A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF DIFFERENT VACCINATION SCHEDULES OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY ADULT PARTICIPANTS

The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.
This study is seeking participants who:
* are generally healthy and between 18 and 44 years of age,
* have never had a vaccine for Lyme disease before,
* are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners, and
* are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine.
All participants in this study will receive a total of 5 doses through a shot in the upper arm. Four doses will be the study vaccine (VLA15), and 1 dose will be saltwater.
The study will compare the experiences of people receiving the study vaccine at different time points. This will help see if the study vaccine is safe and will help understand its effect on the body.
Participants will take part in this study for about 2 years. During this time, the participants will have 11 planned visits - 8 will be at the study clinic and 3 will be done over the phone. The clinic visits may include having a health check, giving a small amount of blood (about 20 mL or 4 teaspoons), and getting the study vaccine or saltwater as a shot.

开始日期2025-11-19

申办/合作机构

Pfizer Inc.

NCT05634811

/ Completed临床3期

A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY OF A 6-VALENT OspA-BASED LYME DISEASE VACCINE (VLA15) IN HEALTHY CHILDREN 5 THROUGH 17 YEARS OF AGE

This study is to understand if the study vaccine (called VLA15) is safe in healthy children.
We are looking for children who:
* are healthy
* are age 5 through 17
* have not been diagnosed with any form of Lyme disease in the past
* have not received any vaccines for Lyme disease in the past
Lyme disease happens most often in children of this age. The study vaccine may be used potentially to help prevent Lyme disease. The goal of this study is to get more information about the safety of the study vaccine in this age group.
Participants will be in this study for about 2 years. During that time, they will receive VLA15 or placebo (sterile saltwater solution) by a "shot" in the arm. We will compare experience of children receiving VLA15 to those receiving the placebo. Participants will not know whether they get VLA15 or placebo.
Everyone participating in this study will:
* get the shots in a clinic or in a hospital office
* receive a total of 4 shots
* receive the first 3 shots within 6 months
* receive the last shot about 1 year afterwards
* need to come to the trial site for 6 planned visits; 4 of these are vaccination visits and 2 are follow-up visits. We will contact you by phone 1 time every year during the study to monitor your experience. You may have extra visits if you experience a severe reaction after a vaccine dose.

开始日期2022-12-12

申办/合作机构

Pfizer Inc.

NCT05477524

/ Active, not recruiting临床3期

A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.
Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season.
Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.
If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

开始日期2022-08-04

申办/合作机构

Pfizer Inc.

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100 项与 VLA15 相关的临床结果

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100 项与 VLA15 相关的转化医学

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100 项与 VLA15 相关的专利（医药）

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项与 VLA15 相关的文献（医药）

2025-11-01·LANCET INFECTIOUS DISEASES

Immunogenicity and safety of an 18-month booster dose of the VLA15 Lyme borreliosis vaccine candidate after primary immunisation in children, adolescents, and adults in the USA: a randomised, observer-blind, placebo-controlled, phase 2 trial

Article

作者: Bézay, Nicole ; Hochreiter, Romana ; Maguire, Jason D ; Obersriebnig, Michaela ; Murphy, Timothy ; Kadlecek, Vera ; Messier, Marc ; Eder-Lingelbach, Susanne ; Hegele, Lisa ; Larcher-Senn, Julian ; Wagner, Laura ; Jaramillo, Juan Carlos ; Derhaschnig, Ulla

BACKGROUND:

Lyme borreliosis is the most common tick-borne disease in temperate climates of the northern hemisphere. Although in some cases Lyme borreliosis progresses to serious outcomes, no human vaccines are available for its prevention. A previous report showed positive immunogenicity and safety of VLA15, an investigational Lyme borreliosis vaccine based on Borrelia burgdorferi outer surface protein A (OspA), when administered as a 0-2-6-month or 0-6-month primary series to children, adolescents, and adults. Here, we report data from the same trial after receipt of an initial booster dose at month 18.

METHODS:

This ongoing, randomised, observer-blind, placebo-controlled, phase 2 trial is taking place at 14 clinical study centres in Lyme borreliosis-endemic areas in the USA. Healthy, eligible participants aged 5-65 years were enrolled. Participants were randomly assigned within each age cohort (18-65 years, 12-17 years, and 5-11 years) in a 1:1:1 ratio to receive intramuscular injections of VLA15 at months 0, 2, and 6; VLA15 at months 0 and 6 and placebo at month 2; or placebo at months 0, 2, and 6. In this phase of the trial, a month 18 VLA15 booster vaccination was administered to participants in both VLA15 groups (termed VLA15 M0-2-6-18 and VLA15 M0-6-18, respectively); the placebo group received placebo at month 18. Data up to month 12, including the primary endpoints, have been reported previously; this report includes data up to month 19. Secondary endpoints related to the month 18 booster vaccination included OspA serotype-specific IgG geometric mean titres (GMTs; evaluated in the per-protocol analysis set) and solicited and unsolicited adverse events (evaluated in the safety analysis set [ie, all participants who received one or more vaccinations]) from month 18 to month 19. This trial is registered at ClinicalTrials.gov, NCT04801420, and is closed for recruitment.

