Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV

开始日期2024-01-30

申办/合作机构

U S Army Medical Research & Development Command

[+6]

NCT05769569

/ Withdrawn临床1期IIT

Safety and Efficacy of Broadly Neutralizing Antibodies Followed by Innate Immune Stimulation and Therapeutic Vaccination for the Induction of HIV Remission

This is a phase I, randomized, open-label trial to investigate the safety of VRC07-523LS, PGDM1400LS and N-803 in combination with Ad26.Mos4.HIV, MVA-Bavarian Nordic (BN)-HIV and A244d11gp120/ALFQ vaccination, and the impact on time to sustained viral rebound of ≥1000 copies/mL for 4 consecutive weeks during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who initiated antiretroviral therapy (ART) during acute HIV-1 infection (AHI).

开始日期2023-09-01

申办/合作机构

The Henry M. Jackson Foundation

[+1]

NCT04983030

/ Active, not recruiting临床1/2期IIT

A Safety, Immunogenicity and Efficacy Phase 1/2a Study of a Heterologous Ad26.Mos4.HIV, MVA-BN-HIV Vaccine Regimen Plus Broadly Neutralizing Antibodies PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults on Suppressive ART

A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).

开始日期2022-04-01

申办/合作机构

Beth Israel Deaconess Medical Center, Inc.

[+3]

100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的临床结果

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100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的转化医学

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100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的专利（医药）

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项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的文献（医药）

2025-12-01·EBioMedicine

Unbiased cell clustering analysis of vaccine-induced T cell responses in the Imbokodo HIV-1 vaccine trial

Article

作者: MacMillan, Hugh R ; Hendriks, Jenny ; Khuzwayo, Sharon ; Newell, Evan W ; van Duijn, Janine ; De Rosa, Stephen C ; Pattacini, Laura ; Schwedhelm, Katharine ; Gilbert, Peter B ; Stieh, Daniel J ; McElrath, M Juliana ; Fiore-Gartland, Andrew ; Voillet, Valentin ; Euler, Zelda ; Andersen-Nissen, Erica ; Omar, Faatima Laher ; Dintwe, One B ; Vanshylla, Kanika

BACKGROUND:

HIV-1 T cell responses are associated with viral control and may be protective in a prophylactic vaccination setting. Traditional methods for analysing these responses might be biased towards specific functionalities or epitopes. This study presents an unsupervised and unbiased clustering analysis workflow, using the Leiden algorithm followed by selection of antigen-specific clusters using MIMOSA positivity calls, for high-dimensional flow cytometry data to identify distinct T cell populations associated with protection in the HVTN 705/HPX2008/Imbokodo HIV-1 vaccine efficacy trial.

METHODS:

Participants were vaccinated with Ad26.Mos4.HIV (M0, M3) and Ad26.Mos4.HIV + Clade C gp140 (M6, M12), and a validated 28-colour intracellular cytokine staining assay was performed on PBMC isolated at M7, M13 and M24 in a pilot immunogenicity (n = 60) and case-control cohort (n = 283). 28-colour phenotyping assays were also performed on PBMC from the case-control cohort (n = 334).

FINDINGS:

Our clustering analysis workflow allowed identification of vaccine-induced subpopulations of both CD4+ and CD8+ T cells expressing combinations of the 28 markers. Durable HIV-1 antigen-specific CD4+ and CD8+ T cell responses were observed for up to 2 years, comprising mainly clusters of polyfunctional T cells expressing anti-viral cytokines and activation markers. Eight CD4+ and six CD8+ HIV-1 antigen-specific T cell clusters were induced by vaccination; only one CD4+ T cell cluster specific for Gag was mildly elevated in cases (acquiring HIV) compared to controls.

INTERPRETATION:

Our study introduces an innovative analysis approach to identify vaccine-induced T cell subpopulations in vaccine trials. Comparison of T cell clusters between cases and controls holds promise for improving the efficacy of future HIV-1 vaccination strategies.

