A Phase 1 interventional study of QTP101 and Placebo in Tuberculosis, Pulmonary, sponsored by Quratis Inc.. Recruiting at 4 sites in Korea, Republic of. Open to participants aged 55 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Quratis Inc. · Phase 1, Interventional, and Prevention
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.
This Phase 1 randomized, double-blind, placebo-controlled clinical trial aims to evaluate the safety and explore the immunogenicity of the investigational tuberculosis (TB) vaccine candidate QTP101 (ID93+GLA-SE) in healthy and medically stable older adults aged 55-74 years. The study targets two specific age groups-55-64 years (middle-aged) and 65-74 years (elderly)-to address the unmet need for effective TB prevention in populations with high disease prevalence and risk, particularly in countries with an aging population.
The trial involves three treatment arms:
Low-dose vaccine group: 2 μg ID93 + 5 μg GLA-SE High-dose vaccine group: 10 μg ID93 + 5 μg GLA-SE Placebo group: Normal saline (0.9%)
Participants will receive three intramuscular (IM) injections of their assigned treatment at baseline (Day 0), Day 28, and Day 56. They will be monitored for safety and immunogenicity over 12 months, with regular follow-up visits scheduled at 1, 6, and 12 months post-final injection.
Key Study Elements:
Eligibility Criteria: Participants must be BCG-vaccinated, HIV-negative, and have QuantiFERON-TB Gold (QFT) test results positive or negative. Chronic conditions are permissible if well-controlled. Women of childbearing potential and men must use approved contraception methods during the study.
Safety Monitoring: Adverse events (AEs) will be closely monitored, categorized as immediate AEs (within 30 minutes of vaccination), solicited local/systemic AEs (within 7 days), unsolicited AEs (up to 28 days), and serious AEs (SAEs) monitored until 12 months post-final dose.
Immunogenicity Assessments: Blood samples will be collected pre-vaccination and at multiple intervals (Day 28, 56, 84, and 392) to measure ID93-specific antibody titers (ELISA) and Th1 cytokine responses (ICS).
Sentinel Design for Older Adults: To ensure participant safety, a sentinel group design is employed for cohorts aged 65-74. Initial vaccination will proceed sequentially within smaller sentinel subgroups, with further cohort enrollment contingent on DSMB approval after reviewing safety data.
Study Objective:
This trial aims to establish the safety profile and preliminary immunogenicity of QTP101 as a step toward addressing the persistent global burden of TB, particularly in vulnerable older populations. The results will inform subsequent clinical development phases to optimize the vaccine's dosing and application.
The study's results will provide critical insights into TB vaccine strategies for aging populations, ensuring a foundation for broader preventative interventions.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 144 is close to the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Quratis Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants must provide evidence at the screening visit (Visit 1) that they meet one of the following criteria to be considered non-fertile:
Exclusion Criteria:
Participants who meet any of the following criteria must be excluded from enrollment.
Participants with the following medical or psychiatric conditions that make it impossible to conduct the clinical trial as judged by the principal investigator:
Participants who have chronically received or other immunomodulatory drugs within 6 months before the first administration of the investigational product
Household contacts and close contacts who have been in an indoor environment with an active tuberculosis patient
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative adults aged 55-64. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. The target population includes individuals without prior TB infection as indicated by the QFT-negative status. The primary objective is to assess safety, focusing on adverse events (AEs), and to explore immunogenicity through antibody titers and cytokine responses. Findings will provide critical insights into the vaccine's effects in middle-aged, previously uninfected individuals.
Biological: QTP101
This study arm evaluates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative adults aged 55-64. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This group focuses on individuals without prior TB infection, as indicated by their QFT-negative status. The primary objective is to assess the safety profile, including adverse events (AEs), and to evaluate the immune response, such as antibody titers and cytokine production. The findings will help determine the vaccine's suitability for middle-aged individuals and guide future dose optimization.
Biological: QTP101
This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-negative adults aged 55-64. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to provide a baseline for evaluating the safety and immunogenicity outcomes of QTP101 by comparing the incidence of adverse events (AEs) and immune responses against those observed in the experimental groups. This group includes individuals without prior TB infection, as indicated by their QFT-negative status, and is essential for assessing the specific effects of the investigational vaccine.
Biological: Placebo
This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative older adults aged 65-74. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm focuses on individuals without prior TB infection, as indicated by their QFT-negative status. The primary objective is to assess the safety profile, including adverse events (AEs), and to explore the vaccine's immunogenicity through antibody titers and cytokine responses. The findings will provide key data on the vaccine's effects in older, previously uninfected populations.
Biological: QTP101
This study arm investigates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-negative older adults aged 65-74. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. The arm focuses on individuals without prior TB infection, as indicated by their QFT-negative status. The primary aim is to evaluate the safety profile, including adverse events (AEs), and to assess the immunogenicity of the high-dose vaccine through antibody titers and cytokine production. The findings will help determine the vaccine's suitability and dose optimization for older populations.
Biological: QTP101
This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-negative older adults aged 65-74. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to establish a baseline for safety and immunogenicity assessments by comparing the incidence of adverse events (AEs) and immune responses against those observed in the experimental groups. This group includes individuals without prior TB infection, as indicated by their QFT-negative status, and plays a crucial role in evaluating the specific effects of the investigational vaccine.
Biological: Placebo
This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive middle-aged adults aged 55-64. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm targets individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary objective is to assess the safety profile, focusing on adverse events (AEs), and to explore the vaccine's immunogenicity through antibody titers and cytokine responses. The results will provide valuable data on the vaccine's performance in previously exposed middle-aged adults.
