SAAVI MVA-C(HIV Vaccine Trials Network)(SAAVI MVA-C(HIV Vaccine Trials Network))

概要

基本信息

药物类型

DNA疫苗

别名

SAAVI MVA-C vaccine

靶点-

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

HIV Vaccine Trials Network

在研机构

University of Cape Town

非在研机构

HIV Vaccine Trials Network

最高研发阶段临床前

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 SAAVI MVA-C(HIV Vaccine Trials Network) 相关的临床试验

NCT01418235 / Completed临床1期IIT

A Phase 1 Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of SAAVI DNA-C2, SAAVI MVA-C and Novartis Subtype C gp140 With MF59 Adjuvant in Various Vaccination Schedules in HIV-uninfected Healthy Vaccinia-naïve Adult Participants in South Africa

Sub-Saharan Africa is the region most affected by the global Human Immunodeficiency Virus (HIV) epidemic. A vaccine is the most promising preventive approach against new HIV infections. The purpose of this study is to evaluate the safety and immunogenicity of 4 experimental preventive HIV vaccine regimens in HIV-uninfected adults in South Africa.

开始日期2011-12-19

申办/合作机构

HIV Vaccine Trials Network

NCT00574600 / Completed临床1期IIT

A Phase 1 Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of SAAVI DNA-C2 Vaccine Boosted by SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Vaccinia Naive Adult Participants in South Africa and the United States

The purpose of this study is to evaluate the safety of and immune response to an experimental DNA HIV vaccine followed by boosting with an experimental modified vaccinia HIV vaccine (MVA) in HIV uninfected adults.

开始日期2008-11-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

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100 项与 SAAVI MVA-C(HIV Vaccine Trials Network) 相关的临床结果

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100 项与 SAAVI MVA-C(HIV Vaccine Trials Network) 相关的转化医学

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100 项与 SAAVI MVA-C(HIV Vaccine Trials Network) 相关的专利（医药）

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13

项与 SAAVI MVA-C(HIV Vaccine Trials Network) 相关的文献（医药）

2021-01-01·Vaccine3区 · 医学

Modifications to the HIV-1 SAAVI MVA-C vaccine improve in vitro expression and in vivo immunogenicity

3区 · 医学

Article

作者: Chapman, Rosamund ; Galant, Shireen ; Hermanus, Tandile ; Margolin, Emmanuel ; Douglass, Nicola ; Ximba, Phindile ; van Diepen, Michiel T ; Williamson, Anna-Lise ; Moore, Penny L

Two HIV-1 vaccines (SAAVI DNA-C2 and SAAVI MVA-C) were previously developed in South Africa and tested in preclinical studies and Phase 1 clinical trials. Here we report on improvements made to the SAAVI MVA-C vaccine design which include: the use of different promoters for both the Gag and Env genes, replacement of the native Gag gene with an in silico designed subtype C mosaic Gag antigen which forms virus-like particles and the modification of Env by sequence changes to improve stability and transport to the cell surface. A head-to-head comparison of the newly conceived MVAGD5 candidate vaccine with SAAVI MVA-C showed increased in vitro expression of both Env and Gag, and superior immunogenicity in rabbits. MVAGD5 induced high levels of binding antibodies to Env and Tier 1A and 1B neutralizing antibodies, neither of which were induced by SAAVI MVA-C.

