Study of "Sputnik Lite" for the Prevention of COVID-19 With Altered Antigenic Composition.

NCT06057025 | Unknown Phase 3

• 1 other identifier: 14-Sputnik Lite / N-2023
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Safety, reactogenicity and immunogenicity study of the drug "Sputnik Lite" for the prevention of coronavirus infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of adult volunteers.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events (AE)

  Occurrence of adverse events (AE)

  Within 28 days after administration of the drug

• Occurrence of serious adverse events (SAEs)

  Occurrence of serious adverse events (SAEs)

  Throughout Study completion, until December 2024

Study Arms (1)

Healthy patients

EXPERIMENTAL

Drug: Sputnik Light vector vaccine for the prevention of coronavirus infection caused by the SARS CoV-2 virus (with altered antigenic composition); A total of 50 people will be randomized and receive the study drug. A single intramuscular injection of the investigational medicinal product (IMP) will be performed.

Biological: "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition

Interventions

"Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition BIOLOGICAL

Single intramuscular injection of "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition.

Healthy patients

Eligibility Criteria

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

You may qualify if:

• The study will include volunteers who meet all the specified criteria:
• Subject's written informed consent to participate in the study;
• Adult volunteer's men and women over 18 years old;
• A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP).
• Consent to the use of effective methods of contraception during the entire period of participation in the study;
• A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential);
• Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit;
• Negative alcohol content test at the screening visit;
• No contraindications to vaccination;

You may not qualify if:

• No signed informed consent to participate in the study;
• Female subjects during pregnancy or lactation;
• Tuberculosis, chronic systemic infections according to anamnesis;
• The presence of neoplasms (ICD codes C00-D09) (according to the anamnesis);
• Splenectomy (according to the anamnesis);
• Subjects with an active form of the disease caused by human immunodeficiency virus, syphilis, hepatitis B and C (according to anamnesis);
• Anorexia, protein deficiency of any origin;
• Alcoholism and drug addiction (according to anamnesis);
• The subject's participation in any other interventional clinical trial (with the exception of rescreening in the current study) in the last 90 days;
• Extensive tattoos at the injection sites (deltoid muscle area), which do not allow to assess the local reaction to the introduction of investigational medicinal product (IMP);
• Any other condition of the subject of the study, which, in the opinion of the research doctor, may prevent the completion of the study in accordance with the protocol;
• Vaccination against COVID-19 or transmitted coronavirus infection COVID-19 less than 6 months before screening;
• Repeated administration of the Sputnik V vaccine, Sputnik Lite, or repeated administration of any other COVID-19 vaccine for more than three injections (Sputnik V vaccination plus Sputnik Lite revaccination);
• Inability to read in Russian; inability or unwillingness to understand the essence of the study;
• Any other conditions that limit the validity of obtaining informed consent or may affect the ability of the volunteer to participate in the study, affect the ability of the volunteer to participate in the study;

Sponsors & Collaborators

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

MeSH Terms

Conditions

COVID-19

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 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09