HIV InfectionsPhase 1NCT00002428
A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
A Phase 1 study testing HIV-1 Peptide Vaccine, Microparticulate Monovalent and rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine in people with HIV Infections, run by United Biomedical at 1 site in United States.
Trial summary
To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV-1 Peptide Vaccine, Microparticulate Monovalent and rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must have:
- Normal history and physical exam.
- HIV negativity.
- CD4 count >= 400 cells/mm3.
- Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
- Normal urine dipstick with esterase and nitrite.
Who cannot join
- Co-existing Condition:
- Volunteers with the following symptoms or conditions are excluded:
- Active tuberculosis.
- Occupational or other responsibilities that would prevent completion of study.
- Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
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- Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
- Acute gastroenteritis or gastrointestinal surgery within the past 12 months.
- Prior Medication:
- Excluded:
- Live or attenuated vaccine within the past 60 days.
- Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110
About this study
To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.
Read the detailed description
Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.
- Conditions
- HIV Infections
- Being tested
- HIV-1 Peptide Vaccine, Microparticulate Monovalent, rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
- Keywords
- Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity
- 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 Vaccine, Microparticulate MonovalentBiological
rgp120/HIV-1MN Monovalent Octameric V3 Peptide VaccineBiological
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 (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- United Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002428
- Sponsor's protocol ID
- 091
- Other IDs
- UBI V106
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Lambert JS, Keefer M, Mulligan MJ, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W. A Phase I safety and immunogenicity trial of UBI microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects. Vaccine. 2001 Apr 30;19(23-24):3033-42. doi: 10.1016/s0264-410x(01)00051-2.
PubMed 11311997
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
- ClinicalTrials.gov ID
- NCT00002428
- Acronym / sponsor ID
- 091
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- United BiomedicalIndustry (pharma, biotech, devices)
- 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 a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.
Detailed description
Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Normal history and physical exam.
- HIV negativity.
- CD4 count >= 400 cells/mm3.
- Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
- Normal urine dipstick with esterase and nitrite.
Key exclusion criteria (14 listed)
- Active tuberculosis.
- Occupational or other responsibilities that would prevent completion of study.
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
- History of anaphylaxis or other serious adverse reactions to vaccines.
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 Vaccine, Microparticulate Monovalent | Biological | – |
| rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine | 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 24 Jun 2005.
- Background: PubMed 11311997Lambert JS, Keefer M, Mulligan MJ, Schwartz D, Mestecky J, Weinhold K, Smith C, Hsieh R, Moldoveanu Z, Fast P, Forrest B, Koff W. A Phase I safety and immunogenicity trial of UBI microparticulate monovalent HIV-1 MN oral peptide immunogen with parenteral boost in HIV-1 seronegative human subjects. Vaccine. 2001 Apr 30;19(23-24):3033-42. doi: 10.1016/s0264-410x(01)00051-2.
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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.
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 Vaccine, Microparticulate Monovalent and rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine in people with HIV Infections, run by United Biomedical 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 6 inclusion and 14 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 24 Jun 2005. 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 NCT00002428, which also lists 1 linked publication.
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 24 Jun 2005.