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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
QTP101
Biological/VaccineQTP101 consists of ID93 and GLA-SE. ID93 is a recombinant protein antigen comprising four antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.
Placebo
Biological/VaccineSterile 0.9% normal saline
Treatment groups
144 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a low dose of QTP101Experimental treatment 1 intervention
Group B: BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with a high dose of QTP101Experimental treatment 1 intervention
Group C: BCG-vaccinated, HIV-negative, QFT-negative and middle-aged adults (55-64) with the placeboPlacebo comparator 1 intervention
Group D: BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a low dose of QTP101Experimental treatment 1 intervention
Group E: BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with a high dose of QTP101Experimental treatment 1 intervention
Group F: BCG-vaccinated, HIV-negative, QFT-negative and older adults (65-74) with the placeboPlacebo comparator 1 intervention
Group G: BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a low dose of QTP101Experimental treatment 1 intervention
Group H: BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with a high dose of QTP101Experimental treatment 1 intervention
Group I: BCG-vaccinated, HIV-negative, QFT-positive and middle-aged adults (55-64) with the placeboPlacebo comparator 1 intervention
Group J: BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a low dose of QTP101Experimental treatment 1 intervention
Group K: BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with a high dose of QTP101Experimental treatment 1 intervention
Group L: BCG-vaccinated, HIV-negative, QFT-positive and older adults (65-74) with the placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety Endpoint - Immediate Adverse Events
Immediate adverse events within 30 minutes after administration
Time frame
Within 30 minutes after each administration2
Safety Endpoint - Solicited local and systemic Adverse Events
Solicited local/systemic AEs occurred up to 7 days after administration
Time frame
Occurred up to 7 days after each administration3
Safety Endpoint - Unsolicited local and systemic Adverse Events
Unsolicited local/systemic AEs occurred up to 28 days after administration
Time frame
Occurred up to 28 days after each administration4
Safety Endpoint - Serious Adverse Events and Adverse Event of of Special Interest
Serious AE (SAEs) and AE of special interest (AESI) occurred from the first administration up to 48 weeks after the last administration
Time frame
Occurred from the first administration up to 48 weeks after the last administrationSponsors and contacts
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Source ClinicalTrials.gov