Pulmonary TuberculosisPhase 1NCT01927159
Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers
A Phase 1 study testing ID93 + GLA-SE in people with Pulmonary Tuberculosis, run by Access to Advanced Health Institute (AAHI) at 1 site in South Africa.
Trial summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary 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
- 66 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2013to Jul 2015
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has completed the written informed consent process prior to start of screening evaluations
- Male or female who is ≥18 years and ≤50 years of age at the time of randomization
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
- Agrees to avoid elective surgery for the full duration of the study
- For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence(not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide gel
- Has general good health, confirmed by medical history and physical examination
- Has body mass index (BMI) between 19 and 33 (weight/height2) by nomogram
- Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
Who cannot join
- Acute illness at the time of randomization
- Oral temperature ≥37.5°C at the time of randomization
- Clinically significant abnormal laboratory values for any of the following screening laboratory parameters, per local laboratory normal ranges from blood collected within 30 days prior to Study Day 0 randomization as follows:
- hemoglobin, hematocrit, absolute neutrophil count, absolute lymphocyte count, or platelet count below lower limit of normal (LLN)
- white blood cell count above upper limit of normal (ULN) or below LLN (i.e., must be within normal limits)
- ALT, AST, total bilirubin, alkaline phosphatase, creatinine, or blood urea nitrogen (BUN) above ULN
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- Evidence of systemic or local disease process on screening urinalysis
- Evidence of significant active infection
- History of treatment for active or latent tuberculosis or evidence of active tuberculosis
- Shared a residence within the last year prior to randomization with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
- History of autoimmune disease or immunosuppression
- Used immunosuppressive medication within 42 days before randomization (inhaled and topical corticosteroids are permitted)
- Received immunoglobulin or blood products within 42 days before randomization
- Received any investigational drug therapy or investigational vaccine within 182 days before randomization, or planned participation in any other investigational study during the study period
- Received investigational Mtb vaccine at any time prior to randomization
- Received a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to randomization.
- Unable to discontinue current chronic prescription drug therapy that can be hepatotoxic or toxic to the bone marrow or kidneys.
- History or laboratory evidence of immunodeficiency state including but not limited to any laboratory indication of HIV-1 infection
- History of allergic disease or reactions (including allergy to kanamycin-related antibiotics, allergic reaction to eggs, and severe eczema), likely to be exacerbated by any component of the study vaccine
- Previous medical history that may compromise the safety of the participant in the study, including but not limited to: severe impairment of pulmonary function from pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy
- Evidence of chronic hepatitis (e.g., hepatitis B surface antigen or hepatitis C antibody)
- Chronic heavy ethanol intake which, in the opinion of the investigator, may compromise the safety of the participant or interfere with the evaluation of the safety of the vaccine
- Cannabis smoking 3 or more days per week
- Positive urine test for illicit drugs (opiates, cocaine, amphetamines)
- 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
- All female participants: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening or on the day of study injection
- Received a tuberculin skin test within 3 months (90 days) prior to Study Day 0
- Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol or may compromise the safety of the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in BCG-Vaccinated Healthy Adults
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- ID93 + GLA-SE, Placebo
- Keywords
- Tuberculosis, TB, Pulmonary, Vaccine, Adjuvant
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID93 + GLA-SEBiological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 10 mcg ID93 + 2 mcg GLA-SE Vaccine (QFT-) | Experimental | Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant. This group limited to adults with negative Quantiferon Gold TB (QFT) test. Receives: Biological: ID93 + GLA-SE |
| 2 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. Low dose of antigen and low dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| 10 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| 10 mcg ID93 + 5 mcg GLA-SE Vaccine | Experimental | Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and high dose of adjuvant. Receives: Biological: ID93 + GLA-SE |
| Saline | Placebo comparator | Three intramuscular injections of saline at Days 0, 28, and 112. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Solicited and unsolicited adverse events will be recorded for 28 days following each study injection; serious adverse events and adverse events of special interest will be recorded for the duration of the study.
Measured: 294 days
Secondary outcomes (1)
Immunogenicity
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at specified timepoints.
