Visceral LeishmaniasisPhase 1NCT02071758
Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers
A Phase 1 study testing LEISH-F3 + SLA-SE and LEISH-F3 + GLA-SE in people with Visceral Leishmaniasis, 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 visceral leishmaniasis. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- LEISH-F3 + SLA-SE and LEISH-F3 + GLA-SE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 to 49 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- Female subjects 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 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 + SLA-SE or LEISH-F3 + GLA-SE might cause in a fetus or newborn infant.
- The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the PI and Medical Monitor (MM): sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, 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.
- Negative urine test for recreational drugs and alcohol per Clinical Research Unit standards.
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- Urinalysis not clinically significant as determined by the study clinician.
- 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 possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing SLA or GLA.
- 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.
- Received a blood transfusion within the past 3 months.
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- Donated blood products (platelets, whole blood, plasma, etc.) within past one month.
- Received any vaccine within past 1 month and no planned immunizations while on study with the exception of seasonal influenza vaccine which should not be given between Day 0-84 or Day 138-168 due to 30-day washout period prior to immunology blood draws.
- 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, that in the opinion of the Investigator, poses a health risk.
- Hypertension (systolic >150 or diastolic >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 (> 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.
About this study
Official title: A Phase 1, Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F3 + SLA-SE Vaccine Compared to LEISH-F3 + GLA-SE Vaccine 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 visceral leishmaniasis.
- Conditions
- Visceral Leishmaniasis
- Being tested
- LEISH-F3 + SLA-SE, LEISH-F3 + GLA-SE
- Keywords
- Leishmaniasis, Visceral leishmaniasis, Vaccine, Adjuvant, GLA, SLA
- Medical subject headings
- Leishmaniasis, Visceral, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEISH-F3 + SLA-SEBiological
LEISH-F3 + GLA-SEBiological
| Study group | Role | What they receive |
|---|---|---|
| 20 mcg LEISH-F3 + 5 mcg SLA-SE Vaccine | Experimental | Three intramuscular injections of LEISH-F3 + SLA-SE at Days 0, 28, and 56. High dose of antigen and low dose of SLA-SE adjuvant. Receives: Biological: LEISH-F3 + SLA-SE |
| 20 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine | Experimental | Three intramuscular injections of LEISH-F3 + GLA-SE at Days 0, 28, and 56. High dose of antigen and high dose of GLA-SE adjuvant. Receives: Biological: LEISH-F3 + GLA-SE |
| 5 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine | Experimental | Three intramuscular injections of LEISH-F3 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of GLA-SE adjuvant. Receives: Biological: LEISH-F3 + GLA-SE |
| 20 mcg LEISH-F3 + 10 mcg SLA-SE Vaccine | Experimental | Three intramuscular injections of LEISH-F3 + SLA-SE at Days 0, 28, and 56. High dose of antigen and high dose of SLA-SE adjuvant. Receives: Biological: LEISH-F3 + SLA-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
Immunogenicity will be evaluated by measuring humoral and cellular responses to LEISH-F3 + SLA-SE or LEISH-F3 + GLA-SE 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 posted26 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Anna Marie Beckmann, PhD, Study director, Access to Advanced Health Institute (AAHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071758
- Sponsor's protocol ID
- IDRI-LVVPX-117
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-F3 + SLA-SE Vaccine Compared to LEISH-F3 + GLA-SE Vaccine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02071758
- Acronym / sponsor ID
- IDRI-LVVPX-117
- Conditions
- Visceral Leishmaniasis
- Keywords
- Leishmaniasis, Visceral leishmaniasis, Vaccine, Adjuvant, GLA, SLA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2014 (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 compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of visceral leishmaniasis.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 mcg LEISH-F3 + 5 mcg SLA-SE Vaccine | Experimental | Biological: LEISH-F3 + SLA-SEThree intramuscular injections of LEISH-F3 + SLA-SE at Days 0, 28, and 56. High dose of antigen and low dose of SLA-SE adjuvant. |
| 20 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine | Experimental | Biological: LEISH-F3 + GLA-SEThree intramuscular injections of LEISH-F3 + GLA-SE at Days 0, 28, and 56. High dose of antigen and high dose of GLA-SE adjuvant. |
| 5 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine | Experimental | Biological: LEISH-F3 + GLA-SEThree intramuscular injections of LEISH-F3 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of GLA-SE adjuvant. |
| 20 mcg LEISH-F3 + 10 mcg SLA-SE Vaccine | Experimental | Biological: LEISH-F3 + SLA-SEThree intramuscular injections of LEISH-F3 + SLA-SE at Days 0, 28, and 56. High dose of antigen and high dose of SLA-SE adjuvant. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males and females 18 to 49 years of age.
- Must be in good general health as confirmed by a medical history and physical exam.
- Female subjects 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 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 + SLA-SE or LEISH-F3 + GLA-SE might cause in a fetus or newborn infant.
- The following screening laboratory values must be within the normal ranges or not clinically significant as determined by the PI and Medical Monitor (MM): sodium, potassium, BUN, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, fasting glucose, 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.
Key exclusion criteria (18 listed)
- History of possible infection with Leishmania or previous exposure to Leishmania vaccines or experimental products containing SLA or GLA.
- 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.
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 + SLA-SE | Biological | 20 mcg LEISH-F3 + 10 mcg SLA-SE Vaccine, 20 mcg LEISH-F3 + 5 mcg SLA-SE Vaccine |
| LEISH-F3 + GLA-SE | Biological | 20 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine, 5 mcg LEISH-F3 + 10 mcg GLA-SE Vaccine |
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
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 23 Feb 2016.
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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.
Anna Marie Beckmann, PhD 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 + SLA-SE and LEISH-F3 + GLA-SE in people with Visceral 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 9 inclusion and 18 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 23 Feb 2016. 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 23 Feb 2016.