A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults

The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

开始日期2003-10-01

申办/合作机构

U S Army Medical Research & Development Command

[+9]

NCT00098163

/ Completed临床1期IIT

A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.

开始日期-

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+3]

100 项与 HIV vaccine vCP1521(Sanofi) 相关的临床结果

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100 项与 HIV vaccine vCP1521(Sanofi) 相关的转化医学

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100 项与 HIV vaccine vCP1521(Sanofi) 相关的专利（医药）

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项与 HIV vaccine vCP1521(Sanofi) 相关的文献（医药）

2014-03-19·Science Translational Medicine

Polyfunctional Fc-Effector Profiles Mediated by IgG Subclass Selection Distinguish RV144 and VAX003 Vaccines

Article

作者: Liao, Larry ; Ackerman, Margaret E. ; Choi, Ickwon ; Streeck, Hendrik ; Alter, Galit ; Kim, Jerome H. ; Bailey-Kellogg, Chris ; Rerks-Ngarm, Supachai ; Rolland, Morgane ; de Souza, Mark S. ; Suscovich, Todd J. ; Chung, Amy W. ; Robinson, Hannah ; Ghebremichael, Musie ; Mahan, Alison E. ; Brown, Eric ; Schoen, Matthew K. ; Lane, Sophie ; Andrews, Charla ; Nitayaphan, Sorachai ; Michael, Nelson L. ; Dugast, Anne-Sophie ; Francis, Donald ; Pitisuttithum, Punnee ; Kaewkungwal, Jaranit

The human phase 2B RV144 ALVAC-HIV vCP1521/AIDSVAX B/E vaccine trial, held in Thailand, resulted in an estimated 31.2% efficacy against HIV infection. By contrast, vaccination with VAX003 (consisting of only AIDSVAX B/E) was not protective. Because protection within RV144 was observed in the absence of neutralizing antibody activity or cytotoxic T cell responses, we speculated that the specificity or qualitative differences in Fc-effector profiles of nonneutralizing antibodies may have accounted for the efficacy differences observed between the two trials. We show that the RV144 regimen elicited nonneutralizing antibodies with highly coordinated Fc-mediated effector responses through the selective induction of highly functional immunoglobulin G3 (IgG3). By contrast, VAX003 elicited monofunctional antibody responses influenced by IgG4 selection, which was promoted by repeated AIDSVAX B/E protein boosts. Moreover, only RV144 induced IgG1 and IgG3 antibodies targeting the crown of the HIV envelope V2 loop, albeit with limited coverage of breakthrough viral sequences. These data suggest that subclass selection differences associated with coordinated humoral functional responses targeting strain-specific protective V2 loop epitopes may underlie differences in vaccine efficacy observed between these two vaccine trials.

2014-03-01·Journal of acquired immune deficiency syndromes (1999)3区 · 医学

Immunogenicity of ALVAC-HIV vCP1521 in Infants of HIV-1–Infected Women in Uganda (HPTN 027)

3区 · 医学

Article

作者: Kintu, Kenneth ; Guay, Laura ; Baglyos, Lynn ; Richardson, Paul ; Jones, Norman ; Ssewanyana, Isaac ; Ou, San-San ; Cao, Huyen ; Kaleebu, Pontiano ; Andrew, Philip ; Musoke, Philippa ; Fowler, Mary Glenn ; Njai, Harr Freeya ; Wang, Lei ; Jackson, J Brooks ; Emel, Lynda

OBJECTIVE:

Maternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1-infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa.

DESIGN:

HIV Prevention Trials Network 027 was a randomized, double-blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1-infected mothers with CD4 counts of >500 cells per microliter, which were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag, and protease gene products.

METHODS:

Infants were vaccinated at birth and 4, 8, and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using interferon-γ enzyme-linked immunosorbent spot, carboxyfluorescein diacetate succinimidyl ester proliferation, intracellular cytokine staining, and binding and neutralizing antibody assays. Fisher exact test was used to compare positive responses between the study arms.

RESULTS:

Low levels of antigen-specific CD4 and CD8 T-cell responses (intracellular cytokine assay) were detected at 24 months (CD4-6/36 vaccine vs. 1/9 placebo; CD8-5/36 vaccine vs. 0/9 placebo) of age. There was a nonsignificant trend toward higher cellular immune response rates in vaccine recipients compared with placebo. There were minimal binding antibody responses and no neutralizing antibodies detected.

