Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older Adults

NCT06890429 | Completed Phase 2 DMC

• 1 other identifier: RSV-II-06/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Respiratory Synctial Virus Infections

Keywords

Respiratory syncytial virus infection; Mucosal Vaccine; Influenza Vector; Intranasal Immunization

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Days 1, 7, 28

Secondary Outcomes (7)

• Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)

  Throughout the study, average 4 months

• Concentration of cytokines in nasal secrets after vaccination

  Days 1, 2, 3

• Level of RSV F antigen-specific IgG antibody in serum

  Days 1, 28, 118±3

• Influenza specific systemic antibody immune response

  Days 1, 28, 118±3

• Level of mucosal IgA antibody in nasal secret

  Days 1, 28

Study Arms (2)

RSV/Flu-01E

EXPERIMENTAL

Single dose of RSV/Flu-01E vector vaccine

Biological: RSV/Flu-01E

Placebo

PLACEBO COMPARATOR

Single dose of Placebo

Other: Placebo

Interventions

RSV/Flu-01E BIOLOGICAL

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

RSV/Flu-01E

Placebo OTHER

Participants will receive single intranasal injection of physiological buffer solution in 0.5 ml

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of signed informed consent
• Adult men and women over the age of 60.
• The diagnosis is "healthy", verified according to standard clinical, laboratory and instrumental methods of examination or the presence of a chronic disease, if the researcher considers it to be compensated.
• BMI from 18 to 30 kg/m2.
• The ability and willingness to make entries in the diary of self-observation, as well as to carry out all the visits foreseen in the study for control medical observation
• Negative test for alcohol in exhaled air
• Values of the complete blood count and biochemical blood analysis (during the screening) within 0.9\*reference range lower limit and 1,1 \* reference range upper limit
• Negative tests for HIV, hepatitis B, hepatitis C, and syphilis

You may not qualify if:

• Participation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period
• Contact with COVID-19 patients within 14 days prior to the start of the clinical study
• Positive rapid test result for SARS-CoV-2 antigen
• Immunization with any other non-study vaccine product within three weeks prior to enrollment in the current study, or refusal to postpone such until the end of the three-week period after completion of the current study
• Regular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screening
• History of frequent nosebleeds (\>5) during the year prior to the current study
• Features of the nasal anatomy that may complicate intranasal administration of the study drug
• Surgical interventions or traumatic injuries in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening
• Symptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screening
• Treatment with immunoglobulins or other blood derived medications in the three months prior to screening or planning such treatment during the period of participation in the current study
• Donation of blood/plasma (450 ml or more) less than 2 months prior to screening.
• The presence or suspicion of the presence of various immunosuppressive or immunodeficiency conditions or continuous use (the drug was prescribed for more than 14 days without a break) of immunosuppressive drugs, immunomodulators for 6 months before the screening.
• History of bronchial asthma
• Hypersensitivity and the presence of severe allergic reactions, including Quincke's edema, anaphylactic shock after the previous administration of any vaccine
• History of wheezing after previous immunization with live influenza vaccine

Sponsors & Collaborators

• Research Institute of Influenza, Russia: lead
• Pavlov First Saint Petersburg State Medical University: collaborator
• St. Petersburg City Polyclinic No. 34: collaborator

Study Sites (3)

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

Smorodintsev Research Institute of Influenza

Saint Petersburg, 197022, Russia

Location

St. Petersburg City Polyclinic No. 34

Saint Petersburg, 197198, Russia

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Marina Stukova, Dr

  Smorodintsev Research Institute of Influenza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the clinical department

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: December 7, 2023
• Primary Completion: January 8, 2024
• Study Completion: April 8, 2024
• Last Updated: March 24, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Access Criteria: IPD will be available upon reasonable request to Study Director. Once the request is approved, the data can be transferred via a secure online platform

Locations

RU (3)