DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases)(DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases))

概要

基本信息

药物类型

DNA疫苗、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

HIV感染

非在研适应症

获得性免疫缺陷综合征曼氏血吸虫病

原研机构

National Institute of Allergy & Infectious Diseases

在研机构

National Institute of Allergy & Infectious Diseases

非在研机构

EuroVacc Foundation

最高研发阶段临床2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

9

项与 DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases) 相关的临床试验

NCT04844775

/ Active, not recruiting临床1期IIT

EHVA P01/ANRS VRI08: A Prophylactic HIV Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Clade C DREP Alone and in Combination With a Clade C ENV Protein in Healthy HIV-uninfected Adults

EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.

开始日期2022-08-05

申办/合作机构

ANRS, Emerging Infectious Diseases

[+6]

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.

[+10]

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 DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases) 相关的临床结果

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100 项与 DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases) 相关的转化医学

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100 项与 DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases) 相关的专利（医药）

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2

项与 DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases) 相关的文献（医药）

2024-11-01·EClinicalMedicine

Safety and immunogenicity of CD40.HIVRI.Env, a dendritic cell-based HIV vaccine, in healthy HIV-uninfected adults: a first-in-human randomized, placebo-controlled, dose-escalation study (ANRS VRI06)

Article

作者: Cardinaud, Sylvain ; Diallo, Alpha ; Hardel, Lucile ; Zurawski, Gerard ; Ding, Song ; Pantaleo, Giuseppe ; Tomaras, Georgia D ; Wiedemann, Aurélie ; Zurawski, Sandra ; Moog, Christiane ; Thiebaut, Rodolphe ; Rieux, Véronique ; Levy, Yves ; Richert, Laura ; Centlivre, Mireille ; Durand, Mélany ; Candotti, Fabio ; Lacabaratz, Christine ; Lelièvre, Jean-Daniel ; Launay, Odile

Background:

Current HIV prophylactic vaccines evaluate HIV Env as purified proteins. CD40.HIVRI.Env is an innovative antigen delivery targeting gp140 Env from HIV Clade C 96ZM651 to CD40-expressing antigen-presenting cells, thus harnessing the intrinsic immune-stimulant properties. DNA-HIV-PT123 vaccine encodes 96ZM651 gp140/Gag and 97CN54 Pol/Nef.

Methods:

Seventy-two HIV-negative volunteers were enrolled between 05/2021 and 10/2022 in a phase 1 placebo-controlled trial conducted in France and Switzerland (N° EudraCT: 2020-001814-40; NCT04842682). Volunteers were randomized (5:1 active versus placebo) in groups receiving either 0.3, 1.0, or 3.0 mg CD40.HIVRI.Env (Hiltonol® adjuvanted) alone or co-administered with DNA-HIV-PT123 at weeks (W) 0, 4, and 24. Safety and immunogenicity were monitored until W48. The primary safety endpoint was the proportion of participants per dose cohort and randomized arm without any grade 3 or 4 biological (abnormal laboratory values), or clinical local or systemic solicited, or unsolicited adverse events between W0 and W48 considered to be related or possibly related to the investigational products.

Findings:

CD40.HIVRI.Env was well tolerated. Env-specific CD4⁺ T-cells (IL-2⁺ or IFN-γ⁺ or TNF⁺) were detected in all vaccinees from W6 to W26 and persisted until W48 without a dose-response signal or an effect of DNA-HIV-PT123 co-administration. At W26, IgG response rates (RR) against autologous and nine heterologous gp120/gp140 were 89-100% across all groups and 56-100% at W48. RR against 96ZM651gp70V1V2 were high (90-100%) at W6 and W26 in all groups. Tier1A MW965.26 neutralizing antibody (nAb) titres were detectable in 50-100% of vaccinated individuals at W26, with a dose-response signal, while one volunteer developed nAbs against five Tier2 viruses.

Interpretation:

CD40.HIVRI.Env alone or administered with DNA-HIV-PT123 was safe and induced early, and sustained anti-Env cellular and V1V2 IgG responses, identified as correlates of protection in the RV144 trial. CD40 targeting Env-based vaccines may be instrumental for inducing protective vaccine responses in prime-boost strategies.

Funding:

ANRS Emerging infectious diseases (ANRS MIE); Vaccine Research Institute (VRI).

