Phase 2 Study of the RSV/Flu-01E Vaccine Against Respiratory Syncytial Virus Infection in Older Adults

NCT ID: NCT06890429

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-07
• Study Completion Date: 2024-04-08

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

RSV/Flu-01E

Single dose of RSV/Flu-01E vector vaccine

Group Type: EXPERIMENTAL

RSV/Flu-01E

Intervention Type: BIOLOGICAL

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

Placebo

Single dose of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive single intranasal injection of physiological buffer solution in 0.5 ml

Interventions

RSV/Flu-01E

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

Intervention Type: BIOLOGICAL

Placebo

Participants will receive single intranasal injection of physiological buffer solution in 0.5 ml

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Availability of signed informed consent

2. Adult men and women over the age of 60.

3. 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.

4. BMI from 18 to 30 kg/m2.

5. 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

6. Negative test for alcohol in exhaled air

7. 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

8. Negative tests for HIV, hepatitis B, hepatitis C, and syphilis

Exclusion Criteria

1. 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

2. Contact with COVID-19 patients within 14 days prior to the start of the clinical study

3. Positive rapid test result for SARS-CoV-2 antigen

4. 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

5. 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

6. History of frequent nosebleeds (>5) during the year prior to the current study

7. Features of the nasal anatomy that may complicate intranasal administration of the study drug

8. Surgical interventions or traumatic injuries in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening

9. Symptoms of acute respiratory disease, including fever, or other acute illness at the time of screening or within two weeks prior to screening

10. 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

11. Donation of blood/plasma (450 ml or more) less than 2 months prior to screening.

12. 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.

13. History of bronchial asthma

14. Hypersensitivity and the presence of severe allergic reactions, including Quincke's edema, anaphylactic shock after the previous administration of any vaccine

15. History of wheezing after previous immunization with live influenza vaccine

16. 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

17. Suspicion of hypersensitivity to any component of the study vaccine, including egg protein

18. 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

19. History of oncological diseases

20. History of thrombocytopenic purpura or bleeding disorders

21. History of convulsions

22. Tuberculosis or residual changes after tuberculosis according to the anamnesis and / or available medical documentation

23. Chronic alcohol dependence or chronic use of illicit drugs, drug abuse

24. Claustrophobia and social phobia according to history and / or available medical records

25. Inability to read Russian; inability or unwillingness to understand the essence of the study

26. Military personnel serving in the military or law enforcement officers.

27. Special diet (eg, vegetarian, vegan, salt-restricted) or lifestyle (night work, extreme physical activity)

28. 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pavlov First Saint Petersburg State Medical University

OTHER

Sponsor Role: collaborator

St. Petersburg City Polyclinic No. 34

UNKNOWN

Sponsor Role: collaborator

Research Institute of Influenza, Russia

OTHER

Sponsor Role: lead

Responsible Party

Tatyana Zubkova

Head of the clinical department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marina Stukova, Dr

Role: STUDY_DIRECTOR

Smorodintsev Research Institute of Influenza

Locations

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, , Russia

Smorodintsev Research Institute of Influenza

Saint Petersburg, , Russia

St. Petersburg City Polyclinic No. 34

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

RSV-II-06/2023

Identifier Type: -

Identifier Source: org_study_id