Biological: QTP101
This study arm investigates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive middle-aged adults aged 55-64. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm focuses on individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary goal is to assess the safety profile, including adverse events (AEs), and to evaluate the immunogenicity of the high-dose vaccine by measuring antibody titers and cytokine responses. The findings will inform dose optimization and vaccine effectiveness in previously exposed middle-aged adults.
Biological: QTP101
This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-positive middle-aged adults aged 55-64. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to establish a baseline for evaluating the safety and immunogenicity outcomes of QTP101 in individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. This comparison will help identify the specific effects of the investigational vaccine by contrasting it with the placebo group in terms of adverse events (AEs) and immune responses.
Biological: Placebo
This study arm evaluates the safety and immunogenicity of a low dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive older adults aged 65-74. Participants receive 2 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm targets individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary objective is to assess the safety profile, focusing on adverse events (AEs), and to explore the vaccine's immunogenicity through antibody titers and cytokine responses. The findings will provide critical insights into the vaccine's safety and effectiveness in previously exposed older populations.
Biological: QTP101
This study arm investigates the safety and immunogenicity of a high dose of QTP101 in BCG-vaccinated, HIV-negative, QFT-positive older adults aged 65-74. Participants receive 10 μg of ID93 and 5 μg of GLA-SE via intramuscular injection on Day 0, Day 28, and Day 56. This arm focuses on individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. The primary goal is to assess the safety profile, including adverse events (AEs), and to evaluate the vaccine's immunogenicity through antibody titers and cytokine responses. The results will inform dose optimization and effectiveness of the vaccine in older adults with prior TB exposure.
Biological: QTP101
This study arm serves as a placebo comparator for BCG-vaccinated, HIV-negative, QFT-positive older adults aged 65-74. Participants receive intramuscular injections of sterile normal saline (placebo) on Day 0, Day 28, and Day 56. The purpose of this arm is to establish a baseline for evaluating the safety and immunogenicity of QTP101 in individuals with prior latent or resolved TB infection, as indicated by their QFT-positive status. Comparing this group to the experimental arms will help identify the specific effects of the investigational vaccine in terms of adverse events (AEs) and immune responses.
Biological: Placebo
QTP101 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.
Sterile 0.9% normal saline
Safety Endpoint - Immediate Adverse Events
Immediate adverse events within 30 minutes after administration
Time frame: Within 30 minutes after each administration
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 administration
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 administration
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 administration
Safety Endpoint - Laboratory assessment (Hematological Test)
Hematological test for each participant
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Laboratory assessment (Hematochemical test)
Hematochemical test for each participant
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Laboratory assessment (Urine test)
Urine test for each participant
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Body temperature)
Body weight will be measured at each scheduled visit after the administration of the investigational product for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Pulse)
Pulse rate will be measured for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Respiratory rate)
Respiratory rate will be measured for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Blood pressure)
Systolic and diastolic blood pressure will be measured for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Immunogenicity Endpoint - Humoral immunity (GMT)
Geometric mean titer (GMT) of antigen-specific IgG measured with ELISA
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Humoral immunity (GMFR)
Geometric mean fold rise (GMFR) of antigen-specific IgG measured with ELISA
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Humoral immunity (SRR)
Seroresponse rate (SRR), defined as a 4-fold rise in antibody titer of antigen-specific IgG measured with ELISA from Baseline
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Cellular immunity (ICS)
The ratio and amount of antigen-specific Th1 cytokine-secreting cells measured with intracellular cytokine staining (ICS)
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Cellular immunity (RR)
Cell response rate (RR), defined as a 4-fold rise in the amount of antigen-specific Th1 cytokine-secreting cells from the baseline.
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Safety Endpoint - Physical examinations (General Appearance)
Overall health and appearance, including posture and obvious abnormalities.
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Skin)
Inspection for rashes, lesions, discoloration, or other visible skin issues
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Head/Neck)
Examination of the skull, scalp, lymph nodes, and thyroid gland
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Chest/Lungs)
Assessment of respiratory sounds, chest wall movement, and breathing patterns using inspection and auscultation
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Heart)
Evaluation of heart sounds, rhythm, and potential murmurs through auscultation and palpation
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Abdomen)
Palpation and auscultation for organ enlargement, tenderness, or abnormal bowel sounds
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Genitourinary System)
Examination of genital and urinary organs, focusing on abnormalities or patient-reported symptoms (if applicable)
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Limbs)
Inspection and assessment for swelling, deformities, or movement limitations
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Musculoskeletal System)
Examination of joints, muscles, and bones for pain, swelling, or restricted mobility
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Nervous System)
Assessment of reflexes, motor and sensory functions, and coordination
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Other)
Any additional assessments based on the participant's symptoms or clinical findings
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Plan to share: Yes — Individual Participant Data (IPD) will be shared for research purposes through publication in peer-reviewed journals. The data will be presented in aggregate form or as part of supplementary materials accompanying the manuscript, ensuring participant confidentiality through anonymization.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be available following the publication of the study results in peer-reviewed journals. This is expected within [specify timeframe, e.g., 6 months to 1 year] after the completion of the study.
Access criteria: Access to the data will be limited to the information published in peer-reviewed journals. Additional data requests beyond the published information may be considered upon reasonable request and subject to institutional and ethical approvals.
No publications or documents are linked to this record.
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Quratis Inc.