FUNDING:

This work was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Division of AIDS (DAIDS), both of the US National Institutes of Health (NIH) [NIAID grants to the HIV Vaccine Trials Network (HVTN) (Fred Hutchinson Cancer Center): UM1AI068618 (HVTN LC to M.J.M.) and UM1AI068635 (HVTN SDMC to P.B.G.)] and by Janssen Vaccines & Prevention B.V. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or Janssen.

2025-12-01·Lancet HIV

Efficacy and safety of a mosaic HIV-1 vaccine regimen in men who have sex with men and transgender individuals (HVTN 706/HPX3002/Mosaico): a global, randomised, double-blind, placebo-controlled, phase 3 trial

Article

BACKGROUND:

There is a high unmet need for effective HIV prevention options, including vaccines, for individuals at high risk of HIV acquisition who choose not to use pre-exposure prophylaxis or other prevention strategies. This study evaluated the efficacy and safety of an HIV-1 vaccine regimen consisting of tetravalent mosaic adenovirus serotype 26-based vaccine (Ad26.Mos4.HIV) and bivalent clade C glycoprotein (gp) 140-mosaic gp140 vaccine, in a population with high seroincidence.

METHODS:

This randomised, double-blind, phase 3 trial enrolled adult cisgender men and transgender individuals without HIV from 52 academic medical centres, health departments, and community-based clinics in Latin America, Europe, and the USA. Participants were randomly assigned (1:1) by use of a centrally prepared, computer-generated randomisation schedule to receive intramuscular injections of vaccine or saline placebo in stratified permuted blocks. Study participants, study site personnel (except for those with primary responsibility for study vaccine preparation and dispensing), and investigators were masked from vaccine allocation. The vaccine regimen consisted of Ad26.Mos4.HIV administered at months 0 and 3 followed by Ad26.Mos4.HIV administered concurrently with aluminium phosphate-adjuvanted clade C gp140-mosaic gp140 at months 6 and 12. The primary endpoint was vaccine efficacy in preventing HIV-1 acquisition between months 7 and 24 or between months 7 and 30 in the per-protocol population, which included all randomly assigned participants who received at least one study vaccination and who had not been diagnosed with HIV-1 4 weeks after the third vaccination, had received all planned vaccinations at the first three vaccination visits within the respective visit windows, and had no major protocol deviations linked to incorrect product administration. Safety outcomes were assessed in all randomised participants who received at least one study vaccination. The trial is registered with ClinicalTrials.gov (NCT03964415) and is complete.

FINDINGS:

Between Nov 4, 2019, and Aug 13, 2021, 3900 participants were enrolled and randomly assigned; 3887 received at least one study vaccination (1942 assigned to vaccine, 1945 to placebo). 3870 (99·6%) of 3887 participants were assigned male at birth, seven (0·2%) were assigned female, and one participant's sex at birth was undifferentiated; 3557 (91·5%) participants identified as male gender, 48 (1·2%) as female gender, and 278 (7·2%) as transgender or non-binary. The per-protocol population included 1525 participants in the vaccine group and 1494 in the placebo group. From month 7 to month 24 in the per-protocol population, HIV-1 incidence per 100 person-years was 3·63 (95% CI 2·77 to 4·67) in the vaccine group and 3·35 (2·53 to 4·36) in the placebo group, with an estimated vaccine efficacy (months 7-24) of -0·7% (95% CI -50·9 to 32·8; p=0·97). Vaccine efficacy (months 7-30) was -149·1% (-737·7 to 26·0; p=0·14). Most solicited local and systemic adverse events were mild or moderate and short-lived. Medically attended adverse events occurred in 999 (51·4%) of 1942 participants given vaccine and 1002 (51·5%) of 1945 participants given placebo; serious adverse events occurred in 82 (4·2%) of 1942 participants given vaccine and 77 (4·0%) of 1945 participants given placebo. No fatal adverse events considered related to the study vaccine occurred. Adverse events of special interest (thrombotic events or thrombocytopenia) occurred in four participants with vaccine and two with placebo; none had thrombosis with thrombocytopenia syndrome.

