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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- Tatyana Zubkova
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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).
Investigators
Tatyana Zubkova
Head of the clinical department
Research Institute of Influenza, Russia
Eligibility Criteria
Inclusion Criteria
- •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/m
- •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:
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Throughout the study, average of 6 months
* 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
Secondary Outcomes
- 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)
- Influenza specific systemic antibody immune response(Days 1, 28)
- Level of RSV F antigen-specific IgG antibody(Days 1, 28, 90, 180)
- Proportion of responders to vaccination(Days 7, 28)
- Concentration of cytokines in nasal secrets after vaccination(Days 1, 2, 3)
- Influenza specific local antibody immune response(Days 1, 28)