Clinical trial NCT04993586: Phase I/II Study of COVID-19 DNA Vaccine (AG0302-COVID19 High-dose)
Official title: A Randomized, Open-label, Uncontrolled, Phase I/II Study to Assess Safety and Immunogenicity of Two or Three Dosing of Intramuscular/Intradermal AG0302-COVID19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19 Lower Respiratory Infection
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: 2021-08-06
Enrollment: 422
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 and immunogenicity of AG0302-COVID19 in healthy volunteers.

Detailed description: This is a Phase I/II, multi-center, randomized, open-label, uncontrolled trial. Approximately 400 healthy volunteers, male or female, aged 18 years or older, will be randomized to one of the following five groups:

\[IM Groups\] Group A: Vaccination 2 mg, three times at 2-week intervals (n = 80) Group B: Vaccination 4 mg, twice at 4-week intervals (n = 80) Group C: Vaccination 8 mg, twice at 4-week intervals(n = 80)

\[ID Groups\] Group D: Vaccination 1 mg, three times at 2-week intervals (n = 80) Group E: Vaccination 1 mg, twice at 4-week intervals (n = 80)

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 with a history of vaccination for the prevention of COVID-19
4. Subjects who have participated in unapproved vaccine clinical trials within 1 year before the start of this study
5. Subjects with an axillary temperature of 37.5 degrees or higher at the time of screening
6. Subjects with an axillary temperature of 37.5 degrees or higher before the first vaccination
7. Subjects who have a history of anaphylaxis
8. Subjects who have a history of hypersensitivity to the ingredients of the investigational drug
9. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases
10. Subjects with a history of convulsion or epilepsy
11. Subjects with a history of diagnosis of immunodeficiency
12. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
13. Subjects who have current bronchial asthma
14. 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.
15. Females who wish to become pregnant from the time of obtaining consent 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
16. 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)
17. 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)
18. 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
19. 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
20. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)
21. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)
22. Subjects who are judged to be ineligible for this clinical trial by the investigator

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Week 1 through Week 13
measure: Immunogenicity
timeFrame: Week 13
measure: Immunogenicity
timeFrame: Week 13
Secondary outcomes:
measure: Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody
timeFrame: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
measure: Change in the neutralizing activity against pseudovirus of SARS-CoV-2
timeFrame: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
measure: Seroconversion rate from baseline (defined as a 4-fold or greater increase) in the neutralizing activity against pseudovirus of SARS-CoV-2 [ID50]
timeFrame: Weeks 5, 7, 9, 13, 17, 21, 25, 37, 53
measure: Change in IFN-gamma production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells
timeFrame: Weeks 5, 7, 9, 13
measure: IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody
timeFrame: Weeks 1, 9, 13
measure: Adverse events
timeFrame: Week 13 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
measure: Rate of swelling and leakage of the drug to the vaccination site during intradermal vaccination
timeFrame: Weeks 1, 3, 5
measure: Number of defects in preparation and vaccination during intradermal vaccination
timeFrame: Week 1 through Week 5
Other outcomes:
Locations:
city: Narita
country: Japan
facility: IUHW Narita Hospital
state: Chiba
city: Suita
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
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: Medical Corporation Heishinkai OPHAC Hospital
Study officials:
affiliation: AnGes, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References: