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更新于：2025-02-06
Rabies vaccine(Novartis)
人狂犬病疫苗(Novartis )
更新于：2025-02-06
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1997-10-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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关联
20
项与 人狂犬病疫苗(Novartis ) 相关的临床试验NCT03192371
A Phase IV, Randomized, Open-label Study to Evaluate One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese Children
NCT03264157
A Prospective, Randomized, Double-Blind Parallel-group, Non-inferiority Phase II/III Study of the Safety and Effectiveness of BPL HRIG With Co Administration of Active Rabies Vaccine in Healthy Subjects
NCT03276962
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or With-out Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
100 项与 人狂犬病疫苗(Novartis ) 相关的临床结果
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100 项与 人狂犬病疫苗(Novartis ) 相关的转化医学
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100 项与 人狂犬病疫苗(Novartis ) 相关的专利（医药）
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78
项与 人狂犬病疫苗(Novartis ) 相关的文献（医药）2024-12-01VACCINE
Safety and immunogenicity of a ChAd155-vectored rabies vaccine compared with inactivated, purified chick embryo cell rabies vaccine in healthy adults
Article
作者: Girmay, Tigisty ; Scherer, Erin M ; Leary, Maranda ; Rouphael, Nadine G ; Min, Ji-Young ; Gromer, Daniel J. ; Sherman, Amy C ; Gromer, Daniel J ; Sherman, Amy C. ; Seetahal, Janine ; McCullough, Michele P ; Mulligan, Mark J ; Rouphael, Nadine G. ; Phadke, Varun K ; Phadke, Varun K. ; Graciaa, Daniel S ; Graciaa, Daniel S. ; Retallick, Jamie ; Koller, Mark ; Rebolledo, Paulina A. ; Tsong, Rachel ; Mulligan, Mark J. ; Capone, Stefania ; McCullough, Michele P. ; Sommella, Andrea ; Rebolledo, Paulina A ; Scherer, Erin M. ; Vitelli, Alessandra ; Wiley, Zanthia ; Neill-Gubitz, Hannah
BACKGROUND:
Rabies is a zoonotic viral encephalitis that is endemic in many countries and confers a high mortality. Licensed vaccines require several doses to ensure efficacy. To investigate a logistically favorable approach, we assessed the safety and immunogenicity of ChAd155-RG, a novel investigational rabies vaccine using a replication-defective chimpanzee adenovirus vector.
METHODS:
We conducted a first-in-human, phase 1, randomized, double-blind, dose-escalation trial comparing ChAd155-RG with a licensed inactivated vaccine (RabAvert) in healthy adults. Participants received either RabAvert at standard dosing or ChAd155-RG at a low dose for one immunization or a high dose for one or two immunizations. To assess safety, we evaluated reactogenicity, unsolicited adverse events, and thrombotic events. To measure immunogenicity, we measured rabies viral neutralizing antibody (VNA) titers and anti-ChAd155 neutralizing antibodies.
RESULTS:
Mild to moderate systemic reactogenicity and transient lymphopenia and neutropenia were more common among recipients of ChAd155-RG compared with those who received RabAvert. No thrombotic events or serious adverse events were reported. Only the groups receiving RabAvert or two doses of high-dose ChAd155-RG achieved 100 % seroconversion, and seroprotection was most durable in the RabAvert group. Most participants had preexisting anti-vector antibodies, which were boosted by ChAd155-RG. Baseline and post-vaccination anti-vector antibody titers were negatively associated with post-vaccination rabies VNA titers.
CONCLUSIONS:
In this phase 1 clinical trial, a novel rabies vaccine using a simian adenovirus vector was safe and tolerable, but generated lower, less durable rabies VNA titers than a standard inactivated rabies virus vaccine, which may be due to preexisting, anti-vector immunity.
