Respiratory Synctial Virus InfectionsPhase 2NCT06890429
Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older Adults
A Phase 2 study testing RSV/Flu-01E in people with Respiratory Synctial Virus Infections, run by Research Institute of Influenza, Russia at 3 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Synctial Virus Infections
- What is being tested?
- RSV/Flu-01E
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesRussia
- Study dates
- 7 Dec 2023to 8 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
- Other adverse events after immunization (fever above 40°C, syncope, non-febrile convulsions, anaphylaxis) when there is a minimal likelihood that they are associated with a previous administration of any vaccine
- Suspicion of hypersensitivity to any component of the study vaccine, including egg protein
- Acute or chronic clinically significant lung, cardiovascular, hepatic, endocrine, neurological, or psychiatric disorders, or impaired renal function identified by history, physical examination, or clinical laboratory findings that, in the opinion of the investigator, may influence the outcome of the study
- History of oncological diseases
- History of thrombocytopenic purpura or bleeding disorders
- History of convulsions
- Tuberculosis or residual changes after tuberculosis according to the anamnesis and / or available medical documentation
- Chronic alcohol dependence or chronic use of illicit drugs, drug abuse
- Claustrophobia and social phobia according to history and / or available medical records
- Inability to read Russian; inability or unwillingness to understand the essence of the study
- Military personnel serving in the military or law enforcement officers.
- Special diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work, extreme physical activity)
- Any condition that, in the opinion of the investigator, may increase the risk to the health of a volunteer participating in the study or affect the results of the study
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022
Smorodintsev Research Institute of Influenza
Saint Petersburg, 197022
St. Petersburg City Polyclinic No. 34
Saint Petersburg, 197198
About this study
Official title: Randomized, Double-blind, Placebo-controlled Phase 2 Trial of RSV/Flu-01E Vaccine for the Prevention of Respiratory Syncytial Virus Infection in Volunteers Over 60 Years
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
Read the detailed description
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)
- Conditions
- Respiratory Synctial Virus Infections
- Being tested
- RSV/Flu-01E, Placebo
- Keywords
- Respiratory syncytial virus infection, Mucosal Vaccine, Influenza Vector, Intranasal Immunization
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV/Flu-01EBiological
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
PlaceboOther
Participants will receive single intranasal injection of physiological buffer solution in 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| RSV/Flu-01E | Experimental | Single dose of RSV/Flu-01E vector vaccine Receives: Biological: RSV/Flu-01E |
| Placebo | Placebo comparator | Single dose of Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Days 1, 7, 28
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Days 1, 7, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start7 Dec 2023
- Primary completion8 Jan 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Synctial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Influenza, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Pavlov First Saint Petersburg State Medical University, St. Petersburg City Polyclinic No. 34
- Responsible party
- Principal investigator, Tatyana Zubkova, Research Institute of Influenza, Russia
- Investigators
- Marina Stukova, Dr, Study director, Smorodintsev Research Institute of Influenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890429
- Sponsor's protocol ID
- RSV-II-06/2023
- Status last verified
- Nov 2023
- First submitted
- 17 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be available
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Phase 2 Trial of RSV/Flu-01E Vaccine for the Prevention of Respiratory Syncytial Virus Infection in Volunteers Over 60 Years
- ClinicalTrials.gov ID
- NCT06890429
- Acronym / sponsor ID
- RSV-II-06/2023
- Conditions
- Respiratory Synctial Virus Infections
- Keywords
- Respiratory syncytial virus infection, Mucosal Vaccine, Influenza Vector, Intranasal Immunization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Research Institute of Influenza, RussiaUniversity, hospital or other
- Collaborators
- Pavlov First Saint Petersburg State Medical University, St. Petersburg City Polyclinic No. 34
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RSV/Flu-01E | Experimental | Biological: RSV/Flu-01ESingle dose of RSV/Flu-01E vector vaccine |
| Placebo | Placebo comparator | Other: PlaceboSingle dose of Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV/Flu-01EParticipants 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 | Biological | RSV/Flu-01E |
| PlaceboParticipants will receive single intranasal injection of physiological buffer solution in 0.5 ml | Other | Placebo |
Primary outcome
Level of RSV F antigen-specific cytokine producing CD4+ and CD8+ T-cells
Time frame: Days 1, 7, 28
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
Level of the RSV F antigen-specific Th1/Th2 cytokine release in whole blood assay
Time frame: Days 1, 7, 28
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
7 secondary outcomes
Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
Time frame: Throughout the study, average 4 months
Concentration of cytokines in nasal secrets after vaccination
Time frame: Days 1, 2, 3
Level of RSV F antigen-specific IgG antibody in serum
Time frame: Days 1, 28, 118±3
Influenza specific systemic antibody immune response
Time frame: Days 1, 28, 118±3
Level of mucosal IgA antibody in nasal secret
Time frame: Days 1, 28
Level of influenza specific cytokine release in whole blood assay
Time frame: Days 1, 7, 28
Level of B-cell populations
Time frame: Days 1, 7, 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Stukova, Dr study director
Smorodintsev Research Institute of Influenza
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSV/Flu-01E in people with Respiratory Synctial Virus Infections, run by Research Institute of Influenza, Russia at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of RSV F antigen-specific cytokine producing CD4+ and CD8+ T-cells (time frame: Days 1, 7, 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.