HIV InfectionsPhase 1NCT00001026
A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals
A Phase 1 study testing gp160 Vaccine (Immuno-AG), rgp120/HIV-1IIIB and rgp120/HIV-1MN in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Primary: To determine whether combination vaccination, i.e., priming with a vaccinia recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to subunit vaccination with the individual recombinant… 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?
- gp160 Vaccine (Immuno-AG), rgp120/HIV-1IIIB and rgp120/HIV-1MN
- Type of treatment
- Vaccines
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Dec 1994
- 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
- Subjects must have:
- Normal history and physical exam.
- Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
- No history of smallpox (vaccinia) vaccination.
- Normal urinalysis.
- Absolute CD4 count = or > 500 cells/mm3.
Who cannot join
- Co-existing Condition:
- Subjects with the following conditions are excluded:
- Hepatitis B surface antigenemia.
- Medical or psychiatric condition that precludes compliance with the protocol.
- Subjects with the following prior conditions are excluded:
- History of immunodeficiency or chronic illness.
Show all 19Show fewer
- Eczema within the past year.
- Prior Medication:
- Excluded:
- Prior experimental HIV vaccine.
- Prior smallpox vaccine.
- Immunoglobulin administration within 2 months prior to enrollment.
- Any experimental agent within 2 months prior to enrollment.
- History of use of immunosuppressive medications.
- Prior Treatment:
- Excluded:
- Blood or blood product transfusion within the past 6 months.
- 1. Current high risk for HIV transmission (persons previously at high risk for HIV transmission can be enrolled provided they have a negative HIV screening and no high-risk behavior has been practiced within the last 6 months).
- Household contact with anyone who is pregnant, has eczema, is less than 12 months of age, or has immunodeficiency disease or is using immunosuppressive medications.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univ. of Rochester AVEG
Rochester, New York, 14642
UW - Seattle AVEG
Seattle, Washington, 98144
About this study
Primary: To determine whether combination vaccination, i.e., priming with a vaccinia recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to subunit vaccination with the individual recombinant envelope proteins only. To compare the relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost.
Secondary: To examine the safety of administering the individual subunit vaccines in combination with the HIV envelope vaccinia recombinant, and to extend the population to whom these proteins have been administered.
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.
Read the detailed description
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.
Healthy volunteers are randomized to one of eight groups. All patients receive initial immunization with HIVAC-1e, followed by two boosts at months 8 and 12 of rgp120/HIV-1SF2 (BIOCINE), rgp120/HIV-1IIIB (Genentech), rgp120/HIV-1MN (Genentech), or gp160 MN (Immuno-AG). Additionally, half of the patients in each subunit vaccine group receive a repriming with HIVAC-1e at month 4. Subjects are followed for 18 months.
- Conditions
- HIV Infections
- Being tested
- gp160 Vaccine (Immuno-AG), rgp120/HIV-1IIIB, rgp120/HIV-1MN, rgp120/HIV-1 SF-2, HIVAC-1e
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp160 Vaccine (Immuno-AG)Biological
rgp120/HIV-1IIIBBiological
rgp120/HIV-1MNBiological
rgp120/HIV-1 SF-2Biological
HIVAC-1eBiological
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 1994
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
- 56 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001026
- Sponsor's protocol ID
- AVEG 010
- Other IDs
- 10555
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Clements ML, Corey L, Weinhold K, Schwartz D, Siliciano R, Matthews T, Hsieh R, Graham B, Keefer M, Gorse G, Zolla-Pazner S, Mascola J, Duliege A, Excler J, Tartaglia J, Paoletti E, Hu SL. HIV immunity induced by priming with canarypox or vaccinia-gp160 recombinants and boosting with rgp120. Inst of Hum Virol Annu Meet. 1996 Sept 7-13
Corey L, McElrath MJ, Weinhold K, Matthews T, Stablein D, Graham B, Keefer M, Schwartz D, Gorse G. Cytotoxic T cell and neutralizing antibody responses to human immunodeficiency virus type 1 envelope with a combination vaccine regimen. AIDS Vaccine Evaluation Group. J Infect Dis. 1998 Feb;177(2):301-9. doi: 10.1086/514202.
