NCT05696067

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

Randomized, Double-blind, Placebo-controlled Phase 1/2 Trial of Corfluvec Intranasal Vector Vaccine for the Prevention of COVID-19 in Healthy Volunteers Aged 18 to 60 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Tatyana Zubkova · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed description

Study include three parts. During the first part the two vaccine components will be administered separately to a small number of seronegative participants in low dose and then high dose to evaluate each component's safety. During the second part vaccine components would be administered one after another with 21 days interval to evaluate safety of the complete vaccine regimen (low dose and high dose). During the third part of the study the high dose vaccine will be administered to participants to evaluate vaccine immunogenicity. The whole study will include 200 participants. Duration of the study for each participant is about 6.5 months (no more than 194 days).

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-13
• Primary completion: 2022-12-30
• Completion: 2023-05-31
• First posted: 2023-01-25
• Last updated: 2024-04-18

Locations

2 sites across 1 country: Russia