rPA-102(rPA-102) - 在研适应症：炭疽_专利_临床

概要

基本信息

药物类型

预防性疫苗、重组亚单位疫苗

别名

Anthrax vaccine recombinant、PreviThrax、Recombinant protective antigen anthrax vaccine, purified

+ [3]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

炭疽

非在研适应症-

原研机构

U.S. Army Medical Research Institute for Infectious Diseases

在研机构

U.S. Army Medical Research Institute for Infectious Diseases

Emergent BioSolutions, Inc.

非在研机构-

权益机构-

最高研发阶段临床2期

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 rPA-102 相关的临床试验

NCT00100724

/ Completed临床2期

A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers

The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.

开始日期2004-04-01

申办/合作机构

VaxGen, Inc.

[+3]

NCT00103467

/ Completed临床1期

A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine

The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.

开始日期2003-06-01

申办/合作机构

VaxGen, Inc.

100 项与 rPA-102 相关的临床结果

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100 项与 rPA-102 相关的转化医学

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100 项与 rPA-102 相关的专利（医药）

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6

项与 rPA-102 相关的文献（医药）

2012-08-01·Clinical and Vaccine Immunology

Recombinant Protective Antigen Anthrax Vaccine Improves Survival when Administered as a Postexposure Prophylaxis Countermeasure with Antibiotic in the New Zealand White Rabbit Model of Inhalation Anthrax

Article

作者: Elizabeth K. Leffel ; E. Diane Williamson ; Thomas R. Fuerst ; James S. Bourdage ; Peter C. Fusco ; Matthew Duchars

ABSTRACTInhalation anthrax is a potentially lethal form of disease resulting from exposure to aerosolizedBacillus anthracisspores. Over the last decade, incidents spanning from the deliberate mailing ofB. anthracisspores to incidental exposures in users of illegal drugs have highlighted the importance of developing new medical countermeasures to protect people who have been exposed to “anthrax spores” and are at risk of developing disease. The New Zealand White rabbit (NZWR) is a well-characterized model that has a pathogenesis and clinical presentation similar to those seen in humans. This article reports how the NZWR model was adapted to evaluate postexposure prophylaxis using a recombinant protective antigen (rPA) vaccine in combination with an oral antibiotic, levofloxacin. NZWRs were exposed to multiples of the 50% lethal dose (LD50) ofB. anthracisspores and then vaccinated immediately (day 0) and again on day 7 postexposure. Levofloxacin was administered daily beginning at 6 to 12 h postexposure for 7 treatments. Rabbits were evaluated for clinical signs of disease, fever, bacteremia, immune response, and survival. A robust immune response (IgG anti-rPA and toxin-neutralizing antibodies) was observed in all vaccinated groups on days 10 to 12. Levofloxacin plus either 30 or 100 μg rPA vaccine resulted in a 100% survival rate (18 of 18 per group), and a vaccine dose as low as 10 μg rPA resulted in an 89% survival rate (16 of 18) when used in combination with levofloxacin. In NZWRs that received antibiotic alone, the survival rate was 56% (10 of 18). There was no adverse effect on the development of a specific IgG response to rPA in unchallenged NZWRs that received the combination treatment of vaccine plus antibiotic. This study demonstrated that an accelerated two-dose regimen of rPA vaccine coadministered on days 0 and 7 with 7 days of levofloxacin therapy results in a significantly greater survival rate than with antibiotic treatment alone. Combination of vaccine administration and antibiotic treatment may be an effective strategy for treating a population exposed to aerosolizedB. anthracisspores.

2007-09-01·Human Vaccines

Safety, Reactogenicity, and Immunogenicity of a Recombinant Protective Antigen Anthrax Vaccine Given to Healthy Adults

Article

作者: Wasserman, Steven S. ; Kotloff, Karen L. ; Donegan, Sarah ; Campbell, James D. ; Clement, Kristin H. ; Chrisley, Lisa

BACKGROUNDBacillus anthracis causes anthrax, a vaccine-preventable zoonotic disease that may follow intentional or unintentional exposure to its spores. Although an anthrax vaccine is currently licensed in the USA, better vaccines are desirable for both pre- and post-exposure prophylaxis.METHODSHealthy adults, aged 18-40 years, received anthrax immunization with either licensed Anthrax Vaccine Adsorbed (AVA, BioThrax), or an experimental recombinant Protective Antigen vaccine (rPA) produced from an avirulent, non-spore-forming strain of B. anthracis at one of four doses (5, 25, 50 or 75 microg). Volunteers were followed for safety, reactogenicity, and immunogenicity.RESULTSrPA vaccine was well tolerated with a low rate of local or systemic reactions. Although antibody responses were poor following unadjuvanted rPA administration, 89 and 100% of volunteers who received Alhydrogel-adjuvanted rPA given intramuscularly had four-fold increases by enzyme-linked immunosorbent and toxin neutralization assays, respectively. Peak antibody responses to adjuvanted rPA given intramuscularly were equivalent to AVA, given either intramuscularly or subcutaneously, when measured by either assay.CONCLUSIONSThis recombinant Protective Antigen anthrax vaccine, when given with the adjuvant Alhydrogel to healthy adults in two intramuscular injections four weeks apart, is very well-tolerated and highly immunogenic.

2007-08-01·Infection and Immunity2区 · 医学

Mucosal Immunization with a Novel Nanoemulsion-Based Recombinant Anthrax Protective Antigen Vaccine Protects againstBacillus anthracisSpore Challenge

2区 · 医学

Article

作者: Sower, Laurie E. ; Baker, James R. ; Makidon, Paul ; Bielinska, Anna U. ; Landers, Jeffrey J. ; Peterson, Johnny W. ; Janczak, Katarzyna W.

ABSTRACTThe currently available commercial human anthrax vaccine requires multiple injections for efficacy and has side effects due to its alum adjuvant. These factors limit its utility when immunizing exposed populations in emergent situations. We evaluated a novel mucosal adjuvant that consists of a nontoxic, water-in-oil nanoemulsion (NE). This material does not contain a proinflammatory component but penetrates mucosal surfaces to load antigens into dendritic cells. Mice and guinea pigs were intranasally immunized with recombinantBacillus anthracisprotective antigen (rPA) mixed in NE as an adjuvant. rPA-NE immunization was effective in inducing both serum anti-PA immunoglobulin G (IgG) and bronchial anti-PA IgA and IgG antibodies after either one or two mucosal administrations. Serum anti-PA IgG2a and IgG2b antibodies and PA-specific cytokine induction after immunization indicate a Th1-polarized immune response. rPA-NE immunization also produced high titers of lethal-toxin-neutralizing serum antibodies in both mice and guinea pigs. Guinea pigs nasally immunized with rPA-NE vaccine were protected against an intradermal challenge with ∼1,000 times the 50% lethal dose (∼1,000× LD50) ofB. anthracisAmes strain spores (1.38 × 103spores), which killed control animals within 96 h. Nasal immunization also resulted in 70% and 40% survival rates against intranasal challenge with 10× LD50and 100× LD50(1.2 × 106and 1.2 × 107) Ames strain spores. Our results indicate that NE can effectively adjuvant rPA for intranasal immunization. This potentially could lead to a needle-free anthrax vaccine requiring fewer doses and having fewer side effects than the currently available human vaccine.

100 项与 rPA-102 相关的药物交易

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