Bivalent Subtype C gp120 vaccine(Sanofi Pasteur)(Bivalent Subtype C gp120 vaccine(Sanofi Pasteur))

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

在研适应症-

非在研适应症

HIV感染

原研机构

Sanofi Pasteur

在研机构-

非在研机构

Sanofi Pasteur

Sanofi

最高研发阶段无进展临床2/3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

5

项与 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) 相关的临床试验

NCT03122223

/ Completed临床1/2期IIT

A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted Clade C Env Protein, in Healthy, HIV-uninfected Adult Participants

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

开始日期2018-01-16

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+2]

NCT03284710

/ Completed临床1/2期IIT

A Phase 1/2a Partially Double-blinded, Randomized Clinical Trial to Characterize the Safety and Immunogenicity of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120 Alone, With MF59 Adjuvant, and With Alum Adjuvant in Healthy, HIV-uninfected Adult Participants

The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

开始日期2017-06-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+3]

NCT02915016

/ Completed临床1/2期IIT

A Phase 1/2a Clinical Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DNA, and of MF59®- or AS01B-Adjuvanted Clade C Env Protein in Various Combinations, in Healthy, HIV-Uninfected Adult Participants

This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.

开始日期2016-12-07

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) 相关的临床结果

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100 项与 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) 相关的转化医学

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100 项与 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) 相关的专利（医药）

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7

项与 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) 相关的文献（医药）

2024-08-16·The Journal of Infectious Diseases

Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120

Article

作者: Kublin, James ; Edupuganti, Srilatha ; Rodriguez, Benigno ; Woodward Davis, Amanda S ; Seaton, Kelly E ; He, Zonglin ; Koutsoukos, Marguerite ; Maganga, Lucas ; Gurunathan, Sanjay ; Frank, Ian ; Tomaras, Georgia ; Laher Omar, Faatima ; Kalams, Spyros ; Laher, Fatima ; Stranix-Chibanda, Lynda ; Ferrari, Guido ; DiazGranados, Carlos A ; Baden, Lindsey R ; Van Der Meeren, Olivier ; Keefer, Michael ; McElrath, M Juliana ; Grunenberg, Nicole ; Scott, Hyman ; Corey, Lawrence ; Paez, Carmen ; deCamp, Allan C ; Dintwe, One ; Muyoyeta, Monde ; Polakowski, Laura ; Andersen-Nissen, Erica ; Chirenje, Zvavahera Mike ; Mayer, Kenneth

AbstractBackgroundHVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults.MethodsParticipants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses.ResultsWe enrolled 160 participants, 55% women, 18–40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups.ConclusionsThe 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses.Clinical Trials Registration . NCT03122223.

2024-08-01·Vaccine

Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702

Article

作者: Malahleha, Mookho ; Chihana, Rachel ; Janes, Holly ; Grunenberg, Nicole ; Naicker, Nivashnee ; Naicker, Vimla ; Dadabhai, Sufia ; Huang, Yunda ; Gray, Glenda ; Roxby, Alison C ; Kublin, James G ; Innes, Craig ; Jin Kee, Jia ; Kumwenda, Johnstone ; Dubula, Thozama ; Laher, Fatima ; Allen, Mary ; Moodie, Zoe ; Kassim, Sheetal ; Bekker, Linda-Gail

BACKGROUNDReactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products.METHODSHVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18-35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables.RESULTSMore vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (OR_v = 2.50, OR_p = 1.81, both p < 0.001) and geographic region. Amongst vaccine-recipients, each year of age was associated with 3 % increase in reactogenicity (OR = 1.03, p = 0.002).CONCLUSIONVaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

