NCT05970744

Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59 Years and Over 60 Years

Completed Phase 1 Last updated 18 April 2024

What this trial tests

Phase 1 trial testing RSV/Flu-01E low dose in Respiratory Syncytial Virus Infections in 60 participants. Completed in 18 September 2023.

Timeline

10 May 2023

Primary endpoint
19 June 2023

18 September 2023

Quick facts

Lead sponsor	Tatyana Zubkova
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	10 May 2023
Primary completion	19 June 2023
Estimated completion	18 September 2023
Sites	1 location across Russia

Drugs / interventions tested

• RSV/Flu-01E low dose — full drug profile →
• RSV/Flu-01E high dose — full drug profile →
• Placebo

Conditions studied

• Respiratory Syncytial Virus Infections — all drugs for Respiratory Syncytial Virus Infections →

Sponsor

Tatyana Zubkova — full company profile →

Who can join

18 and older, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to 59 years and over 60 years.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.
   Terstappen J, Hak SF, Bhan A, Bogaert D, et al · · 2024 · cited 54× · PMID 39326422 · DOI 10.1016/s1473-3099(24)00455-9
2. Landscape of respiratory syncytial virus.
   Duan Y, Liu Z, Zang N, Cong B, et al · · 2024 · cited 17× · PMID 39501814 · DOI 10.1097/cm9.0000000000003354
3. Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.
   Li Q, Li H, Li Z, Wang Y. · · 2024 · cited 16× · PMID 39575302 · DOI 10.1002/mco2.70016
4. Global progress in clinical research on human respiratory syncytial virus vaccines.
   Peng R, Chen C, Chen Q, Zhang Y, et al · · 2024 · cited 8× · PMID 39286350 · DOI 10.3389/fmicb.2024.1457703
5. Respiratory Syncytial Virus Vaccines: Analysis of Pre-Marketing Clinical Trials for Immunogenicity in the Population over 50 Years of Age.
   Papazisis G, Topalidou X, Gioula G, González PA, et al · · 2024 · cited 8× · PMID 38675736 · DOI 10.3390/vaccines12040353
6. Advances and prospects of respiratory mucosal vaccines: mechanisms, technologies, and clinical applications.
   Li J, Wu G, Huang Z, Hu J, et al · · 2025 · cited 5× · PMID 41224752 · DOI 10.1038/s41541-025-01280-0
7. Truncated NS1 Influenza A Virus Induces a Robust Antigen-Specific Tissue-Resident T-Cell Response and Promotes Inducible Bronchus-Associated Lymphoid Tissue Formation in Mice.
   Shurygina AP, Shuklina M, Ozhereleva O, Romanovskaya-Romanko E, et al · · 2025 · cited 2× · PMID 39852837 · DOI 10.3390/vaccines13010058
8. Mucosal Immunization with an Influenza Vector Carrying SARS-CoV-2 N Protein Protects Naïve Mice and Prevents Disease Enhancement in Seropositive Th2-Prone Mice.
   Sergeeva MV, Vasilev K, Romanovskaya-Romanko E, Yolshin N, et al · · 2024 · cited 2× · PMID 39852794 · DOI 10.3390/vaccines13010015