HIV InfectionsPhase 1NCT00001088
A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers
A Phase 1 study testing APL 400-047 and Bupivacaine hydrochloride in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. 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
- What is being tested?
- APL 400-047 and Bupivacaine hydrochloride
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 1997to Feb 2001
- 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:
- Negative ELISA for HIV within 8 weeks of immunization.
- CD4 count >= 400 cells/mm3.
- Normal history and physical examination.
- Negative for Hepatitis B surface antigen.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Positive for anti-dsDNA antibodies.
- Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
- Present psychosis.
- Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., > 6 months treated, infection).
Show all 31Show fewer
- Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).
- Concurrent Medication:
- Excluded:
- Immunosuppressive medications.
- Patients with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or autoimmune disease.
- History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
- History of suicide attempts, recent suicidal ideation or past psychosis.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of severe allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Hypersensitivity to bupivacaine or other amide-type anesthetics.
- Prior Medication:
- Excluded:
- Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
- Use of experimental agents within 30 days prior to study.
- Live attenuated vaccines within 60 days of study.
- Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) within 2 weeks prior to study.
- Prior Treatment:
- Excluded:
- Receipt of blood products or immunoglobulin in the past 6 months.
- Risk Behavior:
- Excluded:
- Volunteers having identifiable higher risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection, specifically:
- History of injection drug use within the last 12 months prior to enrollment.
- Higher or intermediate risk sexual behavior as defined by the AVEG (i.e., meeting the criteria for AVEG Risk Group C or D).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Vanderbilt Univ Hosp
Nashville, Tennessee, 37232
Univ of Rochester Med Ctr
Rochester, New York, 14642
Univ of Washington / Pacific Med Ctr
Seattle, Washington, 98144
About this study
To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. [AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and immunogenicity of an increased dose in an additional group of volunteers.] DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.
Read the detailed description
DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.
A total of 40 volunteers receive four immunizations each (at months 0, 1, 2 and 6) as follows:
10 volunteers are enrolled at the 100 microgram dose given intramuscularly (IM) by needle and syringe. If this dose appears safe and well tolerated through Day 14, 20 more volunteers are enrolled at the 300 microgram dose; 10 receiving vaccine administered by needle and syringe, 10 receiving vaccine administered by Biojector. If the 300 microgram dose appears safe and well tolerated through Day 14 in the 10 volunteers who receive intramuscular (IM) injections with needle and syringe, an additional group of volunteers are enrolled at the 1000 microgram dose given with needle and syringe. NOTE: Within each group of 10 volunteers, 8 receive APL-400-047, 2 receive control preparation (bupivacaine carrier alone). [AS PER AMENDMENT 07/98: An additional group of 12 volunteers will be treated at a dose of 3000 micrograms administered by needle and syringe. Ten of these volunteers will receive APL-400-047 formulated with bupivacaine as a facilitating agent; the remaining 2 patients will receive control preparation (bupivacaine carrier alone).] [AS PER AMENDMENT 4/27/99: Volunteers previously primed with either 300 or 1000 micrograms of the APL-400-047 vaccine receive an additional dose of DNA (or control, for control volunteers in the original protocol) followed one month later by two monthly canarypox (or placebo for control volunteers in the original protocol) boosts.]