INTERPRETATION:

The lack of efficacy in this and other HIV vaccine trials points to the importance of current efforts to develop vaccines that generate broadly neutralising antibodies.

FUNDING:

Johnson & Johnson; HIV Vaccine Trials Network; Division of AIDS, a division of National Institute of Allergy and Infectious Diseases; and US Army Medical Materiel Development Activity, a subordinate command of the US Army Medical Research and Development Command.

2024-11-01·LANCET INFECTIOUS DISEASES

Mosaic HIV-1 vaccine regimen in southern African women (Imbokodo/HVTN 705/HPX2008): a randomised, double-blind, placebo-controlled, phase 2b trial

Article

作者: Swann, Edith ; Van Hoof, Johan ; Tomaka, Frank ; Takalani, Azwidihwi N ; van Duijn, Janine ; Schuitemaker, Hanneke ; Luedtke, Alex ; Kublin, James G ; Stieh, Daniel J ; Tomaras, Georgia D ; Tapley, Asa ; Barouch, Dan H ; Nijs, Steven ; McElrath, M Juliana ; Gray, Glenda E ; Juraska, Michal ; Odhiambo, Jackline A ; Gilbert, Peter B ; Pau, Maria G ; Corey, Lawrence ; Willems, Wouter ; Buchbinder, Susan ; Hural, John ; Mngadi, Kathryn ; Hyrien, Ollivier ; Mann, Philipp ; Lavreys, Ludo

BACKGROUND:

HIV type 1 (HIV-1) remains a global health concern, with the greatest burden in sub-Saharan Africa. Despite 40 years of research, no vaccine candidate has shown durable and protective efficacy against HIV-1 acquisition. Although pre-exposure prophylaxis in groups with high vulnerability can be very effective, barriers to its use, such as perceived low acquisition risk, fear of stigma, and concerns about side-effects, remain. Thus, a population-based approach, such as an HIV-1 vaccine, is needed. The current study aimed to evaluate the efficacy and safety of a heterologous HIV-1 vaccine regimen, consisting of a tetravalent mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) and aluminium phosphate-adjuvanted clade C glycoprotein (gp) 140, in young women at risk of acquiring HIV-1 in southern Africa.

METHODS:

This randomised, double-blind, phase 2b study enrolled sexually active women without HIV-1 or HIV-2 aged 18-35 years at 23 clinical research sites in Malawi, Mozambique, South Africa, Zambia, and Zimbabwe. Participants were centrally randomly assigned (1:1) to receive intramuscular injections of vaccine or saline placebo in stratified permuted blocks via an interactive web response system. Study participants, study site personnel (except those with primary responsibility for study vaccine preparation and dispensing), and investigators were masked to treatment group allocation. The vaccine regimen consisted of Ad26.Mos4.HIV administered at months 0 and 3 followed by Ad26.Mos4.HIV administered concurrently with aluminium phosphate-adjuvanted clade C gp140 at months 6 and 12. The primary efficacy outcome was vaccine efficacy in preventing laboratory-confirmed HIV-1 acquisition diagnosed between visits at month 7 and month 24 after the first vaccination (VE[7-24]) in the per-protocol population, which included participants who had not acquired HIV-1 4 weeks after the third vaccination, received all planned vaccinations at the first three vaccination visits within the protocol-specified windows, and had no major protocol deviations that could affect vaccine efficacy. Primary safety outcomes were assessed in randomly assigned participants who received one study injection or more based on the actual injection received. The primary safety endpoints were the incidences of unsolicited adverse events (AEs), solicited local and systemic AEs, serious AEs, AEs of special interest, and AEs leading to discontinuation of vaccination. This trial is registered with ClinicalTrials.gov, NCT03060629, and is complete.

