Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers
ADVAX-EP
Evaluation of Local and Systemic Reactogenicity Following Serial Administration of ADVAX, a Clade C DNA Vaccine, ADVAX e/g + ADVAX p/N-t, by Ichor TriGrid™ in Vivo Electroporation to HIV-Uninfected, Healthy Volunteers
1 other identifier
interventional
40
1 country
1
Brief Summary
This study will test the safety of a HIV DNA vaccine after it is injected into your muscle using an electroporation device (TriGrid™ Delivery System made by Ichor Medical Systems), and will test the ability of the vaccine to help your body make antibodies and T-Cells. In this study, we would like to learn about the effects that electroporation of the HIV DNA has on you and your immune system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
Started Sep 2007
Typical duration for phase_1 hiv-infections
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
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 5, 2011
May 1, 2011
2.1 years
October 16, 2007
May 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety of an intramuscular prime and boost injection of the ADVAX DNA-based HIV vaccine via TriGrid™ electroporation at all three dosing levels
wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56
Secondary Outcomes (1)
• To evaluate the immunogenicity of an intramuscular prime and boost injection of the ADVAX DNA-based HIV vaccine via TriGrid™ electroporation compared to placebo or standard syringe injection at all three dosing levels.
wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56
Study Arms (2)
intramuscular injection
ACTIVE COMPARATORadministration of an HIV-1 vaccine by conventional intramuscular injection
TriGrid Delivery System
EXPERIMENTALelectroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc.
Interventions
Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.
administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection
Eligibility Criteria
You may qualify if:
- Healthy Men and Women
- Ages 18 to 60
- Not considered to be at high risk to acquire HIV infection.
You may not qualify if:
- Confirmed HIV-1 or HIV-2 infection
- Any clinically significant abnormality on history or examination
- Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation
- Hepatitis B; hepatitis C
- Syphilis
- If female, pregnant, planning a pregnancy during the trial period, or breastfeeding
- Receipt of a live attenuated vaccine (other than influenza) within 30 days or other vaccine within 14 days of ADVAX vaccination
- Receipt of blood transfusion or blood products 6 months prior to vaccination
- Participation in another clinical study of an investigational product currently or within past 3 months, or expected participation while enrolled in this study
- History of severe local or systemic reactogenicity to vaccination or history of severe allergic reactions
- Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years
- 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 mm
- In the opinion of the investigator, unlikely to comply with protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rockefeller Universitylead
- Aaron Diamond AIDS Research Centercollaborator
- Bill and Melinda Gates Foundationcollaborator
- Ichor Medical Systems Incorporatedcollaborator
- International AIDS Vaccine Initiativecollaborator
Study Sites (1)
The Rockefeller University Hospital
New York, New York, 10021, United States
Related Publications (1)
Vasan S, Hurley A, Schlesinger SJ, Hannaman D, Gardiner DF, Dugin DP, Boente-Carrera M, Vittorino R, Caskey M, Andersen J, Huang Y, Cox JH, Tarragona-Fiol T, Gill DK, Cheeseman H, Clark L, Dally L, Smith C, Schmidt C, Park HH, Kopycinski JT, Gilmour J, Fast P, Bernard R, Ho DD. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers. PLoS One. 2011;6(5):e19252. doi: 10.1371/journal.pone.0019252. Epub 2011 May 16.
PMID: 21603651DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Ho, M.D.
The Aaron Diamond AIDS Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 18, 2007
Study Start
September 1, 2007
Primary Completion
October 1, 2009
Study Completion
April 1, 2011
Last Updated
May 5, 2011
Record last verified: 2011-05