An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04437875
• Date of registration: 16/06/2020
• Prospective Registration: Yes
• Primary sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Public title: An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19
• Scientific title: An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
• Date of first enrolment: June 17, 2020
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04437875
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Russian Federation

Contacts

• Name: Lola Morozova, Md
• Affiliation: I.M. Sechenov First Moscow State Medical University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Preventive Immunization COVID-19

Intervention(s)

Biological: Gam-COVID-Vac Lyo

Primary Outcome(s)

Number of Participants With Adverse Events [Time Frame: through the whole study, an average of 180 days]

The changing of antibody levels against the SARS-CoV-2 glycoprotein S at 42 days [Time Frame: at days 0, 14, 21, 28, 42]

Secondary Outcome(s)

The changing of virus neutralizing antibody titer [Time Frame: at days 0, 14, 28, 42]

The changing of antigen-specific cellular immunity level [Time Frame: at days 0, 14, 28]

Secondary ID(s)

03-Gam-COVID-Vac Lyo-2020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Acellena Contract Drug Research and Development