FINDINGS:

Between Nov 3, 2017, and June 30, 2019, 2654 women were randomly assigned, of whom 2636 women (median age of 23 years [IQR 20-25]) were enrolled and received at least one study injection (1313 assigned vaccine, 1323 placebo; 1317 received vaccine, 1319 placebo). Analysis of the primary efficacy outcome in the per-protocol cohort included 1080 women in the vaccine group and 1108 women in the placebo group; the incidence of HIV-1 acquisition per 100 person-years over months 7-24 after the first vaccination was 3·38 (95% CI 2·54-4·41) in the vaccine group and 3·94 (3·04-5·03) in the placebo group, with an estimated VE(7-24) of 14·10% (95% CI -22·00 to 39·51; p=0·40). There were no serious unsolicited AEs, AEs of special interest, or deaths related to the study vaccine. In the vaccine group, 663 (50·3%) of 1317 participants had grade 1 or 2 solicited local AEs and ten (0·8%) of 1317 participants had grade 3 or 4 solicited local AEs. In the placebo group, 305 (23·1%) of 1319 participants had grade 1 or 2 solicited local AEs and three (0·2%) of 1319 participants had grade 3 or 4 solicited local AEs. 863 (65·5%) of 1317 participants in the vaccine group had grade 1 or 2 solicited systemic AEs and 34 (2·6%) of 1317 participants had grade 3 or 4 solicited systemic AEs. 763 (57·8%) of 1319 participants in the placebo group had grade 1 or 2 solicited systemic AEs and 20 (1·5%) of 1319 participants had grade 3 or 4 solicited systemic AEs. Overall, three (0·2%) of 1317 participants in the vaccine group and three (0·2%) of 1319 participants in the placebo group discontinued vaccination due to an unsolicited AE, and three (0·2%) of 1317 participants in the vaccine group and one (0·1%) of 1319 participants in the placebo group discontinued vaccination due to a solicited AE.

INTERPRETATION:

The heterologous Ad26.Mos4.HIV and clade C gp140 vaccine regimen was safe and well tolerated but did not show efficacy in preventing HIV-1 acquisition in a population of young women in southern Africa at risk of HIV-1.

FUNDING:

Division of AIDS at the National Institute of Allergy and Infectious Diseases through the HIV Vaccine Trials Network, Bill & Melinda Gates Foundation, Janssen Vaccines & Prevention, US Army Medical Materiel Development Activity, and Ragon Institute.

