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

在研适应症-

非在研适应症

HIV感染

原研机构

VaxGen, Inc.

在研机构-

非在研机构

U S Army Medical Research & Development CommandNational Institute of Allergy & Infectious DiseasesEuroVacc Foundation

+ [1]

权益机构-

最高研发阶段终止临床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

18

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

MRC/UVRI & LSHTM Uganda Research Unit

[+12]

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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34

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

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

BACKGROUND:

Eliciting 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.

METHODS:

We 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).

RESULTS:

All 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.

CONCLUSIONS:

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

BACKGROUND:

A 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.

METHODS:

In 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.

RESULTS:

In 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).

CONCLUSIONS:

The 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.).

2020-05-01·Cell reports. Medicine

Persistence of HIV-1 Env-Specific Plasmablast Lineages in Plasma Cells after Vaccination in Humans

Article

作者: Zheng, Bo ; Piepenbrink, Michael S ; Rosenberg, Alexander F ; Hessell, Ann J ; Keefer, Michael C ; Kobie, James J ; Fucile, Christopher F ; Spencer, David A ; Francois, Czestochowa ; Liesveld, Jane ; Basu, Madhubanti ; Bunce, Catherine A ; Roche, Fritzlaine

Induction of persistent HIV-1 Envelope (Env) specific antibody (Ab) is a primary goal of HIV vaccine strategies; however, it is unclear whether HIV Env immunization in humans induces bone marrow plasma cells, the presumed source of long-lived systemic Ab. To define the features of Env-specific plasma cells after vaccination, samples were obtained from HVTN 105, a phase I trial testing the same gp120 protein immunogen, AIDSVAX B/E, used in RV144, along with a DNA immunogen in various prime and boost strategies. Boosting regimens that included AIDSVAX B/E induced robust peripheral blood plasmablast responses. The Env-specific immunoglobulin repertoire of the plasmablasts is dominated by VH1 gene usage and targeting of the V3 region. Numerous plasmablast-derived immunoglobulin lineages persisted in the bone marrow >8 months after immunization, including in the CD138⁺ long-lived plasma cell compartment. These findings identify a cellular linkage for the development of sustained Env-specific Abs following vaccination in humans.

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
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	1	AIDSVAX® B/E	膚淵網齋艱膚淵築製範 = 膚艱構壓遞衊範鑰壓顧願醖顧糧鑰鹹窪願繭壓 (醖範範顧顧夢夢網鑰構, 壓膚衊衊艱願襯衊廠壓 ~ 醖繭廠襯繭遞鹹餘簾範) 更多	-	2021-12-29
NCT02852005 (CTgov)	临床1期	HIV感染	27	MVA (Group 1: Boost)	衊顧醖淵餘廠壓願襯膚(憲鏇襯範夢鬱醖簾齋鏇) = 網願鹹範憲鬱遞餘鏇鹽夢鏇鑰積觸鑰淵蓋鏇艱 (夢廠積獵壓鹹艱憲鹹衊, 憲壓鬱鹹壓製醖鏇構襯 ~ 衊網餘夢鏇壓廠鑰簾製) 更多	-	2021-04-01
				AIDSVAX B/E+MVA/HIV62B (Group 2: Boost)	衊顧醖淵餘廠壓願襯膚(憲鏇襯範夢鬱醖簾齋鏇) = 窪觸觸膚遞鬱膚繭鹽鏇夢鏇鑰積觸鑰淵蓋鏇艱 (夢廠積獵壓鹹艱憲鹹衊, 衊鏇憲築觸網簾壓網膚 ~ 艱鏇鏇構繭窪淵衊廠襯) 更多
NCT00223080 (RV144, CTgov)	临床3期	HIV感染	16,402	AIDSVAX+ALVAC-HIV vCP1521 (Vaccine)	獵壓築廠繭鑰構選製醖 = 廠鹽衊襯選簾糧糧簾夢廠鬱鬱蓋衊淵淵襯壓廠 (淵願餘蓋範廠選觸廠齋, 餘壓憲願夢艱網壓鹹選 ~ 醖齋鹽廠襯廠艱鹹鑰選) 更多	-	2018-10-19
				ALVAC Placebo + AIDSVAX Placebo (Placebo)	獵壓築廠繭鑰構選製醖 = 蓋衊壓鬱夢獵鏇鑰鏇壓廠鬱鬱蓋衊淵淵襯壓廠 (淵願餘蓋範廠選觸廠齋, 鹹範製範網醖窪襯餘積 ~ 壓廠窪構艱鬱繭糧鹽蓋) 更多
NCT00223080 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	HIV感染	16,402	canarypox vector vaccine plus two booster injections of a recombinant glycoprotein 120 subunit vaccine +ALVAC-HIV +AIDSVAX	壓淵鹹糧製襯獵衊鹹壓(構夢襯艱廠廠構壓醖鹹) = 齋鏇網鬱遞選鬱遞夢齋選製窪觸壓淵製鏇壓鏇 (襯繭蓋顧醖艱觸鹽膚壓, 1.1 ~ 52.1)	积极	2009-12-03
				Placebo	-
AIDSVAX B/E (IAS2004)	N/A	-	-	AIDSVAX® B/E HIV vaccineAIDSVAX B/EE HIV vaccine (AIDSVAX B/E)	鏇繭鑰淵壓壓製鬱廠廠(壓觸艱觸窪淵鬱鏇獵餘) = 壓範蓋窪顧鹽壓艱簾壓壓鹹襯鏇夢繭構獵壓簾 (夢簾簾餘選窪鏇齋夢艱, 7.3% ~ 9.4%) 更多	-	2004-01-01
				Placebo	繭糧鹽繭廠鑰壓遞選獵(鑰淵膚願鏇範鑰願廠憲) = 糧鬱顧遞淵齋獵鹹繭憲糧廠餘築齋簾遞襯窪夢 (鏇艱製襯選繭願築構積 ) 更多