(AIDSVAX B/E vaccine(NIAID)) - _专利_临床

概要

基本信息

药物类型

预防性疫苗

别名-

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+ [3]

在研适应症-

非在研适应症

眼部感染HIV感染感染+ [3]

原研机构

National Institute of Allergy & Infectious Diseases

在研机构-

非在研机构

Emergent BioSolutions, Inc.National Institute of Allergy & Infectious DiseasesEuroVacc Foundation

+ [1]

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-

关联

14

项与 AIDSVAX B/E vaccine(NIAID) 相关的临床试验

NCT03618056 / Completed临床1期IIT

A Phase 1b Open Label Clinical Trial to Evaluate HIV-1 Neutralization Antibody Breadth in Response to HIV gp120 Protein Vaccine in HIV-uninfected Adults With Quiescent Systemic Lupus Erythematosus

The purpose of this study is to evaluate the breadth and potency of HIV-1 neutralizing antibody (nAb) responses and examine the safety and tolerability of an HIV gp120 protein vaccine (AIDSVAX® B/E) in HIV-uninfected adults diagnosed with Systemic Lupus Erythematosus (SLE) who have stable disease.

开始日期2018-12-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT03391375 / Completed临床1期IIT

An Open Label Phase I Clinical Trial to Evaluate the Effect of Late Boost on HIV-uninfected Vaccinees From EV06 Trial

EV07 is an open label phase I clinical trial to evaluate the effect of late boost on HIV-uninfected vaccinees from EV06 trial.
The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated. Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection may modulate antibody responses induced by vaccination1.
Based on these preliminary immunogenicity results of the EV06 study, a study with an additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to better investigate and understand the effects of the late boost on the response rate, magnitude and durability of vaccine induced immune responses.
The primary objective of EV07 is to evaluate the ability of the late boost combination of DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody responses.

开始日期2017-03-15

申办/合作机构

EuroVacc Foundation

[+2]

NCT02852005 / Completed临床1期IIT

A Phase 1 Clinical Trial to Evaluate the Immunogenicity of AIDSVAX B/E Bivalent gp120 Vaccine and MVA/HIV62B in Healthy, HIV-1-Uninfected Adult Participants Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.

开始日期2017-01-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 AIDSVAX B/E vaccine(NIAID) 相关的临床结果

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100 项与 AIDSVAX B/E vaccine(NIAID) 相关的转化医学

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100 项与 AIDSVAX B/E vaccine(NIAID) 相关的专利（医药）

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73

项与 AIDSVAX B/E vaccine(NIAID) 相关的文献（医药）

2023-05-08·JCI insight

ALVAC-HIV and AIDSVAX B/E vaccination induce improved immune responses compared with AIDSVAX B/E vaccination alone.

Article

作者: Nitayaphan, Sorachai ; Robb, Merlin L ; Kim, Jerome H ; Phanuphak, Nittaya ; Sinangil, Faruk ; Vasan, Sandhya ; Pitisutthithum, Punnee ; Barrera, Michael D ; Costanzo, Margaret C ; Kim, Dohoon ; Gurunathan, Sanjay ; Eller, Michael A ; Thapa, Pallavi ; Kroon, Eugene ; Schuetz, Alexandra ; Chariyalertsak, Suwat ; Trinh, Hung V ; Akapirat, Siriwat ; Tipsuk, Somporn ; Nails, Barbara ; Ake, Julie A ; Paquin-Proulx, Dominic ; Rao, Mangala ; O'Connell, Robert J ; Sacdalan, Carlo ; Zemil, Michelle ; Shubin, Zhanna ; Kaewboon, Boot ; Wieczorek, Lindsay ; Anenia, Hanna ; Polonis, Victoria R ; Jongrakthaitae, Surat ; Boeckelman, Jacob