项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 相关的新闻（医药）

2023-03-30

·佰傲谷BioValley

竞争太过激烈，强生放弃RSV疫苗

2023年3月29日，强生/杨森透露，在对其投资组合进行审查后，并对呼吸道合胞病毒（RSV）疫苗前景进行评估后，决定放弃RSV疫苗项目，并停止其III期临床研究EVERGREEN。强生的RSV疫苗是一款腺病毒载体疫苗，是RSV疫苗进度最领先的项目之一，III期临床于2021年启动，目前已经有23000人入组。根据新闻稿透露，强生/杨森将终止公司RSV成人疫苗计划，更专注于开发对患者具有更大潜在益处的药物。强生在传染病上的收缩值得注意是的，在2月份，就有报道称，强生正在对其传染病部门进行重组，预计在世界各国进行大规模裁员。从近来的动态就可以看出，强生对传染病项目的热情冷却，这要从HIV疫苗的失败说起。 2023年1月，强生宣布终止HIV疫苗HPX3002的III期临床，这是全球进展最快的HIV疫苗。根据报道，三期研究Mosaico的结果显示，该研究的独立数据与安全监测委员会（DSMB）确定，与安慰剂相比，该方案在预防研究参与者并无明显优势，在HIV感染保护方面无效。 Mosaico的失败并非强生在HIV疫苗领域的首次失败。此前，强生另外一款疫苗HPX2008的二期临床Imbokodo试验也被迫停止，该试验历经四年，但结果显示其有效性仅为25.2%。这项投入了1.04 亿美元的试验提前终止。 2023年2月，Arrowhead公司证实，强生正在撤回乙肝药物的研究JNJ-3989。该合作是在2018年达成的，该项目有望于今年公布2b阶段的临床结果。虽然强生尚未正式终止合作伙伴关系，该项目未来可能会转让给其他公司，或退回给Arrowhead。这也不是强生第一次放弃乙肝项目了，2022年强生终止与Bavarian Nordic关于HPV（人乳头瘤病毒）和HBV（乙肝病毒）的两项疫苗合作及许可协议。在新冠疫苗上，强生虽然也成功开发了新冠疫苗，但是由于其安全性问题，在美国的使用受到限制。根据报道，强生未来的重点已经转移到肿瘤和免疫疾病药物上。老年RSV疫苗市场竞争 RSV感染在婴幼儿和老年人中发病率高，病情严重，其药物市场（包括治疗药物及预防药物）逐年上涨，预计将从2020年的18亿美元增至2030年的128亿美元。这有望价值百亿的市场，每年都在吸引大批的药企和研究投身至此。而值得注意的是，今年可能会有两款针对老年人的RSV疫苗获得FDA批准上市。 2022年11月，GSK的重组亚单位RSV F糖蛋白疫苗获得FDA的优先审评资格。2023年3月1日，GSK宣布FDA专家委员会以12:0投票结果认可其RSV疫苗的有效性，以10:2投票结果认可其安全性，支持批准RSV疫苗获批上市。FDA将在5月3日做出最终决定。 2022年12月，辉瑞的RSVpreF同样在老年人中获得优先审评资格。2023年2月28日，辉瑞宣布FDA专家委员会以7:4投票结果认可其RSV疫苗，支持FDA批准其RSV疫苗。FDA将在2023年5月之前做出最终决定。此外，Moderna的RSV mRNA疫苗也可能会在今年向FDA提交上市申请。2023年1月，mRNA-1345获得FDA授予的突破性疗法称号，此次称号授予是基于该疫苗关键III期临床ConquerRSV试验，该试验结果达到了针对老年人感染呼吸道合胞病毒的主要终点（疗效为83.7%）。参考资料：1.https://www.biopharmadive.com/news/johnson-johnson-rsv-vaccine-abandon-exit-study/646273/ 内容来源于网络，如有侵权，请联系删除。

