Study of COVID-19 DNA Vaccine (AG0302-COVID19)

COVID-19 Clinical Trial

Official title:

A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527081
• Other study ID #: AG0302-COVID19-JN-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 31, 2020
• Est. completion date: September 24, 2021

Study information

• Verified date: October 2021
• Source: AnGes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult volunteers.

Description:

This is a Phase 1/2, single-center, randomized, open-label, non-controlled trial. Approximately 30 healthy volunteers, male or female, aged 20-65, will be randomized to one of the following three groups.

Group A: Vaccination twice at 2-week intervals (n = 10) Group B: Vaccination twice at 4-week intervals (n = 10) Group C: Vaccination 3 times at 2-week intervals (n = 10)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 24, 2021
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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 20 years to 65 years

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

4. Subjects with axillary temperature of 37.0 degree or higher

5. Subjects who have a history of anaphylaxis

6. Subjects who have a current or history of serious renal, cardiovascular, respiratory, liver, kidney, gastrointestinal, and neuropsychiatric diseases

7. Subjects with a history of convulsion or epilepsy

8. Subjects with a history of diagnosis of immunodeficiency

9. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency

10. Subjects who have current bronchial asthma

11. Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination, and those who suspected allergy such as a systemic rash

12. Females who wish to become pregnant from the date of study registration to 12 weeks after the first inoculation of the investigational drug, 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

13. 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)

14. 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)

15. 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

16. Subjects who received blood transfusion or gamma globulin therapy within 12 week before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24 weeks before vaccination

17. Subjects who have a history of overseas travel within 4 weeks before the start of the clinical trial (starting from vaccination day)

18. Subjects who are unable to comply with the clinical trial protocol and follow up (for mental, family, social or geographical reasons)

19. Subjects who are judged to be ineligible for this clinical trial by the investigator

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• AG0302-COVID19
2.0 mg of AG0302-COVID19 twice at 2-week intervals
• AG0302-COVID19
2.0 mg of AG0302-COVID19 twice at 4-week intervals
• AG0302-COVID19
2.0 mg of AG0302-COVID19 three times at 2-week intervals

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AnGes, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Frequency and severity of each adverse event, solicited local and systemic AEs 8 weeks after first vaccination	Week 1 through Week 9
Primary	Immunogenicity	Change in Geometric mean titer (GMT) of serum anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody	Weeks 3, 5, 7, 9
Secondary	Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein-specific antibody		Weeks 13, 25, 53
Secondary	Change in GMT of anti-SARS-CoV-2 Spike (S) glycoprotein receptor binding domain-specific antibody		Weeks 3, 5, 7, 9, 13, 25, 53
Secondary	Change in GMT of anti-SARS-CoV-2 B cell epitope antibody		Week 9
Secondary	Change in IgG subclasses (IgG1 and IgG2) of anti-SARS-CoV-2 spike (S) glycoprotein-specific antibody		Weeks 3, 5, 7, 9, 13, 25, 53
Secondary	Change in the neutralizing activity against pseudovirus of SARS-CoV-2		Weeks 3, 5, 7, 9, 13, 25, 53
Secondary	Change in binding inhibition of SARS-CoV-2 spike (S) glycoprotein and ACE2		Weeks 3, 5, 7, 9, 13, 25, 53
Secondary	Change in IFN-? production against SARS-CoV-2 spike (S) glycoprotein by T cells in peripheral blood mononuclear cells		Weeks 3, 5, 7, 9, 13, 25, 53
Secondary	Adverse events		Week 9 through Week 53