HIV InfectionsPhase 1NCT00000795
A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
A Phase 1 study testing HIV-1 Peptide Immunogen, Multivalent 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, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1 peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates. 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-1 Peptide Immunogen, Multivalent
- How many people
- 28 participants
- 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
- Subjects must have:
- Normal history and physical exam.
- HIV negativity by ELISA within 8 weeks of immunization.
- CD4 count >= 400 cells/mm3.
- Normal urinalysis.
Who cannot join
- Co-existing Condition:
- Subjects with the following symptoms or conditions are excluded:
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition or occupational responsibilities that preclude study compliance.
- Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
Show all 21Show fewer
- Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or autoimmune disease.
- History of anaphylaxis or other serious reactions to vaccines.
- Prior Medication:
- Excluded:
- History of immunosuppressive medications.
- Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization).
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
- Prior Treatment:
- Excluded:
- Blood products or immunoglobulin within the past 6 months.
- Identifiable higher risk behavior for HIV infection, including the following:
- History of injection drug use within the past 12 months.
- Higher risk sexual behavior as defined by the AVEG.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Univ / Ctr for Immunological Research
Baltimore, Maryland, 21205
About this study
To evaluate, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1 peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates.
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.
Read the detailed description
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.
Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine. At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and patients are followed for a minimum of 48 weeks after the initial immunization. Approximately 13 clinical visits are required.
- Conditions
- HIV Infections
- Being tested
- HIV-1 Peptide Immunogen, Multivalent
- Keywords
- Vaccines, Synthetic, HIV-1, AIDS Vaccines, 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-1 Peptide Immunogen, MultivalentBiological
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.
- 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
- 28 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Keefer M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000795
- Sponsor's protocol ID
- AVEG 017
- Status last verified
- Oct 2002
- First submitted
- 2 Nov 1999
- Last updated
- 9 Sep 2008
- Results posted
- No
Publications
Kelleher AD, Emery S, Cunningham P, Duncombe C, Carr A, Golding H, Forde S, Hudson J, Roggensack M, Forrest BD, Cooper DA. Safety and immunogenicity of UBI HIV-1MN octameric V3 peptide vaccine administered by subcutaneous injection. AIDS Res Hum Retroviruses. 1997 Jan 1;13(1):29-32. doi: 10.1089/aid.1997.13.29.
PubMed 8989424Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50. doi: 10.1046/j.1365-2249.1998.00486.x.
PubMed 9486388Kahn J, Murcar N, Elbeik T, Staprans S, Hanson C, Mayer Y, Doyle R, Gonzalez L, Koff W. UBI HIV-1MN octameric V3 peptide vaccine in HIV-1 negative humans. Conf Adv AIDS Vaccine Dev. 1996 Feb 11-15:167 [Poster 47]
Study at a glance
From the registry record, last updated by the sponsor on 9 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 UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
- ClinicalTrials.gov ID
- NCT00000795
- Acronym / sponsor ID
- AVEG 017
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, HIV-1, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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, in healthy adult volunteers, the safety and immunogenicity of multivalent HIV-1 peptide immunogen, a formulation of HIV-1 gp120 principal neutralizing domain (PND) branched synthetic peptides from 15 viral strains representative of diverse worldwide isolates.
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.
Detailed description
Because there is considerable variation among HIV-1 virus strains from differing geographical locations worldwide, a multivalent peptide vaccine has been constructed to include prevalent and divergent isolates, potentially providing for wide coverage of geographically isolated epidemics.
Fourteen volunteers are entered at one of two dose levels of multivalent candidate vaccine. At each dose level, 12 volunteers receive vaccine and two receive placebo. At least eight volunteers at the low dose level must be monitored for 2 weeks before subsequent volunteers are entered at the high dose. Intramuscular injections are given on days 0, 28, and 168, and patients are followed for a minimum of 48 weeks after the initial immunization. Approximately 13 clinical visits are required.
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)
- Normal history and physical exam.
- HIV negativity by ELISA within 8 weeks of immunization.
- CD4 count >= 400 cells/mm3.
- Normal urinalysis.
Key exclusion criteria (21 listed)
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition or occupational responsibilities that preclude study compliance.
- Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- History of immunodeficiency, chronic illness, or autoimmune disease.
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-1 Peptide Immunogen, Multivalent | 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 9 Sep 2008.
- Background: PubMed 8989424Kelleher AD, Emery S, Cunningham P, Duncombe C, Carr A, Golding H, Forde S, Hudson J, Roggensack M, Forrest BD, Cooper DA. Safety and immunogenicity of UBI HIV-1MN octameric V3 peptide vaccine administered by subcutaneous injection. AIDS Res Hum Retroviruses. 1997 Jan 1;13(1):29-32. doi: 10.1089/aid.1997.13.29.
- Background: PubMed 9486388Evans TG, Fitzgerald T, Gibbons DC, Keefer MC, Soucier H. Th1/Th2 cytokine responses following HIV-1 immunization in seronegative volunteers. The AIDS Vaccine Evaluation Group. Clin Exp Immunol. 1998 Feb;111(2):243-50. doi: 10.1046/j.1365-2249.1998.00486.x.
- BackgroundKahn J, Murcar N, Elbeik T, Staprans S, Hanson C, Mayer Y, Doyle R, Gonzalez L, Koff W. UBI HIV-1MN octameric V3 peptide vaccine in HIV-1 negative humans. Conf Adv AIDS Vaccine Dev. 1996 Feb 11-15:167 [Poster 47]
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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.
Keefer M 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-1 Peptide Immunogen, Multivalent 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 5 inclusion and 21 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 9 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 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 NCT00000795, 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 9 Sep 2008.