NCT00486382

CompletedPhase 1

Open-Label Safety Study of Three-Antigen Leishmania Polyprot...

Access to Advanced Health Institute (AAHI)Source

Access to Advanced Health Institute (AAHI)

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

IDRI-LVVPX-104

Study Type

interventional

Actual enrollment (reported)

36

Locations

1 country

Sites

1

Timeline

Study Start

April 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2008

Actual (reported)

Study Completion

November 2008

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 36 participants
Study completion date: November 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 12, 2007
Actual (reported)
First Posted
June 14, 2007
Actual (reported)
Primary Completion
November 2008
Actual (reported)
Study Completion
November 2008
Actual (reported)

Last Updated: April 3, 2015
Status Verified: April 2015
Last Update Submitted: April 1, 2015

Conditions

Post-kala-azar Dermal Leishmaniasis Visceral 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

Sponsors & Collaborators

Access to Advanced Health Institute (AAHI)
Otherlead
Bill and Melinda Gates Foundation
Othercollaborator

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221 005, India

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

Enrollment

36 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Completed

NCT00696969

Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis

Phase 3Completed

NCT07809919

A First-in-human, Safety, Tolerability, and Pharmacokinetics Study of LXE408 in Healthy Subjects

Phase 1Completed

NCT00604955

Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis

Phase 4Completed

NCT00497601

A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar

Phase 2Completed

NCT00523965

Combination Therapy in Indian Visceral Leishmaniasis

Phase 3Completed

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.

Primary Completion

November 2008

Actual (reported)

Study Completion

November 2008

Actual (reported)

Last Updated

April 3, 2015

Record last verified: 2015-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00486382
Data provider: ClinicalTrials.gov
Source updated: 2015-04-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:01 UTC

Locations

IN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Low dose

Medium dose

High dose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations