CompletedPhase 2

Phase 2 Study of the ТВ/Flu-05Е Tuberculosis Vaccine

Russia160 participantsStarted 2023-12-13

Plain-language summary

The aim of the study is to investigate immunogenicity and safety of the TB/Flu-05E single-dose intranasal vaccine for the prevention of Tuberculosis infection in BCG-vaccinated Volunteers aged 18-50 years

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. Healthy BCG-vaccinated men and women aged 18 to 50 years
✓. Availability of signed informed consent
✓. Diagnosed "healthy" according to the data of standard clinical, laboratory and instrumental examination methods, with the absence of clinically significant changes. Participants with chronic conditions that do not require special treatment, such as diabetes mellitus, hypertension, or heart disease, are eligible to participate in this study if the investigator considers the participant's condition to be medically stable
✓. 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
✓. 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:
✓. Body weight ≥ 50 kg
✓. 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

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
✕. Clinical, radiological or laboratory signs of active or previously transferred tuberculosis of any localization.
✕. Existence in the past or present of contact with patients with any form of tuberculosis (at home, at work, in the circle of friends and acquaintances)
✕. Tuberculous infection confirmed by the TB-FERON IGRA laboratory test
✕. Immunization with BCG within six months prior to enrollment in the current study
✕. 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

Level of TB antigen-specific cytokine producing T-cells

Timeframe: Days 1, 7, 21

Level of TB antigen-specific cytokine release in whole blood assay

Timeframe: Days 1, 7, 21

Trial details

NCT IDNCT06873282

SponsorResearch Institute of Influenza, Russia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-12

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