Clinical Trials Logo

Clinical 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. 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01484548
Study type Interventional
Source IDRI
Contact
Status Completed
Phase Phase 1
Start date January 2012
Completion date May 2013

See also
  Status Clinical Trial Phase
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT04504435 - Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants Phase 1
Completed NCT00004755 - Allopurinol, Glucantime, or Allopurinol/Glucantime for Cutaneous Leishmaniasis in Brazil Phase 2
Completed NCT00657618 - Use of Sodium Stibogluconate as a Treatment for Leishmaniasis Phase 1/Phase 2
Completed NCT04512742 - A Clinical Study to Develop a Controlled Human Infection Model Using Leishmania Major-infected Sand Flies N/A
Recruiting NCT00344188 - Diagnosis and Treatment of Leishmania Infections
Active, not recruiting NCT03009422 - Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis. N/A
Recruiting NCT05449717 - Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
Recruiting NCT06307171 - Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers N/A
Completed NCT01751048 - LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine Phase 1
Terminated NCT06124144 - Safety and Drug Absorption of Orally Administered Oleylphosphocholine (OlPC) in Healthy Adults Phase 1
Completed NCT00662012 - Sodium Stibogluconate Treatment of Leishmaniasis Phase 2
Completed NCT03993093 - Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
Recruiting NCT03784248 - Mediterranean Visceral Leishmaniasis With Leishmania Infantum
Withdrawn NCT02429505 - Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Completed NCT01377974 - Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis Phase 2
Completed NCT02656797 - Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis Phase 2
Completed NCT01300975 - Intralesional Antimony for Bolivian Cutaneous Leishmaniasis Phase 2
Completed NCT03294161 - Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis Phase 2
Completed NCT00401297 - Th1/Th2 Polarization and Linkage to L. Viannia Infection Outcomes