Preventive Immunization COVID-19 Clinical Trial
Official title:
An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
The purpose of the study is to assess safety, tolerability and immunogenicity of the drug
"Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of
healthy volunteers
Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution
for intramuscular administration, using single dose of each component (Stage 1).
A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular
administration, using prime-boost immunization according to the proposed scheme (Stage 2).
Post-vaccination immunity assessment at different time points after vaccination by:
- Determination of antigen-specific antibody titer in blood serum by ELISA by comparison
with baseline values before the vaccine administration and at days 14, 21, 28, and 42
after vaccination (hereinafter, the countdown comes from the first time of the vaccine
administration);
- Determination of virus neutralizing antibody titer before and at days 14, 28, and 42
after vaccination;
- Determination of antigen-specific cellular immunity (specific T-cell immunity) before
the vaccine administration and at days 14 and 28 after vaccination.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 10, 2020 |
Est. primary completion date | August 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. males and females within the age range from 18 to 60 years; 2. written informed consent; 3. subject body mass index (BMI): 18.5 = BMI = 30; 4. negative PCR test results for SARS-CoV-2 (during the screening); 5. no history of COVID-2019 disease; 6. no contacts of volunteers with patients with COVID-2019 for at least 14 days; 7. negative test results for IgM and IgG antibodies to SARS-CoV-2; 8. subject agrees to use effective contraceptive methods during the entire period of participation in the study; 9. absence of acute infectious diseases at the time of vaccine administration and 14 days before vaccination; 10. negative pregnancy test of blood or urine (for women of childbearing age); 11. subject has negative tests for HIV, hepatitis B and ?, syphilis or confirmed medical history; 12. subject has a negative result of the urine test for residual narcotic drugs; 13. negative test for alcohol in exhaled air; 14. the absence of malignant diseases of any nature and localization; 15. in medical history and based on the screening results, subject has no diseases or pathologies of the gastrointestinal system, liver, kidneys, cardiovascular system and blood, CNS, musculoskeletal system, urogenital, immune and endocrine systems that from the point of view of the researcher and/or of the organizer of the study, may affect the safety of the volunteer and the evaluation of the study results (clinical, instrumental and laboratory tests did not reveal diseases or clinically significant deviations). Exclusion Criteria: 1. volunteer involvement in another study over the last 90 days; 2. any vaccination over the last 30 days; 3. history of COVID-2019 disease; 4. positive PCR test results for SARS-CoV-2 (during the screening); 5. positive test results for IgM and IgG antibodies to SARS-CoV-2; 6. health staff in contact with people with COVID-2019; 7. respiratory symptoms in the last 14 days; 8. the administration of immunoglobulins or other blood products in the last 3 months; 9. regular current or past use of narcotic drugs; 10. subject has received immunosuppressive and/or immunomodulating agents within 6 months before the start of the study; 11. pregnancy or breast feeding; 12. exacerbation of allergic diseases at the time of vaccination; 13. subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg; diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower than 60 beats per minute or above 100 beats per minute; 14. a burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the introduction of any vaccines in history, known allergic reactions to vaccine components, etc.); 15. a history of autoimmune diseases in the volunteer's medical history and in relatives' medical history of the 1-2 degree of kinship; 16. subject smokes more than 10 cigarettes per day; 17. alcohol intake exceeding the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before the administration of the drug; 18. planned hospitalization and/or surgery during the period of participation in the study, as well as 4 weeks before the expected date of the administration of the drug; 19. the presence of an associated disease that may affect the assessment of the results of the study; 20. any conditions that, according to the researcher's doctor, may be a contraindication to the participation in the study. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Main military clinical hospital named after academician N. N. Burdenko | Moscow |
Lead Sponsor | Collaborator |
---|---|
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | Acellena Contract Drug Research and Development |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days | Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values | at days 0,14, 21, 28, 42 | |
Primary | Number of Participants With Adverse Events | Determination of Number of Participants With Adverse Events | through the whole study, an average of 180 days | |
Secondary | Changing of of virus neutralizing antibody titer | Determination of virus neutralizing antibody titer | at days 0,14, 28, 42 | |
Secondary | Changing of antigen-specific cellular immunity level | Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation) | at days 0,14, 42 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04437875 -
An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19
|
Phase 1/Phase 2 |