2017-02-01·Vaccine3区 · 医学

DNA-MVA-protein vaccination of rhesus macaques induces HIV-specific immunity in mucosal-associated lymph nodes and functional antibodies

3区 · 医学

Article

作者: Burgers, Wendy A ; Williamson, Anna-Lise ; Williamson, Carolyn ; Chege, Gerald K ; Barnett, Susan W ; Müller, Tracey L ; Gray, Clive M ; Shephard, Enid G ; Ferrari, Guido ; Montefiori, David

Successful future HIV vaccines are expected to generate an effective cellular and humoral response against the virus in both the peripheral blood and mucosal compartments. We previously reported the development of DNA-C and MVA-C vaccines based on HIV-1 subtype C and demonstrated their immunogenicity when given in a DNA prime-MVA boost combination in a nonhuman primate model. In the current study, rhesus macaques previously vaccinated with a DNA-C and MVA-C vaccine regimen were re-vaccinated 3.5years later with MVA-C followed by a protein vaccine based on HIV-1 subtype C envelope formulated with MF59 adjuvant (gp140Env/MF59), and finally a concurrent boost with both vaccines. A single MVA-C re-vaccination elicited T cell responses in all animals similar to previous peak responses, with 4/7 demonstrating responses >1000 SFU/10⁶ PBMC. In contrast to an Env/MF59-only vaccine, concurrent boosting with MVA-C and Env/MF59 induced HIV-specific cellular responses in multiple mucosal associated lymph nodes in 6/7 animals, with high magnitude responses in some animals. Both vaccine regimens induced high titer Env-specific antibodies with ADCC activity, as well as neutralization of Tier 1 viruses and modest Tier 2 neutralization. These data demonstrate the feasibility of inducing HIV-specific immunity in the blood and mucosal sites of viral entry by means of DNA and poxvirus-vectored vaccines, in combination with a HIV envelope-based protein vaccine.

2016-06-01·Clinical and Vaccine Immunology

Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap

Article

作者: Tucker, Timothy ; Downing, Katrina ; Gray, Glenda E. ; Morris, Lynn ; Montefiori, David ; Allen, Mary ; Gu, Niya ; Bekker, Linda-Gail ; Sato, Alicia ; Shen, Xiaoying ; Corey, Lawrence ; Tomaras, Georgia D. ; Mayer, Kenneth H. ; Barnett, Susan W. ; De Rosa, Stephen C. ; Mkhize, Nonhlanhla N. ; Williamson, Carolyn ; Williamson, Anna-Lise ; Pensiero, Michael ; Elizaga, Marnie L.

ABSTRACT A phase I safety and immunogenicity study investigated South African AIDS Vaccine Initiative (SAAVI) HIV-1 subtype C (HIV-1C) DNA vaccine encoding Gag-RT-Tat-Nef and gp150, boosted with modified vaccinia Ankara (MVA) expressing matched antigens. Following the finding of partial protective efficacy in the RV144 HIV vaccine efficacy trial, a protein boost with HIV-1 subtype C V2-deleted gp140 with MF59 was added to the regimen. A total of 48 participants (12 U.S. participants and 36 Republic of South Africa [RSA] participants) were randomized to receive 3 intramuscular (i.m.) doses of SAAVI DNA-C2 of 4 mg (months 0, 1, and 2) and 2 i.m. doses of SAAVI MVA-C of 1.45 × 10 9 PFU (months 4 and 5) ( n = 40) or of a placebo ( n = 8). Approximately 2 years after vaccination, 27 participants were rerandomized to receive gp140/MF59 at 100 μg or placebo, as 2 i.m. injections, 3 months apart. The vaccine regimen was safe and well tolerated. After the DNA-MVA regimen, CD4 + T-cell and CD8 + T-cell responses occurred in 74% and 32% of the participants, respectively. The protein boost increased CD4 + T-cell responses to 87% of the subjects. All participants developed tier 1 HIV-1C neutralizing antibody responses as well as durable Env binding antibodies that recognized linear V3 and C5 peptides. The HIV-1 subtype C DNA-MVA vaccine regimen showed promising cellular immunogenicity. Boosting with gp140/MF59 enhanced levels of binding and neutralizing antibodies as well as CD4 + T-cell responses to HIV-1 envelope. (This study has been registered at ClinicalTrials.gov under registration no. NCT00574600 and NCT01423825.)

100 项与 SAAVI MVA-C(HIV Vaccine Trials Network) 相关的药物交易

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