疫苗优先审批

2023-02-22

·蒲公英Ouryao

默沙东莫诺拉韦无法预防新冠感染

转自：蒲公英ouryao 整理：水晶2023年2月21日，美国默沙东公司对外表示，其抗新冠病毒药物莫诺拉韦在测试预防新冠感染效果的三期临床试验中失败。结果与去年辉瑞公司Paxlovid预防新冠感染的临床试验相似。两者都未能证明可以阻止新冠病毒在家庭内的传播。默沙东这项研究步辉瑞后尘默沙东莫诺拉韦、辉瑞奈玛特韦片/利托那韦片（Paxlovid）和吉利德瑞德西韦（Remdesivir）是最早获批的三款治疗新冠的药物。在防重症住院和死亡风险上，Paxlovid显示出接近90%的有效率，而莫诺拉韦一直徘徊在30%左右，因此使用量远小于Paxlovid。2023年2月21日，默沙东公布新冠口服药莫诺拉韦用于新冠暴露后预防的三期临床MOVe-AHEAD没有达到主要终点，治疗组相比安慰剂组感染新冠的风险降低23.6%，但没有达到统计学显著。默沙东公司发言人表示，该研究旨在测试抗病毒药物的预防感染效果，详细数据计划稍后在科学会议或出版物中完整公布。此结果与去年辉瑞公司Paxlovid预防新冠感染的临床试验相似。两者都未能证明可以阻止新冠病毒在家庭内的传播。2022年4月29日，辉瑞公司宣布，针对近3000名受试者的家庭接触暴露后预防新冠感染的临床试验失败。与安慰剂相比，接受Paxlovid 5天和10天治疗的成人感染风险分别降低了32%和37%，无统计学意义，未达到主要研究终点。近期三期临床试验失败的药物诺华，镰状细胞药物Adakveo：今年1月份，据endpts媒体报道，据根据初步结果，诺华公司于2019年批准的镰状细胞药物Adakveo，未能通过正在进行的三期临床试验。1月末，这家瑞士制药巨头公布了正在进行的STAND III期研究的早期数据，称Crizanlizumab(Adakveo)在两种不同剂量水平下与安慰剂相比，在随机进入试验后第一年导致医疗访问的血管阻塞危机的年化率上没有统计学上的显著差异。诺华在一份声明中表示，这些发现与之前的试验结果不一致，指出SUSTAIN试验显示，5.0mg/kg的crizanlizumab优于安慰剂。Crizanlizumab于2019年11月获得FDA批准，以降低血管阻塞危机的频率。该药物于2016年以6.65亿美元的价格从Selexys收购。当时被誉为“潜在的10亿美元炸弹”。罗氏，AD药物ganteneruma：2022年11月14日，罗氏发布消息，其在研的阿尔茨海默病（AD，老年痴呆）药物（ganteneruma）三期临床研究失败，官方给出的口径是——未能明显减缓痴呆症的进展，解决阿尔茨海默病早期患者记忆减退、执行能力下降等问题。值得注意的是此次失败是罗氏第二次尝试的结果，早在2014年年，罗氏就启动了gantenerumab的首次三期试验，但在当年年底因中期分析显示“干预无效”而提前停止。但随着渤健药物进展和上市，罗氏将研究再次提上日程。结果还是二次失败。强生，HIV疫苗：2023年1月18日，强生公布了HPX3002，已经进入临床3期的HIV疫苗研究失败。令寄予众望的HIV疫苗研究的希望落空。HIV自1981年被发现到现在，已经过去了40多年，HIV疫苗，无从谈起，研究难度大。即便是接受了人体有效性测试的预防性疫苗，在全球范围内只有寥寥数款。其中进度最快的是强生的HPX3002，已经进入临床3期。现在也落空了......GSK，Blenrep治疗多发性骨髓瘤：2022年11月7日，葛兰素史克更新了BCMA ADC新药Blenrep治疗多发性骨髓瘤三期临床DREAMM-3的数据显示，DREAMM-3试验没有达到主要终点。Blenrep是全球获批的第一个B细胞成熟抗原（BCMA）靶向疗法，该药是一种靶向BCMA的抗体药物偶联物（ADC）。Oramed制药，口服胰岛素胶囊ORMD-0801：2023年1月11日，以色列口服药物递送平台公司Oramed制药宣布了其口服胰岛素胶囊ORMD-0801的3期多中心临床试验（ORA-D-0013-1）顶线结果，随机、双盲、安慰剂对照比较了26周时口服胰岛素ORMD-0801与安慰剂对2型糖尿病（T2D）患者的疗效。ORA-D-013-1招募了710名2型糖尿病患者，服用两种或三种口服降糖药血糖控制不足。每一项失败临床更像是医药领域一座座纪念碑，纪念人类为消除各种疾病做出过的不懈努力。分享相关的经验，为后来者提供借鉴和帮助。参考：医药笔记药事纵横财经大健康强生官网