The RV144 phase III vaccine trial demonstrated that ALVAC-HIV and AIDSVAX B/E administration over 6 months resulted in 31% efficacy in preventing HIV acquisition, while administration of AIDSVAX B/E alone in both VAX003 and VAX004 studies failed to show efficacy. In this study, we aimed to understand the impact of ALVAC-HIV on the development of cellular, humoral, and functional immune responses compared to the administration of AIDSVAX B/E alone. ALVAC-HIV in combination with 3 doses of AIDSVAX B/E significantly increased CD4+ HIV-specific T cell responses, polyfunctionality, and proliferation compared with 3 doses of AIDSVAX B/E alone. Additionally, Env-specific plasmablasts and A244-specific memory B cells were identified with a significantly higher magnitude in the group that received ALVAC-HIV. Subsequently, data revealed increased magnitude of plasma IgG binding to and avidity for HIV Env in participants who received ALVAC-HIV compared with 3 doses of AIDSVAX B/E alone. Lastly, levels of the Fc-mediated effector functions antibody-dependent cellular cytotoxicity, NK cell activation, and trogocytosis were significantly increased in participants who received ALVAC-HIV compared with those receiving AIDSVAX B/E alone. Taken together, these results suggest that ALVAC-HIV plays an essential role in developing cellular and humoral immune responses to protein-boosted regimens relative to protein alone.

2023-05-01·PLoS pathogens

Viral vector delivered immunogen focuses HIV-1 antibody specificity and increases durability of the circulating antibody recall response.

Article

作者: Rerks-Ngarm, Supachai ; Spreng, Rachel L ; O'Connell, Robert J ; Akapirat, Siriwat ; Vasan, Sandhya ; Karasavvas, Nicos ; Dahora, Lindsay C ; Excler, Jean-Louis ; Wills, Saintedym ; Sawant, Sheetal S ; Pittisuttithum, Punnee ; Robb, Merlin L ; Hope, Thomas J ; Michael, Nelson L ; Easterhoff, David ; Eller, Michael A ; Zhang, Lu ; Tay, Matthew Zirui ; Williams, LaTonya D ; Yates, Nicole L ; Tomaras, Georgia D ; Ferrari, Guido ; Goodman, Derrick ; Montefiori, David C ; Kim, Jerome H ; Stanfield-Oakley, Sherry ; Tenney, DeAnna ; Shen, Xiaoying ; Nitayaphan, Sorachai

The modestly efficacious HIV-1 vaccine regimen (RV144) conferred 31% vaccine efficacy at 3 years following the four-shot immunization series, coupled with rapid waning of putative immune correlates of decreased infection risk. New strategies to increase magnitude and durability of protective immunity are critically needed. The RV305 HIV-1 clinical trial evaluated the immunological impact of a follow-up boost of HIV-1-uninfected RV144 recipients after 6-8 years with RV144 immunogens (ALVAC-HIV alone, AIDSVAX B/E gp120 alone, or ALVAC-HIV + AIDSVAX B/E gp120). Previous reports demonstrated that this regimen elicited higher binding, antibody Fc function, and cellular responses than the primary RV144 regimen. However, the impact of the canarypox viral vector in driving antibody specificity, breadth, durability and function is unknown. We performed a follow-up analysis of humoral responses elicited in RV305 to determine the impact of the different booster immunogens on HIV-1 epitope specificity, antibody subclass, isotype, and Fc effector functions. Importantly, we observed that the ALVAC vaccine component directly contributed to improved breadth, function, and durability of vaccine-elicited antibody responses. Extended boosts in RV305 increased circulating antibody concentration and coverage of heterologous HIV-1 strains by V1V2-specific antibodies above estimated protective levels observed in RV144. Antibody Fc effector functions, specifically antibody-dependent cellular cytotoxicity and phagocytosis, were boosted to higher levels than was achieved in RV144. V1V2 Env IgG3, a correlate of lower HIV-1 risk, was not increased; plasma Env IgA (specifically IgA1), a correlate of increased HIV-1 risk, was elevated. The quality of the circulating polyclonal antibody response changed with each booster immunization. Remarkably, the ALVAC-HIV booster immunogen induced antibody responses post-second boost, indicating that the viral vector immunogen can be utilized to selectively enhance immune correlates of decreased HIV-1 risk. These results reveal a complex dynamic of HIV-1 immunity post-vaccination that may require careful balancing to achieve protective immunity in the vaccinated population. Trial registration: RV305 clinical trial (ClinicalTrials.gov number, NCT01435135). ClinicalTrials.gov Identifier: NCT00223080.