PubMed 9466515
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines in Vaccinia-Naive Individuals
- ClinicalTrials.gov ID
- NCT00001026
- Acronym / sponsor ID
- AVEG 010
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Dec 1994 (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.
Primary: To determine whether combination vaccination, i.e., priming with a vaccinia recombinant-containing HIV envelope (HIVAC-1e) followed by boosting with a recombinant subunit envelope protein (gp160 or gp120), provides enhanced immunogenicity compared to subunit vaccination with the individual recombinant envelope proteins only. To compare the relative immunogenicity of a panel of HIV envelope subunit vaccines when administered as boosters following recombinant HIV-vaccinia priming. To evaluate the relative immunogenicity of one versus two doses of recombinant HIV-vaccinia prior to the subunit protein boost.
Secondary: To examine the safety of administering the individual subunit vaccines in combination with the HIV envelope vaccinia recombinant, and to extend the population to whom these proteins have been administered.
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.
Detailed description
Previous studies suggest that priming with an HIV-vaccinia recombinant followed by boosting with subunit envelope proteins offers the most promising strategy to date for a safe and immunogenic vaccine in humans. This study will further examine the combination vaccine approach and define an optimal prime-boost strategy.
Healthy volunteers are randomized to one of eight groups. All patients receive initial immunization with HIVAC-1e, followed by two boosts at months 8 and 12 of rgp120/HIV-1SF2 (BIOCINE), rgp120/HIV-1IIIB (Genentech), rgp120/HIV-1MN (Genentech), or gp160 MN (Immuno-AG). Additionally, half of the patients in each subunit vaccine group receive a repriming with HIVAC-1e at month 4. Subjects are followed for 18 months.
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 (6 listed)
- Normal history and physical exam.
- Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
- No history of smallpox (vaccinia) vaccination.
- Normal urinalysis.
- Absolute CD4 count = or > 500 cells/mm3.
Key exclusion criteria (19 listed)
- Hepatitis B surface antigenemia.
- Medical or psychiatric condition that precludes compliance with the protocol.
- History of immunodeficiency or chronic illness.
- Eczema within the past year.
- Prior experimental HIV vaccine.
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 |
|---|---|---|
| gp160 Vaccine (Immuno-AG) | Biological | – |
| rgp120/HIV-1IIIB | Biological | – |
| rgp120/HIV-1MN | Biological | – |
| rgp120/HIV-1 SF-2 | Biological | – |
| HIVAC-1e | 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 4 Nov 2021.
- BackgroundClements ML, Corey L, Weinhold K, Schwartz D, Siliciano R, Matthews T, Hsieh R, Graham B, Keefer M, Gorse G, Zolla-Pazner S, Mascola J, Duliege A, Excler J, Tartaglia J, Paoletti E, Hu SL. HIV immunity induced by priming with canarypox or vaccinia-gp160 recombinants and boosting with rgp120. Inst of Hum Virol Annu Meet. 1996 Sept 7-13
- Background: PubMed 9466515Corey L, McElrath MJ, Weinhold K, Matthews T, Stablein D, Graham B, Keefer M, Schwartz D, Gorse G. Cytotoxic T cell and neutralizing antibody responses to human immunodeficiency virus type 1 envelope with a combination vaccine regimen. AIDS Vaccine Evaluation Group. J Infect Dis. 1998 Feb;177(2):301-9. doi: 10.1086/514202.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 gp160 Vaccine (Immuno-AG), rgp120/HIV-1IIIB and rgp120/HIV-1MN 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 6 inclusion and 19 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 4 Nov 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?
On the ClinicalTrials.gov record for NCT00001026, 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 4 Nov 2021.