TuberculosisPhase 1NCT03806699
Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent
A Phase 1 study testing ID93+GLA-SE in people with Tuberculosis, run by Quratis Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- ID93+GLA-SE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Apr 2019to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female who is ≥14 and <19 years of age.
- History of BCG vaccination that is confirmed through medical examination (i.e., asking a subject about his/her condition) or presence of a scar.
- Adolescent who are QuantiFERON®-TB Gold Plus negative at screening.
- Body mass index(BMI) ≥19 and ≤33 (kg/m2) who's Body weight≥40kg at screening.
- Able to comply with the scheduled visits and are expected to continue working in the current medical institution and be available for a continuous follow-up by the investigator via provided contact information
- Only for female subjects of childbearing potential:
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- Must be HCG-negative from serum or urine pregnancy test, at screening;
- Agreed to use one of the following acceptable birth control methods to avoid pregnancy until the end of study (Visit 9): hormonal contraceptives, intrauterine device(IUD) or intrauterine system (IUS), tubal ligation or combination of barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical cap, diaphragm, sponge or implant).
- Subjects who understand the study procedures and voluntarily decide to participate in the study and sign the informed consent form.
Who cannot join
- History of severe chronic disease that may compromise the safety of the subject during the study (e.g., impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease or uncontrolled epilepsy).
- Body temperature ≥ 38℃ at the time of randomization or within 24 hours before randomization, from acute fever, acute respiratory diseases, or active infection.
- Malignant tumors or a history of malignant tumors.
- Plans to have surgery during the study period.
- Impaired immune functions including autoimmune disease or immunodeficiency disease.
- History of Guillain-Barre syndrome.
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- Subjects with a history of anaphylaxis or severe allergic reaction to vaccines, eggs or other allergens.
- Clinically significant abnormal laboratory values for any of the following tests conducted in the study center, prior to randomization:
- Hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count or platelet count: < LLN (lower limit of normal)
- White blood cell count: >ULN (upper limit of normal) or <LLN (lower limit of normal) (i.e., must be within normal limits)
- ALT, AST, total bilirubin, alkaline phosphatase, creatinine or blood urea nitrogen(BUN): >ULN (upper limit of normal)
- Received an immunosuppressant, immunity-modifying drug or other treatment that may affect the immune system including cytotoxic anti-cancer agents or radiotherapy, within 3 months before the randomization.
- Use of systemic steroids (equivalent to daily prednisone ≥ 15mg/day for more than 14 days), inhaled or intranasal steroids, within 3 months before randomization; however, use of topical corticosteroids are acceptable, regardless of dose.
- Use of immunoglobulin or blood products within 3 months before randomization or plans to use them during the study period.
- Human Immunodeficiency Virus (HIV) positive at screening.
- Subjects with chronic hepatitis (e.g., hepatitis B core antibody or hepatitis C antibody positive) at screening.
- Unable to discontinue current chronic drug therapy such as thyroxin, insulin or other medications with hepatotoxicity or myelotoxicity; however, estrogen and progesterone replacement therapy or contraceptives and topical medications are acceptable.
- Pregnant or lactating.
- Use of other vaccines within 4 weeks before screening or plans to use other vaccines from screening to 4 weeks after last IP dosing, plan to use of other vaccines within 4 weeks before End visit.
- Use of other investigational drugs within 4 weeks before screening.
- Subjects with history of TB infectivity(Include active, latency TB infection) or positive for Tuberculin Skin Test.
- Subjects living with a household member who has active TB or infectious TB.
- Subjects deemed ineligible by investigator based on other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
HALLYM UNIV. Chuncheon Sacred Heart Hospital
Chuncheon, 24253
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Explore the Immunogenicity of ID93+GLA-SE Vaccine in BCG-Vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. The healthy adolescent will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety and immunogenicity tests. The study hypothesis is that the vaccine is safe and immunogenic in this study population.
Read the detailed description
After signing a written informed consent to participate in the study(under the premise the legal representative also agree their children participate in the study), subjects will be screened by required assessments per protocol. Eligible subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to Group 1, Group 2 or Control Group, receiving either ID93+GLA-SE or saline placebo on Days 0, 28 and 56. The investigator will evaluate the safety, immunogenicity of the Investigational Product in the subjects through-out the study.
For safety assessment, subjects will be instructed to record any adverse events in the Subject diary after each vaccination. Subject's safety will be reported to the investigators after 7 days from each vaccination via site visit or a phone call. Solicited AEs will be collected up to 7 days after the final vaccination with the Investigational Product and unsolicited AEs will be collected up to 28 days after the final vaccination with the Investigational Product. For long-term safety assessment of the Investigational Product, serious adverse events and adverse events of special interest will be monitored up to 12 months after the final vaccination with the Investigational Product.
For immunogenicity assessment, blood samples will be collected and analyzed before and after each vaccination. QFT-Gold Plus testing will be performed after 1 month and 12 months from the final vaccination with the Investigational Product.
