Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT00486382
• Date of registration: 12/06/2007
• Prospective Registration: No
• Primary sponsor: IDRI
• Public title: Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
• Scientific title: A Phase 1, Open-Label, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-111F + MPL-SE Vaccine (Recombinant Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE) in Healthy Adults In India
• Date of first enrolment: April 2007
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00486382
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Shyam Sundar, MD
• Affiliation: Banaras Hindu University

• Name: Franco M Piazza, MD, MPh
• Affiliation: IDRI

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

- DAT titer must be <1:400 and rK39 serology negative (for inclusion in the
DAT-negative group) or DAT titer =1:1600 (for inclusion in the DAT-positive group).

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 54 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Visceral Leishmaniasis

Post-kala-azar Dermal Leishmaniasis

Intervention(s)

Biological: Leish-111f + MPL-SE Adjuvant

Primary Outcome(s)

Injection site reactions [Time Frame: For 7 days following each injection.]

Secondary ID(s)

IDRI-LVVPX-104

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation