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.: PACTR202012691703415 Date of Approval: 09/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Official scientific title A Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate the safety, tolerability and immunological profile of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRATM 2000 device in healthy adult volunteers
Brief summary describing the background and objectives of the trial BACKGROUND AND SCIENTIFIC RATIONALE The lack of available therapy in conjunction with increasing numbers of global cases indicates that MERS-CoV infection remains a serious unmet medical need. Due to cross-species infection, both human and animal outbreaks are possible. Appropriate measures to prevent, control and treat existing and future infections are needed. Primary Objectives: Evaluate the tolerability and safety of INO-4700 administered by ID injection followed by EP in healthy adult volunteers Evaluate the cellular (T cell) and humoral immune response to INO-4700 administered by ID injection followed by EP for identification and confirmation of an optimal dose and regimen Evaluate selected optimal dose for safety and immunogenicity Exploratory Objective: Evaluate the expanded immunological profile by assessing both T and B cell immune responses Evaluate the cellular (T cell) and humoral immune response to INO-4700 administered by ID injection followed by EP for impact of boosting with a third dose
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Healthy Volunteers - MERS COV Vaccine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/05/2021
Actual trial start date
Anticipated date of last follow up 01/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 542
Actual target sample size (number of participants) 0
Recruitment status Not yet recruiting
Publication URL https://clinicaltrials.gov/ct2/show/NCT04588428?cond=MERS&draw=2&rank=8
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group INO4700 followed by Electroporation One 0.6 mg ID injection Day 0 and Week 4 (± 5 days) Part 1 Group A 32
Experimental Group INO4700 followed by Electroporation 1.0 mg ID injection Day 0 and Week 4 (± 5 days) Part 1 Group B 32
Experimental Group INO4700 followed by Electroporation 1.0 mg ID injections Day 0 and Week 8 (± 5 days) Part 1 Group C 32
Experimental Group INO4700 followed by Electroporation Two, 0.5 mg ID injection Day 0 and Week 8 (± 5 days) Part 1 Group D 32
Experimental Group INO4700 followed by Electroporation Two, 1.0 mg ID injection Day 0 and Week 4 (± 5 days) Part 1 Group E 32
Control Group INO4700 followed by Electroporation One ID injection of placebo Day 0 and Week 4 (± 5 days) Part 1 Group F 8 Placebo
Control Group INO4700 followed by Electroporation One ID injection of placebo Day 0 and Week 8 (± 5 days) Part 1 Group G 8 Placebo
Control Group INO4700 followed by Electroporation Two ID injections of placebo Day 0 and Week 8 (± 5 days) Part 1 Group H 8 Placebo
Control Group INO4700 followed by Electroporation Two ID injections of placebo Day 0 and Week 4 (± 5 days) Part 1 Group I 8 Placebo
Experimental Group INO4700 followed by Electroporation Dose and regimen to be determined based on Part 1 data Day 0, Week 4 or Week 8, and a booster dose on Week 48 (Part 2B subjects third dose only) Part 2A and Part 2B 350
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening; Able and willing to comply with all study procedures; Screening laboratory results within normal limits; Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody; Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome); 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 1 month following last dose. Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose; History of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis; Currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0; Previous receipt of an investigational vaccine product for the prevention of MERS or severe acute respiratory syndrome (SARS); Prior exposure to MERS-CoV or camels; Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2; Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles; Prisoner or participants who are compulsorily detained (involuntary incarceration); Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic corticosteroids must be discontinued at least 3 months prior to first dose; Reported active drug or alcohol or substance abuse or dependence. 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
Yes 25/03/2021 Kenya Medical Research Institute Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Frequency of Adverse Events in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage of Participants with Adverse Events in Part 1 Part 1: baseline up to Week 48
Primary Outcome Frequency of Injection Site Reactions in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage of Participants with injection Site Reactions in Part 1 Part 1: baseline up to Week 48
Primary Outcome Frequency of Adverse Events of Special Interest (AESIs) in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1 Part 1: baseline up to Week 48
Primary Outcome Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage Antigen Specific Cellular Immune Response in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage of Seroconverted Participants in Part 1 Part 1: baseline up to Week 48
Primary Outcome Percentage of Participants with Overall Immune Response in Part 1 Part 1: baseline up to Week 48
Primary Outcome Frequency of Adverse Events in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage of Participants with Adverse Events in Part 2 Part 2: baseline up to Week 68
Primary Outcome Frequency of Injection Site Reactions in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage of Participants with Injection Site Reactions in Part 2 Part 2: baseline up to Week 68
Primary Outcome Frequency of Adverse Events of Special Interest (AESIs) in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2 Part 2: baseline up to Week 68
Primary Outcome Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage Antigen Specific Celluar Immune Response in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage of Seroconverted Participants in Part 2 Part 2: baseline up to Week 68
Primary Outcome Percentage of Participants with Overall Immune Response in Part 2 Part 2: baseline up to Week 68
Secondary Outcome N/A None
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahero Clinical Trials Unit Ahero County Hospital , Ahero Clinical Trials Unit , along Kisumu -Nairobi Road Kisumu Kenya
Kenya Medical Research Institute Walter Reed Project KEMRI WRP KEMRI/WRP, KERICHO Off Hospital Road Kericho Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Innovations Marcus Thranes Gate 2 Oslo 0473 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Inovio Pharmaceuticals Inc 660 W. Germantown Pike, Suite 110 Plymouth Meeting Pennsylvania 19462 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
MCT CRO 4th, Sterling Avenue 1053 Les Berges du Lac II Tunis 1053 Tunisia
Coalition for Epidemic Preparedness Innovations CEPI Marcus Thranes Gate 2 Oslo 0473 Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernhards Ogutu ogutu6@gmail.com 254733812613 Ahero County Hospital , Ahero Clinical Trials Unit , along Kisumu -Nairobi Road
City Postal code Country Position/Affiliation
Kisumu Kenya Director
Role Name Email Phone Street address
Principal Investigator Josphat Kosgei Josphat.kosgei@usamru-k.org 254729110112 KEMRI/WRP, KERICHO Off Hospital Road
City Postal code Country Position/Affiliation
Kericho Kenya Head of regulatory affairs
Role Name Email Phone Street address
Scientific Enquiries Bonaventure Orizu Bon.Orizu@inovio.com 12675899474 660 West Germantown Pike, Suite 110
City Postal code Country Position/Affiliation
Plymouth Meeting 19462 United States of America Medical Monitor Associate Director Clinical Development
Role Name Email Phone Street address
Public Enquiries NA NA clinical.trials@inovio.com 12674404237 660 W. Germantown Pike, Suite 110
City Postal code Country Position/Affiliation
Plymouth Meeting 19462 United States of America Public Enquiries
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