- Conditions
- HIV Infections
- Being tested
- APL 400-047, Bupivacaine hydrochloride
- Keywords
- Injections, Intramuscular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Fusion Proteins, gag-pol, Vaccines, DNA, HIV Preventive Vaccine
- 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 400-047Biological
Bupivacaine hydrochlorideDrug
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)
- Study startJul 1997
- Primary completionFeb 2001
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Mulligan M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001088
- Sponsor's protocol ID
- AVEG 031
- Status last verified
- Sep 2008
- First submitted
- 2 Nov 1999
- Last updated
- 29 Sep 2008
- Results posted
- No
Publications
Goepfert P, Mulligan M, Corey L, Graham B, Evans T, Weinhold K, Stablein D, Ginsberg R. AVEG 031: phase I evaluation of a gag-pol facilitated DNA vaccine for HIV-1 prevention. Int Conf AIDS. 1998;12:635 (abstract no 33216)
Tellez I, Sabbaj S, Bansal A, Goepfert P, Evans T, Graham B, Ginsberg R, Weiner D, Corey L, Weinhold K, Mulligan M. HIV-specific T-cell responses in seronegative volunteers immunized with an HIV-1 gag-pol DNA vaccine. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 (abstract no 656)
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers
- ClinicalTrials.gov ID
- NCT00001088
- Acronym / sponsor ID
- AVEG 031
- Conditions
- HIV Infections
- Keywords
- Injections, Intramuscular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Fusion Proteins, gag-pol, Vaccines, DNA, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 1997
- Primary completion
- Feb 2001 (actual)
- Study completion
- Feb 2001 (actual)
- 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.
To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. [AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and immunogenicity of an increased dose in an additional group of volunteers.] DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.
Detailed description
DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.
A total of 40 volunteers receive four immunizations each (at months 0, 1, 2 and 6) as follows:
10 volunteers are enrolled at the 100 microgram dose given intramuscularly (IM) by needle and syringe. If this dose appears safe and well tolerated through Day 14, 20 more volunteers are enrolled at the 300 microgram dose; 10 receiving vaccine administered by needle and syringe, 10 receiving vaccine administered by Biojector. If the 300 microgram dose appears safe and well tolerated through Day 14 in the 10 volunteers who receive intramuscular (IM) injections with needle and syringe, an additional group of volunteers are enrolled at the 1000 microgram dose given with needle and syringe. NOTE: Within each group of 10 volunteers, 8 receive APL-400-047, 2 receive control preparation (bupivacaine carrier alone). [AS PER AMENDMENT 07/98: An additional group of 12 volunteers will be treated at a dose of 3000 micrograms administered by needle and syringe. Ten of these volunteers will receive APL-400-047 formulated with bupivacaine as a facilitating agent; the remaining 2 patients will receive control preparation (bupivacaine carrier alone).] [AS PER AMENDMENT 4/27/99: Volunteers previously primed with either 300 or 1000 micrograms of the APL-400-047 vaccine receive an additional dose of DNA (or control, for control volunteers in the original protocol) followed one month later by two monthly canarypox (or placebo for control volunteers in the original protocol) boosts.]
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 (5 listed)
- Negative ELISA for HIV within 8 weeks of immunization.
- CD4 count >= 400 cells/mm3.
- Normal history and physical examination.
- Negative for Hepatitis B surface antigen.
Key exclusion criteria (31 listed)
- Positive for anti-dsDNA antibodies.
- Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
- Present psychosis.
- Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., > 6 months treated, infection).
- Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).
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 400-047 | Biological | – |
| Bupivacaine hydrochloride | Drug | – |
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 29 Sep 2008.
- BackgroundGoepfert P, Mulligan M, Corey L, Graham B, Evans T, Weinhold K, Stablein D, Ginsberg R. AVEG 031: phase I evaluation of a gag-pol facilitated DNA vaccine for HIV-1 prevention. Int Conf AIDS. 1998;12:635 (abstract no 33216)
- BackgroundTellez I, Sabbaj S, Bansal A, Goepfert P, Evans T, Graham B, Ginsberg R, Weiner D, Corey L, Weinhold K, Mulligan M. HIV-specific T-cell responses in seronegative volunteers immunized with an HIV-1 gag-pol DNA vaccine. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 (abstract no 656)
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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.
Mulligan M study chair
4 sites 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 400-047 and Bupivacaine hydrochloride in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites 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 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
On the ClinicalTrials.gov record for NCT00001088, which also lists 2 linked publications.
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 29 Sep 2008.