Second generation virosome-based HIV vaccine(Mymetics Corp.)(Second generation virosome-based HIV vaccine(Mymetics Corp.))

概要

基本信息

药物类型

预防性疫苗

别名

HIV gp41 vaccine、Mucosal HIV/AIDS vaccine、Virosome-gp41 mucosal vaccine

+ [3]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症

HIV感染

非在研适应症-

原研机构

Mymetics Corp.

在研机构

Texas Biomedical Research Institute

非在研机构

Mymetics Corp.

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 319650384

关联

1

项与 Second generation virosome-based HIV vaccine(Mymetics Corp.) 相关的临床试验

NCT01084343

/ Completed临床1期

A Dose Escalating Phase I Study, Double-blind, Randomized, Placebo-controlled for Examining the Safety and Tolerability to a Prophylactic HIV-1 Vaccine Called MYM-V101, Administered i.m. in Combination With i.n. Administrations to Healthy Female Subjects.

This study is designed to investigate the safety and efficacy of a newly developed vaccine against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic adverse reactions, investigations of blood and urine, and physical exam including vital sign measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.

开始日期2009-11-01

申办/合作机构

Mymetics Corp.

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100 项与 Second generation virosome-based HIV vaccine(Mymetics Corp.) 相关的临床结果

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100 项与 Second generation virosome-based HIV vaccine(Mymetics Corp.) 相关的转化医学

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100 项与 Second generation virosome-based HIV vaccine(Mymetics Corp.) 相关的专利（医药）

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4

项与 Second generation virosome-based HIV vaccine(Mymetics Corp.) 相关的文献（医药）

2008-04-01·Bioconjugate Chemistry2区 · 化学

Application of an HIV gp41-Derived Peptide for Enhanced Intracellular Trafficking of Synthetic Gene and siRNA Delivery Vehicles

2区 · 化学

Article

作者: Kwon, Ester J. ; Pun, Suzie H. ; Bergen, Jamie M.

Endosomal release is an efficiency-limiting step for many nonviral gene delivery vehicles. In this work, nonviral gene delivery vehicles were modified with a membrane-lytic peptide taken from the endodomain of HIV gp41. Peptide was covalently linked to polyethylenimine (PEI) and the peptide-modified polymer was complexed with DNA. The resulting nanoparticles were shown to have similar physicochemical properties as complexes formed with unmodified PEI. The gp41-derived peptide demonstrated significant lytic activity both as free peptide and when conjugated to PEI. Significant increases in transgene expression were achieved in HeLa cells when compared to unmodified polyplexes at low polymer to DNA ratios. Additionally, peptide-modified polyplexes mediated significantly enhanced siRNA delivery compared to unmodified polyplexes. Despite increases in transgene expression and siRNA knockdown, there was no increase in internalization or binding of modified carriers as determined by flow cytometry. The hypothesis that the gp41-derived peptide increases the endosomal escape of vehicles is supported by confocal microscopy imaging of DNA distributions in transfected cells. This work demonstrates the use of a lytic peptide for improved trafficking of nonviral gene delivery vehicles.

2008-02-12·Proceedings of the National Academy of Sciences1区 · 综合性期刊

A vaccine strategy against AIDS: An HIV gp41 peptide immunization prevents NKp44L expression and CD4 ⁺ T cell depletion in SHIV-infected macaques

1区 · 综合性期刊

Article

作者: Vieillard, Vincent ; Le Grand, Roger ; Debré, Patrice ; Dausset, Jean

We previously showed that a gp41 peptide (3S) induces expression of a natural killer (NK) ligand (NKp44L) on CD4 + T cells during HIV-1 infection and that those cells are highly sensitive to NK lysis. In HIV-infected patients, anti-3S antibodies are associated with the maintenance of CD4 + T cell counts close to their baseline values, and CD4 + T cells decrease with the antibody titer. This study sought to determine whether anti-3S immunization could prevent NKp44L expression on these CD4 + T cells in vivo and inhibits the subsequent decline in CD4 + T cell counts by immunizing macaques with 3S and then infecting them with simian HIV 162P3 . The results show that anti-3S antibodies inhibited NKp44L expression and NK activity and cytotoxicity. They also decreased the apoptosis rate of CD4 + T cells in peripheral blood and lymph nodes. These data raise questions about the pathogenesis of HIV and present opportunities for both preventive and therapeutic HIV vaccine strategies.

PLoS ONE3区 · 综合性期刊

Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes

3区 · 综合性期刊

ArticleOA

作者: Maes, Cathy ; van den Dobbelsteen, Marieke ; Lopalco, Lucia ; Adler, Michael ; Fleury, Sylvain ; Chalifour, Anick ; Amacker, Mario ; Bomsel, Morgane ; Clement, Frederic ; van Engelenburg, Frank ; Leroux-Roels, Geert

Mucosal antibodies harboring various antiviral activities may best protect mucosal surfaces against early HIV-1 entry at mucosal sites and they should be ideally induced by prophylactic HIV-1 vaccines for optimal prevention of sexually transmitted HIV-1. A phase I, double-blind, randomized, placebo-controlled trial was conducted in twenty-four healthy HIV-uninfected young women. The study objectives were to assess the safety, tolerability and immunogenicity of virosomes harboring surface HIV-1 gp41-derived P1 lipidated peptides (MYM-V101). Participants received placebo or MYM-V101 vaccine at 10 μg/dose or 50 μg/dose intramuscularly at week 0 and 8, and intranasally at week 16 and 24. MYM-V101 was safe and well-tolerated at both doses administered by the intramuscular and intranasal routes, with the majority of subjects remaining free of local and general symptoms. P1-specific serum IgGs and IgAs were induced in all high dose recipients after the first injection. After the last vaccination, vaginal and rectal P1-specific IgGs could be detected in all high dose recipients. Approximately 63% and 43% of the low and high dose recipients were respectively tested positive for vaginal P1-IgAs, while 29% of the subjects from the high dose group tested positive for rectal IgAs. Serum samples had total specific IgG and IgA antibody concentrations ≥ 0.4 μg/mL, while mucosal samples were usually below 0.01 μg/mL. Vaginal secretions from MYM-V101 vaccinated subjects were inhibiting HIV-1 transcytosis but had no detectable neutralizing activity. P1-specific Th1 responses could not be detected on PBMC. This study demonstrates the excellent safety and tolerability of MYM-V101, eliciting systemic and mucosal antibodies in the majority of subjects. Vaccine-induced mucosal anti-gp41 antibodies toward conserved gp41 motifs were harboring HIV-1 transcytosis inhibition activity and may contribute to reduce sexually-transmitted HIV-1.TRIAL REGISTRATIONClinicalTrials.gov NCT01084343.

100 项与 Second generation virosome-based HIV vaccine(Mymetics Corp.) 相关的药物交易

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