Delving into the Latest Updates on LIPO-5 with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

HIV-LIPO-5

Target

HIV-1 nef

Mechanism

HIV-1 nef modulators(Protein Nef modulators), Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication

Acquired Immunodeficiency Syndrome

Originator Organization

Sanofi

Active Organization

Atos SE

Inactive Organization

Aventis Pharmaceuticals, Inc.

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 139577

Sequence Code 139588

Sequence Code 139594

Sequence Code 139600

Sequence Code 17597639

The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is expected to induce strong and diverse HIV-specific immune responses in HIV-infected patients. The investigators will carry out the clinical therapeutic immunization "proof of concept" trial in HIV infected patients. The investigators propose a multi-center double blind randomized versus placebo phase II clinical trial in patients who are chronic asymptomatic HIV-infected patients, with undetectable viral load while treated with a potent combination of antiviral drugs. Patients will continue antiviral therapy combined with either therapeutic vaccination or placebo vaccination. Patients will undergo the procedure which includes a prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM injections via Biojector (a needle-free injection system) followed by a boost of LIPO-5 vaccine or placebo also given IM.
In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2 doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48. Patients will be intensely monitored during the treatment interruption period. After start of cART treatment (at the latest in W48), a data collection from clinical car will be carried out. A blood sample with W74 will allow to study the persistence ot the immunizing responses, 1 year after the injection of the last vaccine/placebo.
The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after stopping all antiviral treatment).
The main hypothesis for conducting a phase II randomized trial is that immune responses in vaccinated patients may be associated with a better control of viral replication following c-ART interruption as compared to placebo-vaccinated patients.

Start Date01 Jul 2013

Sponsor / Collaborator

ANRS, Emerging Infectious Diseases

NCT00121758 / CompletedPhase 2IIT

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.

Start Date01 Sep 2004

Sponsor / Collaborator

National Agency for Research on AIDS and Viral Hepatitis

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100 Clinical Results associated with LIPO-5

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100 Translational Medicine associated with LIPO-5

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100 Patents (Medical) associated with LIPO-5

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10

Literatures (Medical) associated with LIPO-5

15 Jun 2022·Journal of immunology (Baltimore, Md. : 1950)

T Cell Immunogenicity, Gene Expression Profile, and Safety of Four Heterologous Prime-Boost Combinations of HIV Vaccine Candidates in Healthy Volunteers: Results of the Randomized Multi-Arm Phase I/II ANRS VRI01 Trial

Article

Abstract:

Heterologous prime-boost strategies are of interest for HIV vaccine development. The order of prime-boost components could be important for the induction of T cell responses. In this phase I/II multi-arm trial, three vaccine candidates were used as prime or boost: modified vaccinia Ankara (MVA) HIV-B (coding for Gag, Pol, Nef); HIV LIPO-5 (five lipopeptides from Gag, Pol, Nef); DNA GTU-MultiHIV B (coding for Rev, Nef, Tat, Gag, Env gp160 clade B). Healthy human volunteers (n = 92) were randomized to four groups: 1) MVA at weeks 0/8 + LIPO-5 at weeks 20/28 (M/L); 2) LIPO-5 at weeks 0/8 + MVA at weeks 20/28 (L/M); 3) DNA at weeks 0/4/12 + LIPO-5 at weeks 20/28 (G/L); 4) DNA at weeks 0/4/12 + MVA at weeks 20/28 (G/M). The frequency of IFN-γ–ELISPOT responders at week 30 was 33, 43, 0, and 74%, respectively. Only MVA-receiving groups were further analyzed (n = 62). Frequency of HIV-specific cytokine-positive (IFN-γ, IL-2, or TNF-α) CD4+ T cells increased significantly from week 0 to week 30 (median change of 0.06, 0.11, and 0.10% for M/L, L/M, and G/M, respectively), mainly after MVA vaccinations, and was sustained until week 52. HIV-specific CD8+ T cell responses increased significantly at week 30 in M/L and G/M (median change of 0.02 and 0.05%). Significant whole-blood gene expression changes were observed 2 wk after the first MVA injection, regardless of its use as prime or boost. An MVA gene signature was identified, including 86 genes mainly related to cell cycle pathways. Three prime-boost strategies led to CD4+ and CD8+ T cell responses and to a whole-blood gene expression signature primarily due to their MVA HIV-B component.

