MedTrace Logo

Evaluation of Corfluvec Vaccine for the Prevention of COVID-19 in Healthy Volunteers

NCT05696067 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-04-18

No results posted yet for this study

Summary

The aim of the study is to investigate the safety and immunogenicity of a two-component intranasal vaccine for the prevention of COVID-19 in healthy volunteers 18-60 years old

Conditions

Interventions

BIOLOGICAL

Corfluvec component 1 low dose

Participants will receive single intranasal injection of H3N2 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

BIOLOGICAL

Corfluvec component 2 low dose

Participants will receive single intranasal injection of H1N1pdm09 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

BIOLOGICAL

Corfluvec component 1 high dose

Participants will receive single intranasal injection of H3N2 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

BIOLOGICAL

Corfluvec component 2 high dose

Participants will receive single intranasal injection of H1N1pdm09 recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2

BIOLOGICAL

Corfluvec low dose

Participants will receive two intranasal injections of recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2 tree weeks apart (H3N2 →H1N1pdm09)

BIOLOGICAL

Corfluvec high dose

Participants will receive two intranasal injections of recombinant attenuated influenza vector with modified NS gene coding for the N protein fragment of SARS-CoV-2 tree weeks apart (H3N2 →H1N1pdm09)

BIOLOGICAL

Placebo

Participants will receive two intranasal injections of placebo three weeks apart

Sponsors & Collaborators

  • MDP-CRO, LLC

    collaborator UNKNOWN

  • St. Petersburg State Pavlov Medical University

    collaborator OTHER

  • Tatyana Zubkova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2022-12-30
Completion
2023-05-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696067 on ClinicalTrials.gov