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(DHO-0614) Study of a Potential Preventive Vaccine Against HIV in Healthy Volunteers
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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
Principal Investigator:
David Ho M.D.
Investigators:
Jerry Zaharatos M.D.
Sandhya Vasan M.D.
Sarah Schlesinger M.D.
Arlene Hurley R.N.
Marina Caskey M.D.
Contact Information:
Principal Investigator:
David Ho M.D.
Investigators:
Jerry Zaharatos M.D.
Sandhya Vasan M.D.
Sarah Schlesinger M.D.
Arlene Hurley R.N.
Marina Caskey M.D.
Contact Information:
Danny Dugin
Aaron Diamond AIDS Research Center
455 First Avenue, 7th Floor
New York, NY 10016
Aaron Diamond AIDS Research Center
455 First Avenue, 7th Floor
New York, NY 10016
Enrollment Status:
Closed to Enrollment
Brief Summary of Protocol:
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 humans and has been shown to be more effective than regular needles and safe when tested in animals. 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 defenses against HIV.
In this study, we would like to learn about the effects that electroporation of the HIV DNA has on you and your immune system.
This study will enroll 40 volunteers who are: -HIV-negative -at lower risk of becoming infected with HIV -between 18-60 years of age -well informed about the study -able to provide written informed consent.
Detailed Description of Protocol:
Pre-screening:
• Before screening, you will have the opportunity to review information about the details of the study. You will have the opportunity to talk to the study doctors and nurses and ask them questions.
Screening:
• Screening will determine whether or not you are eligible for the study
If you agree to be screened:
-you will sign a copy of the Informed Consent Form confirming that you have been informed about the study and voluntarily agree to take part. You will be given a signed copy of this consent form and the original consent form will be kept in your confidential study file.
• You will be asked questions about your general health and your sexual behavior
• Pre-HIV test counseling will be provided
• About 1½ tablespoonfuls of blood will be drawn to test for HIV, Hepatitis B and C, Syphilis and other health conditions
• A urine sample will be collected for testing, including a pregnancy test for females of childbearing potential
• A device called an Accu-measure will be used to measure the skin-fold of your upper arm will be performed
• A short video explaining the electroporation device will be shown to you during this visit
• You will have an opportunity to see the electroporation injection device as part of the consent process
• The screening visit will take about 1 hour
Study Participation:
If you are found eligible through the screening process, you have the option of participating in the study.
• You will have another opportunity to talk to and ask questions of the study doctors and nurses.
The informed consent form will be reviewed with you again to ensure that you have been fully informed about the study.
The informed consent form will be reviewed with you again to ensure that you have been fully informed about the study.
You need to know that:
• Your participation is voluntary, that is, it is entirely up to you whether you choose to participate in this study or not
• Attending information seminars and undergoing pre-screening or screening tests do not compel you to join the vaccine study.
• If you decide not to participate, none of your legal rights will be affected
• You may withdraw your consent to participate at any time for any reason without penalty
• If you decide not to participate in this research study, there might be another HIV vaccine trial in the future. Currently there is no licensed HIV vaccine available.
If you decide to participate in the study:
• On the day of the study vaccination visit you will need to be at the clinic for approximately 1½ hours:
-A medical history will be taken
-A physical exam performed
-Blood and urine collected for testing prior to giving you the study vaccine.
You will receive a single vaccination at Day 0 and Week 8, which will be injected in the area of the upper arm, either by a standard needle and syringe, or by the electroporation device.
We will alternate the injections from the right to the left arm.
You will need to stay in the clinic for a minimum of 30 minutes after each vaccination.
After 30 minutes, if you are in the electroporation group, you will be asked to complete a questionnaire describing how the vaccination procedure felt.
• You will receive a telephone call between 2 and 4 days after each of the two vaccinations.
You will return to the outpatient clinic for a total of 11 scheduled visits for medical evaluations, spread over a period approximately 6 months. These follow-up visits will last about 30 to 45 minutes each.
Profile:
Healthy male and female subjects aged 18-60 who are not at high risk for acquiring infection with HIV-1 will be enrolled if they meet the following eligibility criteria:
High risk is defined by any of the following over the past 6 months:
• Unprotected vaginal or anal sex with a known HIV positive person or a casual partner (i.e. no continuing established relationship)
• Engaging in sex work for money or drugs
• Using injection drugs (illicit), or
• Acquiring a sexually transmitted disease in the past six months
What specifically makes a person eligible for the study?
You may be eligible to enter this study:
1. Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests.
2. Age of at least 18 years of age on the day of screening and no greater than 60 years at time of vaccination.
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 14 months)
4. Willing to undergo HIV testing and counseling, and receive HIV test results.
Gender:
Both
Age(s):
18 to 60
Children permitted to participate:
No
Potential Benefits.....
There are no direct benefits for you in taking part in the study except that you will get information about your general health and your HIV status, and you will receive HIV counseling.
However, the information that we gain from this study will help researchers learn more about HIV DNA vaccines and electroporation as a method of injection. This information could help in the development of a preventative vaccine for HIV which would benefit others.
