Malaria vaccine(GlaxoSmithKline Plc)(Malaria vaccine(GlaxoSmithKline Plc))

概要

基本信息

药物类型

重组载体疫苗、预防性疫苗

别名

Malaria vaccine

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-

非在研适应症

疟疾

原研机构

GSK Plc

在研机构-

非在研机构

Crucell Holland B.V.

GSK Plc

权益机构

Protein Potential LLC

Aduro BioTech, Inc.

最高研发阶段无进展临床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 Malaria vaccine(GlaxoSmithKline Plc) 相关的临床试验

NCT01366534

/ Completed临床2期

Safety, Immunogenicity and Efficacy Against Malaria in the Sporozoite Challenge Model of One Dose of Ad35.CS.01 Malaria Vaccine Followed by Two Doses of Malaria 257049 Vaccine in Healthy Malaria-naïve Adults

This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.

开始日期2011-08-10

申办/合作机构

GSK Plc

[+2]

NCT01397227

/ Completed临床1/2期

A Phase I/IIa, Double-blind, Randomized, Placebo-controlled, Dose-escalation Clinical Study Evaluating Safety, Tolerability and Immunogenicity of Two Dose Levels of Recombinant Adenoviral Serotype Ad35 and Serotype Ad26 Vectors Expressing the Malaria Plasmodium Falciparum Circumsporozoite Antigen Administered as Heterologous Prime-boost Regimen, and Assessing Protective Efficacy of the Higher Dose in a Malaria Challenge Model in Unblinded Conditions

The purpose of this study is to assess the safety, tolerability and immunogenicity of two dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad) Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the protective efficacy of the higher dose level in an experimental malaria challenge.
The study will be in 3 phases:
a dose escalation / vaccination phase in which both dose levels will be tested
a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01 5x10^10 vp dose level, together with six infectivity control subjects, will be exposed to experimental challenge with Plasmodium falciparum
a long term follow up phase in which all subjects who received active vaccine from both dose levels and/or malaria challenge will be included

开始日期2011-06-01

申办/合作机构

Crucell Holland B.V.

[+2]

100 项与 Malaria vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Malaria vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Malaria vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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3

项与 Malaria vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2013-12-01·Human vaccines & immunotherapeutics3区 · 医学

Randomized, placebo-controlled trial to assess the safety and immunogenicity of an adenovirus type 35-based circumsporozoite malaria vaccine in healthy adults

3区 · 医学

Article

作者: Mackey, Sally ; Dekker, Cornelia L ; Edwards, Kathryn M ; Murray-Krezan, Cristina ; Creech, C Buddy ; Ho, Dora ; Brown, Valerie ; Hendriks, Jenny ; Versteege, Isabella ; Dally, Leonard G ; Grazia Pau, Maria ; Phillips, Shanda

Malaria results in over 650,000 deaths each year; thus, there is an urgent need for an effective vaccine. Pre-clinical studies and recently reported human trials suggest that pre-erythrocytic stage vaccines can provide protection against infection. A Phase 1, randomized, placebo-controlled, dose-escalation study was conducted with a vaccine composed of a replication-deficient adenovirus-35 backbone with P. falciparum circumsporozoite (CS) surface antigen (Ad35.CS.01). Healthy adult subjects received three doses of 10 (8), 10 (9), 10 (10), or 10 (11) vp/mL Ad35.CS.01 vaccine or saline placebo intramuscularly at 0, 1, and 6-mo intervals. Adverse events were assessed and anti-CS antibody responses were determined by ELISA. Seventy-two individuals were enrolled, with age, gender, and ethnicity similar across each study arm. While the vaccine was generally well tolerated, adverse events were more frequent in the highest dose groups (10 (10) and 10 (11) vp/mL). More robust humoral responses were also noted at the highest doses, with 73% developing a positive ELISA response after the three dose series of 10 (11) vp/mL. The Ad35.CS.01 vaccine was most immunogenic at the highest dosages (10 (10) and 10 (11) vp/mL). Reactogenicity findings were more common after the 10 (11) vp/mL dose, although most were mild or moderate in nature and resolved without therapy.

PLoS ONE3区 · 综合性期刊

A Phase 1b Randomized, Controlled, Double-Blinded Dosage-Escalation Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Burkinabe Healthy Adults 18 to 45 Years of Age

3区 · 综合性期刊

ArticleOA

作者: Esperance Ouédraogo ; Noelie Henri ; David Kangoye ; Sodiomon B. Sirima ; Jerald Sadoff ; Nora L. Watson ; Issiaka Soulama ; Jenny Hendriks ; Adama Gansane ; Valerie Brown ; Edison Wiesken ; Alphonse Ouédraogo ; Jean Baptiste Yaro ; Edith C. Bougouma ; Isabella Versteege ; Amadou T. Konate ; Issa Nebie ; Amidou Diarra ; Youssouf Kaboré ; Souleymane Sanon ; Maria Grazia Pau ; Désiré Kargougou ; Alfred B. Tiono

