 pseudovirus neutralizing titers Baseline up to day 28
Secondary Outcome Change in SARS-CoV-2 pseudovirus neutralizing titers Baseline, Day 7, 14, 84, 180, 224, 280 and 365 post-booster
Secondary Outcome SARS-CoV-2 pseudovirus neutralizing titers Days 7, 14, 28, 84, 180, 224, 280 and 365 post-booster
Secondary Outcome ARS-CoV-2 Spike binding IgG and change in SARS-CoV-2 Spike binding IgG Days 7, 14, 28, 84, 180 and 365 post-booster
Secondary Outcome SARS-CoV-2 cellular immune response as measured by IFN-gamma ELISpot Day 14 post-booster
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Noguchi Memorial Institute for Medical Research College of Health Sciences P. O. Box LG581 Legon 00000 Ghana
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 Kwadwo A. Koram KKoram@noguchi.ug.edu.gh 233302501178 P. O. Box LG581
City Postal code Country Position/Affiliation
Legon Ghana Noguchi Memorial Institute for Medical Research College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Kwadwo A. Koram KKoram@noguchi.ug.edu.gh 233302501178 P. O. Box LG581
City Postal code Country Position/Affiliation
Legon Ghana Noguchi Memorial Institute for Medical Research College of Health Sciences
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