2021-07-01·Vaccine3区 · 医学

AIDSVAX protein boost improves breadth and magnitude of vaccine-induced HIV-1 envelope-specific responses after a 7-year rest period

3区 · 医学

Article

作者: Lama, Javier R ; Cohen, Kristen ; Polakowski, Laura ; Kelley, Colleen F ; Seaton, Kelly E ; Buchbinder, Susan ; Yu, Chenchen ; Sobieszczyk, Magdalena ; Keefer, Michael ; Tomaras, Georgia D ; Elizaga, Marnie ; Robinson, Harriet L ; Miner, Maurine D ; Paez, Carmen ; McElrath, M Juliana ; Maenza, Janine ; Baden, Lindsey R ; Sinangil, Faruk ; De Rosa, Stephen C ; Lee, Carter ; Gulati, Vineeta ; Montefiori, David ; Huang, Yunda ; Casapia, Martin ; Goepfert, Paul

BACKGROUNDEliciting durable humoral immunity with sufficient breadth and magnitude is important for HIV-1 vaccine design. The HVTN 114 vaccine trial evaluated different boost regimens administered after a 7-year rest period in participants previously enrolled in HVTN 205, who received either three MVA/HIV62B (MMM) or two DNA and two MVA/HIV62B (DDMM) injections; both vaccines expressed multiple HIV-1 antigens in non-infectious virus-like-particles. The primary objective of HVTN 114 was to assess the impact of a heterologous gp120 protein AIDSVAX B/E boost on the magnitude, breadth and durability of vaccine-induced immune responses.METHODSWe enrolled 27 participants from HVTN 205 into five groups. Eight participants who previously received MMM were randomized and boosted with either MVA/HIV62B alone (T1; n = 4) or MVA/HIV62B and AIDSVAX B/E (T2; n = 4). Nineteen participants who received DDMM were randomized and boosted with MVA/HIV62B alone (T3; n = 6), MVA/HIV62B and AIDSVAX B/E (T4; n = 6), or AIDSVAX B/E alone (T5; n = 7). Boosts were at months 0 and 4. Participants were followed for safety and immunogenicity for 10 months and were pooled for analysis based on the regimen: MVA-only (T1 + T3), MVA + AIDSVAX (T2 + T4), and AIDSVAX-only (T5).RESULTSAll regimens were safe and well-tolerated. Prior to the boost vaccination, binding antibody and CD4+T-cell responses were observed 7 years after HVTN 205 vaccinations. Late boosting with AIDSVAX, with or without MVA, resulted in high binding antibody responses to gp120 and V1V2 epitopes, with increased magnitude and breadth compared to those observed in HVTN 205. Late boosting with MVA, with or without AIDSVAX, resulted in increased gp140 and gp41 antibody responses and higher CD4+T-cell responses to Env and Gag.CONCLUSIONSLate boosting with AIDSVAX, alone or in combination with MVA, can broaden binding antibody responses and increase T-cell responses even years following the original MVA/HIV62B with or without DNA-priming vaccine.

100 项与 AIDSVAX B/E vaccine(NIAID) 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
系统性红斑狼疮	临床2期	美国	National Institute of Allergy & Infectious Diseases	2018-12-19
HIV感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2001-08-31
眼部感染	临床1期	美国	Emergent BioSolutions, Inc.	2015-03-31
呼吸道感染	临床1期	美国	Emergent BioSolutions, Inc.	2015-03-31
曼氏血吸虫病	临床1期	乌干达	EuroVacc Foundation	2014-09-30
感染	临床前	泰国	National Institute of Allergy & Infectious Diseases	2013-09-24

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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


AIDSVAX B/B vaccine trial (IAS2004)	N/A	HIV感染	291	AIDSVAX® B/B vaccine	網齋膚觸襯鹹膚顧鑰憲(鏇鑰艱醖繭鑰淵顧鹽鹹) = 繭壓製膚鹹齋膚願鑰鬱艱淵膚餘選網鹽襯選繭 (鏇糧衊願築選觸選衊淵 )	不佳	2004-01-01
IAS2002	N/A	-	-	AIDSVAX B/B vaccine	鏇憲蓋網構遞蓋鬱夢願(鹽遞構繭選糧繭鹽獵壓) = Social harms were reported by 3% of volunteers; of these, 97% were resolved and the most common were mild disturbances of personal relationships (63%) 鏇壓顧築鹽鬱淵積衊醖 (襯餘齋選繭膚願壓壓醖 )	积极	2002-01-01
IAS2002	N/A	-	-	Placebo		积极	2002-01-01
NCT03618056 (CTgov)	临床1期	系统性红斑狼疮 \| HIV感染	1	AIDSVAX® B/E	(淵衊選艱艱醖鬱簾選鹽) = 鬱壓簾觸遞憲範淵觸廠簾廠齋襯夢鬱鹹構製夢 (範築餘構夢遞鹹淵蓋窪, 網醖膚觸簾壓糧積遞築 ~ 淵衊鹽艱繭淵網夢衊蓋) 更多	-	2021-12-29
AIDSVAX®B/E vaccine efficacy trial (IAS2002)	N/A	-	-	AIDSVAX®B/E vaccine	範積願廠遞範淵醖繭繭(製鑰製願壓餘鑰衊構壓) = 醖簾選鹹簾壓糧憲構糧艱鬱築製積鏇齋願憲製 (積糧鑰窪齋鏇糧鹹簾壓 )	-	2002-01-01
AIDSVAX®B/E vaccine trial (IAS2002)	N/A	-	-	AIDSVAX®B/E vaccine	壓夢廠醖願膚齋構網觸(齋鏇鑰鬱遞糧膚積顧窪) = 獵選顧艱網艱醖艱醖獵築網遞淵網艱願齋窪糧 (網願餘壓鑰選糧遞遞顧 ) 更多	积极	2002-01-01
AIDSVAX B/E efficacy trial (IAS2008)	N/A	HIV感染	196	AIDSVAX B/E vaccine	網構鹽鬱壓襯醖簾鏇獵(鹽鹹壓願膚遞鹹艱鹽選) = 窪窪鑰鹹醖鑰製鬱願選衊醖醖構鹹衊繭顧鑰窪 (獵齋齋蓋顧蓋夢淵顧顧 )	-	2008-01-01
AIDSVAX B/E (IAS2004)	N/A	-	-	AIDSVAX® B/E HIV vaccine (AIDSVAX B/E)	艱鏇襯構網窪繭廠獵廠(築廠網遞醖獵構觸膚蓋) = 網淵範築壓獵夢膚鬱衊願遞蓋淵鬱夢繭餘夢淵 (鑰齋顧構築淵顧淵構顧, 7.3% ~ 9.4%) 更多	-	2004-01-01
AIDSVAX B/E (IAS2004)	N/A	-	-	Placebo	廠膚艱餘夢範網鹽衊糧(網蓋願襯壓範鹽窪膚憲) = 願構醖築鏇觸網簾鑰鹽構獵築淵艱憲網餘憲窪 (製獵齋鹽餘鏇鹹獵簾淵 ) 更多	-	2004-01-01
NCT02852005 (CTgov)	临床1期	HIV感染	27	MVA (Group 1: Boost)	(積鏇艱齋顧襯網襯簾願) = 顧憲廠襯繭鏇膚艱積窪窪壓鬱範願遞繭製鬱簾 (構積積餘齋夢積蓋膚糧, 齋餘窪襯獵鹽網鹹鬱壓 ~ 網鹽築艱選餘廠鏇窪製) 更多	-	2021-04-01
NCT02852005 (CTgov)	临床1期	HIV感染	27	AIDSVAX B/E+MVA/HIV62B (Group 2: Boost)	(積鏇艱齋顧襯網襯簾願) = 鹽淵蓋鹹鹽顧築襯廠廠窪壓鬱範願遞繭製鬱簾 (構積積餘齋夢積蓋膚糧, 願醖積積憲製製積願鏇 ~ 築遞憲夢網願壓觸膚築) 更多	-	2021-04-01