HIV InfectionsPhase 1NCT00001053
A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
A Phase 1 study testing HIV p17/p24:Ty-VLP and Aluminum hydroxide in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be cross-reactive against multiple HIV-1 stains. 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?
- HIV p17/p24:Ty-VLP and Aluminum hydroxide
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 1996
- 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
- Concurrent Medication: Required:
- Omeprazole given concurrently in patients receiving the oral vaccine dose.
- Volunteers must have:
- HIV-1 negativity.
- Normal history and physical exam.
- Lower risk for HIV infection.
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- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
- NOTE:
- No more than 10 percent of volunteers may be over age 50.
Who cannot join
- Co-existing Condition:
- Volunteers with the following conditions are excluded:
- Positive for hepatitis B surface antigen.
- Medical or psychiatric condition (including recent suicidal ideation or present psychosis) that precludes compliance.
- Occupational responsibilities that preclude compliance.
- Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
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- Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
- Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy, autoimmune disease, or use of immunosuppressive medications.
- History of cancer unless surgically excised with reasonable assurance of cure.
- History of suicide attempts or past psychosis.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of serious allergic reaction requiring hospitalization or emergent medical care.
- Prior Medication:
- Excluded:
- Prior HIV-1 vaccines or placebo in an HIV vaccine trial.
- Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
- Experimental agents within the past 30 days.
- Prior Treatment: Excluded:
- Blood products or immunoglobulin within the past 6 months.
- Higher risk behavior for HIV infection as determined by screening questionnaire, including:
- History of injection drug use within the past year.
- Higher or intermediate risk sexual behavior.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the vaccine orally or rectally will help induce mucosal antibody responses.
Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1.
Read the detailed description
Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1.
Volunteers receive HIV p17/p24:Ty-VLP vaccine or placebo by IM injection (with or without alum adjuvant) at months 0, 2, and 6, and then either by mouth or rectal enema at months 10 and 11. Volunteers who receive oral vaccine boosting will receive concurrent omeprazole to decrease stomach acid.
- Conditions
- HIV Infections
- Being tested
- HIV p17/p24:Ty-VLP, Aluminum hydroxide
- Keywords
- Vaccines, Synthetic, Recombinant Proteins, HIV-1, AIDS Vaccines, HIV Core Protein p24, p24-VLP vaccine, Gene Products, gag, HIV Seronegativity, 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.
HIV p17/p24:Ty-VLPBiological
Aluminum hydroxideBiological
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 completionMar 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Spearman P, Study chairGraham B, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001053
- Sponsor's protocol ID
- AVEG 019
- Other IDs
- 10569
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Martin SJ, Weber J, Roitt I, Matear P, Jones K, Vyakarnam A. Recombinant HIV-1 gag p24-Ty virus-like particles (VLP's) induce HIV-1 p24-specific T helper cells in seronegative volunteers vaccinated with these particles. Int Conf AIDS. 1992 Jul 19-24;8(2):A35 (abstract no PoA 2194)
Weber J, Cheinsong-Popov R, Callow D, Adams S, Patou G, Hodgkin K, Martin S, Gotch F, Kingsman A. Immunogenicity of the yeast recombinant p17/p24:Ty virus-like particles (p24-VLP) in healthy volunteers. Vaccine. 1995 Jun;13(9):831-4. doi: 10.1016/0264-410x(94)00061-q.
PubMed 7483805Martin SJ, Vyakarnam A, Cheingsong-Popov R, Callow D, Jones KL, Senior JM, Adams SE, Kingsman AJ, Matear P, Gotch FM, et al. Immunization of human HIV-seronegative volunteers with recombinant p17/p24:Ty virus-like particles elicits HIV-1 p24-specific cellular and humoral immune responses. AIDS. 1993 Oct;7(10):1315-23.
PubMed 8267904
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 Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
- ClinicalTrials.gov ID
- NCT00001053
- Acronym / sponsor ID
- AVEG 019
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Recombinant Proteins, HIV-1, AIDS Vaccines, HIV Core Protein p24, p24-VLP vaccine, Gene Products, gag, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 1996 (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 and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum induces CD8+ cytotoxic T lymphocytes ( CTLs ) that may be cross-reactive against multiple HIV-1 stains. Also, to determine whether boosting with the vaccine orally or rectally will help induce mucosal antibody responses.
Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1.
Detailed description
Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desirable to induce mucosal immunity as well as systemic immunity. The HIV p17/p24:Ty-VLP vaccine may potentially induce both CTL and mucosal antibody responses against HIV-1.
Volunteers receive HIV p17/p24:Ty-VLP vaccine or placebo by IM injection (with or without alum adjuvant) at months 0, 2, and 6, and then either by mouth or rectal enema at months 10 and 11. Volunteers who receive oral vaccine boosting will receive concurrent omeprazole to decrease stomach acid.
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 (10 listed)
- Omeprazole given concurrently in patients receiving the oral vaccine dose.
- HIV-1 negativity.
- Normal history and physical exam.
- Lower risk for HIV infection.
- CD4 count >= 400 cells/mm3.
Key exclusion criteria (23 listed)
- Positive for hepatitis B surface antigen.
- Medical or psychiatric condition (including recent suicidal ideation or present psychosis) that precludes compliance.
- Occupational responsibilities that preclude compliance.
- Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
- Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
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 |
|---|---|---|
| HIV p17/p24:Ty-VLP | Biological | – |
| Aluminum hydroxide | 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.
- BackgroundMartin SJ, Weber J, Roitt I, Matear P, Jones K, Vyakarnam A. Recombinant HIV-1 gag p24-Ty virus-like particles (VLP's) induce HIV-1 p24-specific T helper cells in seronegative volunteers vaccinated with these particles. Int Conf AIDS. 1992 Jul 19-24;8(2):A35 (abstract no PoA 2194)
- Background: PubMed 7483805Weber J, Cheinsong-Popov R, Callow D, Adams S, Patou G, Hodgkin K, Martin S, Gotch F, Kingsman A. Immunogenicity of the yeast recombinant p17/p24:Ty virus-like particles (p24-VLP) in healthy volunteers. Vaccine. 1995 Jun;13(9):831-4. doi: 10.1016/0264-410x(94)00061-q.
- Background: PubMed 8267904Martin SJ, Vyakarnam A, Cheingsong-Popov R, Callow D, Jones KL, Senior JM, Adams SE, Kingsman AJ, Matear P, Gotch FM, et al. Immunization of human HIV-seronegative volunteers with recombinant p17/p24:Ty virus-like particles elicits HIV-1 p24-specific cellular and humoral immune responses. AIDS. 1993 Oct;7(10):1315-23.
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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.
Spearman P study chair
Graham B 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 HIV p17/p24:Ty-VLP and Aluminum hydroxide in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 10 inclusion and 23 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 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?
On the ClinicalTrials.gov record for NCT00001053, which also lists 3 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.