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Respiratory Syncytial Virus InfectionsPhase 1NCT05970744

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

A Phase 1 study testing RSV/Flu-01E low dose and RSV/Flu-01E high dose in people with Respiratory Syncytial Virus Infections, run by Tatyana Zubkova at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSV/Flu-01E low dose and RSV/Flu-01E high dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteRussia
Study dates
10 May 2023to 18 Sep 2023
Phase
Phase 1
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For the first and second cohort:
  • Availability of signed informed consent.
  • Adult men and women aged 18-59 years.
  • Diagnosed "healthy", according to the data of standard clinical, laboratory and instrumental examination methods provided for in this protocol, with the absence of clinically significant changes.
  • BMI from 18 to 30 kg/m2.
  • Individuals with antibody titer to influenza A/H1N1pdm09 ≤1:20 according to HI assay.
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  • Ability and willingness to independently keep records in the diary of self-observation and carry out all visits according to the protocol.
  • Negative urine test for psychotropic and narcotic substances.
  • Negative breath alcohol test.
  • Consent of study participants to use effective contraceptive methods throughout their participation in the study. In this study, volunteers can use the following methods of contraception:
  • Combined methods:
  • male condom and spermicide
  • cervical cap and spermicide
  • vaginal diaphragm and spermicide
  • Intrauterine device
  • Hormonal intrauterine device
  • Hormonal contraceptives:
  • hormonal implants
  • hormone injections
  • combined oral contraceptives
  • mini-pill
  • contraceptive patch
  • Abstinence from sexual activity.
  • For women of childbearing potential - a negative pregnancy test.
  • Indicators of general and biochemical blood tests at screening within 1.1 x the upper limit - 0.9 x the lower limit of the reference intervals.
  • Negative tests for HIV, hepatitis B and C, syphilis.
  • For the third cohort:
  • 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.
  • Individuals with antibody titer to influenza A/H1N1pdm09 ≤1:20 according to HI assay.
  • The ability and readiness to independently keep records in the diary of self-observation and carry out all the visits provided for in the study, provided for by the protocol.
  • Negative urine test for psychotropic and narcotic substances.
  • Negative breath alcohol test.
  • Indicators of general and biochemical blood tests for screening within 1.1 x the upper limit - 0.9 x the lower limit of the reference intervals.
  • Negative tests for HIV, hepatitis B and C, 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
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  • Anatomical features of the nose that may interfere with intranasal administration of the study drug
  • The presence of surgical intervention in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening.
  • Symptoms of acute respiratory disease 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.
  • Burdened allergic anamnesis.
  • 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.
  • For women of reproductive age - lactation, pregnancy or suspected pregnancy, early postpartum period.
  • Inability to read in Russian; inability or unwillingness to understand the essence of the study. Any other condition that limits the eligibility of obtaining informed consent or may affect the volunteer's ability to participate in the study.
  • Military or law enforcement officers, persons serving sentences in places of deprivation of liberty or in custody.
  • 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

1 site in 1 country.

Russia1 site

  • Smorodintsev Research Institute of Influenza

    Saint Petersburg

Other trials in Russia

About this study

Official title: Randomized, Double-blind, Placebo-controlled Phase 1 Trial of the RSV/Flu-01E Vaccine for the Prevention of Respiratory Syncytial Virus Infection in Volunteers Aged 18 to 59 Years and Over 60 Years

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.

Read the detailed description

Study includes 60 participants in three cohorts. First cohort includes 15 volunteers aged 18 to 59, randomized at 2:1 ratio, to receive low dose RSV/Flu-01E vaccine or placebo, correspondingly. Second cohort includes 15 volunteers aged 18 to 59, randomized at 2:1 ratio, to receive high dose RSV/Flu-01E vaccine or placebo, correspondingly. Third cohort includes 30 participants aged 60 years and older, randomized at 2:1 ratio to receive high dose RSV/Flu-01E vaccine or placebo. Duration of the study for each participant is about 6 months (no more than 190 days).