Measured: Days 0, 14, 42, 112, 126, 196, 294
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Aeras, South African Tuberculosis Vaccine Initiative
- Responsible party
- Sponsor
- Investigators
- Michele Tameris, M.B.Ch.B., Principal investigator, SATVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927159
- Sponsor's protocol ID
- IDRI-TBVPX-114
- Status last verified
- Jan 2018
- First submitted
- 15 Aug 2013
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Penn-Nicholson A, Tameris M, Smit E, Day TA, Musvosvi M, Jayashankar L, Vergara J, Mabwe S, Bilek N, Geldenhuys H, Luabeya AK, Ellis R, Ginsberg AM, Hanekom WA, Reed SG, Coler RN, Scriba TJ, Hatherill M; TBVPX-114 study team. Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial. Lancet Respir Med. 2018 Apr;6(4):287-298. doi: 10.1016/S2213-2600(18)30077-8.
PubMed 29595510
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in BCG-Vaccinated Healthy Adults
- ClinicalTrials.gov ID
- NCT01927159
- Acronym / sponsor ID
- IDRI-TBVPX-114
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis, TB, Pulmonary, Vaccine, Adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Aeras, South African Tuberculosis Vaccine Initiative
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Aug 2013 (estimated)
- 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 determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 10 mcg ID93 + 2 mcg GLA-SE Vaccine (QFT-) | Experimental | Biological: ID93 + GLA-SEThree intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant. This group limited to adults with negative Quantiferon Gold TB (QFT) test. |
| 2 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Biological: ID93 + GLA-SEThree intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. Low dose of antigen and low dose of adjuvant. |
| 10 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Biological: ID93 + GLA-SEThree intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and low dose of adjuvant. |
| 10 mcg ID93 + 5 mcg GLA-SE Vaccine | Experimental | Biological: ID93 + GLA-SEThree intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 112. High dose of antigen and high dose of adjuvant. |
| Saline | Placebo comparator | Other: PlaceboThree intramuscular injections of saline at Days 0, 28, and 112. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Has completed the written informed consent process prior to start of screening evaluations
- Male or female who is ≥18 years and ≤50 years of age at the time of randomization
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
- Agrees to avoid elective surgery for the full duration of the study
- For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence(not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide gel
Key exclusion criteria (28 listed)
- Acute illness at the time of randomization
- Oral temperature ≥37.5°C at the time of randomization
- Clinically significant abnormal laboratory values for any of the following screening laboratory parameters, per local laboratory normal ranges from blood collected within 30 days prior to Study Day 0 randomization as follows:
- Evidence of systemic or local disease process on screening urinalysis
- Evidence of significant active infection
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-SE | Biological | 10 mcg ID93 + 2 mcg GLA-SE Vaccine, 10 mcg ID93 + 2 mcg GLA-SE Vaccine (QFT-), 10 mcg ID93 + 5 mcg GLA-SE Vaccine, 2 mcg ID93 + 2 mcg GLA-SE Vaccine |
| Placebo | Other | Saline |
Primary outcome
Number of Adverse Events
Time frame: 294 days
Solicited and unsolicited adverse events will be recorded for 28 days following each study injection; serious adverse events and adverse events of special interest will be recorded for the duration of the study.
1 secondary outcome
Immunogenicity
Time frame: Days 0, 14, 42, 112, 126, 196, 294
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 29595510Penn-Nicholson A, Tameris M, Smit E, Day TA, Musvosvi M, Jayashankar L, Vergara J, Mabwe S, Bilek N, Geldenhuys H, Luabeya AK, Ellis R, Ginsberg AM, Hanekom WA, Reed SG, Coler RN, Scriba TJ, Hatherill M; TBVPX-114 study team. Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial. Lancet Respir Med. 2018 Apr;6(4):287-298. doi: 10.1016/S2213-2600(18)30077-8.
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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.
Michele Tameris, M.B.Ch.B. principal investigator
SATVI
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 Tuberculosis, run by Access to Advanced Health Institute (AAHI) at 1 site in South Africa.
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 8 inclusion and 28 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 Feb 2018. 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 Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Adverse Events (time frame: 294 days). 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 NCT01927159, 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 Feb 2018.