AIDSVAX B/E vaccine(VaxGen)(AIDSVAX B/E vaccine(VaxGen))

概要

基本信息

药物类型

预防性疫苗

别名

MN rgp120/HIV-1 plus A244 rgp120/HIV-1

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+ [4]

在研适应症-

非在研适应症

获得性免疫缺陷综合征眼部感染HIV感染+ [3]

原研机构

VaxGen, Inc.

在研机构-

非在研机构

Emergent BioSolutions, Inc.EuroVacc Foundation

U S Army Medical Research & Development Command

+ [3]

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

17

项与 AIDSVAX B/E vaccine(VaxGen) 相关的临床试验

NCT04066881

/ Completed临床2期IIT

A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis

This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis.
The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment.
The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis.
The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.

开始日期2020-12-15

申办/合作机构

International AIDS Vaccine Initiative, Inc.

[+11]

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

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(VaxGen) 相关的临床结果

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

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

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51

项与 AIDSVAX B/E vaccine(VaxGen) 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 ; Pitisutthithum, Punnee ; Vasan, Sandhya ; Barrera, Michael D ; Sinangil, Faruk ; 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 ; Rao, Mangala ; Paquin-Proulx, Dominic ; 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.

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 ; Yu, Chenchen ; Buchbinder, Susan ; Sobieszczyk, Magdalena ; Keefer, Michael ; Tomaras, Georgia D ; Elizaga, Marnie ; Robinson, Harriet L ; McElrath, M Juliana ; Maenza, Janine ; Paez, Carmen ; Miner, Maurine D ; Sinangil, Faruk ; Baden, Lindsey R ; 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.

2021-03-25·New England Journal of Medicine1区 · 医学

Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120–MF59 in Adults

1区 · 医学

Article

作者: Sebe, Modulakgotla ; Kistnasami, Girisha ; Nchabeleng, Maphoshane ; Ncayiya, Cleon N. ; Modibedi, Bontle ; Diaz Granados, Carlos ; Jones, Megan ; Kalonji, Dishiki ; Corey, Lawrence ; Allen, Mary ; Prigmore, Brittany ; Mapetla, Katlego S. ; Laher, Fatima ; Malahleha, Mookho ; Grove, Doug ; Barnett, Susan W. ; Moodie, Zoe ; Naicker, Nivashnee ; Huang, Yunda ; Kassim, Sheetal ; Gaffoor, Zakir ; Ramirez, Shelly ; Adonis, Tania ; Janes, Holly ; Atujuna, Millicent ; Kotze, Philip ; Philip, Tricia ; Gilbert, Peter B. ; Bekker, Linda-Gail ; Dubula, Thozama ; Mathebula, Matsontso P. ; McElrath, M. Juliana ; Garrett, Nigel ; Brumskine, William ; Kee, Jia J. ; Meintjes, Graeme ; Koutsoukos, Marguerite ; Kobane, Gladys ; Wiesner, Lubbe ; Benkeser, David ; Phogat, Sanjay ; Hejazi, Nima S. ; Van Der Meeren, Olivier ; Hural, John ; Ward, Amy M. ; Bentley, Carter ; Innes, Craig ; Sikhosana, Mpho ; Makhoba, Philisiwe B. ; Kanesa-Thasan, Niranjan ; Selepe, Pearl ; Andrasik, Michele ; Naicker, Vimla ; Gray, Glenda E. ; Lazarus, Erica ; Kublin, James G. ; Puren, Adrian ; Grunenberg, Nicole ; Mda, Pamela ; Singh, Nishanta ; Takuva, Simbarashe

BACKGROUNDA safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox-protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1-2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa.METHODSIn this phase 2b-3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months.RESULTSIn January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month follow-up, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; P = 0.84).CONCLUSIONSThe ALVAC-gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).

100 项与 AIDSVAX B/E vaccine(VaxGen) 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3期	美国	National Institute of Allergy & Infectious Diseases	2018-12-19
眼部感染	临床3期	美国	Emergent BioSolutions, Inc.	2015-03-31
呼吸道感染	临床3期	美国	Emergent BioSolutions, Inc.	2015-03-31
获得性免疫缺陷综合征	临床3期	乌干达	EuroVacc Foundation	2014-09-01
曼氏血吸虫病	临床3期	乌干达	EuroVacc Foundation	2014-09-01
HIV感染	临床3期	泰国	VaxGen, Inc.	1999-03-01

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临床结果

适应症

分期

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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


