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Safety, Tolerability and Immunogenicity of Gam-COVID-Vac Vaccine in a Nasal Spray (SPRAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05248373
Recruitment Status : Not yet recruiting
First Posted : February 21, 2022
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study Description
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Brief Summary:

Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicity of intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus.

The duration of participation in the study for one subject will be 180±14 days after the first dose of vaccine, during which each subject will undergo a screening visit (within a week) and face-to-face visits according to the study plan. Intranasal vaccine administration will be done at day 1 vaccination visits and day 21±2 days on an outpatient basis.

During the follow-up visits key vital signs will be assessed, and will collect data on changes in the state and well-being subjects from a previous visit. Subject data will be collected using electronic forms of individual registration cards, as well as with using questionnaires (diaries) filled by the subjects of the study.

Immunogenicity will be assessed on day 1, 10, 28, 42 and 90 days. Humoral and cellular immune response will be evaluated.


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Acute Respiratory Disease Biological: Gam-COVID-Vac Other: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Safety, Tolerability and Immunogenicity of a Vaccine "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus" in a Nasal Spray Dosage Form With the Participation of Adult Volunteers
Estimated Study Start Date : March 8, 2022
Estimated Primary Completion Date : February 14, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: rAd26 single administration Biological: Gam-COVID-Vac
two-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus
Experimental: rAd5 single administration Biological: Gam-COVID-Vac
two-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus
Experimental: prime-boost regimen with rAd26 followed rAd5 administration Biological: Gam-COVID-Vac
two-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus
Placebo Comparator: placebo Other: Placebo
solution with same composition as for vaccine formulation except rAds


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in geometric mean titer of IgGs specific to S protein [ Time Frame: 0, 10, 28, 42, 90 day ]
    Change from baseline in Geometric mean titer of IgGs specific to S protein at different time points after vaccination

  2. Change from baseline in number of participants with detected specific IgGs [ Time Frame: 0, 10, 28, 42, 90 day ]
    Change from baseline in Number of participants with detected specific IgGs at different time points after vaccination

  3. Change from baseline in Number of participants with detected specific IgAs [ Time Frame: 0, 10, 28, 42 day ]
    Change from baseline in Number of participants with detected specific IgAs at different time points after vaccination

  4. Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus [ Time Frame: 0, 28, 42, 90 day ]
    Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination

  5. Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus [ Time Frame: 0, 28, 42, 90 day ]
    Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination

  6. Proportion of participants with any adverse events [ Time Frame: 1-180 days ]
    AEs evaluation during the whole period of the study

  7. Proportion of participants with severe adverse events [ Time Frame: 1-180 days ]
    SAEs evaluation during the whole period of the study


Secondary Outcome Measures :
  1. Efficacy of symptomatic COVID-19 prevention [ Time Frame: 28-180 days ]
    Efficacy of symptomatic COVID-19 prevention


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The presence of a written informed consent of the subject to participate in the study;
  2. Adult volunteers over 18;
  3. Negative test result for HIV, hepatitis, syphilis;
  4. Negative test result for COVID-2019, determined by PCR at the visit screening, and, if available, the result of the examination performed in medical organizations that are research centers 7 days before inclusion into research;
  5. The result of the study for the presence of IgG antibodies to SARS CoV2 up to 10 VGR, which corresponds to value up to 100 BAU, regardless of the immune status before;
  6. Absence of contact of the research subject with patients with COVID-2019 for at least 14 days before enrollment in the study (according to the study participant);
  7. Consent to use effective methods of contraception during the entire period of participation in research;
  8. Negative Urine Pregnancy Test at Screening Visit (for women of childbearing age);
  9. Negative test for the presence of narcotic and psychostimulant drugs in the urine for screening visit;
  10. Negative alcohol test at screening visit;
  11. No history of severe post-vaccination reactions or post-vaccination complications after the use of immunobiological preparations;
  12. Absence of acute infectious and/or respiratory diseases for at least within 14 days prior to enrollment in the study.

Exclusion Criteria:

  1. Inability to give informed consent, inability to understand the essence of the study
  2. Any vaccination/immunization carried out within 30 days prior to inclusion in study;
  3. Steroid therapy (excluding hormonal contraceptives) and/or immunoglobulins or other blood products, not completed 30 days before inclusion in the study;
  4. COVID-2019 disease or vaccination to prevent COVID-2019 in less than six months before inclusion in the study
  5. Immunosuppressive drug therapy completed less than 3 months before inclusion in the study;
  6. Postponed less than one year prior to enrollment in the study acute coronary syndrome or stroke;
  7. Tuberculosis, chronic systemic infections;
  8. Exacerbation of rhinitis
  9. Burdened allergic history (presence in the anamnesis of information about anaphylactic shock, angioedema, polymorphic exudative eczema, serum sickness), hypersensitivity or allergic reactions to the introduction of immunobiological drugs, known allergic reactions to drug components, exacerbation allergic diseases on the day of inclusion in the study;
  10. History of neoplasms (ICD codes C00-D09);
  11. Donation of blood or plasma (in a volume of 450 ml or more) less than 2 months before inclusion in the study;
  12. Splenectomy in history;
  13. Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l), immunodeficiency in history within 6 months prior to enrollment in the study;
  14. Subjects with active human immunodeficiency virus disease syphilis, hepatitis B and C;
  15. Anorexia, protein deficiency of any origin;
  16. History of alcoholism and drug addiction;
  17. Participation of the subject in any other interventional clinical trial during this study;
  18. Any other condition of the research subject that, in the opinion of the research physician, may prevent completion of the study in accordance with the protocol;
  19. Staff of research centers and other staff directly involved in conducting the study (principal investigator and members of the research team) and members of their families.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05248373


Contacts
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Contact: Nadezhda L Lubenec 8 (499) 193-30-01 info@gamaleya.org

Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
More Information
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT05248373    
Other Study ID Numbers: SPRAY vaccine against COVID-19
First Posted: February 21, 2022    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
vaccine
Sputnik
adenoviral vector vaccine
intranasal vaccine
Additional relevant MeSH terms:
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Respiratory Tract Diseases
Respiration Disorders