- Conditions
- Tuberculosis
- Being tested
- Placebo, ID93+GLA-SE
- Keywords
- Tuberculosis, TB, vaccine, adjuvant
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Sterile normal saline
ID93+GLA-SEBiological
ID93 is a recombinant protein antigen comprising 4 antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.
| Study group | Role | What they receive |
|---|---|---|
| Low dose ID93+GLA-SE | Experimental | Participants will receive 0.5 mL (2 μg ID93 + 5 μg GLA-SE) intramuscular injection (IM) into deltoid area, three times in 4-week intervals on Days 0, 28, and 56. Receives: Biological: ID93+GLA-SE |
| High dose ID93+GLA-SE | Experimental | Participants will receive 0.5 mL (10 μg ID93 + 5 μg GLA-SE) IM injection into deltoid area, three times in 4-week intervals on Days 0, 28, and 56. Receives: Biological: ID93+GLA-SE |
| Control group | Placebo comparator | Participants will receive 0.5 mL (physiological saline) IM injection into deltoid area, three times on 4-week intervals on Days 0, 28, and 56. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Solicited (local and systemic reactogenicity), unsolicited (all other adverse events, including laboratory assessments and vital signs), serious AEs and AEs of special interest.
Measured: Solicited AEs for 7 days following each injection, unsolicited AEs for 28 days after each injection, SAEs and AESIs for 12 months after the last injection.
Secondary outcomes (1)
Humoral and cellular immunogenicity assays
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at specified timepoints
Measured: Days 0, 28, 56, 84, and 12 months after last injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start2 Apr 2019
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of three groups: low dose vaccine, high dose vaccine, or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quratis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Hwa Choi, Study director, Quratis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806699
- Sponsor's protocol ID
- CT-QTP101-002
- Status last verified
- Jul 2019
- First submitted
- 14 Jan 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Explore the Immunogenicity of ID93+GLA-SE Vaccine in BCG-Vaccinated Healthy Adolescent
- ClinicalTrials.gov ID
- NCT03806699
- Acronym / sponsor ID
- CT-QTP101-002
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, TB, vaccine, adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Quratis Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. The healthy adolescent will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety and immunogenicity tests. The study hypothesis is that the vaccine is safe and immunogenic in this study population.
Detailed description
After signing a written informed consent to participate in the study(under the premise the legal representative also agree their children participate in the study), subjects will be screened by required assessments per protocol. Eligible subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to Group 1, Group 2 or Control Group, receiving either ID93+GLA-SE or saline placebo on Days 0, 28 and 56. The investigator will evaluate the safety, immunogenicity of the Investigational Product in the subjects through-out the study.
For safety assessment, subjects will be instructed to record any adverse events in the Subject diary after each vaccination. Subject's safety will be reported to the investigators after 7 days from each vaccination via site visit or a phone call. Solicited AEs will be collected up to 7 days after the final vaccination with the Investigational Product and unsolicited AEs will be collected up to 28 days after the final vaccination with the Investigational Product. For long-term safety assessment of the Investigational Product, serious adverse events and adverse events of special interest will be monitored up to 12 months after the final vaccination with the Investigational Product.
For immunogenicity assessment, blood samples will be collected and analyzed before and after each vaccination. QFT-Gold Plus testing will be performed after 1 month and 12 months from the final vaccination with the Investigational Product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three groups: low dose vaccine, high dose vaccine, or placebo
| Arm | Type | Receives |
|---|---|---|
| Low dose ID93+GLA-SE | Experimental | Biological: ID93+GLA-SEParticipants will receive 0.5 mL (2 μg ID93 + 5 μg GLA-SE) intramuscular injection (IM) into deltoid area, three times in 4-week intervals on Days 0, 28, and 56. |
| High dose ID93+GLA-SE | Experimental | Biological: ID93+GLA-SEParticipants will receive 0.5 mL (10 μg ID93 + 5 μg GLA-SE) IM injection into deltoid area, three times in 4-week intervals on Days 0, 28, and 56. |
| Control group | Placebo comparator | Biological: PlaceboParticipants will receive 0.5 mL (physiological saline) IM injection into deltoid area, three times on 4-week intervals on Days 0, 28, and 56. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male or female who is ≥14 and <19 years of age.
- History of BCG vaccination that is confirmed through medical examination (i.e., asking a subject about his/her condition) or presence of a scar.
- Adolescent who are QuantiFERON®-TB Gold Plus negative at screening.
- Body mass index(BMI) ≥19 and ≤33 (kg/m2) who's Body weight≥40kg at screening.
- Able to comply with the scheduled visits and are expected to continue working in the current medical institution and be available for a continuous follow-up by the investigator via provided contact information
Key exclusion criteria (23 listed)
- History of severe chronic disease that may compromise the safety of the subject during the study (e.g., impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease or uncontrolled epilepsy).
- Body temperature ≥ 38℃ at the time of randomization or within 24 hours before randomization, from acute fever, acute respiratory diseases, or active infection.
- Malignant tumors or a history of malignant tumors.
- Plans to have surgery during the study period.
- Impaired immune functions including autoimmune disease or immunodeficiency disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSterile normal saline | Biological | Control group |
| ID93+GLA-SEID93 is a recombinant protein antigen comprising 4 antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion. | Biological | High dose ID93+GLA-SE, Low dose ID93+GLA-SE |
Primary outcome
Adverse events
Time frame: Solicited AEs for 7 days following each injection, unsolicited AEs for 28 days after each injection, SAEs and AESIs for 12 months after the last injection.
Solicited (local and systemic reactogenicity), unsolicited (all other adverse events, including laboratory assessments and vital signs), serious AEs and AEs of special interest.
1 secondary outcome
Humoral and cellular immunogenicity assays
Time frame: Days 0, 28, 56, 84, and 12 months after last injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Hwa Choi study director
Quratis Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ID93+GLA-SE in people with Tuberculosis, run by Quratis Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Solicited AEs for 7 days following each injection, unsolicited AEs for 28 days after each injection, SAEs and AESIs for 12 months after the last injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.