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2024-01-01

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）

2024-11-01·The 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: Juraska, Michal ; McElrath, M Juliana ; Hural, John ; Luedtke, Alex ; Tapley, Asa ; Mann, Philipp ; Takalani, Azwidihwi N ; Pau, Maria G ; Swann, Edith ; Mngadi, Kathryn ; van Duijn, Janine ; Lavreys, Ludo ; Kublin, James G ; Van Hoof, Johan ; Schuitemaker, Hanneke ; Gray, Glenda E ; Barouch, Dan H ; Buchbinder, Susan ; Willems, Wouter ; Gilbert, Peter B ; Hyrien, Ollivier ; Nijs, Steven ; Stieh, Daniel J ; Tomaras, Georgia D ; Corey, Lawrence ; Odhiambo, Jackline A ; Tomaka, Frank

BACKGROUNDHIV 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.METHODSThis 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.FINDINGSBetween 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.INTERPRETATIONThe 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.FUNDINGDivision 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.

2020-11-01·Archives of Virology4区 · 医学

Review of preventative HIV vaccine clinical trials in South Africa

4区 · 医学

Review

作者: Lazarus, Erica M ; Bekker, Linda-Gail ; Garrett, Nigel ; Gray, Glenda E ; Laher, Fatima

AbstractNew HIV infections continue relentlessly in southern Africa, demonstrating the need for a vaccine to prevent HIV subtype C. In South Africa, the country with the highest number of new infections annually, HIV vaccine research has been ongoing since 2003 with collaborative public-private-philanthropic partnerships. So far, 21 clinical trials have been conducted in South Africa, investigating seven viral vectors, three DNA plasmids, four envelope proteins, five adjuvants and three monoclonal antibodies. Active vaccine candidates have spanned subtypes A, B, C, E and multi-subtype mosaic sequences. All were well tolerated. Four concepts were investigated for efficacy: rAd5-gag/pol/nef showed increased HIV acquisition in males, subtype C ALVAC/gp120/MF59 showed no preventative efficacy, and the trials for the VRC01 monoclonal antibody and Ad26.Mos4.HIV/subtype C gp140/ aluminum phosphate are ongoing. Future trials are planned with DNA/viral vector plus protein combinations in concert with pre-exposure prophylaxis, and sequential immunization studies with transmitted/founder HIV envelope to induce broadly neutralizing antibodies. Finally, passive immunization trials are underway to build on the experience with VRC01, including single and combination antibody trials with an antibody derived from a subtype-C-infected South African donor. Future consideration should be given to the evaluation of novel strategies, for example, inactivated-whole-virus vaccines.

2020-10-01·The Lancet HIV1区 · 医学

Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study

1区 · 医学

Article

作者: Lauren Peter ; Colleen Kelly ; Nadine Rouphael ; Philipp Mann ; Steven Nijs ; Michal Sarnecki ; James G Kublin ; Julie A. Ake ; Georgia D Tomaras ; Magda Sobieszczyk ; Michael Keefer ; Dan H Barouch ; Dimitri Goedhart ; Merlin L. Robb ; Johannes P Langedijk ; Kristen W. Cohen ; Srilatha Edupuganti ; Lawrence Corey ; Karen Buleza ; Frank Tomaka ; Daniel J Stieh ; Maria G Pau ; Galit Alter ; Etienne Karita ; Lorenz Scheppler ; Hong Van Tieu ; Susan Buchbinder ; Zelda Euler ; Paul Goepfert ; Hanneke Schuitemaker ; Guido Ferrari ; M Juliana McElrath ; Trevor A. Crowell ; Joseph Nkolola ; Frank Wegmann ; Ken Mayer ; David Montefiori ; Katleen Callewaert ; Ian Frank ; Stephen R Walsh ; Lindsey R Baden

