HIV InfectionsPhase 1NCT00013572
HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults
A Phase 1 study testing ALVAC-HIV MN120TMG (vCP205) in people with HIV Infections and HIV Seronegativity, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- What is being tested?
- ALVAC-HIV MN120TMG (vCP205)
- How many people
- 36 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers may be eligible for this study if they:
- Are legal US residents.
- Are healthy adults from 18 to 55 years of age.
Who cannot join
- Volunteers will not be eligible for this study if they:
- Are HIV-positive.
- Are at highest risk for HIV infection.
- Are pregnant or breast-feeding.
- Are allergic to eggs or neomycin.
- Use certain prescription medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research (WRAIR)
Rockville, Maryland, 20850
About this study
Official title: A Phase I Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly
The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).
Read the detailed description
Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- ALVAC-HIV MN120TMG (vCP205)
- Keywords
- Injections, Intramuscular, Injections, Intradermal, Injections, Subcutaneous, HIV-1, AIDS Vaccines, Dendritic Cells, HIV Seronegativity, Genes, env, Genes, pol, Genes, gag, Transfection, 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.
ALVAC-HIV MN120TMG (vCP205)Biological
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
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Investigators
- Mary Marovich, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013572
- Sponsor's protocol ID
- B011
- Other IDs
- RV 138
- Status last verified
- Mar 2003
- First submitted
- 21 Mar 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Eller MA, Slike BM, Cox JH, Lesho E, Wang Z, Currier JR, Darden JM, Polonis VR, Vahey MT, Peel S, Robb ML, Michael NL, Marovich MA. A double-blind randomized phase I clinical trial targeting ALVAC-HIV vaccine to human dendritic cells. PLoS One. 2011;6(9):e24254. doi: 10.1371/journal.pone.0024254. Epub 2011 Sep 16.
PubMed 21949699
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 Study of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP205, HIV-1 Env/Gag/Pol) in Seronegative Adults Administered (1) Subcutaneously Via Ex Vivo Transfected, Autologous Dendritic Cells, (2) Intradermally, or (3) Intramuscularly
- ClinicalTrials.gov ID
- NCT00013572
- Acronym / sponsor ID
- B011
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- Injections, Intramuscular, Injections, Intradermal, Injections, Subcutaneous, HIV-1, AIDS Vaccines, Dendritic Cells, HIV Seronegativity, Genes, env
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- 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.
The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).
Detailed description
Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Are legal US residents.
- Are healthy adults from 18 to 55 years of age.
Key exclusion criteria (6 listed)
- Are HIV-positive.
- Are at highest risk for HIV infection.
- Are pregnant or breast-feeding.
- Are allergic to eggs or neomycin.
- Use certain prescription medications.
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 |
|---|---|---|
| ALVAC-HIV MN120TMG (vCP205) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Derived from this study: PubMed 21949699Eller MA, Slike BM, Cox JH, Lesho E, Wang Z, Currier JR, Darden JM, Polonis VR, Vahey MT, Peel S, Robb ML, Michael NL, Marovich MA. A double-blind randomized phase I clinical trial targeting ALVAC-HIV vaccine to human dendritic cells. PLoS One. 2011;6(9):e24254. doi: 10.1371/journal.pone.0024254. Epub 2011 Sep 16.
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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.
Mary Marovich principal investigator
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 ALVAC-HIV MN120TMG (vCP205) in people with HIV Infections and HIV Seronegativity, run by Walter Reed Army Institute of Research (WRAIR) 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 3 inclusion and 6 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: status not confirmed, 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?
Results are not available in the source record.
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 NCT00013572, 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.