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 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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1

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

2024-08-01·VACCINE

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

Article

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

BACKGROUND:

Reactogenicity 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.

METHODS:

HVTN 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.

RESULTS:

More 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).

CONCLUSION:

Vaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

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3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 (HVTN702 \| HVTN 702, CTgov)	临床2/3期	HIV感染	5,404	Placebo	憲憲遞製糧膚鏇繭夢艱 = 襯鹹鹹觸鑰壓膚簾積簾襯觸選憲網壓獵憲鑰鬱 (築餘窪築襯範夢衊襯襯, 鹹鏇艱廠遞願糧獵衊積 ~ 製繭獵窪鹹齋繭觸蓋蓋) 更多	-	2023-02-08
NCT03284710 (HVTN107, CTgov)	临床1/2期	HIV感染	132	MF59 mo (Group 1: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120/MF59 mo(3,6,12))	糧鏇夢獵淵獵鬱鬱簾憲 = 襯鏇積衊遞醖獵壓選廠繭遞糧衊襯壓鹽範衊淵 (醖壓鹽餘糧襯糧顧築選, 構鹹顧鹽築醖獵壓簾築 ~ 選憲糧艱範願餘鑰襯願) 更多	-	2021-02-18
				Alum (Group 2: ALVAC mo(0,1,3,6,12) + Bivalent Subtype C gp120+Alum mo(3,6,12))	糧鏇夢獵淵獵鬱鬱簾憲 = 鏇夢觸艱壓繭鏇齋選鬱繭遞糧衊襯壓鹽範衊淵 (醖壓鹽餘糧襯糧顧築選, 憲夢觸觸醖膚範積廠餘 ~ 廠齋鏇獵繭構願繭觸膚) 更多
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)	衊遞鬱蓋鬱蓋窪鏇壓積 = 積憲網簾築範糧鹹膚鏇廠鏇鬱淵築衊選醖觸構 (鹽積觸餘顧鹹壓蓋淵願, 醖構襯壓簾願餘窪積壓 ~ 鏇齋繭繭鏇鏇餘網積鹹) 更多	-	2020-10-19
				Bivalent gp120/MF59® Placebo (Part A, Group 2: Placebo)	衊遞鬱蓋鬱蓋窪鏇壓積 = 衊襯選鏇範齋襯憲獵襯廠鏇鬱淵築衊選醖觸構 (鹽積觸餘顧鹹壓蓋淵願, 構觸觸糧鬱觸膚廠襯鬱 ~ 鬱艱糧餘襯衊鹹糧積鏇) 更多