LeishmaniasisPhase 1NCT01484548
Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers
A Phase 1 study testing LEISH-F3 + GLA-SE and LEISH-F3 alone in people with Leishmaniasis, run by Access to Advanced Health Institute (AAHI) at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prophylaxis of visceral leishmaniasis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Leishmaniasis
- What is being tested?
- LEISH-F3 + GLA-SE and LEISH-F3 alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet ALL of the following criteria to be eligible for inclusion in the study:
- Males and females 18 years to 45 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, a negative urine pregnancy test on the day of each study injection, must not be breast-feeding, and are required to use one of the following methods of contraception during the first 3 months of the study: hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence; or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that LEISH-F3 + GLA SE or LEISH-F3 alone might have in a fetus or newborn infant.
- The following screening laboratory blood tests must have values within the normal ranges or not clinically significant as determined by the PI and Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, fasting lipid panel, total WBC count, hemoglobin, and platelet count.
- The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
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- Negative urine test for recreational drugs and alcohol per Clinical Research Unit standards.
- Urinalysis not clinically significant as determined by the study clinician.
- Must be capable of completing a study diary in English.
- Must give written informed consent, be able and willing to attend all evaluation visits, be reachable by telephone or personal contact by the study site personnel, and have a permanent address.
Who cannot join
- Subjects who meet ANY of the following criteria will be excluded from the study (ineligible):
- History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing GLA-SE.
- Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania.
- Travelers to, or immigrants from, areas endemic to Leishmania.
- Participation in another experimental protocol or receipt of any investigational products within the past 3 months.
- 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) within the past 6 months.
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- Received a blood transfusion within the past 3 months.
- Donated blood products (platelets, whole blood, plasma, etc.) within past 1 month.
- Received any vaccine within past 1 month. Note: No immunizations while on study with the exception of seasonal influenza vaccine which should not be given until 1 month after the third study injection (Day 84).
- History of autoimmune disease or other causes of immunosuppressive states.
- History or evidence of any acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic, or renal disorders, controlled 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 greater than 30 kg/m2
- Hypertension (systolic greater than 150 or diastolic greater than 95).
- History of significant psychiatric illness with current use of medication.
- Known or suspected alcohol or drug abuse within the past 6 months.
- Chronic smoker (less than 20 pack years).
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, 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
Comprehensive Clinical Development NW, Inc.
Tacoma, Washington, 98418
About this study
Official title: A Phase 1, Randomized Clinical Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of The LEISH-F3 + GLA-SE Vaccine Compared To The LEISH-F3 Protein Alone In Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prophylaxis of visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant GLA-SE.
- Conditions
- Leishmaniasis
- Being tested
- LEISH-F3 + GLA-SE, LEISH-F3 alone
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEISH-F3 + GLA-SEBiological
20 ug of LEISH-F3 and 2 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
LEISH-F3 + GLA-SEBiological
20 ug of LEISH-F3 and 5 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
LEISH-F3 aloneBiological
20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine: 20 ug LEISH-F3 + 2 ug GLA-SE | Experimental | Low dose of adjuvant. Receives: Biological: LEISH-F3 + GLA-SE |
| Vaccine: 20 ug LEISH-F3 + 5 ug GLA-SE | Experimental | Higher dose of adjuvant. Receives: Biological: LEISH-F3 + GLA-SE |
| 20 ug LEISH-F3 alone | Active comparator | 20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56. Receives: Biological: LEISH-F3 alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing adverse events.
To evaluate the safety and tolerability of 20 μg of LEISH-F3 together with 2 or 5 μg of GLA-SE compared to 20 µg of LEISH-F3 alone following intramuscular administration on Days 0, 28, and 56. The safety assessments will be based on local and systemic reactions, including reported adverse events, changes in laboratory values, and changes in vital signs. The severity and relationship to treatment will be recorded for all adverse events.
Measured: 421 days
Secondary outcomes (1)
Immunogenicity
To assess the immunogenicity of LEISH-F3 + GLA-SE compared to LEISH-F3 alone by evaluating IgG antibody and T-cell responses to LEISH-F3 at specified timepoints.
Measured: Days 0, 7, 35, 63, 84, and 168.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franco Piazza, MD, MPH, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484548
- Sponsor's protocol ID
- IDRI-LVVPX-111
- Status last verified
- Feb 2014
- First submitted
- 29 Nov 2011
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Clinical Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of The LEISH-F3 + GLA-SE Vaccine Compared To The LEISH-F3 Protein Alone In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01484548
- Acronym / sponsor ID
- IDRI-LVVPX-111
- Conditions
- Leishmaniasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 Dec 2011 (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 healthy adult subjects of an investigational vaccine being developed for the prophylaxis of visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant GLA-SE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine: 20 ug LEISH-F3 + 2 ug GLA-SE | Experimental | Biological: LEISH-F3 + GLA-SELow dose of adjuvant. |
| Vaccine: 20 ug LEISH-F3 + 5 ug GLA-SE | Experimental | Biological: LEISH-F3 + GLA-SEHigher dose of adjuvant. |
| 20 ug LEISH-F3 alone | Active comparator | Biological: LEISH-F3 alone20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects must meet ALL of the following criteria to be eligible for inclusion in the study:
- Males and females 18 years to 45 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, a negative urine pregnancy test on the day of each study injection, must not be breast-feeding, and are required to use one of the following methods of contraception during the first 3 months of the study: hormonal (e.g. oral, transdermal, intravaginal, implant, or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); abstinence; or bilateral tubal ligation (if no conception post-procedure). These precautions are necessary due to unknown effects that LEISH-F3 + GLA SE or LEISH-F3 alone might have in a fetus or newborn infant.
- The following screening laboratory blood tests must have values within the normal ranges or not clinically significant as determined by the PI and Medical Monitor: sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, fasting lipid panel, total WBC count, hemoglobin, and platelet count.
Key exclusion criteria (19 listed)
- Subjects who meet ANY of the following criteria will be excluded from the study (ineligible):
- History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing GLA-SE.
- Veterans who served in the military in the Middle East (Iran, Iraq), Afghanistan, or any other areas endemic to Leishmania.
- Travelers to, or immigrants from, areas endemic to Leishmania.
- Participation in another experimental protocol or receipt of any investigational products within the past 3 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 |
|---|---|---|
| LEISH-F3 + GLA-SE20 ug of LEISH-F3 and 2 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56. | Biological | Vaccine: 20 ug LEISH-F3 + 2 ug GLA-SE |
| LEISH-F3 + GLA-SE20 ug of LEISH-F3 and 5 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56. | Biological | Vaccine: 20 ug LEISH-F3 + 5 ug GLA-SE |
| LEISH-F3 alone20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56. | Biological | 20 ug LEISH-F3 alone |
Primary outcome
Number of patients experiencing adverse events.
Time frame: 421 days
To evaluate the safety and tolerability of 20 μg of LEISH-F3 together with 2 or 5 μg of GLA-SE compared to 20 µg of LEISH-F3 alone following intramuscular administration on Days 0, 28, and 56. The safety assessments will be based on local and systemic reactions, including reported adverse events, changes in laboratory values, and changes in vital signs. The severity and relationship to treatment will be recorded for all adverse events.
1 secondary outcome
Immunogenicity
Time frame: Days 0, 7, 35, 63, 84, and 168.
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 26 Feb 2014.
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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.
Franco Piazza, 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 LEISH-F3 + GLA-SE and LEISH-F3 alone in people with Leishmaniasis, 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 10 inclusion and 19 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 26 Feb 2014. 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 patients experiencing 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 26 Feb 2014.