Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older A… (NCT06890429) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older Adults
Russia120 participantsStarted 2023-12-07
Plain-language 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
Who can participate
Age range60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
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
What they're measuring
1
Level of RSV F antigen-specific cytokine producing CD4+ and CD8+ T-cells
Timeframe: Days 1, 7, 28
2
Level of the RSV F antigen-specific Th1/Th2 cytokine release in whole blood assay
✕. 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