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

NCT05970744 | Completed Phase 1 DMC

• 2 other identifiers: RSV-I-01/2022736 30.12.2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus infection; Vaccine; Influenza vector; Intranasal immunization

Outcome Measures

Primary Outcomes (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

  Throughout the study, average of 6 months

Secondary Outcomes (8)

• Level of RSV F antigen-specific cytokine producing T-cells

  Days 1, 7, 28, 90, 180

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

  Days 1, 7, 28

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

  Days 1, 28

• Level of RSV F antigen-specific IgG antibody

  Days 1, 28, 90, 180

• Proportion of responders to vaccination

  Days 7, 28

Study Arms (5)

RSV/Flu-01E low dose 18-59

EXPERIMENTAL

Participants aged 18 to 59 years will receive single injection of low dose RSV/Flu-01E Vaccine

Biological: RSV/Flu-01E low dose

RSV/Flu-01E high dose 18-59

EXPERIMENTAL

Participants aged 18 to 59 years will receive single injection of high dose RSV/Flu-01E Vaccine

Biological: RSV/Flu-01E high dose

Placebo 18-59

PLACEBO COMPARATOR

Participants aged 18 to 59 years will receive single injection of Placebo

Biological: Placebo

RSV/Flu-01E high dose over 60

EXPERIMENTAL

Participants aged over 60 years will receive single injection of high dose RSV/Flu-01E Vaccine

Biological: RSV/Flu-01E high dose

Placebo over 60

PLACEBO COMPARATOR

Participants aged over 60 years will receive single injection of Placebo

Biological: Placebo

Interventions

RSV/Flu-01E low dose BIOLOGICAL

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 low dose 18-59

RSV/Flu-01E high dose BIOLOGICAL

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

RSV/Flu-01E high dose 18-59; RSV/Flu-01E high dose over 60

Placebo BIOLOGICAL

Participants will receive single intranasal injection of Placebo

Placebo 18-59; Placebo over 60

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

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
• 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.

Sponsors & Collaborators

• Tatyana Zubkova: lead

Study Sites (1)

Smorodintsev Research Institute of Influenza

Saint Petersburg, 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

• Tatiana Zubkova, PhD

  Smorodintsev Research Institute of Influenza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the clinical department

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: May 10, 2023
• Primary Completion: June 19, 2023
• Study Completion: September 18, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)