Human Immunodeficiency VirusPhase 1NCT00187148
Evaluate Tolerability of a Recombinant DNA HIV-1 Vaccine in Healthy Adults
A Phase 1 study testing EnvDNA in people with Human Immunodeficiency Virus and HIV Infections, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to date. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, HIV Infections
- What is being tested?
- EnvDNA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Nov 2009
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults; age greater than 18 years, less than or equal to 40 years
- HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization
- Normal history and physical exam
- Normal complete blood count and differential obtained within 60 days prior to immunization, and 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
- white blood cell count greater than or equal to 3500 cells/mm3
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- platelet count between 150,000 and 550,000 cells/mm3
- CD4+ T cell count greater than or equal to 400 cells/mm3 (if a single CD4+ T cell count <400 cells/mm3 is obtained, a repeat count will be performed and immunization will proceed if the repeat count is greater than or equal to 400 cells/mm3)
- Anti-nuclear antibody titer <1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization
- Negative for Hepatitis B surface antigen and Hepatitis C
- AST and ALT within normal institutional limits obtained within 60 days prior to immunization
- Serum creatinine, Na+, K+ and Cl- within normal institutional limits, obtained within 60 days prior to immunization
- Serum creatine phosphokinase (CPK) within normal institutional limits obtained within 60 days prior to immunization
- Not planning to become pregnant during study vaccinations and for three months after last vaccination
- Availability for at least one year of follow-up
Who cannot join
- History of immunosuppressive illness, chronic illness (e.g. asthma, diabetes, hypertension, bleeding diathesis, etc), or
- Receiving therapy or prophylaxis for tuberculosis
- Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis
- Live attenuated vaccines within 60 days of study enrollment (Note: subunit or killed vaccines [e.g. influenza or pneumococcal] are not exclusionary, but should be given at least 2 weeks before or after HIV immunization)
- Use of experimental agents within 30 days prior to study enrollment
- Receipt of blood products or immunoglobulin in the past 6 months
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- Subjects with known allergy to the antibiotic kanamycin
- Pregnancy at the time of vaccination (urine pregnancy test)
- Nursing mother at the time of vaccination
- 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: Evaluation of the Tolerability and Safety of a Recombinant HIV-1 Multi-Envelope DNA Plasmid Vaccine (EnvDNA) in Healthy Adults
This protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to date. The vaccine that will be tested in this study was made from 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. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
Read the detailed description
This is a research (investigational) study to find out about the safety of a new potential vaccine for HIV. This potential vaccine may eventually become a part of a sequence of three experimental vaccines that will be studied to see if they can help to protect people from HIV. HIV infection is the cause of AIDS (Acquired Immune Deficiency Syndrome). AIDS is one of the most serious viral infections we know. This study is being done to help us find an HIV vaccine that works.
The vaccine that will be tested in this study was made from 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 the vaccine in a test tube. The vaccine is made up of DNA. DNA is like an instruction manual that cells use to make basic building blocks called proteins. This DNA has the information that cells will use to make the envelope coat of HIV. Once the DNA is injected intramuscularly, it should tell cells to make the envelope protein. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
- Conditions
- Human Immunodeficiency Virus, HIV Infections
- Being tested
- EnvDNA
- Keywords
- Vaccine, Prevention, HIV, AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvDNABiological
administered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Biological: EnvDNA |
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 EnvDNA vaccine
Measured: 1 year
Secondary outcomes (1)
To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA
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 posted16 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Pat Flynn, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187148
- Sponsor's protocol ID
- EnvDNA
- Other IDs
- IND11130
- Status last verified
- Jun 2011
- First submitted
- 12 Sep 2005
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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
- Evaluation of the Tolerability and Safety of a Recombinant HIV-1 Multi-Envelope DNA Plasmid Vaccine (EnvDNA) in Healthy Adults
- ClinicalTrials.gov ID
- NCT00187148
- Acronym / sponsor ID
- EnvDNA
- Conditions
- Human Immunodeficiency Virus, HIV Infections
- Keywords
- Vaccine, Prevention, HIV, AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Sep 2005 (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 protocol will evaluate the safety and tolerability of the vaccine EnvDNA in healthy adults. DNA-based vaccines are being studied for the prevention of human immunodeficiency virus (HIV), malaria and hepatitis. DNA vaccines have been well tolerated in human studies to date. The vaccine that will be tested in this study was made from 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. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
Detailed description
This is a research (investigational) study to find out about the safety of a new potential vaccine for HIV. This potential vaccine may eventually become a part of a sequence of three experimental vaccines that will be studied to see if they can help to protect people from HIV. HIV infection is the cause of AIDS (Acquired Immune Deficiency Syndrome). AIDS is one of the most serious viral infections we know. This study is being done to help us find an HIV vaccine that works.
The vaccine that will be tested in this study was made from 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 the vaccine in a test tube. The vaccine is made up of DNA. DNA is like an instruction manual that cells use to make basic building blocks called proteins. This DNA has the information that cells will use to make the envelope coat of HIV. Once the DNA is injected intramuscularly, it should tell cells to make the envelope protein. We hope the body will make an immune response against the HIV envelope coat. Our potential HIV DNA envelope vaccine is called EnvDNA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: EnvDNA |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy adults; age greater than 18 years, less than or equal to 40 years
- HIV-1 negative as documented by negative ELISA and negative Western blot analysis within 30 days prior to immunization
- Normal history and physical exam
- Normal complete blood count and differential obtained within 60 days prior to immunization, and defined as:
- Anti-nuclear antibody titer <1:80 (by IFA) and negative anti-DNA antibody within 60 days prior to immunization
Key exclusion criteria (11 listed)
- History of immunosuppressive illness, chronic illness (e.g. asthma, diabetes, hypertension, bleeding diathesis, etc), or
- Receiving therapy or prophylaxis for tuberculosis
- Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol. Specifically excluded are persons with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis
- Live attenuated vaccines within 60 days of study enrollment (Note: subunit or killed vaccines [e.g. influenza or pneumococcal] are not exclusionary, but should be given at least 2 weeks before or after HIV immunization)
- Use of experimental agents within 30 days prior to study enrollment
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 |
|---|---|---|
| EnvDNAadministered as 100 mcg of DNA in 1.5mL PBS every 28 days for 3 injections | Biological | 1 |
Primary outcome
To evaluate the tolerability and safety of the EnvDNA vaccine
Time frame: 1 year
1 secondary outcome
To characterize the kinetics, duration and magnitude of any HIV-envelope specific immune response elicited by EnvDNA
Time frame: 1 year
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 26 Apr 2017.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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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 in people with Human Immunodeficiency Virus and 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 15 inclusion and 11 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 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 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 tolerability and safety of the EnvDNA vaccine (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.