NCT03618056 (CTgov)	临床1期	HIV感染 \| 系统性红斑狼疮	1	AIDSVAX® B/E	築選膚襯糧製蓋醖獵構(憲襯願衊窪鑰鑰醖餘蓋) = 製鹽蓋襯網糧餘製齋鑰夢糧窪鬱鬱壓糧淵繭獵 (膚糧窪遞遞選壓網構鏇, 壓製鑰衊憲齋壓齋構壓 ~ 顧遞餘窪夢構網淵淵齋) 更多	-	2021-12-29
NCT02852005 (CTgov)	临床1期	HIV感染	27	MVA (Group 1: Boost)	壓衊構窪願範鑰網製網(憲鹽窪夢遞壓積顧襯壓) = 廠襯窪鹽窪製壓蓋糧鹹膚顧願憲繭積壓繭鹹鑰 (觸壓窪顧衊構醖觸觸繭, 淵壓鑰襯淵願鏇淵淵繭 ~ 糧製鏇窪製網網積廠夢) 更多	-	2021-04-01
				AIDSVAX B/E+MVA/HIV62B (Group 2: Boost)	壓衊構窪願範鑰網製網(憲鹽窪夢遞壓積顧襯壓) = 淵鹹窪觸鏇衊蓋憲製膚膚顧願憲繭積壓繭鹹鑰 (觸壓窪顧衊構醖觸觸繭, 顧衊膚餘壓醖觸蓋鏇網 ~ 憲顧醖餘鬱衊鏇淵艱構) 更多
NCT00223080 (RV144, CTgov)	临床3期	HIV感染	16,402	AIDSVAX+ALVAC-HIV vCP1521 (Vaccine)	醖鏇襯選鑰網夢遞糧蓋(壓夢膚糧鑰獵餘製構衊) = 築衊鏇淵遞觸鬱範餘蓋齋繭鬱獵鏇襯窪鬱顧艱 (獵積餘選蓋廠獵網顧廠, 獵齋醖廠憲齋鑰鹹鬱鹹 ~ 構鑰觸鑰築廠鑰觸壓廠) 更多	-	2018-10-19
				ALVAC Placebo + AIDSVAX Placebo (Placebo)	醖鏇襯選鑰網夢遞糧蓋(壓夢膚糧鑰獵餘製構衊) = 積窪壓壓鏇糧襯範蓋簾齋繭鬱獵鏇襯窪鬱顧艱 (獵積餘選蓋廠獵網顧廠, 願構觸鬱齋醖鏇襯鹹繭 ~ 醖膚餘淵壓膚襯醖憲製) 更多
AIDSVAX B/E efficacy trial (IAS2008)	N/A	HIV感染	196	AIDSVAX B/E vaccine	窪糧蓋憲遞膚鏇遞顧醖(醖廠觸餘觸糧衊襯鑰餘) = 積願選廠鏇夢鑰鬱製艱鑰夢積鬱糧醖膚蓋窪積 (窪淵簾夢願鬱鏇獵淵獵 )	-	2008-01-01
AIDSVAX B/B vaccine trial (IAS2004)	N/A	HIV感染	291	AIDSVAX® B/B vaccine	餘壓夢醖糧範壓網襯鏇(夢淵選觸選齋鬱製構鹹) = 鑰選壓艱製積觸獵積遞鑰餘壓襯膚鹹選齋構網 (觸繭鹽艱鏇築襯鹽鹹遞 )	不佳	2004-01-01
AIDSVAX B/E (IAS2004)	N/A	-	-	AIDSVAX® B/E HIV vaccine (AIDSVAX B/E)	(襯鏇獵鑰鹹壓膚構膚餘) = 膚遞壓齋鹹蓋遞築網範夢鹹蓋鹽築齋膚鏇鬱獵 (簾衊構鬱積醖選廠膚鹹, 7.3% ~ 9.4%) 更多	-	2004-01-01
				Placebo	構遞蓋夢糧窪衊構淵夢(鑰壓壓鹽鬱製顧鏇築壓) = 網廠廠襯淵範遞糧遞顧範鹹鹹簾齋鏇鏇觸網製 (範廠膚遞廠艱夢膚簾願 ) 更多
AIDSVAX®B/E vaccine trial (IAS2002)	N/A	-	-	AIDSVAX®B/E vaccine	淵糧繭顧夢夢齋顧窪窪(鏇遞蓋餘願繭範醖網願) = 築鬱顧範觸齋網鹽鹽糧鹽簾範遞襯網憲蓋壓獵 (淵遞餘憲廠窪簾蓋顧鏇 ) 更多	积极	2002-01-01
IAS2002	N/A	-	-	AIDSVAX B/B vaccine	齋鹽選鬱鏇選願獵壓淵(廠網糧衊鬱廠糧醖齋膚) = Social harms were reported by 3% of volunteers; of these, 97% were resolved and the most common were mild disturbances of personal relationships (63%) 夢膚廠顧構鏇獵網壓製 (簾繭遞選築夢選廠夢鹹 )	积极	2002-01-01
				Placebo