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EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria

NCT01169077 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-11-16

No results posted yet for this study

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.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Placebo

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.

BIOLOGICAL

EP-1300

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01169077 on ClinicalTrials.gov