2023-04-05Journal of travel medicine
Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial
Article
作者: Stijnis, Cornelis ; van Gucht, Steven ; Grobusch, Martin P ; Goorhuis, Abraham ; Garcia Garrido, Hannah M ; Terryn, Sanne ; van Put, Bridget ; Spuls, Phyllis I ; van de Sande, Marleen G ; D’Haens, Geert R ; de Pijper, Cornelis A
Abstract:
Background:
For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.
Methods:
In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21–28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21–28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results:
We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83–9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21–28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0–6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.
Conclusion:
In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.
2021-09-01Vaccine3区 · 医学
Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial
3区 · 医学
Article
作者: Chuang, Ariel ; Moore, Susan M ; Reid, Caroline ; McClain, J Bruce ; Tsao, Eric
BACKGROUND:
SYN023-002 is a randomized, blinded, controlled study comparing rabies virus neutralizing activity (RVNA) and safety of SYN023, a monoclonal anti-rabies antibody mixture, to human-serum derived anti-rabies immunoglobulin (RIG) when administered with commercially available vaccines to healthy adult volunteers.
METHODS:
Participants were randomized among 4 treatment groups (SYN023 + Imovax, SYN023 + RabAvert, HyperRab + Imovax, HyperRab + RabAvert). On Day 0, subjects received 1 dose of RIG (0.3 mg/kg SYN023 or 20 IU/mL HyperRab) and their first of 5 vaccine doses. The primary objective was to compare cumulative RVNA between SYN023 and HyperRab recipients. Secondary objectives were to compare safety and to assess SYN023 pharmacokinetics and immunogenicity.
RESULTS:
All 164 randomized subjects initiated treatment and were included in safety analyses. At least 34 subjects/treatment group received all treatment and had complete RVNA results, thus were included in the primary endpoint analysis. Mean RVNAs were approximately ten-fold higher in SYN023 recipients compared to HyperRab recipients until Day 14. From Day 14 onwards, mean RVNA was lower in SYN023 recipients, but remained above the RVNA level widely considered adequate (≥0.5 IU/mL) through Day 112 (study end). The point estimate of the cumulative RVNA (83.22% SYN023/HyperRab), but not the lower CI bound (90% CI: 66.06%, 104.83%), fell within the protocol-defined similarity margin. Each RIG + vaccine regimen appeared safe with mostly mild AEs and no serious or severe related events observed. Except injection site pain (22% HyperRab recipients vs. 6% SYN023 recipients), treatment-related AEs incidences were similar between RIGs. Anti-SYN023 antibodies were observed but had no apparent effects on PK or safety.
CONCLUSIONS:
SYN023 administered with commercially available vaccines provides adequate antibody coverage beginning earlier than other commercially available RIGs with an acceptable safety profile. Some suppression of vaccine response occurred, but RVNA levels ≥ 0.5 IU/mL were maintained throughout the relevant period.
REGISTRATION:
ClinicalTrials.gov #NCT02956746.
FUNDING:
Synermore biologics.
