HIV InfectionsPhase 1NCT00121121
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers
A Phase 1 study testing Lipopeptides LIPO-4 in people with HIV Infections and HIV Seronegativity, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1… 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?
- Lipopeptides LIPO-4
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2004to Dec 2005
- 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
- HIV uninfected
- Acceptable methods of contraception for females of reproductive potential
- Good general health
- Signed written inform consent
Who cannot join
- Risk to be infected by HIV virus
- Uveitis, chronic lyme disease, active syphilis, active mycobacterial diseases or sarcoidosis
- Autoimmune disease or immunodeficiency
- Medical history of food allergy, Lyell's or Steven Johnson's disease, unstable asthma
- Active, generalized eczema or chronic urticaria
- Blood products within 2 months prior to first study vaccine administration
Show all 12Show fewer
- HIV vaccines in prior HIV vaccine trial or participation in an immunomodulator study
- Vaccines within 30 days prior to first study vaccine administration
- Pregnant
- Long-term immunosuppressive or immunomodulator medications or within 6 months to first study vaccine administration
- Blood transfusion within 6 months to first study vaccine administration
- Treated with extracted pituitary hormones
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux
Paris, 75014
About this study
Official title: A Phase Ib Vaccine Trial Evaluating the Safety and Immunogenicity of HIV Lipopeptides by Two Administration Routes (Intramuscular And Intradermal) in Healthy Adult Volunteers. ANRS VAC16 Trial
Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally (ID) compared to IM administration.
Read the detailed description
Dose-sparing strategies that use intradermal (ID) delivery of vaccines may be one approach for improving a vaccines immunogenicity and reducing the cost of vaccines.
In this study, 68 HIV-negative healthy adult volunteers, 21-55 years old, all belonging to the "Volunteers for a Vaccine" network set up by ANRS, were randomized to receive at weeks 0, 4, and 12, either 3 IM doses of 0.5 ml of LIPO-4 containing 500 µg of each peptide (n= 35 volunteers), or 3 ID doses of 0.1 ml, containing 100 µg of each peptide (n=33 volunteers). Total follow-up was 48 weeks. Safety was assessed clinically and by laboratory tests. Participants were given diary cards to record adverse events. HIV-1 immune responses were assessed by ELISPOT and lymphoproliferative assay at weeks 0, 2, 6, 14, 24, and 48
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- Lipopeptides LIPO-4
- Keywords
- HIV 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.
Lipopeptides LIPO-4Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and biological safety (over or equal to degree two of a adverse event grading scale) of LIPO-4 by ID and IM routes during the study
Secondary outcomes (2)
Comparaison of CD4 positive cells responses using
lymphoprolifération test and CD8 positive cells responses using the capacity of these cells to synthesize IFN following stimulation with peptides of interest (ELISPOT IFN test) following IM or ID administration at weeks 2, 6, 14, 24, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2004
- Study completionDec 2005
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Investigators
- Odile Launay, MD, Principal investigator, Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinauxChristine Durier, MD, Study director, Inserm SC10
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121121
- Sponsor's protocol ID
- ANRS VAC16
- Status last verified
- Nov 2005
- First submitted
- 13 Jul 2005
- Last updated
- 15 Mar 2007
- Results posted
- No
Publications
Launay O, Durier C, Desaint C, Silbermann B, Jackson A, Pialoux G, Bonnet B, Poizot-Martin I, Gonzalez-Canali G, Cuzin L, Figuereido S, Surenaud M, Ben Hamouda N, Gahery H, Choppin J, Salmon D, Guerin C, Bourgault Villada I, Guillet JG; ANRS VAC16 Study Group. Cellular immune responses induced with dose-sparing intradermal administration of HIV vaccine to HIV-uninfected volunteers in the ANRS VAC16 trial. PLoS One. 2007 Aug 22;2(8):e725. doi: 10.1371/journal.pone.0000725.
PubMed 17712402
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Vaccine Trial Evaluating the Safety and Immunogenicity of HIV Lipopeptides by Two Administration Routes (Intramuscular And Intradermal) in Healthy Adult Volunteers. ANRS VAC16 Trial
- ClinicalTrials.gov ID
- NCT00121121
- Acronym / sponsor ID
- ANRS VAC16
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- HIV Vaccines, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Jul 2004
- Study completion
- Dec 2005
- First posted
- 21 Jul 2005 (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.
Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally (ID) compared to IM administration.
Detailed description
Dose-sparing strategies that use intradermal (ID) delivery of vaccines may be one approach for improving a vaccines immunogenicity and reducing the cost of vaccines.
In this study, 68 HIV-negative healthy adult volunteers, 21-55 years old, all belonging to the "Volunteers for a Vaccine" network set up by ANRS, were randomized to receive at weeks 0, 4, and 12, either 3 IM doses of 0.5 ml of LIPO-4 containing 500 µg of each peptide (n= 35 volunteers), or 3 ID doses of 0.1 ml, containing 100 µg of each peptide (n=33 volunteers). Total follow-up was 48 weeks. Safety was assessed clinically and by laboratory tests. Participants were given diary cards to record adverse events. HIV-1 immune responses were assessed by ELISPOT and lymphoproliferative assay at weeks 0, 2, 6, 14, 24, and 48
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- HIV uninfected
- Acceptable methods of contraception for females of reproductive potential
- Good general health
- Signed written inform consent
Key exclusion criteria (12 listed)
- Risk to be infected by HIV virus
- Uveitis, chronic lyme disease, active syphilis, active mycobacterial diseases or sarcoidosis
- Autoimmune disease or immunodeficiency
- Medical history of food allergy, Lyell's or Steven Johnson's disease, unstable asthma
- Active, generalized eczema or chronic urticaria
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 |
|---|---|---|
| Lipopeptides LIPO-4 | Biological | – |
Primary outcome
Clinical and biological safety (over or equal to degree two of a adverse event grading scale) of LIPO-4 by ID and IM routes during the study
2 secondary outcomes
Comparaison of CD4 positive cells responses using
lymphoprolifération test and CD8 positive cells responses using the capacity of these cells to synthesize IFN following stimulation with peptides of interest (ELISPOT IFN test) following IM or ID administration at weeks 2, 6, 14, 24, and 48
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 15 Mar 2007.
- Derived from this study: PubMed 17712402Launay O, Durier C, Desaint C, Silbermann B, Jackson A, Pialoux G, Bonnet B, Poizot-Martin I, Gonzalez-Canali G, Cuzin L, Figuereido S, Surenaud M, Ben Hamouda N, Gahery H, Choppin J, Salmon D, Guerin C, Bourgault Villada I, Guillet JG; ANRS VAC16 Study Group. Cellular immune responses induced with dose-sparing intradermal administration of HIV vaccine to HIV-uninfected volunteers in the ANRS VAC16 trial. PLoS One. 2007 Aug 22;2(8):e725. doi: 10.1371/journal.pone.0000725.
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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.
Odile Launay, MD principal investigator
Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinaux
Christine Durier, MD study director
Inserm SC10
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 Lipopeptides LIPO-4 in people with HIV Infections and HIV Seronegativity, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
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 12 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 15 Mar 2007. 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 France. 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.
What does the primary outcome measure?
Clinical and biological safety (over or equal to degree two of a adverse event grading scale) of LIPO-4 by ID and IM routes during the study. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00121121, 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 15 Mar 2007.