The aim of the study is to investigate immunogenicity and safety of the RSV/Flu-01E intranasal vaccine for the prevention of respiratory syncytial virus infection in volunteers over 60 years
Study includes 120 participants over 60 years randomized at 3:1 ratio, to receive single intranasal dose of RSV/Flu-01E vaccine or placebo, correspondingly. Duration of the study for each participant is about 4 months (118±3 days)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Participants will receive single intranasal injection of RSV/Flu-01E vaccine in 0.5 ml, containing 8.4 lg EID50 of A/H1N1pdm09 recombinant attenuated influenza vector with modified NS gene, encoding for the F antigen of respiratory syncytial virus
Participants will receive single intranasal injection of physiological buffer solution in 0.5 ml
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, Russia
Smorodintsev Research Institute of Influenza
Saint Petersburg, Russia
St. Petersburg City Polyclinic No. 34
Saint Petersburg, Russia
Level of RSV F antigen-specific cytokine producing CD4+ and CD8+ T-cells
Change from baseline in the level of cytokine producing CD4+ and CD8+ T-cells upon in vitro stimulation of PBMC with RSV F-peptide epitopes measured by FACS/ELISPOT
Time frame: Days 1, 7, 28
Level of the RSV F antigen-specific Th1/Th2 cytokine release in whole blood assay
Change from the baseline of the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with RSV F-peptide epitopes measured in ELISA
Time frame: Days 1, 7, 28
Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
Adverse events (AEs) and serious AEs (SAEs), both vaccine related, and non-vaccine related; AEs/SAEs of particular importance: * Immediate AEs (allergic reactions) occurring within two hours of vaccination. * Post-vaccination reactions (anticipated clinical manifestations of a local and systemic nature), usually due to intranasal vaccination between two hours and the next 7 days after vaccination
Time frame: Throughout the study, average 4 months
Concentration of cytokines in nasal secrets after vaccination
Change from baseline in the concentration of cytokines in nasal secrets measured in ELISA
Time frame: Days 1, 2, 3
Level of RSV F antigen-specific IgG antibody in serum
Change from the baseline in the level of RSV F antigen-specific serum IgG antibodies measured in ELISA
Time frame: Days 1, 28, 118±3
Influenza specific systemic antibody immune response
Change from the baseline in the titer of influenza specific antibodies in serum measured in hemagglutination inhibition/microneutralization assay
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Time frame: Days 1, 28, 118±3
Level of mucosal IgA antibody in nasal secret
Change from the baseline in the level of IgA antibody measured in ELISA in nasal secret
Time frame: Days 1, 28
Level of influenza specific cytokine release in whole blood assay
Change from the baseline of the cytokine concentration in whole-blood cytokine release assay upon in vitro stimulation with influenza A/H1N1pdm antigen measured in ELISA
Time frame: Days 1, 7, 28
Level of B-cell populations
Change from the baseline in the relative amount of B-cell populations in PBMC measured by FACS
Time frame: Days 1, 7, 28