Respiratory Syncytial Virus Infection PreventionPhase 2NCT07762014
rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
A Phase 2 study testing Vaccination with rBCG-N-RSV and Vaccination with conventional BCG (BCG-WT) in people with Respiratory Syncytial Virus Infection Prevention and Tuberculosis Prevention, run by Biothervax SpA at 1 site in Greece.
Trial summary
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years. It will also compare the cellular anti-mycobacterial immune response of both vaccines in adults older than 60 years and characterize the cellular immune response against RSV… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infection Prevention, Tuberculosis Prevention
- What is being tested?
- Vaccination with rBCG-N-RSV and Vaccination with conventional BCG (BCG-WT)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 14 Sep 2026to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has completed the written informed consent process.
- Males or females, over 60 years of age as of the date of signature of the informed consent form.
- Has a stable state of health or controlled (health parameters within the normal range for their disease) chronic diseases that do not fall within the exclusion criteria.
- Willingness to comply with study procedures.
- No plans to move to another city in the next 6 months and willing to be contacted by the research team within the study period.
- Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months.
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- Agrees to avoid elective surgery during the study.
- Willingness to receive HIV test results.
- Not having received a BCG vaccination within the last 10 years before study vaccination.
- Exlusion Criteria
- Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours.
- Weight less than 50 kg, as well as BMI less than 18.5 or higher than 35 kg/m2.
- History of treatment or current history of active or latent tuberculosis infection.
- History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months.
- Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed).
- Received documented investigational tuberculosis vaccine at any time.
- Unstable hormonal status, i.e. subjects with any change (dose, formulation, or route) in hormone replacement therapies (including levothyroxine, insulin, estrogen, progesterone etc.) in the last 12 weeks.
- History or laboratory evidence of any possible past, present, or future immunodeficiency status, including, but not limited to, any laboratory indication of HIV-1 infection.
- Allergy to BCG vaccine or its components, as well as the existence of contraindications for BCG administration as described in the BCG prescribing information.
- Previous medical history that may compromise the safety of the study participant, including but not limited to significant impairment of lung function (such as pulmonary diffusion of carbon dioxide <80% or FEV1 ≤80%) due to tuberculosis infection or other pulmonary disease; chronic heart disease with signs of heart failure (NYHA Class II Heart Failure or more) or coronary heart disease, suspicion of progressive neurological disease; uncontrolled epilepsy, liver disease.
- Administration of attenuated vaccines within 30 days before the start of the study or 14 days for inactivated ones.
- Having received transfusions or blood products within the 6 months before the start of the study.
- Uncontrolled hypertension or systolic blood pressure greater than 160 mmHg at the beginning of the study or diastolic greater than 90 mmHg.
- Active neoplasia.
- Stage 2 or higher chronic obstructive pulmonary disease.
- Chronic bronchial asthma with systemic corticosteroids, or with a history of having presented crises that have led to an emergency consultation within the last 2 months.
- Renal disease with estimated or relative creatinine clearance ≤ 70 ml/min x 1.73 m2.
- Evidence of a new acute illness that may compromise the safety of the study participant, such as fever (oral or axillary temperature greater than or equal to 37.5°C) or suspicion of active infection.
- History or laboratory evidence of chronic viral hepatitis.
- History of alcohol or drug abuse in the last 2 years.
- Smoking more than 30 cigarettes a day, or cannabis use three or more days a week.
- History of keloid formation.
- Congenital diseases of importance, such that they weaken the basal condition of the volunteer.
- Congenital or acquired absence of the spleen.
- Coagulation disorders or known thrombocytopenia of less than 100,000 platelets/mm3.
- Having undergone chemotherapy treatment in the last 6 months.
- Generalized urticaria in the last 2 months.
- History of hereditary or acquired angioneurotic edema.
- Any previous medical condition that the investigator considers may compromise the safety of the subject in the study.
- Not being available for all study visits (both face-to-face and by telephone) and specific instructions as appropriate (fasting, abstaining from intense physical exercise during the 24 hours before the study visits and during the 72 hours after vaccination).
- Pregnant women or women of childbearing potential (WOCBP) who are unable or unwilling to utilize appropriate methods of contraception during the study.
- Breast-feeding women.
- Male with heterosexual sexual activity with WOCBP who do not agree to use adequate contraception.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Sotiria Thoracic Diseases Hospital of Athens
Athens
Nikoletta Rovina, MD, +30 2107763100, nikrovina@med.uoa.gr
About this study
Official title: Randomized, Double-blind, Phase 2 Clinical Trial Controlled With Conventional Bacillus Calmette-Guérin (BCG) Vaccine to Evaluate the Safety and Immunogenicity of a Recombinant BCG Vaccine That Expresses the Respiratory Syncytial Virus (RSV) Nucleoprotein (N) (rBCG-N-RSV) in Adults Over 60 Years of Age.
