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.: PACTR201910864382850 Date of Registration: 18/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
Official scientific title Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana
Brief summary describing the background and objectives of the trial This is a randomized and blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LSV002
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Lassa Fever
Purpose of the trial Prevention
Anticipated trial start date 15/01/2021
Actual trial start date 27/01/2021
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group INO 4500 Group A 1 ID injection of 1 mg/dose INO-4500 Day 0 and Week 4 Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device. 88
Experimental Group INO 4500 Group B 2 ID injections of 1 mg/dose INO-4500 Day 0 and Week 4 Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit. 88
Control Group Placebo Group C 1 ID injection of 1 mg/dose placebo Day 0 and Week 4 Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. 22 Placebo
Control Group Placebo Group D 2 injections of 1 mg/dose placebo Day 0 and Week 4 Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit. 22 Placebo
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; 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); Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is 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 enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months 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 three (3) months following last dose; Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing; Is 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 prevention of Lassa Fever; Audiometry testing that demonstrates a hearing level threshold of 30dB or greater for any frequency tested between 500 Hz - 8000Hz; Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles; Current or anticipated concomitant immunosuppressive therapy; Fever with or without cough or any other concurrent illness which the PI feels is contraindicated to clinical trial participation. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 18/09/2019 Noguchi Memorial Institute for Medical Research IRB
Ethics Committee Address
Street address City Postal code Country
P.O. Box LG581 Legon 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of Participants with Adverse Events (AEs) Baseline up to Week 48
Primary Outcome Number of Participants with Injection Site Reactions Day 0 up to Week 48
Primary Outcome Number of Participants with Adverse Events of Special Interest (AESIs) Baseline up to Week 48
Primary Outcome Change from Baseline in Antigen Specific Binding Antibody titers Day 0 up to Week 48
Primary Outcome Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies Day 0 up to Week 48
Secondary Outcome Change from Baseline in Interferon-Gamma Response Magnitude Day 0 up to Week 48
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Noguchi Memorial Institute for Medical Research P.O. Box LG 581 Legon Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Innovations 1901 Pennsylvania Ave Washington 20006 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Inovio Pharmaceuticals 660 W. Germantown Pike 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 Koram KKoram@noguchi.ug.edu.gh 233302501178 P.O. Box LG 581
City Postal code Country Position/Affiliation
Legon 00233 Ghana Noguchi Memorial Institute for Medical Research
Role Name Email Phone Street address
Public Enquiries Susan Adu Amankwah SAdu-Amankwah@noguchi.ug.edu.gh 233244734811 P.O. Box LG 581
City Postal code Country Position/Affiliation
Legon 00233 Ghana Noguchi Memorial Institute for Medical Research
Role Name Email Phone Street address
Public Enquiries Kwadwo Koram KKoram@noguchi.ug.edu.gh 233302501178 P.O. Box LG 581
City Postal code Country Position/Affiliation
Legon 00233 Ghana Noguchi Memorial Institute for Medical Research
Role Name Email Phone Street address
Scientific Enquiries Kwadwo Koram KKoram@noguchi.ug.edu.gh 233302501178 P.O. Box LG 581
City Postal code Country Position/Affiliation
Legon 00233 Ghana Noguchi Memorial Institute for Medical Research
Role Name Email Phone Street address
Scientific Enquiries Inovio Call center clinical.trials@inovio.com 12674404237 660 W. Germantown Pike
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 2 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