CONCLUSIONS:

HIV-1-exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.

2013-05-01·Journal of acquired immune deficiency syndromes (1999)3区 · 医学

Feasibility and Safety of ALVAC-HIV vCP1521 Vaccine in HIV-Exposed Infants in Uganda

3区 · 医学

Article

作者: Brenda Asiimwe-Kateera ; Lynda Emel ; Lynn Baglyos ; Lei Wang ; Philippa Musoke ; Jay Brooks Jackson ; Laura Guay ; Mary Glenn Fowler ; Teopista Nakyanzi ; Sanjay Gurunathan ; Kenneth Kintu ; Sheryl Zwerski ; San San Ou ; Paul Richardson ; Philip Andrew

BACKGROUND:

The development of a safe and effective vaccine against HIV type 1 for the prevention of mother-to-child transmission of HIV would significantly advance the goal of eliminating HIV infection in children. Safety and feasibility results from phase 1, randomized, double-blind, placebo-controlled trial of ALVAC-HIV vCP1521 in infants born to HIV type 1-infected women in Uganda are reported.

METHODS:

HIV-exposed infants were enrolled at birth and randomized (4:1) to receive vaccine or saline placebo intramuscular injections at birth, 4, 8, and 12 weeks of age. Vaccine reactogenicity was assessed at vaccination and days 1 and 2 postvaccination. Infants were followed until 24 months of age. HIV infection status was determined by HIV DNA polymerase chain reaction.

RESULTS:

From October 2006 to May 2007, 60 infants (48 vaccine and 12 placebo) were enrolled with 98% retention at 24 months. One infant was withdrawn, but there were no missed visits or vaccinations among the 59 infants retained. Immune responses elicited by diphtheria, polio, hepatitis B, haemophilus influenzae type B, and measles vaccination were similar in the 2 arms. The vaccine was well tolerated with no severe or life-threatening reactogenicity events. Adverse events were equally distributed across both study arms. Four infants were diagnosed as HIV infected [3 at birth (2 vaccine and 1 placebo) and 1 in vaccine arm at 2 weeks of age].

CONCLUSION:

The ALVAC-HIV vCP1521 vaccination was feasible and safe in infants born to HIV-infected women in Uganda. The conduct of high-quality infant HIV vaccine trials is achievable in Africa.