This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years. It will also compare the cellular anti-mycobacterial immune response of both vaccines in adults older than 60 years and characterize the cellular immune response against RSV nucleoprotein (N) generated by the rBCG-N-RSV vaccine in adults older than 60 years as compared to the response induced by the conventional BCG.
- Being tested
- Vaccination with rBCG-N-RSV, Vaccination with conventional BCG (BCG-WT)
- Keywords
- Respiratory Syncytial Virus, RSV, Respiratory Syncytial Virus vaccine, Vaccine, Tuberculosis, TB, Tuberculosis vaccine, BCG
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with rBCG-N-RSVBiological
Intradermal vaccination with rBCG-N-RSV that expresses the N protein of the respiratory syncytial virus (RSV)
Vaccination with conventional BCG (BCG-WT)Biological
Intradermal vaccination with conventional BCG (BCG-WT).
| Study group | Role | What they receive |
|---|---|---|
| rBCG-N-RSV vaccine | Experimental | rBCG-N-RSV is a live-attenuated vaccine of Mycobacterium bovis bacillus Calmette-Guerin (BCG) modified to heterologously and constitutively express the RSV nucleoprotein (N). The clinical formulation with this bacterium has been produced under strict quality and safety standards using current Good Manufacturing Practices (cGMP) in the United States of America (USA).
Pharmaceutical form: Lyophilisate for solution for injection
Medicinal product characteristics: Immunological
Route of administration: Intradermal use
Maximum duration of treatment: 1 Day
Maximum daily dose allowed: 0.1
Daily dose unit of measure: CFU/ml colony forming unit(s)/millilitre
Maximum total dose allowed: 0.1
Total dose unit of measure: CFU/ml colony forming unit(s)/millilitre Receives: Biological: Vaccination with rBCG-N-RSV |
| Mycobacterium bovis bacillus Calmette-Guerin (BCG) | Active comparator | BCG is a cryo-lyophilized vaccine of an attenuated strain of Mycobacterium bovis BCG, used for active immunization against tuberculosis. It is currently administered in numerous countries worldwide according to national immunization plans.
Medicinal product characteristics: Immunological
Route of administration: Intradermal use
Maximum duration of treatment: 1 Day
Maximum daily dose allowed: 0.1
Daily dose unit of measure: CFU/ml colony forming unit(s)/millilitre
Maximum total dose allowed: 0.1
Total dose unit of measure: CFU/ml colony forming unit(s)/millilitre Receives: Biological: Vaccination with conventional BCG (BCG-WT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity, and duration of the local solicited AEs (evolution of the "flare-up") until the generation of the scar
Measured: From vaccination through 180 days post-vaccination
Occurrence, intensity and duration of unsolicited AEs during the 6-month follow-up.
Measured: From vaccination through 180 days post-vaccination
Occurrence of AEs during the 6-month follow-up duration.
Measured: From vaccination through 180 days post-vaccination
Alterations to the hemogram and/or biochemical profile at 30- and 180- days post vaccination compared to pre-vaccination profile
Measured: Day 30 and day 180 post-vaccination
Production of IFN-γ and IL-2 by T cells upon exposure to purified protein derivative (PPD) mycobacterial antigen via ELISPOT 7 days prior vaccination and 30- and 180-days post vaccination.
Measured: Day 30 and day 180 post-vaccination
Production of IFN-γ and IL-2 by T cells upon exposure to recombinant RSV nucleoprotein antigen via ELISPOT 7 days prior vaccination and 30- and 180-days post vaccination
Measured: Day 30 and day 180 post-vaccination
Secondary outcomes (2)
Presence and titers of serum IgG antibodies against Purified Protein Derived Mycobacterial antigen (PPD) via ELISA
Measured: Day 30 and day 180 post-vaccination
Presence and titers of serum IgG against RSV nucleoprotein via ELISA.
Measured: Day 30 and day 180 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start14 Sep 2026
- Primary completion7 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus Infection PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biothervax SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmassist Ltd, Hellenic Pasteur Institute, Sotiria Thoracic Diseases Hospital of Athens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762014
- Sponsor's protocol ID
- rBCG-N-RSV 002GR
- Other IDs
- 2023-509048-80-01, 2023
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not been decided where the results of the study will be published.