临床3期临床失败临床结果并购临床成功

2023-01-20

·佰傲谷BioValley

全球进展最快的HIV疫苗再次折戟

艾滋病一直是全球庞大的传染病群体，且艾滋病治疗却一直未取得重大突破。用于治疗HIV感染的药物只能控制病毒复制，不能彻底清除病毒。因此，研制安全、有效的疫苗是控制HIV传播的重要手段之一。艾滋病易感人群通过接种HIV疫苗，发生免疫反应，从而产生对疾病的特异抵抗力，提高免疫水平，达到预防和治疗HIV的目的。目前全球进展最快的HIV疫苗便是已经进入三期临床的强生HPX3002，不过就在昨日，强生宣布此次三期临床终止。数次折戟的HIV疫苗1月19日，强生宣布其三期临床Mosaico试验停止，Mosaico 由子公司杨森于 2019 年推出，于2022年10月结束。是一项随机、双盲和安慰剂对照试验，招募了约 3900 名男性和跨性别者。此HIV疫苗方案包括一年内四次接种的26型腺病毒载体。在第三次和第四次接种时，使用了不同的蛋白质混合物。三期Mosaico研究的结果显示，该研究的独立数据与安全监测委员会（DSMB）确定，与安慰剂相比，该方案在预防研究参与者并无明显优势，在HIV感染保护方面无效。Mosaico的失败并非强生在HIV疫苗领域的首次，在18个月前，强生另外一款疫苗HPX2008的二期临床Imbokodo试验也被迫停止。此试验历经四年，但结果显示其有效性仅为25.2%。这项投入了1.04 亿美元的试验提前终止。纵观历史，已有数款HIV疫苗被证实成功无望而停止试验。2009年美国国家卫生研究院启动的一项大型的HIV疫苗研究“HVTN 505”，在美国19个城市招募大约2500名志愿者。中期评估发现，疫苗组中41人感染艾滋病，而安慰剂组中30人感染艾滋病，导致研究终止。2016年，泰国与美国合作展开的“RV144”试验曾显示接种疫苗者可在短时间内降低感染HIV的风险，甚至比使用安慰剂的人低60%，但这种预防效果却在一年内大打折扣，最终疫苗未被建议推广。2020年，此前最具希望的GSK/赛诺菲合作开发的HIV疫苗IIb/III期研究“HVTN702”失败，该研究在南非14个地区招募了5407名HIV阴性的志愿者。结果显示疫苗接种者中发生了129例HIV感染，而安慰剂接种者中发生了123例HIV感染，HIV疫苗未显示任何功效，甚至效果还不如安慰剂。作为RV144的升级版HVTN702，在临床试验中结果反而更不尽人意，如今强生的HIV疫苗也惨遭失败，难免不让人沮丧。未来仍在努力不过除了以上之外，仍有数十家生物制药公司也在努力解决艾滋病毒中未得到满足的医疗需求，无论是通过疫苗预防还是治疗。RNA疫苗领域的龙头企业Moderna于2022年3月启动了mRNA-1574的I期试验，该疫苗是其正在研究的HIV三聚体疫苗，该研究旨在评估Moderna候选疫苗的免疫原性和安全性。此外Moderna还有另一种HIV疫苗mRNA-1644，于2022年初进入第一阶段评估。除了Moderna，牛津大学的研究人员已经开始了HIVconsvX的临床试验，HIVconsvX疫苗是一种能靶向作用广泛HIV突变体的嵌合体疫苗，这或许就有可能使其适用于任何地理区域的HIV毒株。在治疗方面，吉利德科学处于领先地位。2022年8月，吉利德的药物Sunlenca获得了欧盟委员会的上市授权；又于12月获得了FDA上市批准，为患有多药耐药HIV的成年人提供药物治疗。Sunlenca是首个基于衣壳抑制剂的HIV治疗选项，被设计用于在其生命周期的多个阶段抑制HIV。此“first-in-class”药物向HIV患者提供了一种新的、一年两次的治疗选择。小结不管在国内还是国际上，抗HIV病毒药物均具有可待开发的市场前景，其广阔市场空间仍待挖掘。但不可否认的是，这条路上存在诸多挑战。尽管如此，研究者们仍旧没有放弃。未来相信在科技不断进步以及药企的不断努力下，能够找到针对HIV感染预防和治愈的方法。参考资料：1.J&J Shuts Down Second HIV Vaccine Trial in as Many Years | BioSpace2.http://stock.10jqka.com.cn/usstock/20221223/c643808564.shtml3.http://www.360doc.com/content/23/0120/01/56526713_1064262316.shtml4.https://baijiahao.baidu.com/s?id=1710605352909634884&wfr=spider&for=pc更多精彩视频，尽在佰傲谷视频号，欢迎关注~本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀点亮在看，传递信息♥

