ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
ConditionTuberculosis, Pulmonary
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age55-74
SponsorQuratis Inc.
About this trial
The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin (BCG)-vaccinated older adults aged 55 to 74 with negative or positive result on the QuantiFERON-TB (QFT) test. Eligible participants will be randomly assigned based on age group and the QFT test results to receive either QTP101 (Dose 1 and Dose 2) or placebo.
Safety and immunogenicity will be monitored from the first dose until 12 months after the final dose of the investigational product. Blood samples for immunogenicity analysis will be collected at five-time points: before the first dose (Day 0), 4 weeks after the first dose (Day 28), 4 weeks after the second dose (Day 56), 4 weeks after the third dose (Day 84), and 48 weeks after the third dose (Day 392). Once the safety and immunogenicity follow-up is completed 48 weeks after the third dose (Day 392) for the last enrolled participant, a final report will be compiled based on the collected data.
Eligibility criteria
Qualifiers
Participants who can comply with all scheduled assessment visits during the clinical trial period and who can be continuously monitored by the investigator through the provided contact information
Males or females aged 55 to 74 years at the time of consent
Participants and/or legally authorized representatives who are capable of providing written informed consent (signed in person in the presence of a witness)
Participants with either positive or negative QFT test results at the time of screening; QFT testing can be omitted in the following case: If participants have a documented history of a positive QFT test result, evidenced by submitted records or recorded in the EMR
Disqualifiers
Participants who are suspected of having tuberculosis, have a history of tuberculosis, are currently undergoing treatment for tuberculosis, are being treated for latent tuberculosis infection, or have a history of medication treatment for latent tuberculosis infection at the time of the Screening (Visit 1) or the first administration (Visit 2)
Participants who have received other investigational products or used unapproved drugs within 6 months prior to participating in the clinical trial or who plan to use them during the trial period
Participants who have previously received an investigational tuberculosis vaccine
Participants who test positive for HIV at the screening visit
Trial design
Treatments tested in this trial
- QTP101
- Placebo
Treatment groups
144 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov