HIV vaccine vCP1521(Sanofi)(HIV vaccine vCP1521(Sanofi))

概要

基本信息

药物类型

减毒活疫苗、预防性疫苗

别名

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-

非在研适应症

HIV感染

原研机构

Sanofi

在研机构-

非在研机构

National Institute of Allergy & Infectious Diseases

Sanofi Pasteur SA

U S Army Medical Research & Development Command

权益机构-

最高研发阶段无进展临床3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 HIV vaccine vCP1521(Sanofi) 相关的临床试验

NCT00098163

/ Completed临床1期IIT

A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.

开始日期-

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+3]

NCT00223080

/ Completed临床3期IIT

A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults

The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

开始日期2003-10-01

申办/合作机构

U S Army Medical Research & Development Command

[+9]

100 项与 HIV vaccine vCP1521(Sanofi) 相关的临床结果

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100 项与 HIV vaccine vCP1521(Sanofi) 相关的转化医学

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100 项与 HIV vaccine vCP1521(Sanofi) 相关的专利（医药）

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12

项与 HIV vaccine vCP1521(Sanofi) 相关的文献（医药）

2014-03-19·Science translational medicine

Polyfunctional Fc-Effector Profiles Mediated by IgG Subclass Selection Distinguish RV144 and VAX003 Vaccines

Article

作者: Dugast, Anne-Sophie ; Michael, Nelson L. ; Brown, Eric ; Alter, Galit ; Pitisuttithum, Punnee ; Choi, Ickwon ; Robinson, Hannah ; Liao, Larry ; Rolland, Morgane ; Kim, Jerome H. ; Ghebremichael, Musie ; Andrews, Charla ; Schoen, Matthew K. ; Bailey-Kellogg, Chris ; Rerks-Ngarm, Supachai ; Streeck, Hendrik ; Lane, Sophie ; Mahan, Alison E. ; Chung, Amy W. ; Kaewkungwal, Jaranit ; Francis, Donald ; Suscovich, Todd J. ; Nitayaphan, Sorachai ; de Souza, Mark S. ; Ackerman, Margaret E.

The human phase 2B RV144 ALVAC-HIV vCP1521/AIDSVAX B/E vaccine trial, held in Thailand, resulted in an estimated 31.2% efficacy against HIV infection. By contrast, vaccination with VAX003 (consisting of only AIDSVAX B/E) was not protective. Because protection within RV144 was observed in the absence of neutralizing antibody activity or cytotoxic T cell responses, we speculated that the specificity or qualitative differences in Fc-effector profiles of nonneutralizing antibodies may have accounted for the efficacy differences observed between the two trials. We show that the RV144 regimen elicited nonneutralizing antibodies with highly coordinated Fc-mediated effector responses through the selective induction of highly functional immunoglobulin G3 (IgG3). By contrast, VAX003 elicited monofunctional antibody responses influenced by IgG4 selection, which was promoted by repeated AIDSVAX B/E protein boosts. Moreover, only RV144 induced IgG1 and IgG3 antibodies targeting the crown of the HIV envelope V2 loop, albeit with limited coverage of breakthrough viral sequences. These data suggest that subclass selection differences associated with coordinated humoral functional responses targeting strain-specific protective V2 loop epitopes may underlie differences in vaccine efficacy observed between these two vaccine trials.

2014-03-01·JAIDS Journal of Acquired Immune Deficiency Syndromes3区 · 医学

The First Pediatric HIV Vaccine Trial in Africa

3区 · 医学

Article

作者: Cao, Huyen ; Guay, Laura ; Kaleebu, Pontiano ; Musoke, Philippa ; Njai, Harr Freeya ; Fowler, Mary Glenn ; Baglyos, Lynn ; Emel, Lynda ; Richardson, Paul ; Ssewanyana, Isaac ; Jones, Norman ; Kintu, Kenneth ; Wang, Lei ; Ou, San-San ; Andrew, Philip ; Jackson, J Brooks

OBJECTIVEMaternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1-infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.DESIGNHIV Prevention Trials Network 027 was a randomized, double-blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1-infected mothers with CD4 counts of >500 cells per microliter, which were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag, and protease gene products.METHODSInfants were vaccinated at birth and 4, 8, and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using interferon-γ enzyme-linked immunosorbent spot, carboxyfluorescein diacetate succinimidyl ester proliferation, intracellular cytokine staining, and binding and neutralizing antibody assays. Fisher exact test was used to compare positive responses between the study arms.RESULTSLow levels of antigen-specific CD4 and CD8 T-cell responses (intracellular cytokine assay) were detected at 24 months (CD4-6/36 vaccine vs. 1/9 placebo; CD8-5/36 vaccine vs. 0/9 placebo) of age. There was a nonsignificant trend toward higher cellular immune response rates in vaccine recipients compared with placebo. There were minimal binding antibody responses and no neutralizing antibodies detected.CONCLUSIONSHIV-1-exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.

2013-05-01·JAIDS Journal of Acquired Immune Deficiency Syndromes3区 · 医学

Feasibility and Safety of ALVAC-HIV vCP1521 Vaccine in HIV-Exposed Infants in Uganda

3区 · 医学

Article

作者: San San Ou ; Jay Brooks Jackson ; Paul Richardson ; Kenneth Kintu ; Sanjay Gurunathan ; Laura Guay ; Sheryl Zwerski ; Lynda Emel ; Lei Wang ; Teopista Nakyanzi ; Philippa Musoke ; Brenda Asiimwe-Kateera ; Mary Glenn Fowler ; Philip Andrew ; Lynn Baglyos

BACKGROUNDThe development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported.METHODSHIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction.RESULTSFrom October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age].CONCLUSIONThe ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.

100 项与 HIV vaccine vCP1521(Sanofi) 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
HIV感染	临床3期	泰国	U S Army Medical Research & Development Command	2003-10-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00223080 (RV144, CTgov)	临床3期	HIV感染	16,402	AIDSVAX+ALVAC-HIV vCP1521 (Vaccine)	築膚壓淵壓網窪獵鹽網(製鹹衊壓觸齋鏇構繭積) = 廠襯醖積淵獵餘鬱鑰選糧遞鹽鹹簾鏇鑰積艱襯 (淵醖襯膚窪顧齋範餘餘, 窪夢築製製繭構鏇淵蓋 ~ 範蓋窪餘齋願膚窪簾鹽) 更多	-	2018-10-19
NCT00223080 (RV144, CTgov)	临床3期	HIV感染	16,402	ALVAC Placebo + AIDSVAX Placebo (Placebo)	築膚壓淵壓網窪獵鹽網(製鹹衊壓觸齋鏇構繭積) = 觸襯範築製網蓋選積觸糧遞鹽鹹簾鏇鑰積艱襯 (淵醖襯膚窪顧齋範餘餘, 廠網選餘範鹽膚願觸衊 ~ 膚衊鹽顧範網鬱餘窪膚) 更多	-	2018-10-19
NCT00223080 (Pubmed \| PLoS One)	临床3期	HIV感染	16,402	ALVAC-HIV (vCP1521)canarypox ALVAC-HIV (vCP1521) (ALVAC-HIV (vCP1521))	顧夢醖壓鹹憲窪鏇繭顧(獵繭繭壓窪齋願構願獵) = 鹹獵遞觸餘繭壓蓋構簾鬱廠襯憲夢鏇窪廠鑰選 (鬱簾鬱鑰簾窪選遞壓顧 ) 更多	-	2011-01-01
NCT00223080 (Pubmed \| PLoS One)	临床3期	HIV感染	16,402	Placebo	顧夢醖壓鹹憲窪鏇繭顧(獵繭繭壓窪齋願構願獵) = 鬱衊繭餘鏇鹹網願糧淵鬱廠襯憲夢鏇窪廠鑰選 (鬱簾鬱鑰簾窪選遞壓顧 ) 更多	-	2011-01-01
IAS2002	N/A	-	45	ALVAC-HIV (vCP1521)	(網夢壓淵艱膚製簾襯獵) = Seven serious adverse events were reported, none attributable to vaccine 鏇餘積網醖糧窪憲簾觸 (鏇襯糧膚製積鏇網鬱構 ) 更多	-	2002-01-01
IAS2002	N/A	-	-	ALVAC-HIV (vCP1521)	繭積襯構積觸窪觸齋膚(製夢構簾顧醖簾鬱願鏇) = 膚顧簾獵網願遞糧蓋鏇壓廠壓遞餘鬱範製艱積 (衊獵繭齋衊壓蓋選遞獵 ) 更多	-	2002-01-01