Clinical trial NCT04655625: Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Official title: A Randomized, Double-blind, Placebo Controlled Phase II / III Study to Assess Safety, Immunogenicity and Efficacy of Twice Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: vaccine
COVID-19
SARS-CoV-2
Lead sponsor: AnGes, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Japan Agency for Medical Research and Development
First posted: 2020-12-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the safety, immunogenicity and efficacy of AG0302-COVID19 in healthy adult volunteers.

Detailed description: This is a Phase II /III, multi-center, randomized, double-blind, placebo controlled trial. Approximately 500 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following two groups:

Group A: Vaccination twice at 2-week intervals (n = 250) Group B: Vaccination twice at 4-week intervals (n = 250)

Fifty subjects in each group will receive placebos.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have obtained written consent voluntarily to participate in this clinical trial
2. Subjects whose age at the time of obtaining consent is 18 years or older
3. Subjects who are negative for SARS-CoV-2 by PCR test
4. Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody by antibody test

Exclusion Criteria:

1. Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms, headache, malaise, olfactory disorders, taste disorders, etc.)
2. Subjects with a history of COVID-19 (hearing from subjects)
3. Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
4. Subjects with axillary temperature of 37.0 degree or higher at the time of screening and before the first vaccination
5. Subjects who have a history of anaphylaxis
6. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
7. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
8. Subjects with a history of convulsion or epilepsy
9. Subjects with a history of diagnosis of immunodeficiency
10. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
11. Subjects who have current bronchial asthma
12. Subjects who have had a fever of 39.0 degrees or higher within 2 days after vaccination, or who have been suspected of having an allergy such as a systemic rash.
13. Females who wish to become pregnant from the study registration to 12 weeks after the first vaccination, and pregnant females who are breast-feeding. In addition, females who may become pregnant and their male sexual partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing system, etc. from the study entry date until 12 weeks after the first vaccination
14. Subjects who have participated in clinical trials of other unapproved drugs and received the investigational drug within 4 weeks before the start of this clinical trial (starting from vaccination day)
15. Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within 4 weeks before the start of this clinical trial (starting from vaccination day)
16. Subjects who have been administered with drugs that affect the immune system (excluding external preparations) such as immunomodulators (DMARDs, etc.), immunosuppressants, biologics, etc. within 4 weeks before vaccination
17. Subjects who received blood transfusion or gamma globulin therapy within 12 weeks before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination
18. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
19. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
20. Subjects who are judged to be ineligible for this clinical trial by the investigator

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Group A: 6 weeks Group B: 8 weeks
measure: Immunogenicity
timeFrame: Group A: Week 7 Group B: Week 9
Secondary outcomes:
measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
timeFrame: Group A: Weeks 5, 25, 53 Group B: Weeks 7, 25, 53
measure: Change in the neutralizing activity against pseudovirus of SARS-CoV-2
timeFrame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
measure: Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
timeFrame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
measure: IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
timeFrame: Group A: Weeks 5, 7, 25, 53 Group B: Weeks 7, 9, 25, 53
measure: Adverse events
timeFrame: Group A: Week 7 through Week 53 Group B: Week 9 through Week 53
measure: Rate of SARS-CoV-2 positive and incidence rate of COVID-19 after the first vaccination
timeFrame: Week 1 through Week 53
Other outcomes:
Locations:
city: Narita
country: Japan
facility: UHW Narita Hospital
state: Chiba
city: Suita
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Shibuya-ku
country: Japan
facility: Medical Corporation Tsurukamekai Shinjuku Tsurukame C linic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Shinanokai Shinanozaka Clinic
state: Tokyo
city: Toshima-ku
country: Japan
facility: Sekino Clinical Pharmacology Clinic
state: Tokyo
city: Osaka
country: Japan
facility: NISHI-UMEDA Clinic for Asian Medical Collaboration
city: Osaka
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital
Study officials:
affiliation: AnGes, Inc.
name: AnGes, Inc. Clinical Development
role: STUDY_DIRECTOR
References: