rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorBiothervax SpA
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Agrees to avoid elective surgery during the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Vaccination with rBCG-N-RSV
Biological/VaccineIntradermal vaccination with rBCG-N-RSV that expresses the N protein of the respiratory syncytial virus (RSV)
Vaccination with conventional BCG (BCG-WT)
Biological/VaccineIntradermal vaccination with conventional BCG (BCG-WT).
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: rBCG-N-RSV vaccineExperimental treatment 1 intervention
Group B: Mycobacterium bovis bacillus Calmette-Guerin (BCG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence, intensity, and duration of the local solicited AEs (evolution of the "flare-up") until the generation of the scar
Time frame
From vaccination through 180 days post-vaccination2
Occurrence, intensity and duration of unsolicited AEs during the 6-month follow-up.
Time frame
From vaccination through 180 days post-vaccination3
Occurrence of AEs during the 6-month follow-up duration.
Time frame
From vaccination through 180 days post-vaccination4
Alterations to the hemogram and/or biochemical profile at 30- and 180- days post vaccination compared to pre-vaccination profile
Time frame
Day 30 and day 180 post-vaccinationSecondary outcomes
1
Presence and titers of serum IgG antibodies against Purified Protein Derived Mycobacterial antigen (PPD) via ELISA
Time frame
Day 30 and day 180 post-vaccination2
Presence and titers of serum IgG against RSV nucleoprotein via ELISA.
Time frame
Day 30 and day 180 post-vaccinationOther outcomes
1
Cases of symptomatic RSV infection confirmed by RT-qPCR detection in respiratory specimens from 14 days to 6 months after vaccination.
Time frame
From day 14 to 6 months post-vaccination2
Cases of hospitalization/intensive care unit admission and/or death in participants with RSV infection confirmed by RT-qPCR in vaccinated subjects from 14 days to 6 months postvaccination
Time frame
From day 14 to 6 months post-vaccination3
Increase in the percentage of specific CD4+ and CD8+ T cells that express AIM and memory markers via flow cytometry in the peripheral blood of a subgroup of participants that receive the control and the study vaccine.
Time frame
Day 30 and day 180 post-vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biothervax SpA
Lead sponsor
Pharmassist Ltd
Collaborator
Hellenic Pasteur Institute
Collaborator
Sotiria Thoracic Diseases Hospital of Athens
Collaborator
Source ClinicalTrials.gov