2024-08-01·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Safety and Immunogenicity of a DNA Vaccine With Subtype C gp120 Protein Adjuvanted With MF59 or AS01B: A Phase 1/2a HIV-1 Vaccine Trial

Article

作者: Church, E Chandler ; Gray, Glenda E ; Pantaleo, Giuseppe ; Tomaras, Georgia D ; Church, E. Chandler ; Ferrari, Guido ; McElrath, M. Juliana ; Robinson, Samuel T ; Gray, Glenda E. ; Dintwe, One ; Hosseinipour, Mina C ; Van Der Meeren, Olivier ; Hutter, Julia ; Huang, Yunda ; deCamp, Allan ; Kublin, James G. ; Seaton, Kelly E. ; Andersen-Nissen, Erica ; Jones, Megan ; Heptinstall, Jack ; Jensen, Ryan L ; Monaco, Cynthia L ; Gilbert, Peter B. ; Kublin, James G ; Hosseinipour, Mina C. ; Ding, Song ; Gilbert, Peter B ; Tomaras, Georgia D. ; Jensen, Ryan L. ; Grunenberg, Nicole ; Corey, Lawrence ; Garrett, Nigel ; Seaton, Kelly E ; Lu, Huiyin ; Robinson, Samuel T. ; Monaco, Cynthia L. ; McElrath, M Juliana ; Koutsoukos, Marguerite ; Mann, Philipp

Background::

An effective vaccine is required to end the HIV pandemic. We evaluated the safety and immunogenicity of a DNA (DNA-HIV-PT123) vaccine with low- or high-dose bivalent (TV1.C and 1086.C glycoprotein 120) subtype C envelope protein combinations, adjuvanted with MF59 or AS01B.

Methods::

HIV Vaccine Trials Network (HVTN)108 was a randomized, placebo-controlled, double-blind, phase 1/2a trial conducted in the United States and South Africa. HIV-negative adults were randomly assigned to 1 of 7 intervention arms or placebo to assess DNA prime with DNA/protein/adjuvant boosts, DNA/protein/adjuvant co-administration, and low-dose protein/adjuvant regimens. HVTN111 trial participants who received an identical regimen were also included. Outcomes included safety and immunogenicity 2 weeks and 6 months after final vaccination.

Results::

From June 2016 to July 2018, 400 participants were enrolled (N = 334 HVTN108, N = 66 HVTN111); 370 received vaccine and 30 received placebo. There were 48 grade 3 and 3 grade 4 reactogenicity events among 39/400 (9.8%) participants, and 32 mild/moderate-related adverse events in 23/400 (5.8%) participants. All intervention groups demonstrated high IgG response rates (>89%) and high magnitudes to HIV-1 Env gp120 and gp140 proteins; response rates for AS01B-adjuvanted groups approached 100%. V1V2 IgG magnitude, Fc-mediated functions, IgG3 Env response rates, and CD4+T-cell response magnitudes and rates were higher in the AS01B-adjuvanted groups. The AS01B-adjuvanted low-dose protein elicited greater IgG responses than the higher protein dose.

Conclusions::

The vaccine regimens were generally well tolerated. Co-administration of DNA with AS01B-adjuvanted bivalent Env gp120 elicited the strongest humoral responses; AS01B-adjuvanted regimens elicited stronger CD4+T-cell responses, justifying further evaluation.ClinicalTrials.gov registration: NCT02915016, registered 26 September 2016.

100 项与 DNA-HIV-PT123 vaccine(National Institute of Allergy & Infectious Diseases) 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	美国	National Institute of Allergy & Infectious Diseases	2016-12-07
HIV感染	临床2期	南非	National Institute of Allergy & Infectious Diseases	2016-12-07
获得性免疫缺陷综合征	临床1期	乌干达	EuroVacc Foundation	2014-09-01
曼氏血吸虫病	临床1期	乌干达	EuroVacc Foundation	2014-09-01

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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


NCT02915016 (HVTN108, Pubmed)	临床1/2期	HIV感染辅助 \| 辅助 \| 辅助	400	DNA-HIV-PT123 vaccine with low-dose bivalent subtype C envelope protein adjuvanted with MF59	鑰廠醖齋鏇夢鹽鬱糧鏇(餘壓範顧憲製獵觸衊觸) = 48 grade 3 reactogenicity events among 39/400 (9.8%) participants 衊夢膚衊壓鹽遞衊蓋餘 (夢膚遞夢構鹹鹹範窪範 ) 更多	积极	2024-08-01
				DNA-HIV-PT123 vaccine with high-dose bivalent subtype C envelope protein adjuvanted with MF59
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)	鹹願顧網顧鏇遞獵鏇鑰(構顧淵膚蓋製憲淵築餘) = 築餘構範壓築願襯蓋艱鬱糧蓋繭廠糧繭衊簾觸 (蓋艱築範鑰鏇鑰築網遞, 窪積鬱簾齋淵艱膚遞遞 ~ 衊鏇鏇網簾製齋憲齋範) 更多	-	2020-09-16
				Placebo+Bivalent Subtype C gp120/AS01B vaccine+DNA-HIV-PT123 vaccine (Group 2: DNA-HIV-PT123 + Placebo + Protein/AS01B)	鹹願顧網顧鏇遞獵鏇鑰(構顧淵膚蓋製憲淵築餘) = 衊淵憲鏇鑰淵鬱築廠鏇鬱糧蓋繭廠糧繭衊簾觸 (蓋艱築範鑰鏇鑰築網遞, 衊憲夢觸襯壓鏇衊鹹網 ~ 醖觸膚窪築醖糧餘鏇醖) 更多