Being tested
RSV/Flu-01E low dose, RSV/Flu-01E high dose, Placebo
Keywords
Respiratory syncytial virus infection, 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-01E low doseBiological

    Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (7.7 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus

  • RSV/Flu-01E high doseBiological

    Participants will receive single intranasal injection of A/H1N1pdm09 recombinant attenuated influenza vector (8.4 lg EID50) with modified NS gene coding for the F antigen of respiratory syncytial virus

  • PlaceboBiological

    Participants will receive single intranasal injection of Placebo

Study groups in NCT05970744
Study groupRoleWhat they receive
RSV/Flu-01E low dose 18-59ExperimentalParticipants aged 18 to 59 years will receive single injection of low dose RSV/Flu-01E Vaccine
Receives: Biological: RSV/Flu-01E low dose
RSV/Flu-01E high dose 18-59ExperimentalParticipants aged 18 to 59 years will receive single injection of high dose RSV/Flu-01E Vaccine
Receives: Biological: RSV/Flu-01E high dose
Placebo 18-59Placebo comparatorParticipants aged 18 to 59 years will receive single injection of Placebo
Receives: Biological: Placebo
RSV/Flu-01E high dose over 60ExperimentalParticipants aged over 60 years will receive single injection of high dose RSV/Flu-01E Vaccine
Receives: Biological: RSV/Flu-01E high dose
Placebo over 60Placebo comparatorParticipants aged over 60 years will receive single injection of Placebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.
    • Evaluation of influenza A virus shedding evaluated by immunochromatographic rapid test in nasal swab samples in control points after vaccination

    Measured: Throughout the study, average of 6 months

Secondary outcomes (8)

  1. Level of RSV F antigen-specific cytokine producing 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 ICS/ELISPOT

    Measured: Days 1, 7, 28, 90, 180

  2. Level of RSV F antigen-specific cytokine release in whole blood assay

    Change from baseline in 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

  3. Level of RSV F antigen-specific mucosal IgA antibody in saliva/nasal secrets

    Change from baseline in the level of secretory IgA antibody specific to RSV F-antigen measured in ELISA in nasal secret/saliva

    Measured: Days 1, 28

  4. Level of RSV F antigen-specific IgG antibody

    Changes in the levels of RSV F antigen-specific total serum IgG antibodies measured in ELISA in serum

    Measured: Days 1, 28, 90, 180

  5. Proportion of responders to vaccination

    Proportion of participants who responded to vaccination by significant increase in any of the immunogenicity parameters at any of the time points. The increase is considered significant if the fold change of the parameter value exceeds the conventional threshold, measured as geometric mean fold change in Placebo group multiplied by two geometric mean standard deviations.

    Measured: Days 7, 28

  6. Concentration of cytokines in nasal secrets after vaccination

    Change from baseline in the concentration of cytokines in nasal secrets measured in ELISA (pg/ml, 13-plex assay, IFN-α2, TSLP, IL-1α, IL-1β, GM-CSF, IL-11, IL-12p40, IL-12p70, IL-15, IL-18, IL-23, IL-27, IL-33)

    Measured: Days 1, 2, 3

  7. Influenza specific systemic antibody immune response

    Change from baseline in the titer of influenza specific antibodies in serum measured in hemagglutination inhibition/microneutralization assay

    Measured: Days 1, 28

  8. Influenza specific local antibody immune response

    Change from baseline in the level of influenza specific IgA antibodies in nasal secret/saliva measured in ELISA

    Measured: Days 1, 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start10 May 2023
  3. Primary completion19 Jun 2023
  4. Study completion18 Sep 2023

Resources

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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970744
Sponsor's protocol ID
RSV-I-01/2022
Other IDs
736 30.12.2022
Status last verified
Apr 2024
First submitted
24 Jul 2023
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV/Flu-01E low dose and RSV/Flu-01E high dose in people with Respiratory Syncytial Virus Infections, run by Tatyana Zubkova at 1 site 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 37 inclusion and 30 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs) (time frame: Throughout the study, average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970744.

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 18 Apr 2024.

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