TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases)(TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases))

概要

基本信息

药物类型

预防性疫苗

别名

靶点-

作用机制-

治疗领域

感染其他疾病

在研适应症

裂谷热

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

非在研机构

U S Army Medical Research & Development Command

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 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的临床试验

NCT00869713 / Completed临床2期IIT

Long-Term Open-Label Primary Vaccination and Booster Dose Study of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200) in At-Risk Adults

This study is designed to determine the safety and immunogenicity of an inactivated Rift Valley Fever (RVF) Vaccine in adults

开始日期2009-09-01

申办/合作机构

U S Army Medical Research & Development Command

NCT00584194 / Completed临床2期IIT

Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study

This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine

开始日期2004-06-01

申办/合作机构

U S Army Medical Research & Development Command

100 项与 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的临床结果

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100 项与 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的转化医学

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100 项与 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的专利（医药）

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4

项与 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的文献（医药）

2000-06-01·African journal of medicine and medical sciences

Response of laboratory staff to vaccination with an inactivated Rift Valley fever vaccine--TSI-GSD 200.

Article

作者: Frank-Peterside, N

Laboratory staff and students were vaccinated with a formalin-inactivated rift valley fever (RVF) vaccine. This study showed that the vaccine used (TSI-GSD 200) was able to bring about the production of antibodies in recipients. For the production of a high titered antibody response, three doses of the vaccine were required. One or two doses of the vaccine did not produce a greater than four-fold rise in antibody titre. A greater than four-fold rise in antibody titre following vaccination, is considered significant. The complete dose of the vaccine, that is, three doses, was necessary for protection. This study also showed that the haemagglutination inhibition (HI) test was capable of detecting antibodies, few weeks post vaccination. Though such HI antibodies broaden with time, it could be used for screening purposes and a more specific test, e.g., plaque reduction neutralisation (PRN) test used for confirmation of such results.

1999-08-01·Vaccine3区 · 医学

Immunogenicity of an inactivated Rift Valley fever vaccine in humans: a 12-year experience

3区 · 医学

Article

作者: Clarence J. Peters ; Richard S. Makuch ; Joseph A. Mangiafico ; Phillip R. Pittman ; Paul H. Gibbs ; C.T. Liu ; Timothy L. Cannon

Rift Valley fever (RVF) virus causes serious and fatal disease in animals and man. To protect personnel who work with RVF virus in the laboratory, or troops who may be exposed to this virus, the US Army successfully developed an improved version of inactivated RVF vaccine, TSI-GSD-200. From early 1986 to late 1997, 598 at-risk workers at the US Army Medical Research Institute of Infectious Diseases (USAMRIID) were vaccinated as part of an occupational safety and health program. The subjects of this study received three subcutaneous doses (0, 7 and 28 days) of 0.5 ml of TSI-GSD-200. A total of 540 vaccinees (90.3%) initially responded (group A) with an 80% plaque-reduction neutralization antibody titer (PRNT80) of > or =1:40; whereas 58 subjects (9.7%) were initial nonresponders (group B) failing to achieve this titer. Volunteers who either failed to respond or who achieved a titer of > or =1:40 but whose titer waned below 1:40 were boosted 1-4 times with the same vaccine. Among 247 group A subjects who received the first recall injection, 242 (98%) were successfully boosted, achieving a PRNT80 > or =1:40. Thirty-three of 44 (75%) initial nonresponders were converted to responder status after the first booster, which is a lower rate than that of group A (P < 0.001). After the primary series and the first booster, Kaplan-Meier analysis showed 50% probability of group A members maintaining a titer of > or =1:40 for approximately eight years; whereas group B had a 50% probability of maintaining a titer for only 204 days. Group A immune response rates to boosts 1-4 ranged from 87 to 100% with geometric mean titers (GMTs) ranging from 80 to 916. Boosts 1-4 immune response rates of group B volunteers ranged from 67 to 79% with GMTs ranging from 90 to 177. Minor side effects to TSI-GSD-200 were noted in 2.7% of all vaccinees after primaries and 3.5% of all vaccinees who had primaries and up to four boosters. We conclude that the use of TSI-GSD-200 is safe and provides good long-term immunity in humans when the primary series and one boost are administered.

1991-10-01·Vaccine3区 · 医学

Efficacy of a Rift Valley fever virus vaccine against an aerosol infection in rats

3区 · 医学

Article

作者: N. Powell ; G.W. Anderson ; G. Meadors ; J.A. Mangiafico ; J.O. Lee ; A.O. Anderson

The formalin-inactivated Rift Valley fever virus (RVFV) vaccine, TSI-GSD-200, was administered subcutaneously to highly susceptible adult Wistar-Furth rats (LD50-1 p.f.u., ZH501 strain). Vaccine was administered on days 0, 7 and 28, the same time course used for at-risk personnel. Six months postimmunization, when the serum plaque-reduction neutralization titre (PRNT)80 had declined to low or undetectable levels, rats were challenged with 4.4 log10 p.f.u. of the virulent ZH501 strain in a nose-only dynamic aerosol apparatus. Ninety-seven per cent (33/34) of the non-vaccinated control rats died. In contrast, only 32% (33/105) of the vaccinated animals died. In vaccinated rats that succumbed, there was a doubling of the mean time to death and the cause of death shifted from hepatitis to encephalitis. Rats with a PRNT80 of greater than or equal to 1:40 were protected from clinical disease and histological evidence of hepatic or encephalitic lesions. While the precise mechanisms of immunity against aerosol challenge remain unresolved, here the serum PRNT titre correlated with protection.

1

项与 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的新闻（医药）

2023-10-10

·Endpoints

CEPI puts $25M into Rift Valley fever vaccine; Gates invests in AI for scientists in Africa in equity bid

Plus, Olema and Novartis update an agreement for a breast cancer trial, and Roche shares long-term data for Vabysmo in macular edema. CEPI puts $25M into vaccine for Rift Valley fever: The Coalition for Epidemic Preparedness Innovation is giving $25.9 million to Wageningen Bioveterinary Research to advance a live-attenuated vaccine for Rift Valley fever into a Phase I/IIa trial. CEPI said Tuesday that heavy rain and flooding are linked to outbreaks of the virus, which is primarily spread by mosquitoes in sub-Saharan Africa. “A RVF vaccine will contribute to preparedness for potential virus emergence in yet unaffected regions like Europe,” WBVR’s Paul Wichgers Schreur said in a statement. — Jaimy Lee

疫苗

100 项与 TSI-GSD-200(U.S. Army Medical Research Institute for Infectious Diseases) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
裂谷热	临床2期	-	U.S. Army Medical Research Institute for Infectious Diseases	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00584194 (RVF, CTgov)	临床2期	裂谷热	278	TSI-GSD 200 RVF Vaccine	獵衊獵鏇鏇願選齋簾網(顧淵齋衊衊鏇廠製遞選) = 範醖襯壓鹹製鏇齋築範餘築壓觸衊鹽廠選醖鹹 (廠選鏇鏇鑰憲鑰製構淵, 壓醖遞鹽選鹽齋鏇鹽鏇 ~ 蓋夢顧觸願醖壓積顧廠) 更多	-	2017-07-14