项与 HIV vaccine vCP1521(Sanofi) 相关的新闻（医药）

2025-08-07

·药智网

中国「艾滋病疫苗」新突破

艾滋病，一个让人谈之色变的疾病，以迅猛的姿态席卷全球。根据世界卫生组织于2024年7月发布的报告，截至2023年，全球估计有3990万艾滋病病毒感染者。2023年，全球新增艾滋病病毒感染者约130万，艾滋病相关死亡人数约为63万。庆幸的是，近期艾滋病预防领域传来一则振奋人心的好消息。中国疾病预防控制中心（中国预防医学科学院）艾防中心、国药中生和北京协和医院联合宣布：完成我国首个复制型天坛痘苗载体HIV疫苗I期临床试验。艾滋病防治，曙光将至。注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 01 破晓之光自1981年美国疾病控制与预防中心首次报告艾滋病病例以来，全球范围内已有超过7500万人感染HIV病毒，约3300万人因艾滋病及相关并发症死亡。在人类与艾滋病抗争的漫长历史中，疫苗研发始终是攻克这一顽疾的关键战场。近期，中国疾病预防控制中心（中国预防医学科学院）艾防中心、国药中生和北京协和医院联合完成我国首个复制型天坛痘苗载体艾滋病疫苗I期临床试验，无疑为全球艾滋病疫苗研发注入了一剂强心针。图片来源：中国疾病预防控制中心该研究创造性地选用我国自主研发的复制型天坛痘苗病毒作为载体，这一载体曾助力中国在1965年成功消灭天花疫情，拥有超过50年、超1亿剂次的人群接种安全数据。与传统复制缺陷型腺病毒载体相比，复制型痘苗病毒载体具备显著优势：其可在人体细胞内持续表达HIV抗原长达数周，模拟天然病毒感染引发的免疫应答过程，从而激活更广泛、更持久的细胞免疫与体液免疫反应。在疫苗设计上，团队巧妙地将HIV-1 CN54株的Gag、Pol蛋白以及MN、LAI株的Env蛋白基因片段嵌入痘苗病毒基因组，构建出能够同时激发针对病毒结构蛋白与包膜蛋白的免疫反应的重组疫苗。临床试验设计和CONSORT图图片来源：中国疾病预防控制中心试验结果显示，所有受试者在接种后均未出现3级及以上不良事件，仅有部分志愿者在接种部位出现轻微红肿、硬结，以及短暂的发热、乏力等1-2级不良反应，且无需特殊处理即可自行缓解。血液学与生化指标监测未发现异常波动，表明该疫苗对肝肾功能等重要生理机能无不良影响。更为关键的是，研究团队运用高通量测序技术对疫苗病毒载量进行动态监测，发现其在人体内的复制水平严格控制在安全范围内，既保证了持续抗原表达，又杜绝了病毒扩散风险。 02 艾滋病疫苗研发进展自20世纪80年代起，科学家们基于传统疫苗研发理念，尝试通过注射纯化HIV表面蛋白gp120或gp160激发免疫反应。然而，1998年启动的AIDSVAX疫苗Ⅲ期临床试验却遭遇滑铁卢，该疫苗虽能诱导产生中和抗体，但在特定群体中的保护效率较低，宣告了单纯蛋白亚单位疫苗策略的失败。此后，以DNA疫苗与腺病毒载体疫苗为代表的基因疫苗技术崭露头角，2003年开展的Vax003与Vax004试验虽初步验证了ALVAC-HIV（vCP1521）疫苗联合AIDSVAX的免疫原性，但其保护效力仍不足以满足公共卫生需求。近年来，随着对HIV病毒进化规律与人体免疫系统相互作用机制的深入理解，科学家们将目光聚焦于能够识别HIV病毒高度保守区域的广谱中和抗体（bNAb）。 2016年启动的HVTN 703/HVTN 704试验采用“mosaic”疫苗设计，通过计算机算法整合全球不同HIV亚型病毒抗原表位，试图诱导更广泛的免疫反应，尽管该试验在南非开展的中期分析中因保护效力不足而提前终止，但其积累的免疫学数据为后续研究提供了宝贵参考。 2021年，基于mRNA技术的HIV疫苗（mRNA-1644）进入Ⅰ期临床试验，利用纳米颗粒递送mRNA分子至人体细胞，指导合成HIV抗原蛋白，这一技术平台的优势在于能够快速迭代优化抗原设计，以应对病毒快速变异的挑战。目前，艾滋病疫苗研究方兴未艾，全球范围内研究团队正致力于开发有效疫苗，采用多种策略和技术路线，努力攻克艾滋病疫苗研发难关。艾滋病疫苗在研情况图片来源：药智数据 03 艾滋病药物研发进展艾滋病疫苗研发已取得关键进展，为预防感染提供了新的可能，艾滋病药物研发领域同样捷报频传。 1996年，美籍华裔科学家何大一提出的高效抗逆转录病毒治疗（HAART）方案彻底改变了艾滋病治疗格局，通过联合使用三种或四种不同作用机制的抗逆转录病毒药物，能够抑制HIV病毒在体内的复制，为患者争取数年的高质量生存时间。截至2023年底，全球约有2800万艾滋病患者接受ART治疗，这一成就主要得益于以替诺福韦、恩曲他滨、多替拉韦为代表的新型抗病毒药物的问世，以及世界卫生组织与各国政府推动的扩大治疗覆盖面政策。艾滋病药物一览图片来源：财通证券然而，ART治疗体系仍面临诸多挑战：每日服药的复杂性导致患者依从性不足，长期服药引发的代谢紊乱、骨质疏松等副作用显著降低了患者生活质量，全球仍有艾滋病患者因治疗可及性问题无法受益于ART。暴露前预防（PrEP）作为艾滋病预防领域的重要突破，已被纳入世界卫生组织的艾滋病综合防治指南。以Truvada（替诺福韦/恩曲他滨）为代表的PrEP药物在高危人群中展现出卓越的预防效果，但实际推广过程中却遭遇重重阻碍，比如药物费用高昂限制了发展中国家高危人群的可及性。近年来，以长效注射剂、单克隆抗体为代表的新型艾滋病药物不断涌现。2021年获批上市的Cabenuva（卡替拉韦+利匹韦林）长效注射剂，使患者从每日口服服药转变为每月或每两月一次肌肉注射，显著改善了治疗依从性。同时，新型CCR5拮抗剂（如马拉韦罗）与整合酶抑制剂（如比克恩丙诺）的联合应用，为耐药患者提供了更多治疗选择。注：本文仅作信息交流之目的，文中观点不代表药智网立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 04 结语中国首个复制型天坛痘苗载体艾滋病疫苗I期临床试验的成功，恰似黑暗中划破夜空的第一缕曙光，为全球艾滋病防治注入了新的希望。这项研究不仅以其创新的技术路线与卓越的临床表现，验证了复制型痘苗病毒载体在艾滋病疫苗研发中的可行性，更为未来疫苗的大规模应用描绘了低成本、广覆盖的宏伟蓝图。参考来源： 1.药智数据 2.https://www-who-int.libproxy1.nus.edu.sg/zh 3.https://www.chinacdc.cn/kxyj/kjjz/202507/t20250725_308942.html 4.https://mp.weixin.qq.com/s/GaqdRDyioST2wDCTfFV88Q 5.https://mp.weixin.qq.com/s/D979tPwQwXNCzF6ZxtYbLw 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

