NCT00486382

Brief Summary

The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

June 12, 2007

Last Update Submit

April 1, 2015

Conditions

Visceral LeishmaniasisPost-kala-azar Dermal Leishmaniasis

Keywords

visceral leishmaniasisvaccine

Outcome Measures

Primary Outcomes (1)

  • Injection site reactions

    For 7 days following each injection.

Study Arms (3)

Low dose

EXPERIMENTAL

Biological/Vaccine: Leish-111f + MPL-SE Adjuvant

Biological: Leish-111f + MPL-SE Adjuvant

Medium dose

EXPERIMENTAL

Biological/Vaccine: Leish-111f + MPL-SE Adjuvant

Biological: Leish-111f + MPL-SE Adjuvant

High dose

EXPERIMENTAL

Biological/Vaccine: Leish-111f + MPL-SE Adjuvant

Biological: Leish-111f + MPL-SE Adjuvant

Interventions

Leish-111f + MPL-SE AdjuvantBIOLOGICAL
High doseLow doseMedium dose

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females ≥ 18 years and \< 55 years of age.
  • Must be in good general health as confirmed by a medical history and physical exam.
  • The following laboratory blood tests must have values within the normal ranges at screening (Appendix 4): sodium, potassium, urea, ALT, AST, total bilirubin, creatinine, alkaline phosphatase, glucose, hemoglobin, total WBC count and platelet count.
  • The following serology tests must be negative at screening: HIV 1/2, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. All subjects will receive HIV related counseling prior to testing. Subjects with positive HIV test results will receive counseling at the University and will be referred to the national AIDS control program for treatment if appropriate.
  • Subjects must give written informed consent, be willing and able to attend all required visits, have a permanent address, and be reachable by study site personnel.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening, a negative urine pregnancy test within 24 hours before study injection, must not be breast-feeding, and are required to use adequate contraception through Day 84 of the study. These precautions are necessary due to unknown effects that Leish-111f + MPL-SE might have in a fetus or newborn infant.

You may not qualify if:

  • Previous exposure to Leishmania vaccines or experimental products containing MPL-SE.
  • Participation in another experimental protocol or receipt of any investigational products within 30 days prior to the first administration of study injection.
  • Known use of injected or oral corticosteroids within 6 weeks prior to the first administration of study injection.
  • History of autoimmune disease or other causes of immunosuppressive states.
  • History or evidence of any acute or chronic illness that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or the immunogenicity of the vaccine. (Potential subjects presenting with concomitant illness will be referred for clinical care.)
  • History of use of any medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or the immunogenicity of the vaccine.
  • History of significant psychiatric illness.
  • Known to be a current drug or alcohol abuser.
  • Subjects with a history of previous anaphylaxis, severe allergic reaction to vaccines or unknown allergens, or allergic reaction to eggs.
  • History of chronic headaches or migraine.
  • Subjects who are unlikely to cooperate with the requirements of the study protocol.
  • Subjects who are not permanent residents or who are planning to move to another town/city.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221 005, India

Location

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Shyam Sundar, MD

    Banaras Hindu University

    PRINCIPAL INVESTIGATOR

  • Franco M Piazza, MD, MPh

    Access to Advanced Health Institute (AAHI)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 14, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

IN(1)