Study of Gam-COVID-Vac in Adolescents

NCT04954092 | Unknown Phase 2 DMC

• 1 other identifier: OLSTAD
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief Summary

Double-blind, placebo-controlled study with open dose selection period for safety assessment, tolerance and immunogenicity of the drug "GamKOVID-Vac M, a combined vector vaccine for prevention of coronavirus infection caused by the virus SARS-CoV-2" in adolescents

Conditions

Covid19; Vaccine Preventable Disease

Keywords

rAd vector based vaccine; Sputnik; rAd26; rAd5; adolescent

Outcome Measures

Primary Outcomes (5)

• Geometric mean titer of antigen-specific IgGs

  To define geometric mean titer of antigen-specific IgGs after vaccination

  21, 28, 42, 90, 180 days

• Geometric mean titer of neutralizing antibodies

  To define geometric mean titer of neutralizing antibodies against SARS-Cov-2 virus after vaccination

  21, 28, 42, 90, 180 days

• IFN-gamma secretion by T lymphocytes

  To define changes in level of IFN-gamma secretion by T lymphocytes under antigen stimulation

  21, 28, 42, 90, 180 days

• Frequency of adverse reactions

  Frequency of vaccine-related adverse reactions

  365+/-14 days

• Severity of adverse reactions

  Severity of vaccine-related adverse reactions

  365+/-14 days

Secondary Outcomes (1)

• Incidence of COVID-19 cases

  within 28 to 365 days

Other Outcomes (1)

• Presence of anti-vector antibodies

  before intervention and on 42, 180 days

Study Arms (4)

1/10 of full adult dose

EXPERIMENTAL

Biological: Gam-COVID-vac M

1/5 of full adult dose

EXPERIMENTAL

Biological: Gam-COVID-vac M

Selected dose for second stage of the trial

EXPERIMENTAL

Biological: Gam-COVID-vac M

Placebo for second stage of the trial

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Gam-COVID-vac M BIOLOGICAL

The vaccine consists of two components: component I and component II. Component I includes a recombinant adenoviral vector based on human adenovirus serotype 26 carrying the gene for the S-protein of the SARS-CoV-2 virus, component II includes a vector based on human adenovirus serotype 5 carrying the protein S gene of the SARS-CoV-2 virus

1/10 of full adult dose; 1/5 of full adult dose; Selected dose for second stage of the trial

Placebo BIOLOGICAL

Composition without active ingredients

Placebo for second stage of the trial

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Availability of written informed consent of the research subject and parents / adoptive parents of the subject to participate in the research;
• Boys and girls aged 12-17 inclusive;
• Negative test result for HIV, hepatitis, syphilis;
• A negative test result for COVID-2019, determined by the PCR method at the screening visit, and, if available, can be taken into account the result of the examination performed in the medical organizations of the Moscow City Health Department 7 days before being included in the study;
• No history of COVID-2019;
• Consent to the use of effective contraceptive methods during the entire period of participation in the study;
• Negative pregnancy test based on urine test results at the screening visit (for all girls - study participants);
• Negative test for the presence of drugs and psychostimulants in the urine at the screening visit;
• Negative alcohol test at screening visit;
• No history of pronounced post-vaccination reactions or post-vaccination complications after the use of immunobiological drugs;
• Absence of acute infectious and / or respiratory diseases for at least 14 days prior to enrollment in the study

You may not qualify if:

• Any vaccination / immunization carried out within 30 days prior to enrollment in the study.
• Therapy with steroids (with the exception of hormonal contraceptive drugs) and / or immunoglobulins or other blood products, not completed 30 days before enrollment in the study;
• Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], etc.).
• Infectious diseases:
• history of HIV (antibodies to HIV type 1 or 2), positive test for HBsAg or HCV RNA \[qualitative\]), active form of syphilis;
• Tuberculosis;
• Active infection (with the exception of onychomycosis), or any significant episode of infection requiring intravenous antibiotic treatment for 4 weeks before screening or by mouth for 2 weeks before screening;
• A history of a serious recurrent or chronic infection not listed above.
• Major surgery within 4 weeks prior to screening.
• Chronic autoimmune diseases or systemic collagenoses in history, requiring the appointment of immunosuppressive therapy.
• Volunteers who have undergone organ transplants, including bone marrow or peripheral blood stem cell (PBC) transplants, and are receiving immunosuppressive therapy.
• History of splenectomy.
• Volunteers with a previous or concomitant history of neoplasms (ICD codes C00-D09).
• Neutropenia (decrease in the absolute number of neutrophils less than 1000 cells / mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin concentration less than 80 g / l), thrombocytopenia (decrease in the absolute number of platelets less than 50,000 cells / mm3).
• Anorexia, protein deficiency of any origin.

Sponsors & Collaborators

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

Study Sites (2)

Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health

Moscow, Russia

RECRUITING

Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health

Moscow, Russia

RECRUITING

Related Publications (1)

• Tukhvatulin AI, Dolzhikova IV, Dzharullaeva AS, Grousova DM, Kovyrshina AV, Zubkova OV, Zorkov ID, Iliukhina AA, Shelkov AY, Erokhova AS, Popova O, Ozharovskaia TA, Zrelkin DI, Izhaeva FM, Shcheblyakov DV, Esmagambetov IB, Tokarskaya EA, Nikitenko NA, Lubenets NL, Khadorich EA, Gushchin VA, Borzakova SN, Vlasova AV, Osmanov IM, Gorev VV, Naroditsky BS, Logunov DY, Gintsburg AL. Safety and immunogenicity of rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine against SARS-CoV-2 in healthy adolescents: an open-label, non-randomized, multicenter, phase 1/2, dose-escalation study. Front Immunol. 2023 Aug 1;14:1228461. doi: 10.3389/fimmu.2023.1228461. eCollection 2023.

  PMID: 37600800 DERIVED

MeSH Terms

Conditions

COVID-19; Vaccine-Preventable Diseases

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 Officials

• Anna Vlasova

  Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health

  PRINCIPAL INVESTIGATOR

• Svetlana Borzakova

  Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadezhda Lubenec

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 8, 2021
• Study Start: July 5, 2021
• Primary Completion: November 6, 2022
• Study Completion: December 31, 2023
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

RU (2)