疫苗临床3期信使RNA临床结果临床1期

100 项与 Ad26 Mos4 HIV tetravalent vaccine (Janssen Vaccines and Prevention B.V) 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	美国	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	阿根廷	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	巴西	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	意大利	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	墨西哥	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	秘鲁	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	波兰	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	波多黎各	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	西班牙	Janssen Vaccines & Prevention BV	2019-10-31

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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


NCT03964415 (MOSAICO, CTgov)	临床3期	HIV感染	3,900	Placebo	膚積築範鹹鬱顧築遞鬱 = 遞鬱鏇糧艱衊膚簾齋簾構鏇夢繭襯簾觸遞餘糧 (窪齋鹹獵製選範網製簾, 襯構願積顧構鑰觸壓鏇 ~ 願餘鹽顧願窪範衊廠簾) 更多	-	2024-07-31
NCT02788045 (TRAVERSE, CTgov)	临床1/2期	-	201	Ad26.Mos4.HIV Vaccine (Tetravalent Ad26.Mos4.HIV Vaccine)	遞築鏇鹽鬱鏇鹹顧淵選 = 憲餘鹹淵鹽顧願糧築鹹積遞壓憲範鹹艱築夢醖 (選願壓艱築衊憲膚膚餘, 壓積願觸獵範顧鏇糧壓 ~ 鹽襯製觸鬱醖艱憲鑰餘) 更多	-	2023-06-09
NCT02788045 (TRAVERSE, CTgov)	临床1/2期	-	201	Ad26.Mos.HIV Vaccine (Trivalent Ad26.Mos.HIV Vaccine)	遞築鏇鹽鬱鏇鹹顧淵選 = 淵鑰蓋糧鬱選淵積願顧積遞壓憲範鹹艱築夢醖 (選願壓艱築衊憲膚膚餘, 築膚衊艱築願蓋範觸窪 ~ 繭築繭觸餘顧選觸鬱糧) 更多	-	2023-06-09
NCT03060629 (CTgov)	临床2期	HIV感染	2,636	Ad26.Mos.HIV Vaccine (Group 1: Ad26.Mos.HIV Vaccine)	鏇選製鏇選齋顧艱觸構 = 鹽蓋鬱積構鹹積願衊獵範簾衊顧襯鹹觸憲願鏇 (顧獵憲築壓顧窪範願艱, 築願窪艱鬱鹹窪積鹹醖 ~ 蓋衊選膚醖醖簾製構夢) 更多	-	2023-04-18
NCT03060629 (CTgov)	临床2期	HIV感染	2,636	Placebo+Ad26.Mos4.HIV (Group 2: Placebo)	鏇選製鏇選齋顧艱觸構 = 構糧齋鹽衊鏇廠鬱餘鹹範簾衊顧襯鹹觸憲願鏇 (顧獵憲築壓顧窪範願艱, 築糧窪範窪鏇夢襯積觸 ~ 獵鹹願蓋鹹鹽齋憲餘襯) 更多	-	2023-04-18
NCT02788045 (TRAVERSE, Pubmed \| Lancet HIV)	临床1/2期	-	201	Trivalent vaccine	膚顧壓遞鑰獵遞憲網願(範鹽餘簾鑰獵顧壓艱範) = 遞窪鏇構遞願製醖遞獵簾構夢顧構鹽襯襯窪選 (鹽觸鹹淵窪齋淵醖廠齋, 3759 ~ 8029)	-	2020-10-01