HIV InfectionsPhase 1NCT00002232
A Study of GENEVAX-HIV, a Possible Vaccine
A Phase 1 study testing APL 400-003 in people with HIV Infections and HIV Seronegativity, run by Wyeth-Lederle Vaccines at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin. 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, HIV Seronegativity
- What is being tested?
- APL 400-003
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Patients must have:
- Good health.
- Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections.
- The following parameters within normal range:
- Hematopoietic:
- total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit.
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- Renal:
- BUN and creatinine, urinalysis.
- Hepatic:
- total serum bilirubin.
- Endocrine/Metabolic:
- Serum calcium, serum glucose, total serum CPK.
- Immunologic:
- total serum immunoglobulin and absolute CD4 count.
- Hepatitis B and Hepatitis C negative.
- Urinalysis:
- Normal screen with dipstick for esterase and nitrite.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- HIV-seropositive status.
- Any positive result for anti-DNA antibodies considered of potential clinical significance as measured by anti-DNA antibody and/or anti-nuclear antibody (ANA) assays.
- Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results.
- Known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines.
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- Concurrent Medication:
- Excluded:
- Any medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma.
- Patients with the following prior conditions are excluded:
- HIV-seropositive.
- Known or suspected history of impairment or abnormality in immune functioning.
- Exposure to potentially-infective HIV fluids within the prior 6 months or tested positive for HIV at any time.
- History of any prior disease or therapy which would affect immune function including:
- Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma in situ of the cervix.
- Immunodeficiency or autoimmune disease.
- Acute infection or a recent (within 6 months) history of chronic infection.
- History of serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapy that may affect immune function.
- Prior Treatment:
- Excluded:
- Previous immunization with any experimental vaccines directed against HIV or receipt of any experimental agent within 30 days prior to enrollment.
- Receipt of any blood products or immunoglobulin within 6 months prior to enrollment.
- Exposure to live attenuated vaccines within 60 days of study.
- Radiotherapy that may affect immune function.
- Risk Behavior:
- Excluded:
- Active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation.
- Higher- or intermediate-risk sexual behavior (AVEG criteria)
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Washington D.C., District of Columbia, 20307
About this study
Official title: GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Study of GENEVAX-HIV Given by Intramuscular or Intradermal Administration in HIV Seronegative Volunteers
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin.
Read the detailed description
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- APL 400-003
- Keywords
- Injections, Intradermal, Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA, Immunity, Mucosal
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APL 400-003Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
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.
- 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Wyeth-Lederle Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Merlin Robb, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002232
- Sponsor's protocol ID
- 005
- Other IDs
- 400-003-05
- Status last verified
- Jun 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Study of GENEVAX-HIV Given by Intramuscular or Intradermal Administration in HIV Seronegative Volunteers
- ClinicalTrials.gov ID
- NCT00002232
- Acronym / sponsor ID
- 005
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Injections, Intradermal, Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wyeth-Lederle VaccinesIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin.
Detailed description
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Good health.
- Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections.
- The following parameters within normal range:
- Hematopoietic:
- total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit.
Key exclusion criteria (31 listed)
- HIV-seropositive status.
- Any positive result for anti-DNA antibodies considered of potential clinical significance as measured by anti-DNA antibody and/or anti-nuclear antibody (ANA) assays.
- Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results.
- Known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines.
- Any medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma.
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 |
|---|---|---|
| APL 400-003 | Biological | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
Merlin Robb study chair
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 APL 400-003 in people with HIV Infections and HIV Seronegativity, run by Wyeth-Lederle Vaccines 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 17 inclusion and 31 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 24 Jun 2005. 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.
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 24 Jun 2005.