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

NCT05248373 | Unknown Phase 1 DMC

• 1 other identifier: SPRAY vaccine against COVID-19
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; SARS-CoV-2 Acute Respiratory Disease

Keywords

vaccine; Sputnik; adenoviral vector vaccine; intranasal vaccine

Outcome Measures

Primary Outcomes (7)

• Change from baseline in geometric mean titer of IgGs specific to S protein

  Change from baseline in Geometric mean titer of IgGs specific to S protein at different time points after vaccination

  0, 10, 28, 42, 90 day

• Change from baseline in number of participants with detected specific IgGs

  Change from baseline in Number of participants with detected specific IgGs at different time points after vaccination

  0, 10, 28, 42, 90 day

• Change from baseline in Number of participants with detected specific IgAs

  Change from baseline in Number of participants with detected specific IgAs at different time points after vaccination

  0, 10, 28, 42 day

• Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus

  Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination

  0, 28, 42, 90 day

• Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus

  Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination

  0, 28, 42, 90 day

• Proportion of participants with any adverse events

  AEs evaluation during the whole period of the study

  1-180 days

• Proportion of participants with severe adverse events

  SAEs evaluation during the whole period of the study

  1-180 days

Secondary Outcomes (1)

• Efficacy of symptomatic COVID-19 prevention

  28-180 days

Study Arms (4)

rAd26 single administration

EXPERIMENTAL

Biological: Gam-COVID-Vac

rAd5 single administration

EXPERIMENTAL

Biological: Gam-COVID-Vac

prime-boost regimen with rAd26 followed rAd5 administration

EXPERIMENTAL

Biological: Gam-COVID-Vac

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Gam-COVID-Vac BIOLOGICAL

two-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus

prime-boost regimen with rAd26 followed rAd5 administration; rAd26 single administration; rAd5 single administration

Placebo OTHER

solution with same composition as for vaccine formulation except rAds

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of a written informed consent of the subject to participate in the study;
• Adult volunteers over 18;
• Negative test result for HIV, hepatitis, syphilis;
• 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;
• 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);
• Consent to use effective methods of contraception during the entire period of participation in research;
• Negative Urine Pregnancy Test at Screening Visit (for women of childbearing age);
• Negative test for the presence of narcotic and psychostimulant drugs in the urine for screening visit;
• Negative alcohol test at screening visit;
• No history of severe post-vaccination reactions or post-vaccination complications after the use of immunobiological preparations;
• Absence of acute infectious and/or respiratory diseases for at least within 14 days prior to enrollment in the study.

You may not qualify if:

• Inability to give informed consent, inability to understand the essence of the study
• Postponed less than one year prior to enrollment in the study acute coronary syndrome or stroke;
• Tuberculosis, chronic systemic infections;
• Exacerbation of rhinitis
• History of neoplasms (ICD codes C00-D09);
• Splenectomy in history;
• 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;
• Subjects with active human immunodeficiency virus disease syphilis, hepatitis B and C;
• Anorexia, protein deficiency of any origin;
• History of alcoholism and drug addiction;
• Participation of the subject in any other interventional clinical trial during this study;
• 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;
• 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.

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead

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

Central Study Contacts

Nadezhda L Lubenec

CONTACT

8 (499) 193-30-01; info@gamaleya.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 21, 2022
• Study Start: March 8, 2022
• Primary Completion: February 14, 2023
• Study Completion: December 30, 2023
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share