EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Placebo; EP-1300
Intervention type(s): Drug; Biological
Intervention description(s): Injections of normal saline to be used as control; given at Days 0, 28, and 56. Administered via electroporation, using a DNA vaccine delivery device, in the deltoid.; Single DNA plasmid dissolved in phosphate-buffered saline (PBS). Dose levels: 0.25, 1 and 4 mg based on DNA content, administered on Days 0, 28 and 56 via electroporation using a DNA vaccine delivery device, in the deltoid.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: malaria, plasmodium falciparum, electroporation