HIV InfectionsPhase 1NCT00623753
Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults
A Phase 1 study testing EnvDNA, PolyEnv1, EnvPro in people with HIV Infections, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the virus. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- EnvDNA, PolyEnv1, EnvPro
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2008
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults; age > 18 years, born after 1972 if born in U.S.
- Informed consent
- Normal history and physical exam
- HIV-1 negative as documented by ELISA and Western blot analysis within 30 days prior to immunization
- Normal laboratory values within 60 days prior to immunization defined as:
- hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males
Show all 23Show fewer
- White blood cell count > 3500 cells/mm3
- Platelet count 150,000 - 550,000 cells/mm3
- Absolute CD4+ count > 400 cells/mm3
- AST and ALT within normal institutional limits
- Serum creatinine within normal institutional limits
- Normal CPK-MB (creatine kinase isoenzyme MB) and troponin I within 30 days prior to immunization
- Normal ECG within 30 days prior to immunization
- No evidence of smallpox vaccination (born in the U.S. after 1972 with no typical scar on the deltoid, ankle, thigh or between the scapulae and no history of vaccination in personal immunization record)
- No entry into military service before 1990
- Fewer than 3 of the following:
- Current cigarette smoker
- History of high cholesterol
- History of diabetes or high blood sugar
- High blood pressure
- Heart disease before age 50 in parent or sibling
- Not planning to become pregnant during study vaccinations and for 3 months after last vaccination
- Vaccinia virus seronegative
Who cannot join
- History of immunosuppressive illness, chronic illness (e.g. asthma, bleeding diathesis, etc) or use of any immunosuppressive medications (e.g. steroids)
- History of neurological disorder
- Receiving therapy or prophylaxis for tuberculosis
- Known allergy to the antibiotic kanamycin
- History of eczema, atopic dermatitis and other acute, chronic or exfoliative conditions
- Household contact with persons with eczema or other exfoliative skin conditions
Show all 13Show fewer
- Pregnant or nursing women
- Household contact with persons with immunodeficiency (including eczema or use of immunosuppressive medications)
- Household contact with persons less than 12 months of age
- Household contact with pregnant women
- History of cardiac disease such as previous myocardial infarction, angina, congestive heart failure, or cardiomyopathy
- Any member of the Investigator's laboratory program
- Participation in previous HIV vaccine trial
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: Evaluate Tolerability and Safety of Multi-Envelope, Prime-boost HIV Vaccine (DVP) in Healthy Adults
Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the virus. Due to the success in treating other viral infections, scientists are trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral infections we know.
This is a research study to evaluate the safety of a possible vaccine against HIV. Researchers want to determine that a person's immune system can respond to the HIV before he or she is exposed to it. Therefore that person may be able to be protected from infection with HIV.
Read the detailed description
This is a research study to find out about the safety of a new potential vaccine regimen against HIV. This potential vaccine regimen consists of a sequence of six vaccine shots that are being studied to see if they can help to protect people from the human immunodeficiency virus (HIV). HIV infection is the cause of AIDS. AIDS is one of the most serious viral infections we know. Twenty million people around the world have already died of AIDS and over 40 million people are currently infected with the virus. This study is being done to help us find an HIV vaccine that works.
Vaccines have been very successful in preventing other viral infections, such as hepatitis B, polio, and measles. Viral vaccines work by causing a person's immune system to make antibodies and immune cells against the virus or to "respond" to the virus. Because of the success with other viral infections, scientists are trying to develop a successful vaccine for HIV. If a person's immune system can respond to HIV before he or she is exposed to it, that person may be able to be protected from infection with HIV.
The vaccine regimen that will be tested in this study is based on the information that the virus uses to make a small part of the HIV. This small part is called the "envelope" or coating around the virus. Because only the information for this one part of the virus is used in the vaccine, the vaccine cannot cause HIV infection. We make all parts of the vaccine regimen in test tubes.
- Conditions
- HIV Infections
- Being tested
- EnvDNA, PolyEnv1, EnvPro
- Keywords
- Vaccine, Prevention, HIV, AIDS, Human Immunodeficiency Virus, HIV Seronegativity, HIV Preventive Vaccine
- 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.
EnvDNA, PolyEnv1, EnvProBiological
Description: The vaccine regimen is a series of 6 injections given 28 days apart. EnvDNA is administered intramuscularly as 100 mcg of recombinant DNA in 1.5 mL of PBS as injections #1, 2 and 5. PolyEnv1 is recombinant vaccinia virus administered subcutaneously as 107 pfu in 0.8 mL of PBS as injection #3. EnvPro is administered intramuscularly as 100 mcg of recombinant protein and 500 mcg of aluminum hydroxide (alum) adjuvant in 1.0 mL of PBS as injections #4 and 6.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Biological: EnvDNA, PolyEnv1, EnvPro |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the tolerability and safety of the multi-envelope vaccine regimen.