疫苗临床1期

100 项与 HIV vaccine vCP1521(Sanofi) 相关的药物交易

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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	U S Army Medical Research & Development Command	2003-10-01

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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


NCT00223080 (RV144, CTgov)	临床3期	HIV感染	16,402	AIDSVAX+ALVAC-HIV vCP1521 (Vaccine)	鹹顧鏇醖獵鑰夢襯積鏇 = 鑰糧膚顧鹹鹹鹹糧獵鹽鏇願壓壓願鑰衊衊糧繭 (鹽憲範繭襯構鑰襯鑰膚, 範觸艱餘鹹齋窪淵範壓 ~ 襯醖選鑰願願築構廠築) 更多	-	2018-10-19
				ALVAC Placebo + AIDSVAX Placebo (Placebo)	鹹顧鏇醖獵鑰夢襯積鏇 = 繭鹹衊製窪鹽淵鹽鹹鏇鏇願壓壓願鑰衊衊糧繭 (鹽憲範繭襯構鑰襯鑰膚, 構願構顧壓夢膚蓋夢淵 ~ 襯夢鹹積襯製齋夢積衊) 更多
NCT00223080 (Pubmed \| PLoS One)	临床3期	HIV感染	16,402	ALVAC-HIV (vCP1521)canarypox ALVAC-HIV (vCP1521) (ALVAC-HIV (vCP1521))	顧衊顧糧鬱鑰獵顧鹽鏇(膚壓鬱衊鹽衊齋壓顧選) = 窪窪遞獵積顧襯鬱鹹憲廠餘壓觸網獵襯積鏇簾 (鹹齋選衊鏇衊壓網獵衊 ) 更多	-	2011-01-01
				Placebo	顧衊顧糧鬱鑰獵顧鹽鏇(膚壓鬱衊鹽衊齋壓顧選) = 憲築蓋顧積製窪廠窪餘廠餘壓觸網獵襯積鏇簾 (鹹齋選衊鏇衊壓網獵衊 ) 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	衊顧鏇襯積鑰網襯鏇簾(餘鹽範窪齋選觸範鏇齋) = 膚範製製繭壓艱齋觸範鑰餘廠壓壓鬱願願憲獵 (範憲壓獵簾餘鏇醖襯獵, 1.1 ~ 52.1)	积极	2009-12-03
				Placebo	-
IAS2002	N/A	-	45	ALVAC-HIV (vCP1521)	憲鏇淵淵淵繭廠觸顧繭(廠鏇窪範觸鹹醖膚範壓) = Seven serious adverse events were reported, none attributable to vaccine 艱蓋艱醖網網範繭觸鹽 (鏇積膚齋繭壓鹹繭鏇廠 ) 更多	-	2002-01-01