12 Apr 2021·Journal of virologyQ2 · MEDICINE

A Randomized Placebo-Controlled Efficacy Study of a Prime Boost Therapeutic Vaccination Strategy in HIV-1-Infected Individuals: VRI02 ANRS 149 LIGHT Phase II Trial

Q2 · MEDICINE

Article

Author: Hocqueloux, L. ; Girard, P.-M. ; Bauduin, C. ; Lhomme, E. ; Lelièvre, J. D. ; Morlat, P. ; Rieux, V. ; Fenwick, C. ; Thiébaut,, R. ; Pantaleo, G. ; Bouchaud, O. ; Lévy, Y. ; Guillaumat, L. ; Foucat, E. ; Boilet, V. ; Richert, L. ; Surenaud, M. ; Wiedemann, A. ; Lacabaratz, C. ; Molina, J.-M.

In this placebo-controlled phase II randomized clinical trial, we evaluated the safety and immunogenicity of a therapeutic prime-boost vaccine strategy using a recombinant DNA vaccine (GTU-MultiHIV B clade) followed by a boost vaccination with a lipopeptide vaccine (HIV-LIPO-5) in HIV-infected patients on combined antiretroviral therapy. We show here that this prime-boost strategy is well tolerated, consistently with previous studies in HIV-1-infected individuals and healthy volunteers who received each vaccine component individually.

01 May 2015·VaccineQ3 · MEDICINE

HIV specific responses induced in nonhuman primates with ANRS HIV-Lipo-5 vaccine combined with rMVA-HIV prime or boost immunizations

Q3 · MEDICINE

Article

Author: Yousfi, Rahima ; Clayette, Pascal ; Contreras, Vanessa ; Martinon, Frédéric ; Le Grand, Roger ; Baron, Marie-Laurence ; Mangeot, Isabelle ; Dereuddre-Bosquet, Nathalie ; Levy, Yves ; Gosse, Leslie

We evaluated the immunogenicity of a prime/boost vaccine strategy combining 5 lipopeptides (HIV-Lipo-5) and a recombinant modified vaccinia virus Ankara (rMVA-HIV) in cynomolgus macaques. Both of these vaccine components deliver HIV LAI Gag, Pol, and Nef antigens. Systemic and local safety was excellent in all groups. Immunization with HIV-Lipo-5 alone induced significant serum anti-HIV antibody titers which were not modified by rMVA-HIV immunization. However, induction of T-cell responses, as measured by IFNγ and IL-2 producing cells upon short-term stimulation with HIV peptide pools, required combined immunization with rMVA-HIV. Responses were preferentially observed against Gag antigen. Interestingly, HIV-Lipo-5 efficiently primed HIV induced T-cell responses upon the injection of rMVA-HIV, which may help to reduce the required number of vector injections. Our results provide a rationale for the use of a strategy involving HIV-Lipo-5 priming followed by rMVA-HIV booster immunization as a prophylactic or therapeutic vaccine approach against HIV infection and AIDS.

100 Deals associated with LIPO-5

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 2	FR	Aventis Pharmaceuticals, Inc.	01 Sep 2004
HIV Infections	Phase 2	-	Atos SE	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ANRS/INSERM VRI01 (IAS2017)	Not Applicable	-	-	MVA HIV-B	jlfautthjd(hufgxognuw) = bnmrgwqadv xguubmpoey (qoyezonbpv )	-	01 Jan 2017
				LIPO-5	jlfautthjd(hufgxognuw) = ygkffxeusx xguubmpoey (qoyezonbpv )