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HIV InfectionsPhase 2NCT00121758

AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV Volunteers

A Phase 2 study testing LIPO-5 in people with HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
LIPO-5
How many people
156 participants
Where
1 siteFrance
Study dates
Sep 2004to Dec 2007
Phase
Phase 2
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 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy volunteers selected by ANRS (French National Agency for Research on AIDS and Viral Hepatitis)
  • For woman of child-bearing age: use of effective contraception
  • Ability to sign informed consent
  • Beneficiary subjects of social security regimen-- Hepatitis B, hepatitis C, HIV, HTLV1 infection and syphilis negative
  • Hemoglobin over 12.5 g/dl for women and over 13.5 g/dl for men

Who cannot join

  • Previous participation in an HIV clinical trial
  • Volunteers with risk to contract HIV infection during the trial
  • Previous vaccination in the last month, and volunteers requiring vaccination during the trial
  • Gift of blood in the last 2 months
  • Eczema, urticaria
  • Medical history of food allergy, Lyell or Stevens Johnson syndrome and aggravated asthma
Show all 11Show fewer
  • Previous (last 6 months) or ongoing administration of immunological treatment, chemotherapy, radiotherapy or corticosteroid
  • Medical history of autoimmune disease
  • Clinical or biological aftermath of previous disease
  • Medical history of uveitis
  • Transfusion in the last 6 months

Trial locations and contacts

1 site in 1 country.

France1 site

  • CIC de Vaccinologie Cochin Pasteur

    Paris, 75014

Other trials in France

About this study

Official title: Randomised Double Blinded Phase II AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptide (LIPO-5) Versus Placebo in Non Infected HIV Volunteers (ANRS VAC 18)

This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar immunogenicity.

Read the detailed description

The aims of HIV lipopeptide vaccination approach are to improve cell mediated immune responses in order to obtain strong, long lasting and polyepitopic responses and to focus these responses on highly conserved and immunogenic epitopes.

Lipopeptides are chemically synthetized peptides, bearing HIV epitopes, covalently bound to a fatty acid moiety, a monopalmtoyl chain in this case. This lipid chain produces internalization of the lipopeptide into the cytoplasm of the antigen presenting cells. Combinations of several lipopeptides containing sequences from different HIV proteins are used in vaccination trials in order to increase polyepitopic responses. Lipopeptides have been synthetized by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) preventive program by the group of Helen Gras following a long and meticulous work of epitope screening performed by the team of Jean-Gérard Guillet at the Cochin Institute in Paris. The epitopes were selected on the basis of their strong affinity for HLA class I molecule, on their ability to form a stable complex with these molecules, and on the capacity of these epitopes to be recognized by T cells. The selected peptides are those containing the richest array of epitopes and those most frequently recognized by HIV infected patients. Each peptide has a length of 23 to 32 amino acids (AA).

Different types of lipopeptides constructs have been tested in humans. Among these constructs, LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar immunogenicity.

Conditions
HIV Infections
Being tested
LIPO-5
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.

  • LIPO-5Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with CD8 immune response on ELISPOT IFN-gamma at week (W) 48

Secondary outcomes (4)

  1. Local and general adverse events

  2. Percentage of subjects with CD4 immune response against different peptides of LIPO-5

  3. Percentage of subjects with sustained response at week 48

  4. Percentage of subjects with response against more than 1 peptide (multiepitopic response)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionNov 2007
  4. Study completionDec 2007

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00121758
Sponsor's protocol ID
2004-000233-10
Other IDs
ANRS VAC18, 2004
Status last verified
Jun 2008
First submitted
18 Jul 2005
Last updated
6 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Richert L, Hue S, Hocini H, Raimbault M, Lacabaratz C, Surenaud M, Wiedemann A, Tisserand P, Durier C, Salmon D, Lelievre JD, Chene G, Thiebaut R, Levy Y; ANRS Vaccine Network/Vaccine Research Institute. Cytokine and gene transcription profiles of immune responses elicited by HIV lipopeptide vaccine in HIV-negative volunteers. AIDS. 2013 Jun 1;27(9):1421-31. doi: 10.1097/QAD.0b013e32835f5b60.

    PubMed 23759749

  • Salmon-Ceron D, Durier C, Desaint C, Cuzin L, Surenaud M, Hamouda NB, Lelievre JD, Bonnet B, Pialoux G, Poizot-Martin I, Aboulker JP, Levy Y, Launay O; ANRS VAC18 trial group. Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial. AIDS. 2010 Sep 10;24(14):2211-23. doi: 10.1097/QAD.0b013e32833ce566.

    PubMed 20625264

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LIPO-5 in people with HIV Infections, 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 5 inclusion and 11 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 6 Jun 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Percentage of patients with CD8 immune response on ELISPOT IFN-gamma at week (W) 48. 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 NCT00121758, which also lists 2 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 6 Jun 2008.

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