EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria

Plasmodium Falciparum Malaria Clinical Trial

Official title: A Phase I, Randomized, Controlled Dosage-Escalation Study of the Safety and Reactogenicity of the EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria Administered Via Electroporation to Healthy Adults

Status Completed

Clinical Trial Summary

Malaria, a disease responsible for over one million deaths per year, is caused by a germ spread by mosquito bites. The purpose of this study is to evaluate a vaccine designed for the prevention of malaria caused by the parasite, Plasmodium falciparum, and to evaluate the device used to give the vaccine. This study will provide information on how safe, effective, and tolerable the vaccine is in healthy adults. The participants will be assigned, by chance, to receive 3 doses/shots of the vaccine or a placebo (substance that contains no medication) by injection in the upper arm. Study participants will include 39 healthy adults aged 18-40 years who have not been exposed to malaria and who will enroll at the Emory Vaccine and Treatment Evaluation Unit in Atlanta, Georgia. Study procedures include physical exams and several blood samples. Participants will be involved in the study for approximately seven and one half months.

Clinical Trial Description

Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium (P.). It is estimated that there are 350-500 million clinical cases of malaria per year, accounting for over one million deaths. The majority of deaths occur among children under five years of age in Africa, especially in those areas with poor access to healthcare services. Severe disease occurs most frequently with P. falciparum, at least partially due to its ability to infect a higher percentage of erythrocytes and to adhere to capillary walls. Development of a safe and effective vaccine targeting P. falciparum is a major public health goal. To be truly effective in the general population, a vaccine should induce responses targeting "immunologically" conserved regions. Epitope-based vaccines represent a very logical approach to this problem because they can be designed to focus immune responses only on conserved epitopes. The proposed clinical trial will be the first to evaluate a novel deoxyribonucleic acid (DNA)-based, polyepitope vaccine against P. falciparum malaria. The study will be conducted as a phase I, randomized, prospective, controlled, single-center, dose-escalating trial. This study is designed to provide information regarding the safety and tolerability of the EP (Electroporation) 1300 vaccine that will allow further development of the vaccine in future studies. Immunogenicity will be assessed in a preliminary fashion as a secondary endpoint. The primary objective of this study is to evaluate the safety, reactogenicity and tolerability of the EP1300 (DNA) vaccine administered via electroporation in healthy adult volunteers. The secondary objectives are to obtain preliminary immunogenicity data for the EP1300 polyepitope DNA vaccine as assessed by interferon-gamma enzyme-linked immunospot assay and to assess the tolerability of the administration procedure in healthy volunteers. Thirty-nine healthy adults aged 18 through 40 who have no previous history of malaria exposure or infection, no history of travel to malaria-endemic areas, and who have not received vaccines for malaria infection will be enrolled in this study. Subjects will be randomized to receive 3 doses of either the DNA vaccine or normal saline placebo at day 0, 28, and 56. DNA doses will be administered in dose-escalating fashion from 0.25 mg to 4 mg. Dose escalation will proceed following a review of all safety data up to and including the 2-week safety data time point following the second immunization in the prior dosage group; review includes participation by Division of Microbiology and Infectious Diseases and the Safety Monitoring Committee. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

• NCT number: NCT01169077
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: August 2010
• Completion date: July 2012