Compensation:
Participants will receive $100 per visit to compensate for travel expenses, time lost from employment, child-care costs and other expenses they may have incurred while participating in this study.
They will receive a check for their participation after their 2 month, 4 month and 6 month clinic visit.
If a participant is unable to complete the entire study, he/she will be paid for the portion of the study that he/she completed.
Closed to Enrollment
Brief Summary of Protocol:
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 humans and has been shown to be more effective than regular needles and safe when tested in animals. 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 defenses against HIV.
In this study, we would like to learn about the effects that electroporation of the HIV DNA has on you and your immune system.
This study will enroll 40 volunteers who are: -HIV-negative -at lower risk of becoming infected with HIV -between 18-60 years of age -well informed about the study -able to provide written informed consent.
Detailed Description of Protocol:
Pre-screening:
• Before screening, you will have the opportunity to review information about the details of the study. You will have the opportunity to talk to the study doctors and nurses and ask them questions.
Screening:
• Screening will determine whether or not you are eligible for the study
If you agree to be screened:
-you will sign a copy of the Informed Consent Form confirming that you have been informed about the study and voluntarily agree to take part. You will be given a signed copy of this consent form and the original consent form will be kept in your confidential study file.
• You will be asked questions about your general health and your sexual behavior
• Pre-HIV test counseling will be provided
• About 1½ tablespoonfuls of blood will be drawn to test for HIV, Hepatitis B and C, Syphilis and other health conditions
• A urine sample will be collected for testing, including a pregnancy test for females of childbearing potential
• A device called an Accu-measure will be used to measure the skin-fold of your upper arm will be performed
• A short video explaining the electroporation device will be shown to you during this visit
• You will have an opportunity to see the electroporation injection device as part of the consent process
• The screening visit will take about 1 hour
Study Participation:
If you are found eligible through the screening process, you have the option of participating in the study.
• You will have another opportunity to talk to and ask questions of the study doctors and nurses.
The informed consent form will be reviewed with you again to ensure that you have been fully informed about the study.
The informed consent form will be reviewed with you again to ensure that you have been fully informed about the study.
You need to know that:
• Your participation is voluntary, that is, it is entirely up to you whether you choose to participate in this study or not
• Attending information seminars and undergoing pre-screening or screening tests do not compel you to join the vaccine study.
• If you decide not to participate, none of your legal rights will be affected
• You may withdraw your consent to participate at any time for any reason without penalty
• If you decide not to participate in this research study, there might be another HIV vaccine trial in the future. Currently there is no licensed HIV vaccine available.
If you decide to participate in the study:
• On the day of the study vaccination visit you will need to be at the clinic for approximately 1½ hours:
-A medical history will be taken
-A physical exam performed
-Blood and urine collected for testing prior to giving you the study vaccine.
You will receive a single vaccination at Day 0 and Week 8, which will be injected in the area of the upper arm, either by a standard needle and syringe, or by the electroporation device.
We will alternate the injections from the right to the left arm.
You will need to stay in the clinic for a minimum of 30 minutes after each vaccination.
After 30 minutes, if you are in the electroporation group, you will be asked to complete a questionnaire describing how the vaccination procedure felt.
• You will receive a telephone call between 2 and 4 days after each of the two vaccinations.
You will return to the outpatient clinic for a total of 11 scheduled visits for medical evaluations, spread over a period approximately 6 months. These follow-up visits will last about 30 to 45 minutes each.
Profile:
Healthy male and female subjects aged 18-60 who are not at high risk for acquiring infection with HIV-1 will be enrolled if they meet the following eligibility criteria:
High risk is defined by any of the following over the past 6 months:
• Unprotected vaginal or anal sex with a known HIV positive person or a casual partner (i.e. no continuing established relationship)
• Engaging in sex work for money or drugs
• Using injection drugs (illicit), or
• Acquiring a sexually transmitted disease in the past six months
What specifically makes a person eligible for the study?
You may be eligible to enter this study:
1. Healthy adult males and females, as assessed by a medical history, physical exam, and laboratory tests.
2. Age of at least 18 years of age on the day of screening and no greater than 60 years at time of vaccination.
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 14 months)
4. Willing to undergo HIV testing and counseling, and receive HIV test results.
Gender:
Both
Age(s):
18 to 60
Children permitted to participate:
No
Potential Benefits.....
There are no direct benefits for you in taking part in the study except that you will get information about your general health and your HIV status, and you will receive HIV counseling.
However, the information that we gain from this study will help researchers learn more about HIV DNA vaccines and electroporation as a method of injection. This information could help in the development of a preventative vaccine for HIV which would benefit others.
Compensation:
Participants will receive $100 per visit to compensate for travel expenses, time lost from employment, child-care costs and other expenses they may have incurred while participating in this study.
They will receive a check for their participation after their 2 month, 4 month and 6 month clinic visit.
If a participant is unable to complete the entire study, he/she will be paid for the portion of the study that he/she completed.
