HIV InfectionsPhase 1NCT00000630
Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
A Phase 1 study testing HIVAC-1e and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two HIV envelope… 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?
- HIVAC-1e and gp160 Vaccine (MicroGeneSys)
- Type of treatment
- Vaccines
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Dec 1992
- 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
- Volunteers must be healthy adults without high-risk behavior for HIV-1 infection and with history of smallpox vaccination more than 5 years prior to enrollment.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Identifiable high-risk behavior for HIV infection including active intravenous drug use and multiple sexual partners or sexual contact with high-risk partners within the past 6 months.
- Eczema, active or within the past year.
- Household contact with someone who is pregnant.
- Household contact with children less than 12 years old.
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- Household contact with anyone with eczema.
- Household contact with anyone with immunodeficiencies.
- Hypersensitivity to insects.
- Medical or psychiatric conditions that would make compliance unlikely.
- Evidence of depression.
- Patients with the following prior conditions are excluded:
- History of immunodeficiency or chronic illness or use of immunosuppressive medications.
- Blood or blood product transfusion within previous six months.
- Eczema, active or within the past year.
- Prior receipt of experimental HIV vaccine. [Specific other requirements are stated elsewhere in the record.]
- Prior Treatment:
- Excluded within 6 months prior to study entry:
- Blood or blood product transfusions.
- Risk Behavior:
- Excluded:
- Active intravenous drug use.
- Syphilis, gonorrhea, or any sexually transmitted diseases including chlamydia or pelvic inflammatory disease within the past 6 months.
- More than 2 sexual partners in the past 6 months or sexual contact with a high-risk partner.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, 37232
UW - Seattle AVEG
Seattle, Washington, 981050371
About this study
To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two HIV envelope vaccines utilized in the study.
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Read the detailed description
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Volunteers will be randomized to one of four groups. Group A (20 volunteers) will receive gp160 (VaxSyn) followed two months later by a repeat dose. Group B (20 volunteers) will receive VaxSyn followed two months later by HIVAC-1e. Group C (20 volunteers) will receive HIVAC-1e followed two months later by VaxSyn. Group D (10 volunteers) will receive HIVAC-1e followed two months later by HIVAC-1e. For volunteers in Groups A, B, and C who do not react to the initial vaccination, a second attempt to obtain a reaction may be made 7 or more days following the initial inoculation. Per addendum, two additional booster inoculations are given: one at 6 months or later post initial inoculation (Groups A, C, and D receive VaxSyn and Group B receives HIVAC-1e) and another at 12 months or later (all Groups receive VaxSyn).
- Conditions
- HIV Infections
- Being tested
- HIVAC-1e, gp160 Vaccine (MicroGeneSys)
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Envelope Proteins, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections, Vaccinia, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVAC-1eBiological
gp160 Vaccine (MicroGeneSys)Biological
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 completionDec 1992
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 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
- Allocation
- Randomised
- Enrolment
- 35 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Koff W, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000630
- Sponsor's protocol ID
- AVEG 002A
- Other IDs
- 10538
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 27 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
- ClinicalTrials.gov ID
- NCT00000630
- Acronym / sponsor ID
- AVEG 002A
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Envelope Proteins, Acquired Immunodeficiency Syndrome, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Dec 1992 (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 determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e) provides a significant advantage in immunogenicity (production of antibodies) compared to priming with a soluble recombinant protein (gp160); to learn more about the safety of the combination use of the two HIV envelope vaccines utilized in the study.
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Detailed description
Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines, HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include: Does combination vaccination result in a synergistic (added) response not predicted by just the addition of a second vaccination, and does this synergism depend on the unique priming effect of a vaccinia recombinant, or will any combination do?
Volunteers will be randomized to one of four groups. Group A (20 volunteers) will receive gp160 (VaxSyn) followed two months later by a repeat dose. Group B (20 volunteers) will receive VaxSyn followed two months later by HIVAC-1e. Group C (20 volunteers) will receive HIVAC-1e followed two months later by VaxSyn. Group D (10 volunteers) will receive HIVAC-1e followed two months later by HIVAC-1e. For volunteers in Groups A, B, and C who do not react to the initial vaccination, a second attempt to obtain a reaction may be made 7 or more days following the initial inoculation. Per addendum, two additional booster inoculations are given: one at 6 months or later post initial inoculation (Groups A, C, and D receive VaxSyn and Group B receives HIVAC-1e) and another at 12 months or later (all Groups receive VaxSyn).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers must be healthy adults without high-risk behavior for HIV-1 infection and with history of smallpox vaccination more than 5 years prior to enrollment.
Key exclusion criteria (24 listed)
- Identifiable high-risk behavior for HIV infection including active intravenous drug use and multiple sexual partners or sexual contact with high-risk partners within the past 6 months.
- Eczema, active or within the past year.
- Household contact with someone who is pregnant.
- Household contact with children less than 12 years old.
- Household contact with anyone with eczema.
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 |
|---|---|---|
| HIVAC-1e | Biological | – |
| gp160 Vaccine (MicroGeneSys) | 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 27 Oct 2021.
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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.
Koff W study chair
2 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 HIVAC-1e and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 1 inclusion and 24 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 27 Oct 2021.