LeprosyPhase 1NCT03302897
Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
A Phase 1 study testing LEP-F1 + GLA-SE in people with Leprosy, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of leprosy. Two dose levels of the vaccine will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Leprosy
- What is being tested?
- LEP-F1 + GLA-SE
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 5 Mar 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 years to 55 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination, must not be breast-feeding, and are required to use one of the following methods of contraception from enrollment (Day 0) in study until 30 days after last injection (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. These precautions are necessary due to unknown effects that LEP-F1 + GLA-SE might cause in a fetus or newborn infant. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy.
- The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the Investigator and approved by the Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count. Abnormal results may be repeated once for confirmation at Investigator discretion.
- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), QuantiFERON®-TB Gold (QFT), and hepatitis C virus (HCV) antibody.
- Negative test for recreational drugs and alcohol per Clinical Research Unit standards.
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- Normal or not clinically significant urinalysis as determined by the study clinician or designee. Abnormal results may be repeated at Investigator discretion.
- Must be capable of completing a study memory aid in English.
- Must give informed consent, be able and willing to make all evaluation visits, be reachable by telephone or personal contact by the study site personnel, and have a permanent address.
Who cannot join
- History of infection with M. leprae or previous exposure to M. leprae vaccines or experimental products containing GLA-SE.
- History of BCG vaccination.
- History of active or documented latent TB.
- History of previous infection with other non-tuberculous mycobacteria.
- Travel to or residence in India, Brazil, or Indonesia for more than 6 months.
- Participation in another experimental protocol and/or receipt of any investigational products within the past 3 months prior to Screening.
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- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) or cytotoxic therapies (e.g., chemotherapy drugs or radiation) in the past 6 months prior to Screening.
- Received a blood transfusion within past 3 months prior to Screening.
- Donated blood products (platelets, whole blood, plasma, etc.) within past one month prior to Screening.
- Received any vaccine within past 1 month prior to Screening or have any planned immunizations while on study, with the exception of seasonal influenza vaccine which can be given after 1 month post the third study injection (Day 84).
- History of autoimmune disease or other causes of immunosuppressive states.
- History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders, uncontrolled hypertension), or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Rash, tattoos, or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation.
- BMI ≥ 32.
- Hypertension (systolic > 150 or diastolic > 95) at screening and Day 0.
- History of significant psychiatric illness with current use of medication.
- Known or suspected alcohol or drug abuse within the past 6 months prior to Screening.
- Chronic tobacco user (> 20 pack years).
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines or unknown allergens.
- Subjects who are unlikely to cooperate with the requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open Label, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Subjects
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of leprosy. Two dose levels of the vaccine will be evaluated.
Read the detailed description
The purpose of this study is to compare the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE vaccine. The vaccine consists of the recombinant four-antigen Mycobacterium leprae antigen LEP-F1 in combination with the adjuvant formulation GLA-SE (Glucopyranosyl Lipid A - Stable Emulsion) and is being developed for the prevention of leprosy disease. This is a first-in-human study and will be conducted in healthy adult subjects. Two dose levels of the vaccine (2 μg LEP-F1 + 5 μg GLA-SE and 10 μg LEP-F1 + 5 μg GLA-SE) will be given by intramuscular administration on study Days 0, 28, and 56.
- Conditions
- Leprosy
- Being tested
- LEP-F1 + GLA-SE
- Keywords
- Leprosy, vaccine, adjuvant, GLA, GLA-SE
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEP-F1 + GLA-SEBiological
Investigational vaccine
| Study group | Role | What they receive |
|---|---|---|
| 2 μg LEP-F1 + 5 μg GLA-SE | Experimental | Three intramuscular injections of LEP-F1 + GLA-SE at Days 0, 28, and 56. Low dose of antigen. Receives: Biological: LEP-F1 + GLA-SE |
| 10 μg LEP-F1 + 5 μg GLA-SE | Experimental | Three intramuscular injections of LEP-F1 + GLA-SE at Days 0, 28, and 56. Higher dose of antigen. Receives: Biological: LEP-F1 + GLA-SE |
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: 421 days
Secondary outcomes (1)
Immunogenicity (IgG antibody and T cell responses to LEP-F1)
Immunogenicity will be evaluated by measuring humoral and cellular responses to LEP-F1 + GLA-SE at specified timepoints.
