HIV InfectionsPhase 1ADVAX-EPNCT00545987
Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers
A Phase 1 study testing TriGrid™ Delivery System and conventional intramuscular injection in people with HIV Infections, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TriGrid™ Delivery System and conventional intramuscular injection
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Men and Women
- Ages 18 to 60
- Not considered to be at high risk to acquire HIV infection.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: 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
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.
Read the detailed description
Over 40 million people worldwide are currently infected with HIV, the virus that causes AIDS (Acquired Immune Deficiency Syndrome). The number of new cases continues to rise at an alarming rate. Other infectious diseases, such as smallpox or poliomyelitis, have been controlled, or even eliminated, by vaccination programs. Many experts believe that an HIV vaccine offers the best hope for controlling the epidemic.
Many different possible HIV vaccines are currently being developed and tested.
The ADVAX vaccine which you will receive is one vaccine that has been tested. To date, one to three doses of the ADVAX vaccine have been given to 45 individuals in a study that took place between December 2003 and October 2005 at the Rockefeller University and the University of Rochester and it appears to be safe. The difference between this ADVAX study and the previous one is that you will only receive two doses of the vaccine or placebo by either standard intramuscular injection or by "electroporation."
This study is part of a broader research effort to see if changes in the way vaccines are given can make vaccines more effective.
The results of other studies suggest that using regular needles may not be the most potent way to inject this type of vaccine. This is why we are studying a new method of injection called electroporation.
Electroporation uses a device that injects substances into muscle along with small amounts of electricity. This device has been used to a limited extent in human subjects and has been shown to be more effective than regular needles and safe when tested in animals. Devices similar to this have been used in many studies to deliver chemotherapy directly into patients' tumors.
- Conditions
- HIV Infections
- Being tested
- TriGrid™ Delivery System, conventional intramuscular injection
- Keywords
- HIV vaccine, HIV, AIDS, prevention, HIV/AIDS, HIV Preventative Vaccine, HIV Seronegativity
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriGrid™ Delivery SystemDevice
Subjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device.
conventional intramuscular injectionDevice
administration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| intramuscular injection | Active comparator | administration of an HIV-1 vaccine by conventional intramuscular injection Receives: Device: conventional intramuscular injection |
| TriGrid Delivery System | Experimental | electroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc. Receives: Device: TriGrid™ Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2009
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation, Ichor Medical Systems Incorporated, International AIDS Vaccine Initiative
- Investigators
- David Ho, M.D., Principal investigator, The Aaron Diamond AIDS Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545987
- Sponsor's protocol ID
- DHO-0614
- Acronym
- ADVAX-EP
- Status last verified
- May 2011
- First submitted
- 16 Oct 2007
- Last updated
- 5 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21603651
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00545987
- Acronym / sponsor ID
- ADVAX-EP / DHO-0614
- Conditions
- HIV Infections
- Keywords
- HIV vaccine, HIV, AIDS, prevention, HIV/AIDS, HIV Preventative Vaccine, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Aaron Diamond AIDS Research Center, Bill and Melinda Gates Foundation, Ichor Medical Systems Incorporated, International AIDS Vaccine Initiative
- Study start
- Sep 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 18 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over 40 million people worldwide are currently infected with HIV, the virus that causes AIDS (Acquired Immune Deficiency Syndrome). The number of new cases continues to rise at an alarming rate. Other infectious diseases, such as smallpox or poliomyelitis, have been controlled, or even eliminated, by vaccination programs. Many experts believe that an HIV vaccine offers the best hope for controlling the epidemic.
Many different possible HIV vaccines are currently being developed and tested.
The ADVAX vaccine which you will receive is one vaccine that has been tested. To date, one to three doses of the ADVAX vaccine have been given to 45 individuals in a study that took place between December 2003 and October 2005 at the Rockefeller University and the University of Rochester and it appears to be safe. The difference between this ADVAX study and the previous one is that you will only receive two doses of the vaccine or placebo by either standard intramuscular injection or by "electroporation."
This study is part of a broader research effort to see if changes in the way vaccines are given can make vaccines more effective.
The results of other studies suggest that using regular needles may not be the most potent way to inject this type of vaccine. This is why we are studying a new method of injection called electroporation.
Electroporation uses a device that injects substances into muscle along with small amounts of electricity. This device has been used to a limited extent in human subjects and has been shown to be more effective than regular needles and safe when tested in animals. Devices similar to this have been used in many studies to deliver chemotherapy directly into patients' tumors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intramuscular injection | Active comparator | Device: conventional intramuscular injectionadministration of an HIV-1 vaccine by conventional intramuscular injection |
| TriGrid Delivery System | Experimental | Device: TriGrid™ Delivery Systemelectroporation-mediated intramuscular delivery using the TriGridTM device by Ichor Medical Systems, Inc. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Men and Women
- Ages 18 to 60
- Not considered to be at high risk to acquire HIV infection.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriGrid™ Delivery SystemSubjects will be administered the study drug using Ichor Medical Systems' intramuscular TriGrid™ delivery device. | Device | TriGrid Delivery System |
| conventional intramuscular injectionadministration of an HIV-1 vaccine encoding the gag, env, pol, nef, and tat antigens (ADVAX)by conventional intramuscular injection | Device | intramuscular injection |
Primary outcome
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
Time frame: wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56
1 secondary outcome
• 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.
Time frame: wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2011.
- Derived from this study: PubMed 21603651Vasan 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.
- The Aaron Diamond AIDS Research CenterLink provided by the sponsor.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ho, M.D. principal investigator
The Aaron Diamond AIDS Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TriGrid™ Delivery System and conventional intramuscular injection in people with HIV Infections, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: wk. 1,2, 4, 9, 10, 12, 16, 24, 36, 48 and 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2011.