BACKGROUNDBioinformatically designed mosaic antigens increase the breadth of HIV vaccine-elicited immunity. This study compared the safety, tolerability, and immunogenicity of a newly developed, tetravalent Ad26 vaccine with the previously tested trivalent formulation.METHODSThis randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a study (TRAVERSE) was done at 11 centres in the USA and one centre in Rwanda. Eligible participants were adults aged 18 to 50 years, who were HIV-uninfected, healthy at screening based on their medical history and a physical examination including laboratory assessment and vital sign measurements, and at low risk of HIV infection in the opinion of study staff, who applied a uniform definition of low-risk guidelines that was aligned across sites. Enrolled participants were randomly assigned at a 2:1 ratio to tetravalent and trivalent groups. Participants in tetravalent and trivalent groups were then further randomly assigned at a 5:1 ratio to adenovirus 26 (Ad26)-vectored vaccine and placebo subgroups. Randomisation was stratified by region (USA and Rwanda) and based on a computer-generated schedule using randomly permuted blocks prepared under the sponsor's supervision. We masked participants and investigators to treatment allocation throughout the study. On day 0, participants received a first injection of tetravalent vaccine (Ad26.Mos4.HIV or placebo) or trivalent vaccine (Ad26.Mos.HIV or placebo), and those injections were repeated 12 weeks later. At week 24, vaccine groups received a third dose of tetravalent or trivalent together with clade C gp140, and this was repeated at week 48, with placebos again administered to the placebo group. All study vaccines and placebo were administered by intramuscular injection in the deltoid muscle. We assessed adverse events in all participants who received at least one study injection (full analysis set) and Env-specific binding antibodies in all participants who received at least the first three vaccinations according to the protocol-specified vaccination schedule, had at least one measured post-dose blood sample collected, and were not diagnosed with HIV during the study (per-protocol set). This study is registered with Clinicaltrials.gov, NCT02788045.FINDINGSOf 201 participants who were enrolled and randomly assigned, 198 received the first vaccination: 110 were in the tetravalent group, 55 in the trivalent group, and 33 in the placebo group. Overall, 185 (93%) completed two scheduled vaccinations per protocol, 180 (91%) completed three, and 164 (83%) completed four. Solicited, self-limiting local, systemic reactogenicity and unsolicited adverse events were similar in vaccine groups and higher than in placebo groups. All participants in the per-protocol set developed clade C Env binding antibodies after the second vaccination, with higher total IgG titres after the tetravalent vaccine than after the trivalent vaccine (10 413 EU/mL, 95% CI 7284-14 886 in the tetravalent group compared with 5494 EU/mL, 3759-8029 in the trivalent group). Titres further increased after the third and fourth vaccinations, persisting at least through week 72. Other immune responses were also higher with the tetravalent vaccine, including the magnitude and breadth of binding antibodies against a cross-clade panel of Env antigens, and the magnitude of IFNγ ELISPOT responses (median 521 SFU/10⁶ peripheral blood mononuclear cells [PBMCs] in the tetravalent group and median 282 SFU/10⁶ PBMCs in the trivalent group after the fourth vaccination) and Env-specific CD4+ T-cell response rates after the third and fourth vaccinations. No interference by pre-existing Ad26 immunity was identified.INTERPRETATIONThe tetravalent vaccine regimen was generally safe, well-tolerated, and found to elicit higher immune responses than the trivalent regimen. Regimens that use this tetravalent vaccine component are being advanced into field trials to assess efficacy against HIV-1 infection.FUNDINGNational Institutes of Health, Henry M Jackson Foundation for Advancement of Military Medicine and the US Department of Defense, Ragon Institute of MGH, MIT, & Harvard, Bill & Melinda Gates Foundation, and Janssen Vaccines & Prevention.

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	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	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	秘鲁	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	西班牙	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	意大利	Janssen Vaccines & Prevention BV	2019-10-31
HIV感染	临床3期	美国	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


NCT02788045 (TRAVERSE, CTgov)	临床1/2期	-	201	Ad26.Mos4.HIV Vaccine (Tetravalent Ad26.Mos4.HIV Vaccine)	顧蓋鹹淵顧壓積醖衊繭(壓淵選製繭膚壓憲願積) = 憲艱範構觸鑰淵醖顧膚構簾艱鹽觸鹽鏇製繭淵 (遞繭鏇憲艱廠蓋淵衊齋, 網顧範觸獵膚獵選網餘 ~ 壓襯夢衊鏇願網範鏇窪) 更多	-	2023-06-09
				Ad26.Mos.HIV Vaccine (Trivalent Ad26.Mos.HIV Vaccine)	顧蓋鹹淵顧壓積醖衊繭(壓淵選製繭膚壓憲願積) = 網構淵窪鏇衊簾觸膚蓋構簾艱鹽觸鹽鏇製繭淵 (遞繭鏇憲艱廠蓋淵衊齋, 簾鑰選積鏇鏇夢鹹夢蓋 ~ 醖顧膚鏇壓積築獵簾遞) 更多
NCT03060629 (CTgov)	临床2期	HIV感染	2,636	Ad26.Mos.HIV Vaccine (Group 1: Ad26.Mos.HIV Vaccine)	範鑰衊範夢願憲顧築製(網積醖壓憲餘蓋選顧選) = 膚繭鏇夢餘衊鏇窪鑰簾網構糧淵蓋繭壓鏇遞願 (廠範窪鏇製鑰鬱壓遞餘, 廠糧蓋鏇淵範選簾範願 ~ 範蓋淵鹽憲醖積鏇鬱選) 更多	-	2023-04-18
				Placebo+Ad26.Mos4.HIV (Group 2: Placebo)	範鑰衊範夢願憲顧築製(網積醖壓憲餘蓋選顧選) = 網築艱鏇鏇襯齋製壓襯網構糧淵蓋繭壓鏇遞願 (廠範窪鏇製鑰鬱壓遞餘, 餘廠顧鏇顧餘衊壓壓鹽 ~ 蓋獵淵鏇夢鑰網餘網築) 更多