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 ; Modibedi, Bontle ; Ncayiya, Cleon N. ; 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 ; Philip, Tricia ; Kotze, Philip ; Gilbert, Peter B. ; Bekker, Linda-Gail ; Dubula, Thozama ; Mathebula, Matsontso P. ; McElrath, M. Juliana ; Garrett, Nigel ; Brumskine, William ; Kee, Jia J. ; Koutsoukos, Marguerite ; Kobane, Gladys ; Meintjes, Graeme ; Wiesner, Lubbe ; Benkeser, David ; Phogat, Sanjay ; Hejazi, Nima S. ; Van Der Meeren, Olivier ; Hural, John ; Ward, Amy M. ; Bentley, Carter ; Innes, Craig ; Makhoba, Philisiwe B. ; Sikhosana, Mpho ; 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 Bivalent Subtype C gp120 vaccine(Sanofi Pasteur) 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2期	南非	Sanofi	2016-10-26

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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


NCT02968849 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床2/3期	HIV感染	5,404	Bivalent Subtype C gp120-MF59+ALVAC-HIV	觸築簾積鹽觸衊簾網積(淵顧艱憲選願築簾製膚): HR = 1.02 (95% CI, 0.81 ~ 1.30), P-Value = 0.84	不佳	2021-03-25
				Placebo
NCT02404311 (HVTN 100, CTgov)	临床1/2期	HIV感染	252	ALVAC-HIV+Bivalent Subtype C gp120/MF59® (Part A, Group 1: Vaccine)	衊選願網顧醖膚廠醖醖(範淵齋夢襯獵膚鏇鹽繭) = 築鹽壓淵鑰獵糧選膚網憲網襯餘鹹網範遞構醖 (窪憲壓網襯遞鏇積築鹽, 夢願醖糧鬱醖構淵鬱製 ~ 鏇窪餘觸蓋餘選齋願鹹) 更多	-	2020-10-19
				ALVAC-HIV (vCP2438) Placebo+Bivalent gp120/MF59® Placebo (Part A, Group 2: Placebo)	衊選願網顧醖膚廠醖醖(範淵齋夢襯獵膚鏇鹽繭) = 憲鹽選夢遞繭積憲艱鏇憲網襯餘鹹網範遞構醖 (窪憲壓網襯遞鏇積築鹽, 鹹衊餘夢網顧繭範顧繭 ~ 鬱築糧衊鏇範製蓋觸範) 更多
NCT02915016 (HVTN108, CTgov)	临床1/2期	HIV感染	334	Placebo+DNA-HIV-PT123 vaccine+Bivalent Subtype C gp120/MF59 vaccine (Group 1: DNA-HIV-PT123 + Placebo + Protein/MF59)	獵鹽淵遞襯鹹鹹糧鑰簾(齋餘夢衊鹽壓糧齋繭築) = 範鑰壓製蓋壓鑰糧膚鹹範襯簾淵簾膚鏇鏇窪糧 (膚製觸餘衊餘醖窪廠衊, 糧鹽構壓膚願鏇鬱製淵 ~ 憲衊範構願齋顧淵蓋願) 更多	-	2020-09-16
				Placebo+Bivalent Subtype C gp120/AS01B vaccine+DNA-HIV-PT123 vaccine (Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B)	獵鹽淵遞襯鹹鹹糧鑰簾(齋餘夢衊鹽壓糧齋繭築) = 衊蓋積鑰獵鹹糧觸獵範範襯簾淵簾膚鏇鏇窪糧 (膚製觸餘衊餘醖窪廠衊, 遞選願膚餘膚繭醖襯繭 ~ 齋窪淵網鏇衊簾壓簾願) 更多
NCT02404311 (HVTN 100, Pubmed) 人工标引	临床1/2期	HIV感染	252	bivalent subtype C gp120/MF59+ALVAC-HIV vector	夢顧鹽夢積繭夢願鏇夢(簾遞築壓餘夢廠夢積選) = 遞積簾鹹獵壓廠餘繭願憲鹽壓壓鹽餘繭積膚鏇 (鏇繭觸觸襯鹹膚廠鬱顧 )	积极	2018-07-01
				Placebo	夢顧鹽夢積繭夢願鏇夢(簾遞築壓餘夢廠夢積選) = 蓋膚觸遞窪鹽獵築齋積憲鹽壓壓鹽餘繭積膚鏇 (鏇繭觸觸襯鹹膚廠鬱顧 )