BACKGROUNDAd35.CS.01 is a pre-erythrocytic malaria candidate vaccine. It is a codon optimized nucleotide sequence representing the P. falciparum circumsporozoite (CS) surface antigen inserted in a replication deficient Adenovirus 35 backbone. A Phase 1a trial has been conducted in the USA in naïve adults and showed that the vaccine was safe. The aim of this study is to assess the safety and immunogenicity of ascending dosages in sub Saharan Africa.METHODSA double blind, randomized, controlled, dose escalation, phase Ib trial was conducted in a rural area of Balonghin, the Saponé health district (Burkina Faso). Forty-eight healthy adults aged 18-45 years were randomized into 4 cohorts of 12 to receive three vaccine doses (day 0, 28 and 84) of 10(9), 10(10), 5X10(10), 10(11) vp of Ad35.CS.01 or normal saline by intra muscular injection. Subjects were monitored carefully during the 14 days following each vaccination for non serious adverse events. Severe and serious adverse events were collected throughout the participant study duration (12 months from the first vaccination). Humoral and cellular immune responses were measured on study days 0, 28, 56, 84, 112 and 140.RESULTSOf the forty-eight subjects enrolled, forty-four (91.7%) received all three scheduled vaccine doses. Local reactions, all of mild severity, occurred in thirteen (27.1%) subjects. Severe (grade 3) laboratory abnormalities occurred in five (10.4%) subjects. One serious adverse event was reported and attributed to infection judged unrelated to vaccine. The vaccine induced both antibody titers and CD8 T cells producing IFNγ and TNFα with specificity to CS while eliciting modest neutralizing antibody responses against Ad35.CONCLUSIONStudy vaccine Ad35.CS.01 at four different dose levels was well-tolerated and modestly immunogenic in this population. These results suggest that Ad35.CS.01 should be further investigated for preliminary efficacy in human challenge models and as part of heterologous prime-boost vaccination strategies.TRIAL REGISTRATIONClinicalTrials.gov NCT01018459 http://clinicaltrials.gov/ct2/show/NCT01018459.

PLOS ONE3区 · 综合性期刊

Ad35.CS.01 - RTS,S/AS01 Heterologous Prime Boost Vaccine Efficacy against Sporozoite Challenge in Healthy Malaria-Naïve Adults

3区 · 综合性期刊

ArticleOA

作者: Moris, Philippe ; Cummings, James ; Tosh, Donna ; Murphy, Jitta ; Vekemans, Johan ; Ballou, W Ripley ; Vanloubbeeck, Yannick ; Regules, Jason ; Sedegah, Martha ; Moon, James ; Cowden, Jessica ; Sadoff, Jerold ; Lee, Cynthia ; Cohen, Joe ; Birkett, Ashley ; Kamau, Edwin ; Voss, Gerald ; Oliver, Thomas ; Kathcart, April ; Guerra Mendoza, Yolanda ; Paolino, Kristopher ; Ockenhouse, Christian F ; Laurens, Matthew ; Lyke, Kirsten ; Pau, Maria Grazia ; Jongert, Erik ; Komisar, Jack ; Wille-Reece, Ulrike ; Lievens, Marc ; Versteege, Isabella ; Heerwegh, Dirk ; Chhoeu, Austin ; Hendriks, Jenny ; Weltzin, Rich

METHODSIn an observer blind, phase 2 trial, 55 adults were randomized to receive one dose of Ad35.CS.01 vaccine followed by two doses of RTS,S/AS01 (ARR-group) or three doses of RTS,S/AS01 (RRR-group) at months 0, 1, 2 followed by controlled human malaria infection.RESULTSARR and RRR vaccine regimens were well tolerated. Efficacy of ARR and RRR groups after controlled human malaria infection was 44% (95% confidence interval 21%-60%) and 52% (25%-70%), respectively. The RRR-group had greater anti-CS specific IgG titers than did the ARR-group. There were higher numbers of CS-specific CD4 T-cells expressing > 2 cytokine/activation markers and more ex vivo IFN-γ enzyme-linked immunospots in the ARR-group than the RRR-group. Protected subjects had higher CS-specific IgG titers than non-protected subjects (geometric mean titer, 120.8 vs 51.8 EU/ml, respectively; P = .001).CONCLUSIONSAn increase in vaccine efficacy of ARR-group over RRR-group was not achieved. Future strategies to improve upon RTS,S-induced protection may need to utilize alternative highly immunogenic prime-boost regimens and/or additional target antigens.TRIAL REGISTRATIONClinicalTrials.gov NCT01366534.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
疟疾	临床2期	美国	Crucell Holland B.V.	2011-06-01

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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


NCT01366534 (Ad35.CS.01, CTgov)	临床2期	疟疾	67	GSK Biologicals' malaria vaccine 257049 (2 doses)+Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01) (Ad35.CS.01 Group)	鬱廠願醖鏇壓獵獵網壓(網壓窪觸窪憲願積積艱) = 積蓋鏇範繭鹹網鹽齋觸齋襯顧餘淵範繭餘鏇網 (膚憲觸壓艱簾膚餘簾艱, 獵觸襯膚範築鏇壓鹽積 ~ 築鑰糧醖鹹鏇顧淵鬱鬱) 更多	-	2017-06-09
				GSK Biologicals' malaria vaccine 257049 (3 doses) (GSK257049 Group)	鬱廠願醖鏇壓獵獵網壓(網壓窪觸窪憲願積積艱) = 窪壓築簾衊襯齋鑰齋艱齋襯顧餘淵範繭餘鏇網 (膚憲觸壓艱簾膚餘簾艱, 選簾夢壓鹹繭淵鹹鏇齋 ~ 顧觸鏇積築繭艱淵鹹艱) 更多
NCT01366534 (Pubmed \| J Biol Chem \| PLoS One) 人工标引	临床2期	疟疾	55	Ad35.CS.01+RTS,S/AS01	鬱鏇範觸構顧鹹觸鑰網(蓋蓋鏇範鏇膚積積醖遞) = 蓋窪觸積構鏇繭襯鑰蓋願醖蓋窪齋憲餘觸簾壓 (網築鏇齋淵積醖夢夢淵, 21 ~ 60)	不佳	2015-07-06
				RTS,S/AS01	鬱鏇範觸構顧鹹觸鑰網(蓋蓋鏇範鏇膚積積醖遞) = 鏇顧顧觸壓齋築網蓋壓願醖蓋窪齋憲餘觸簾壓 (網築鏇齋淵積醖夢夢淵, 25 ~ 70)