Measured: 1 year
Secondary outcomes (1)
To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope vaccine regimen.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pat Flynn, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623753
- Sponsor's protocol ID
- DVP-I
- Status last verified
- Sep 2011
- First submitted
- 18 Feb 2008
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Tolerability and Safety of Multi-Envelope, Prime-boost HIV Vaccine (DVP) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00623753
- Acronym / sponsor ID
- DVP-I
- Conditions
- HIV Infections
- Keywords
- Vaccine, Prevention, HIV, AIDS, Human Immunodeficiency Virus, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 26 Feb 2008 (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.
Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the virus. Due to the success in treating other viral infections, scientists are trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral infections we know.
This is a research study to evaluate the safety of a possible vaccine against HIV. Researchers want to determine that a person's immune system can respond to the HIV before he or she is exposed to it. Therefore that person may be able to be protected from infection with HIV.
Detailed description
This is a research study to find out about the safety of a new potential vaccine regimen against HIV. This potential vaccine regimen consists of a sequence of six vaccine shots that are being studied to see if they can help to protect people from the human immunodeficiency virus (HIV). HIV infection is the cause of AIDS. AIDS is one of the most serious viral infections we know. Twenty million people around the world have already died of AIDS and over 40 million people are currently infected with the virus. This study is being done to help us find an HIV vaccine that works.
Vaccines have been very successful in preventing other viral infections, such as hepatitis B, polio, and measles. Viral vaccines work by causing a person's immune system to make antibodies and immune cells against the virus or to "respond" to the virus. Because of the success with other viral infections, scientists are trying to develop a successful vaccine for HIV. If a person's immune system can respond to HIV before he or she is exposed to it, that person may be able to be protected from infection with HIV.
The vaccine regimen that will be tested in this study is based on the information that the virus uses to make a small part of the HIV. This small part is called the "envelope" or coating around the virus. Because only the information for this one part of the virus is used in the vaccine, the vaccine cannot cause HIV infection. We make all parts of the vaccine regimen in test tubes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: EnvDNA, PolyEnv1, EnvPro |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Healthy adults; age > 18 years, born after 1972 if born in U.S.
- Informed consent
- Normal history and physical exam
- HIV-1 negative as documented by ELISA and Western blot analysis within 30 days prior to immunization
- Normal laboratory values within 60 days prior to immunization defined as:
Key exclusion criteria (13 listed)
- History of immunosuppressive illness, chronic illness (e.g. asthma, bleeding diathesis, etc) or use of any immunosuppressive medications (e.g. steroids)
- History of neurological disorder
- Receiving therapy or prophylaxis for tuberculosis
- Known allergy to the antibiotic kanamycin
- History of eczema, atopic dermatitis and other acute, chronic or exfoliative conditions
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 |
|---|---|---|
| EnvDNA, PolyEnv1, EnvProDescription: The vaccine regimen is a series of 6 injections given 28 days apart. EnvDNA is administered intramuscularly as 100 mcg of recombinant DNA in 1.5 mL of PBS as injections #1, 2 and 5. PolyEnv1 is recombinant vaccinia virus administered subcutaneously as 107 pfu in 0.8 mL of PBS as injection #3. EnvPro is administered intramuscularly as 100 mcg of recombinant protein and 500 mcg of aluminum hydroxide (alum) adjuvant in 1.0 mL of PBS as injections #4 and 6. | Biological | A |
Primary outcome
To evaluate the tolerability and safety of the multi-envelope vaccine regimen.
Time frame: 1 year
1 secondary outcome
To characterize the kinetics, duration and magnitude of the HIV-envelope specific immune responses elicited by the multi-envelope vaccine regimen.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- St. Jude Children's Research HospitalLink provided by the sponsor.
Related trials for HIV Infections
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
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
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
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.
Pat Flynn, MD principal investigator
St. Jude Children's Research Hospital
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 EnvDNA, PolyEnv1, EnvPro in people with HIV Infections, run by St. Jude Children's Research Hospital 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 23 inclusion and 13 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: stopped early, as of the sponsor's last update on 26 Apr 2017. 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 was stopped early. Results are not available in the source record.
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 tolerability and safety of the multi-envelope vaccine regimen. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.