EP1300 Polyepitope DNA Vaccine Against Plasmodium Falciparum Malaria
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
2 other identifiers
interventional
39
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 16, 2012
November 1, 2012
1.9 years
July 22, 2010
November 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The number of serious adverse events considered associated with the vaccine.
Reported at any point during follow-up.
The number of subjects reporting solicited systemic adverse events of severity (grade 3) or higher.
Within 14 days after receiving any dose of vaccine.
The number of subjects experiencing spontaneous adverse events of severity (grade 3) or higher and considered associated with the vaccine.
Reported at any point during follow-up.
The number of subjects reporting local reactogenicity of severity (grade 3) or higher.
Within 14 days after receiving any dose of vaccine.
Secondary Outcomes (4)
Responses to tolerability questionnaire used to document subject feedback of electroporation mediated DNA vaccine delivery; proportion of subjects judging the procedure to be suitable for use in context of a prophylactic malaria vaccine.
Day 0, 28 and 56.
Antibody titers in serum measured against malaria circumsporozoite protein [Geometric Mean Titer and individual log Enzyme-Linked Immunosorbent Assay (ELISA) units] for subjects in groups II and III.
Day 0, 42, and 70.
Sample number showing positive falciparum-specific responses, Geometric Mean Titer spot-forming cells/million peripheral blood mononuclear cell per cohort, subject frequency per cohort with at least 1 positive response.
Days 0, 42 and 70.
Interferon-gamma Enzyme-Linked Immunospot Assay (ELISPOT) assay.
Days 0, 42 and 70.
Study Arms (3)
Group I: 0.25 mg EP-1300
EXPERIMENTALTen subjects will receive 3 immunizations of EP1300, 0.25 mg, on Day 0, Day 28 and Day 56. Three control subjects in this group will receive placebo injections at the same timepoints.
Group II: 1.0 mg EP-1300
EXPERIMENTALTen subjects will receive 3 immunizations of EP1300, 1.0 mg, on Day 0, Day 28 and Day 56. Three control subjects in this group will receive placebo injections at the same timepoints.
Group III: 4.0 mg EP-1300
EXPERIMENTALTen subjects will receive 3 immunizations of EP1300, 4.0 mg, Day 0, Day 28 and Day 56. Three control subjects in this group will receive placebo injections at the same timepoints.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Men and women, 18 through 40 years old, who deny exposure to or infection with malaria or prior participation in a malaria vaccine study.
- In good health, defined as a person who consents to participate in the trial, agrees to not donate blood until 6 months following the last blood draw in the protocol, and whose clinical laboratory assessments are within parameters as specified in this protocol in Appendix C, (Acceptable Screening Laboratory Ranges). (Women of childbearing potential (not surgically sterile or postmenopausal for \>/= 1 year) must not be pregnant as indicated by a negative pregnancy test (urine or serum) within 24 hours prior to vaccine administration.
- Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier methods in conjunction with spermicidal gel, abstinence, monogamous relationship with vasectomized partner, intrauterine devices, Depo-Provera, Norplant, oral contraceptives, contraceptive patches or other licensed, effective methods) until 30 days following receipt of the last dose of vaccine.
- Able to understand and comply with planned study procedures.
- Able to provide informed consent prior to initiation of any study procedures and be available for all study visits.
- Have access to a telephone.
You may not qualify if:
- Prior history of travel to a malaria-endemic area.
- History of previous malaria infection.
- Planned travel to a malaria-endemic area during the course of the study.
- History of splenectomy.
- Known hypersensitivity to components of the vaccine (deoxyribonucleic acid, phosphate-buffered saline, potassium dihydrogen phosphate, sodium hydrogen phosphate) or to kanamycin or other aminoglycoside antibiotics.
- Is female of child-bearing potential who is breastfeeding or intends to become pregnant during the study period up to 30 days following receipt of the last dose of vaccine.
- Has immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer radiation therapy within the preceding 60 months.
- History of significant cardiac abnormality and/or abnormal baseline electrocardiogram (ECG) readout, and/or history of arrhythmia, including any cardiac pre-excitation syndromes (such as Wolff Parkinson White) or other cardiac syndromes or diseases (such as congestive heart failure) associated with arrhythmias, a history of syncopal episodes, and/or family history of prolonged QTc syndrome.
- Subjects with a seizure disorder, except for those who have been seizure free for 5 years or are felt to be at low risk for seizure as determined by their neurologist (the effects of electric field generation near sites where the threshold of field sensitivity is low is unknown).
- Subjects with hemophilia, thrombocytopenia, bleeding or clotting disorders, muscular atrophy or muscular/neuromuscular degenerative disorders.
- Presence of any implanted any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
- Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid muscles with intact lymph drainage) exceeds 40 millimeters.
- Presence of surgical or traumatic metal implant in the upper limb and/or upper torso.
- Subjects with tattoos, lesions, rashes, scars or tumors at the proposed sites of administration.
- Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy. Active is defined as: no neoplastic disease or treatment for neoplastic disease within the past 5 years.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322, United States
Related Publications (1)
Spearman P, Mulligan M, Anderson EJ, Shane AL, Stephens K, Gibson T, Hartwell B, Hannaman D, Watson NL, Singh K. A phase 1, randomized, controlled dose-escalation study of EP-1300 polyepitope DNA vaccine against Plasmodium falciparum malaria administered via electroporation. Vaccine. 2016 Nov 4;34(46):5571-5578. doi: 10.1016/j.vaccine.2016.09.041. Epub 2016 Sep 30.
PMID: 27697302DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 23, 2010
Study Start
August 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 16, 2012
Record last verified: 2012-11