HIV InfectionsPhase 1NCT00002204
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
A Phase 1 study testing HIV p24/MF59 Vaccine in people with HIV Infections and HIV Seronegativity, run by Chiron Corporation at 1 site in United States.
Trial summary
To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine. 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, HIV Seronegativity
- What is being tested?
- HIV p24/MF59 Vaccine
- Type of treatment
- Vaccines
- How many people
- 40 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must have:
- Good health as determined by medical history, physical examination, and clinical judgment.
- Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization.
- In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only).
Who cannot join
- Co-existing Condition:
- Volunteers with the following symptoms or conditions are excluded:
- Significant acute systemic infection.
- Occupational or other responsibilities that would prevent completion of participation in the study.
- Any condition that might interfere with the evaluation of the study objectives.
- Volunteers with the following prior conditions are excluded:
Show all 17Show fewer
- History of immunodeficiency, autoimmune disease, or any serious chronic illness.
- Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
- History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.
- 1. Immunosuppressive medications.
- Live, attenuated vaccine within 60 days of study entry.
- NOTE:
- Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions.
- Experimental agents within 30 days of study entry.
- HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months.
- Engaging in high-risk behavior within 6 months of study entry, i.e.:
- injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton Univ Med Ctr / Ped Infect Disease Div
Omaha, Nebraska, 68178
About this study
To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
Read the detailed description
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- HIV p24/MF59 Vaccine
- Keywords
- Reference Values, Placebos, AIDS Vaccines, HIV Core Protein p24, HIV Seronegativity, MF59 oil emulsion
- 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 p24/MF59 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.
- 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
- Intervention model
- Parallel groups
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Chiron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002204
- Sponsor's protocol ID
- 095
- Other IDs
- V24P1
- Status last verified
- Jun 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
- ClinicalTrials.gov ID
- NCT00002204
- Acronym / sponsor ID
- 095
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Reference Values, Placebos, AIDS Vaccines, HIV Core Protein p24, HIV Seronegativity, MF59 oil emulsion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Chiron CorporationIndustry (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 tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
Detailed description
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at 0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo. If no serious adverse events are observed within 1 week after the first injection in these first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine and 5 volunteers receive the placebo.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good health as determined by medical history, physical examination, and clinical judgment.
- Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization.
- In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only).
Key exclusion criteria (17 listed)
- Significant acute systemic infection.
- Occupational or other responsibilities that would prevent completion of participation in the study.
- Any condition that might interfere with the evaluation of the study objectives.
- History of immunodeficiency, autoimmune disease, or any serious chronic illness.
- Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
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 p24/MF59 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.
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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 p24/MF59 Vaccine in people with HIV Infections and HIV Seronegativity, run by Chiron Corporation 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 4 inclusion and 17 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?
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.