A244(A244) - 在研适应症：获得性免疫缺陷综合征，HIV感染_专利_临床

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

获得性免疫缺陷综合征HIV感染

非在研适应症-

原研机构

U S Army Medical Research & Development Command

在研机构

U S Army Medical Research & Development Command

Case Western Reserve University

University of Maryland Baltimore County

+ [2]

非在研机构-

最高研发阶段临床1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

2

项与 A244 相关的临床试验

NCT05423418 / Recruiting临床1期IIT

A Phase 1 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Ranging Doses of ALFQ Adjuvant in a Candidate HIV Vaccine Containing A244 and B.65321

This study will evaluate the safety and tolerability (including reactogenicity) of candidate vaccine A244/B.63521 with Army Liposome Formulation (ALF) mixed with the saponin QS-21(Quillaja saponaria-21) (ALFQ) adjuvant. The purpose of this phase I randomized, double-blind clinical trial is to optimize vaccine adjuvant ALFQ dosing by assessing safety, reactogenicity, and immunogenicity. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Sixty human immunodeficiency virus (HIV) negative participants will be enrolled to one of three arms. Vaccinations via intramuscular (IM) injection will occur at months 0, 1, and 2. All participants will receive A244 and B.63521 (300 micrograms of each). In addition, Arm 1 will receive 200 micrograms of ALFQ. Arm 2 will receive 100 micrograms of ALFQ. Arm 3 will receive 50 micrograms of ALFQ.

开始日期2022-08-29

申办/合作机构

U S Army Medical Research & Development Command

[+2]

NCT04658667 / Recruiting临床1期IIT

Randomized, Double Blind Evaluation of Late Boost Strategies With IHV01 (FLSC in Aluminum Phosphate) and A244 With or Without ALFQ for HIV-uninfected Participants in the HIV Vaccine Trial RV306 / WRAIR 1920

The purpose of this study is to test whether delayed boosting (an extra administration of a vaccine) with the IHV01 (FLSC) protein and A244/AHFG with or without ALFQ will cause the body to make higher amounts of antibodies or different types of antibodies after the vaccination.

开始日期2022-01-18

申办/合作机构

U S Army Medical Research & Development Command

[+3]

100 项与 A244 相关的临床结果

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100 项与 A244 相关的转化医学

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100 项与 A244 相关的专利（医药）

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2

项与 A244 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 ; Rao, Mangala ; Ake, Julie A ; Paquin-Proulx, Dominic ; O'Connell, Robert J ; Sacdalan, Carlo ; Zemil, Michelle ; Shubin, Zhanna ; Kaewboon, Boot ; Anenia, Hanna ; Wieczorek, Lindsay ; 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.

Vaccines3区 · 医学

Frequent and Durable Anti-HIV Envelope VIV2 IgG Responses Induced by HIV-1 DNA Priming and HIV-MVA Boosting in Healthy Tanzanian Volunteers

3区 · 医学

ArticleOA

作者: Sandström, Eric ; Bakari, Muhammad ; Rao, Mangala ; Nilsson, Charlotta ; Munseri, Patricia ; Joachim, Agricola ; Biberfeld, Gunnel ; Onkar, Sayali ; Aboud, Said ; Lyamuya, Eligius F ; Robb, Merlin L ; Mhalu, Fred S ; Msafiri, Frank ; Wahren, Britta ; Billings, Erik

We evaluated antibody responses to the human immunodeficiency virus (HIV) envelope variable regions 1 and 2 (V1V2) in 29 vaccinees who had received three HIV-1 DNA immunizations and two HIV-modified vaccinia virus Ankara (MVA) boosts in the phase I/II HIVIS03 vaccine trial. Twenty vaccinees received a third HIV-MVA boost after three years in the HIVIS06 trial. IgG and IgG antibody subclasses to gp70V1V2 proteins of HIV-1 A244, CN54, Consensus C, and Case A2 were analysed using an enzyme-linked immunosorbent assay (ELISA). Cyclic V2 peptides of A244, Consensus C, and MN were used in a surface plasmon resonance (SPR) assay. Four weeks after the second HIV-MVA, anti-V1V2 IgG antibodies to A244 were detected in 97% of HIVIS03 vaccinees, in 75% three years later, and in 95% after the third HIV-MVA. Anti-CN54 V1V2 IgG was detectable in 48% four weeks after the second HIV-MVA. The SPR data supported the findings. The IgG response was predominantly IgG1. Four weeks after the second HIV-MVA, 85% of vaccinees had IgG1 antibodies to V1V2 A244, which persisted in 25% for three-years. IgG3 and IgG4 antibodies to V1V2 A244 were rare. In conclusion, the HIV-DNA/MVA vaccine regimen induced durable V1V2 IgG antibody responses in a high proportion of vaccinees.

100 项与 A244 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
获得性免疫缺陷综合征	临床1期	美国	U S Army Medical Research & Development Command	2022-08-29
HIV感染	临床1期	泰国	University of Maryland Baltimore County	2022-01-18
HIV感染	临床1期	泰国	Case Western Reserve University	2022-01-18
HIV感染	临床1期	泰国	Duke University	2022-01-18
HIV感染	临床1期	泰国	University of Maryland Baltimore	2022-01-18