HIV InfectionsPhase 1NCT00002231
Safety and Effects of Giving a New HIV Vaccine (GENEVAX-HIV) to HIV-Negative Volunteers
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 new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers. 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
- You may be eligible for this study if you:
- Are 18 - 60 years old.
- Are HIV-negative and in good health.
- Are able to understand how infections such as HIV are spread.
- Agree to use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have hepatitis B or C.
- Have any condition that may prevent you from completing the study.
- Are allergic to bupivacaine, vaccines, or certain local anesthetics.
- Have taken certain medications or have received certain therapies that may affect your immune system.
- Have an immune system disorder or have received therapy for an immune system disorder.
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- Have been exposed to HIV within 6 months prior to study entry.
- Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.
- Have received blood transfusions within 6 months prior to study entry.
- Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.
- Are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, 19104
About this study
Official title: GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers
The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.
Read the detailed description
In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- APL 400-003
- Keywords
- Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA
- 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
- None (open label)
Sponsor and investigators
- Lead sponsor
- Wyeth-Lederle Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- RR MacGregor, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002231
- Sponsor's protocol ID
- 004
- Other IDs
- 04/400-003-04
- Status last verified
- May 2000
- 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 Dose Escalation Study of GENEVAX-HIV Delivered Intramuscularly Using the Biojector 2000 in HIV Seronegative Volunteers
- ClinicalTrials.gov ID
- NCT00002231
- Acronym / sponsor ID
- 004
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- 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 new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.
Detailed description
In this open-label study, volunteers are given an intramuscular injection of GENEVAX-HIV vaccine using the Biojector 2000. Safety measures and immune response are assessed accordingly.
Study design
- Primary purpose
- Prevention
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Are 18 - 60 years old.
- Are HIV-negative and in good health.
- Are able to understand how infections such as HIV are spread.
- Agree to use effective methods of birth control during the study.
Key exclusion criteria (11 listed)
- Have hepatitis B or C.
- Have any condition that may prevent you from completing the study.
- Are allergic to bupivacaine, vaccines, or certain local anesthetics.
- Have taken certain medications or have received certain therapies that may affect your immune system.
- Have an immune system disorder or have received therapy for an immune system disorder.
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.
RR MacGregor 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 5 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 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.