Pulmonary TBPhase 1NCT03722472
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
A Phase 1 study testing ID93 + GLA-SE in people with Pulmonary TB, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
Trial summary
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary TB
- What is being tested?
- ID93 + GLA-SE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 15 Jun 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 to 55 years of age.
- In good general health as confirmed by a medical history and physical exam, vital signs*, and screening laboratories conducted no more than 30 days prior to study injection administration.
- Temperature <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >54 bpm, systolic blood pressure ≤140 mmHg and >89 mmHg, diastolic blood pressure ≤90 mmHg and ≥60 mmHg.
- NOTE: Athletically trained subjects with a pulse ≥40 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator.
- Screening laboratory values within normal limits: sodium, potassium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, random glucose, total WBC count, hemoglobin, and platelet count.
- Negative HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
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- Urine dipstick for protein and glucose (negative to trace protein are acceptable).
- Women of childbearing potential* in sexual relationships with men must agree to practice acceptable contraception** for the 30-day period before Day 0 through 90 days after the last study injection.
- Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year of the last menses if menopausal). Post-menopausal defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml.
- Includes, but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing ®, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
- Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
- Provide written informed consent before initiation of any study procedures.
- Willing to abstain from donating whole blood or blood derivatives until 90 days after the final study injection.
Who cannot join
- Previous exposure to ID93 vaccines or experimental products containing GLA-SE.
- History of treatment for active or latent tuberculosis infection.
- History or evidence of active or documented latent tuberculosis, or positive QuantiFERON®-TB Gold test.
- Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis.
- Received a tuberculin skin test within 3 months (90 days) prior to randomization.
- History of autoimmune disease or immunosuppression.
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- Used immunosuppressive medication (e.g., oral or injected steroids) within 3 months prior to randomization (inhaled and topical corticosteroids are permitted).
- Received any investigational drug therapy or investigational vaccine within past 6 months prior to randomization, or planned participation in any other investigational study during the study period.
- Received investigational TB vaccine at any time prior to randomization.
- Received any vaccine within 30 days prior to the first study vaccination and no planned immunizations between Day 0-84 or Day 210-224 due to the washout period prior to immunology blood draws.
- History or laboratory evidence of immunodeficiency state including but not limited to laboratory indication of HIV-1 infection at screening.
- History of allergic disease or reactions, likely to be exacerbated by any component of the study vaccine.
- History of allergic reaction to kanamycin-related antibiotics.
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
- Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe 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 or infantile spasms.
- Known or suspected alcohol or drug abuse within the past 5 years.
- Smokes 1 pack or more of cigarettes per day.
- History of keloid formation or excessive scarring.
- History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine, including axillary lymphadenopathy.
- Received a blood transfusion or immunoglobulin within the past 3 months prior to randomization.
- Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month prior to randomization.
- Presence of any febrile illness, oral temperature of >100.4 °F/38.0 °C within 24 hours of study injection administration. Such subjects may be re-evaluated for enrolment after resolution of illness.
- Positive serum (at screening visit only) or urine pregnancy test at screening or within 24 hours prior to study injection for women of childbearing potential.
- Breastfeeding at any time throughout the study.
- Rash, tattoos, or any other dermatological condition on the upper anterolateral arm that could adversely affect the vaccine injection site or interfere with its evaluation.
- BMI <18 or >35 kg/m2.
- Any medical or neuropsychiatric condition which, in the Investigator's opinion, would render the subject incompetent to provide informed consent or unable to provide valid safety observations and reporting.
- Cancer or treatment for cancer within 3 years of study injection administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible.
- Subjects unlikely to cooperate with the requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104
About this study
Official title: A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).
Read the detailed description
Subjects will receive a total of two doses administered IM on Days 0 and 56. Subjects will be monitored for approximately 421 days (one year following the last study injection), including safety laboratory analyses done just prior to and 7 days following each study injection. Tears and nasal swabs will be obtained for exploratory antibody analysis at Days 0, 70, and 224. Blood samples will be obtained for immunological assays (secondary and exploratory) at Days 0, 7, 14, 56, 63, 70, 84, and 224).
- Conditions
- Pulmonary TB
- Being tested
- ID93 + GLA-SE
- Keywords
- Vaccine, recombinant, adjuvant, GLA-SE, ID93
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID93 + GLA-SEBiological
The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.
| Study group | Role | What they receive |
|---|---|---|
| Single-vial ID93 + GLA-SE | Experimental | Single-vial presentation of ID93 + GLA-SE. Participants will receive two intramuscular (IM) injections of the vaccine on Days 0 and 56. 2 mcg ID93 and 5 mcg GLA-SE in 0.5 mL volume will be given per injection. Receives: Biological: ID93 + GLA-SE |
| Two-vial ID93 + GLA-SE | Active comparator | Two-vial presentation of ID93 + GLA-SE. Participants will receive two intramuscular (IM) injections of the vaccine on Days 0 and 56. 2 mcg ID93 and 5 mcg GLA-SE in 0.5 mL volume will be given per injection. Receives: Biological: ID93 + GLA-SE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Injection Site Reactogenicity
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Measured: 7 days following each injection
Systemic Reactogenicity
The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
Measured: 7 days following each injection
All Adverse Events
The number of subjects spontaneously reporting adverse events from Day 0 through Day 84.
Measured: Day 0 - 84
Serious Adverse Events
The number of serious adverse events considered related to any of the study injections reported at any point during the study period.
Measured: Day 0 - 421
Secondary outcomes (6)
IgG Antibody Response Rate
Total IgG antibody ELISA: Responder rate is defined as the proportion of subjects with at least a 4-fold increase from baseline in IgG antibody titer for ID93 antigen.