Measured: Days 0, 35, and 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start2 Oct 2017
- Primary completion5 Mar 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- American Leprosy Missions
- Responsible party
- Sponsor
- Investigators
- Corey Casper, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302897
- Sponsor's protocol ID
- IDRI-LEPVPX-118
- Status last verified
- Apr 2019
- First submitted
- 2 Oct 2017
- Last updated
- 11 Apr 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 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03302897
- Acronym / sponsor ID
- IDRI-LEPVPX-118
- Conditions
- Leprosy
- Keywords
- Leprosy, vaccine, adjuvant, GLA, GLA-SE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- American Leprosy Missions
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 5 Oct 2017 (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 compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of leprosy. Two dose levels of the vaccine will be evaluated.
Detailed description
The purpose of this study is to compare the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE vaccine. The vaccine consists of the recombinant four-antigen Mycobacterium leprae antigen LEP-F1 in combination with the adjuvant formulation GLA-SE (Glucopyranosyl Lipid A - Stable Emulsion) and is being developed for the prevention of leprosy disease. This is a first-in-human study and will be conducted in healthy adult subjects. Two dose levels of the vaccine (2 μg LEP-F1 + 5 μg GLA-SE and 10 μg LEP-F1 + 5 μg GLA-SE) will be given by intramuscular administration on study Days 0, 28, and 56.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 μg LEP-F1 + 5 μg GLA-SE | Experimental | Biological: LEP-F1 + GLA-SEThree intramuscular injections of LEP-F1 + GLA-SE at Days 0, 28, and 56. Low dose of antigen. |
| 10 μg LEP-F1 + 5 μg GLA-SE | Experimental | Biological: LEP-F1 + GLA-SEThree intramuscular injections of LEP-F1 + GLA-SE at Days 0, 28, and 56. Higher dose of antigen. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females 18 years to 55 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study vaccination, must not be breast-feeding, and are required to use one of the following methods of contraception from enrollment (Day 0) in study until 30 days after last injection (only if in sexual relationships with men): hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm, or cervical cap with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; bilateral tubal ligation (if no conception post-procedure); tubal occlusion; or bilateral salpingectomy. These precautions are necessary due to unknown effects that LEP-F1 + GLA-SE might cause in a fetus or newborn infant. Women are considered non-child-bearing potential if they are post-menopausal (defined as at least 12 months spontaneous amenorrhea and confirmed with FSH > 40 mIU/ml) or have had documented hysterectomy and/or oophorectomy.
- The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the Investigator and approved by the Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, total WBC count, hemoglobin, and platelet count. Abnormal results may be repeated once for confirmation at Investigator discretion.
- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), QuantiFERON®-TB Gold (QFT), and hepatitis C virus (HCV) antibody.
Key exclusion criteria (20 listed)
- History of infection with M. leprae or previous exposure to M. leprae vaccines or experimental products containing GLA-SE.
- History of BCG vaccination.
- History of active or documented latent TB.
- History of previous infection with other non-tuberculous mycobacteria.
- Travel to or residence in India, Brazil, or Indonesia for more than 6 months.
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 |
|---|---|---|
| LEP-F1 + GLA-SEInvestigational vaccine | Biological | 10 μg LEP-F1 + 5 μg GLA-SE, 2 μg LEP-F1 + 5 μg GLA-SE |
Primary outcome
Number of adverse events
Time frame: 421 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 (IgG antibody and T cell responses to LEP-F1)
Time frame: Days 0, 35, and 63
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 11 Apr 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.
Corey Casper, MD, MPH study director
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 LEP-F1 + GLA-SE in people with Leprosy, 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 9 inclusion and 20 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 11 Apr 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 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?
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: 421 days). 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 11 Apr 2019.