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

NCT04436471 | Completed Phase 1

• 1 other identifier: 02-Gam-COVID-Vac-2020
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preventive Immunization COVID-19

Keywords

COVID-19; SARS-CoV-2; vector vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 180 days

Secondary Outcomes (2)

• Changing of of virus neutralizing antibody titer

  at days 0,14, 28, 42

• Changing of antigen-specific cellular immunity level

  at days 0,14, 42

Study Arms (3)

Component 1

EXPERIMENTAL

rAd26 Component, 1 vaccination Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene

Biological: Gam-COVID-Vac

Component 2

EXPERIMENTAL

rAd5 Component, 1 vaccination Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene.

Biological: Gam-COVID-Vac

Prime-Boost Immunization

EXPERIMENTAL

Day 1 rAd26 Component Day 21 rAd5 Component

Biological: Gam-COVID-Vac

Interventions

Gam-COVID-Vac BIOLOGICAL

adenoviral-based vaccine against SARS-CoV-2

Component 1; Component 2; Prime-Boost Immunization

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males and females within the age range from 18 to 60 years;
• written informed consent;
• subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;
• negative PCR test results for SARS-CoV-2 (during the screening);
• no history of COVID-2019 disease;
• no contacts of volunteers with patients with COVID-2019 for at least 14 days;
• negative test results for IgM and IgG antibodies to SARS-CoV-2;
• subject agrees to use effective contraceptive methods during the entire period of participation in the study;
• absence of acute infectious diseases at the time of vaccine administration and 14 days before vaccination;
• negative pregnancy test of blood or urine (for women of childbearing age);
• subject has negative tests for HIV, hepatitis B and С, syphilis or confirmed medical history;
• subject has a negative result of the urine test for residual narcotic drugs;
• negative test for alcohol in exhaled air;
• the absence of malignant diseases of any nature and localization;
• 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).

You may not qualify if:

• volunteer involvement in another study over the last 90 days;
• any vaccination over the last 30 days;
• history of COVID-2019 disease;
• positive PCR test results for SARS-CoV-2 (during the screening);
• positive test results for IgM and IgG antibodies to SARS-CoV-2;
• health staff in contact with people with COVID-2019;
• respiratory symptoms in the last 14 days;
• the administration of immunoglobulins or other blood products in the last 3 months;
• regular current or past use of narcotic drugs;
• subject has received immunosuppressive and/or immunomodulating agents within 6 months before the start of the study;
• pregnancy or breast feeding;
• exacerbation of allergic diseases at the time of vaccination;
• 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;
• 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.);
• a history of autoimmune diseases in the volunteer's medical history and in relatives' medical history of the 1-2 degree of kinship;

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Acellena Contract Drug Research and Development: collaborator

Study Sites (1)

Main military clinical hospital named after academician N. N. Burdenko

Moscow, Russia

Location

Related Publications (1)

• Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet. 2020 Sep 26;396(10255):887-897. doi: 10.1016/S0140-6736(20)31866-3. Epub 2020 Sep 4.

  PMID: 32896291 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Gam-COVID-Vac vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 17, 2020
• Primary Completion: August 3, 2020
• Study Completion: August 10, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)