100 项与 人狂犬病疫苗(Novartis ) 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 狂犬病 | 美国 | 1997-10-20 | |
| 狂犬病 | 美国 | 1997-10-20 | |
| 狂犬病 | 美国 | 1997-10-20 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 459 | Blood sampling+Rabipur (Conv-R/JE Group) | 鬱糧顧艱鑰築鹽鏇艱襯(淵構繭鹹膚簾膚憲壓簾) = 繭窪蓋衊餘選顧鏇積觸 餘淵鹽蓋鏇鬱鹹夢艱鏇 (衊蓋窪遞淵鏇構簾鑰選, 醖選範製遞淵範艱壓觸 ~ 願鏇鏇襯蓋鹽餘選製網) 更多 | - | 2024-07-18 | ||
Blood sampling+Rabipur (Acc-R/JE Group) | 鬱糧顧艱鑰築鹽鏇艱襯(淵構繭鹹膚簾膚憲壓簾) = 艱範範憲廠襯醖襯廠鏇 餘淵鹽蓋鏇鬱鹹夢艱鏇 (衊蓋窪遞淵鏇構簾鑰選, 製壓壓築蓋淵遞醖鹹鹽 ~ 願鬱網網憲夢鏇製範淵) 更多 | ||||||
临床2/3期 | 162 | HRIG+RabAvert (BPL HRIG + RabAvert) | 衊鏇積鹹願醖鹹顧廠觸(襯範鬱獵窪窪淵鑰積構) = 鬱鏇壓鑰顧淵餘窪範壓 憲顧鑰構醖獵積鏇構簾 (餘醖糧廠繭獵顧醖觸築, 夢淵淵淵顧願餘鹹選範 ~ 積繭繭膚構醖鹹窪襯艱) 更多 | - | 2020-02-11 | ||
衊鏇積鹹願醖鹹顧廠觸(襯範鬱獵窪窪淵鑰積構) = 簾網觸憲窪繭範選餘糧 憲顧鑰構醖獵積鏇構簾 (餘醖糧廠繭獵顧醖觸築, 繭憲膚蓋網鏇蓋範鬱憲 ~ 鹽醖齋壓積構膚憲簾膚) 更多 | |||||||
临床3期 | 885 | (4-sites, 1-week WITH HRIG) | 鬱餘網構選築膚衊範顧(憲構糧觸廠築築蓋範鹹) = 顧廠獵製獵選獵艱齋鏇 遞膚夢築遞願獵壓糧膚 (鬱範獵憲夢餘淵齋壓願, 遞顧艱糧構網膚範廠構 ~ 觸願憲廠窪蓋鑰蓋艱醖) 更多 | - | 2017-04-07 | ||
(4-sites, 1-week WITHOUT HRIG) | 鬱餘網構選築膚衊範顧(憲構糧觸廠築築蓋範鹹) = 獵顧夢鹹淵憲鹽範鏇獵 遞膚夢築遞願獵壓糧膚 (鬱範獵憲夢餘淵齋壓願, 遞鏇願繭襯淵膚廠製鬱 ~ 壓鹽窪獵製網鹽積鏇顧) 更多 | ||||||
临床3期 | 661 | Japanese Encephalitis+Rabies (R/JE - Acc) | 鏇構遞觸蓋網窪鑰願壓(築選壓憲齋艱製鏇餘遞) = 積夢壓鹽衊艱壓觸衊艱 襯築衊選網鏇鏇憲醖積 (醖範觸願積醖鑰蓋衊衊, 廠窪壓衊範繭膚艱範範 ~ 鑰網製範襯簾選鹽顧遞) 更多 | - | 2014-12-08 | ||
Placebo+Rabies (R - Conv) | 鏇構遞觸蓋網窪鑰願壓(築選壓憲齋艱製鏇餘遞) = 鹽遞淵艱壓憲鬱積遞積 襯築衊選網鏇鏇憲醖積 (醖範觸願積醖鑰蓋衊衊, 窪鏇網積壓構糧構醖憲 ~ 襯鏇膚衊膚繭窪餘築鬱) 更多 | ||||||
临床4期 | 250 | Rabipur vaccine+Rabies Vaccine (Zagreb) | 餘憲築觸鹹夢蓋獵願衊(齋憲簾蓋獵蓋顧顧製夢) = 獵醖選簾艱窪膚艱餘鬱 鏇製餘簾廠獵襯構衊構 (選鬱糧襯窪遞淵壓醖鬱, 艱顧網淵鹽觸鑰餘積遞 ~ 淵壓蓋淵繭壓艱簾窪膚) 更多 | - | 2014-05-05 | ||
Rabipur vaccine+Rabies Vaccine (Essen) | 餘憲築觸鹹夢蓋獵願衊(齋憲簾蓋獵蓋顧顧製夢) = 範齋遞網鹹鹽夢遞鹹窪 鏇製餘簾廠獵襯構衊構 (選鬱糧襯窪遞淵壓醖鬱, 願選構窪膚鑰廠壓鬱窪 ~ 淵醖鏇選願膚遞範網膚) 更多 |
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