Clinical trial NCT04715997: Safety and Immunogenicity Study of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Adults
Official title: A Phase 1/2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Immunogenicity of GX-19N, a COVID-19 Preventive DNA Vaccine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The objective of our study is to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive DNA vaccine in healthy volunteers.

Detailed description: This clinical study is phase 1/2a clinical trial to evaluate safety, tolerability, and immunogenicity of COVID-19 preventive vaccine by intramuscularly administration in healthy volunteers.

Phase 1 of this study is designed as single arm, open-labeled and a total of 20 subjects will be enrolled. Phase 2a of study is designed as randomized, double-blind, placebo controlled and a total of 150 subjects are planned to be enrolled.

Eligibility criteria: Inclusion Criteria:

* Able and willing to comply with all study procedures and voluntarily signs informed consent form
* Healthy adult male or female aged 19-55 years
* Willing to provide specimens such as blood and urine during the study, including end of study visit.

Exclusion Criteria:

* Immunosuppresion including immunodeficiency disease or family history
* Any history of malignant disease within the past 5 years
* Scheduled to undergo any surgery or dental treatment during the study
* Having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration.
* Having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration
* Positive of serology test at screening
* Suspected of drug abuse or a history within 12 months prior to administration
* Active alcohol use or history of alcohol abuse
* Serious adverse reaction to a drug containing GX-19N or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history
* History of hypersensitivity to vaccination such as Guillain-Barre syndrome
* Those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease)
* Having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants
* Subjects who have been contact with COVID-19 infections in the past prior to administration, have been classified as COVID-19 confirmed patients, medical patients or patients with symptoms or have been identified with SARS and MERS infection history in the past
* Acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration
* Other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study
* History of having taken immunosuppressant or Immune modifying drug within 3 months prior to administration
* Having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration
* Pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening
* Fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study
* Any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

Primary outcomes:
measure: Incidence of Solicited Adverse Events
timeFrame: Through 1 year post vaccination
measure: Incidence of Unsolicited Adverse Events
timeFrame: Through 1 year post vaccination
measure: Incidence of Serious Adverse Events
timeFrame: Through 1 year post vaccination
Secondary outcomes:
measure: GMT of Antigen-specific Binding Antibody Titers
timeFrame: Through 1 year post vaccination
measure: GMFR of Antigen-specific Binding Antibody Titers
timeFrame: Through 1 year post vaccination
measure: Percentage of Subjects Who Seroconverted After Vaccination
timeFrame: Through 1 year post vaccination
measure: GMT and GMFR of Neutralizing Antibody Level
timeFrame: Through 1 year post vaccination
measure: GMFR of Neutralizing Antibody Level
timeFrame: Through 1 year post vaccination
measure: GMSN and GMFR of Spot Forming Unit (SFU) detected by IFN-gamma ELISPOT assay
timeFrame: Through 1 year post vaccination
Other outcomes:
measure: Change From Baseline in Antigen-specific IFN-gamma Cellular Immune Response
timeFrame: Through 1 year post vaccination
Locations:
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Genexine, Inc.
name: JungWon Woo, Ph.D.
role: STUDY_DIRECTOR
affiliation: Severance Hospital
name: Jun Yong Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahn JY, Lee J, Suh YS, Song YG, Choi YJ, Lee KH, Seo SH, Song M, Oh JW, Kim M, Seo HY, Kwak JE, Youn JW, Woo JW, Shin EC, Sung YC, Park SH, Choi JY. Safety and immunogenicity of two recombinant DNA COVID-19 vaccines containing the coding regions of the spike or spike and nucleocapsid proteins: an interim analysis of two open-label, non-randomised, phase 1 trials in healthy adults. Lancet Microbe. 2022 Mar;3(3):e173-e183. doi: 10.1016/S2666-5247(21)00358-X. Epub 2022 Feb 8.