Measured: Days 0, 14, 56, 70, 84, and 224
IgG Antibody Response Magnitude
Total IgG mean endpoint titer for ID93
Measured: Days 0, 14, 56, 70, 84, and 224
Cytokine Response
PBMC ELISpot: IFN-γ response to the ID93 antigen. Responder status is determined by the SCHARP method.
Measured: Days 0, 14, 56, 70, 84, and 224
Cytokine Response
PBMC ELISpot: IL-10 response to the ID93 antigen. Responder status is determined by the SCHARP method.
Measured: Days 0, 14, 56, 70, 84 and 224
T Cell Response
PBMC ICS: Responder Rate of the "Any Two" CD4 T cell responses to the ID93 antigen; CD4 T cells producing 1 or more cytokines (IFN-γ, TNF, IL-2, IL-4, IL-21 and CD154) simultaneously in response to stimulation with the ID93 antigen as measured by intracellular cytokine staining of PBMCs.
Measured: Days 0, 7, 14, 56, 63, 70, 84 and 224
T Cell Response
PBMC ICS: Responder Rate of the "Any Two" CD8 T cell responses to the ID93 antigen; CD8 T cells producing 1 or more cytokines (IFN-γ, TNF, IL-2, IL-4, IL-21 and CD154) simultaneously in response to stimulation with the ID93 antigen as measured by intracellular cytokine staining of PBMCs.
Measured: Days 0, 7, 14, 56, 63, 70, 84 and 224.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start2 Oct 2018
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TBStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Christopher Fox, PhD, Principal investigator, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722472
- Sponsor's protocol ID
- IDRI-TBVPX-120
- Other IDs
- DMID 17-0104, 272201400041C-0-0-1
- Status last verified
- May 2023
- First submitted
- 25 Oct 2018
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB. Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults. Nat Commun. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2.
PubMed 36878897
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03722472
- Acronym / sponsor ID
- IDRI-TBVPX-120
- Conditions
- Pulmonary TB
- Keywords
- Vaccine, recombinant, adjuvant, GLA-SE, ID93
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).
Detailed description
Subjects will receive a total of two doses administered IM on Days 0 and 56. Subjects will be monitored for approximately 421 days (one year following the last study injection), including safety laboratory analyses done just prior to and 7 days following each study injection. Tears and nasal swabs will be obtained for exploratory antibody analysis at Days 0, 70, and 224. Blood samples will be obtained for immunological assays (secondary and exploratory) at Days 0, 7, 14, 56, 63, 70, 84, and 224).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-vial ID93 + GLA-SE | Experimental | Biological: ID93 + GLA-SESingle-vial presentation of ID93 + GLA-SE. Participants will receive two intramuscular (IM) injections of the vaccine on Days 0 and 56. 2 mcg ID93 and 5 mcg GLA-SE in 0.5 mL volume will be given per injection. |
| Two-vial ID93 + GLA-SE | Active comparator | Biological: ID93 + GLA-SETwo-vial presentation of ID93 + GLA-SE. Participants will receive two intramuscular (IM) injections of the vaccine on Days 0 and 56. 2 mcg ID93 and 5 mcg GLA-SE in 0.5 mL volume will be given per injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Males and females 18 to 55 years of age.
- In good general health as confirmed by a medical history and physical exam, vital signs*, and screening laboratories conducted no more than 30 days prior to study injection administration.
- Temperature <38°C, respiratory rate < 17 breaths pm, heart rate ≤100 bpm and >54 bpm, systolic blood pressure ≤140 mmHg and >89 mmHg, diastolic blood pressure ≤90 mmHg and ≥60 mmHg.
- NOTE: Athletically trained subjects with a pulse ≥40 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator.
- Screening laboratory values within normal limits: sodium, potassium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, random glucose, total WBC count, hemoglobin, and platelet count.
Key exclusion criteria (29 listed)
- Previous exposure to ID93 vaccines or experimental products containing GLA-SE.
- History of treatment for active or latent tuberculosis infection.
- History or evidence of active or documented latent tuberculosis, or positive QuantiFERON®-TB Gold test.
- Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis.
- Received a tuberculin skin test within 3 months (90 days) prior to randomization.
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 |
|---|---|---|
| ID93 + GLA-SEThe single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE. | Biological | Single-vial ID93 + GLA-SE, Two-vial ID93 + GLA-SE |
Primary outcome
Local Injection Site Reactogenicity
Time frame: 7 days following each injection
The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Systemic Reactogenicity
Time frame: 7 days following each injection
The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
All Adverse Events
Time frame: Day 0 - 84
The number of subjects spontaneously reporting adverse events from Day 0 through Day 84.
Serious Adverse Events
Time frame: Day 0 - 421
The number of serious adverse events considered related to any of the study injections reported at any point during the study period.
6 secondary outcomes
IgG Antibody Response Rate
Time frame: Days 0, 14, 56, 70, 84, and 224
IgG Antibody Response Magnitude
Time frame: Days 0, 14, 56, 70, 84, and 224
Cytokine Response
Time frame: Days 0, 14, 56, 70, 84, and 224
Cytokine Response
Time frame: Days 0, 14, 56, 70, 84 and 224
T Cell Response
Time frame: Days 0, 7, 14, 56, 63, 70, 84 and 224
T Cell Response
Time frame: Days 0, 7, 14, 56, 63, 70, 84 and 224.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36878897Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB. Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults. Nat Commun. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2.
- Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adultsLink provided by the sponsor.
- 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.
Christopher Fox, PhD principal investigator
Access to Advanced Health Institute (AAHI)
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 Pulmonary TB, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
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 13 inclusion and 29 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: finished, as of the sponsor's last update on 1 Jun 2023. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Local Injection Site Reactogenicity (time frame: 7 days following each injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722472, which also lists 1 linked publication.
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 1 Jun 2023.