FINDINGS:

Between March 15, 2021, and Feb, 24, 2022, 625 participants were randomly assigned and received the first vaccination. 532 (85%) of 625 participants were White, 68 (11%) were Black or African American, 13 (2%) were Asian, one (<1%) was an American Indian or Alaska Native, and 11 (2%) had their race recorded as other. 321 (51%) of 625 participants were female and 304 (49%) were male. The month 18 booster vaccination was administered to 449 participants at 13 of the trial sites (148 participants in the VLA15 M0-2-6-18 group; 143 participants in the VLA15 M0-6-18 group; 12 other VLA15 recipients; and 146 participants in the placebo group) between Sept 21, 2022, and Jan 24, 2023. The 12 other VLA15 booster recipients, of whom 11 received VLA15 and one received placebo for the month 18 booster, received at least one primary or booster VLA15 dose but could not be evaluated within a designated VLA15 group for safety because of missed or incorrect vaccinations, and were excluded from post-booster immunogenicity analyses. Of the 513 participants included in the per-protocol analysis set, 398 received the booster and 394 completed the month 19 visit. OspA-specific IgG GMTs in both VLA15 groups declined after the primary series up to month 18. At 1 month after the month 18 booster vaccination, GMTs in both VLA15 groups rose to levels that exceeded those after the primary series, ranging in the overall population from 1057·0 U/mL (95% CI 843·1-1325·1; serotype 1) to 1807·9 U/mL (1486·2-2199·3; serotype 2) in the M0-2-6-18 group and from 830·0 U/mL (621·3-1108·9; serotype 1) to 1603·1 U/mL (1239·7-2073·0; serotype 2) in the M0-6-18 group. GMTs at month 19 were higher in the paediatric cohorts compared with adults, consistent with observations after the primary vaccination series. The tolerability profile of the month 18 booster was similar to that of the primary doses and generally similar across age cohorts. Related unsolicited adverse events were reported by four (1%) of 302 VLA15 booster vaccination recipients and three (2%) of 147 placebo booster recipients within 1 month after the month 18 booster; all of these events resolved without sequelae. Unsolicited adverse events leading to trial withdrawal, unsolicited serious adverse events, and adverse events of special interest that were reported up to month 19 were all considered unrelated to trial vaccination and occurred before the month 18 booster. No deaths were reported up to month 19 of the trial.

INTERPRETATION:

The safety and robust anamnestic immune responses associated with VLA15 boosting support its use as a strategy to increase anti-OspA antibody levels before tick season among children, adolescents, and adults. Forthcoming data after administration of subsequent annual boosters will provide further information about VLA15 antibody persistence and boostability.

FUNDING:

Valneva and Pfizer.

2025-10-01·Therapeutic advances in vaccines and immunotherapy

Exploring the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk population: a systematic review and meta-analysis of randomized controlled trials

Review

Background::

Lyme disease, the most common vector-borne illness in the Northern Hemisphere, is caused by Borrelia burgdorferi and transmitted via tick bites. With rising global incidence and no approved human vaccine, VLA15, a novel recombinant vaccine targeting six OspA serotypes, shows promise as an effective preventive strategy.

Objective::

This study aims to assess the safety and immunogenicity of the VLA15 vaccine among healthy or high-risk populations.

Design::

We conducted a systematic review and meta-analysis of three randomized controlled trials.

Methods::

This systematic review and meta-analysis, registered in PROSPERO (CRD420251058818), was conducted following PRISMA guidelines. A thorough search of PubMed, EMBASE, Cochrane Library, Scopus, ScienceDirect, and ClinicalTrials.gov was performed up to May 2025. Data extraction and quality assessment (using Cochrane ROB 2) were performed independently by reviewers. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using random-effects models.

Results::

Three RCTs, including 5907 participants (4500 VLA15; 1407 placebo), met inclusion criteria. VLA15 recipients showed a significantly higher risk of adverse events: fever (RR 2.65, 95% CI: 1.77–3.96), headache (RR 1.40, 95% CI: 1.21–1.62), fatigue (RR 1.33, 95% CI: 1.15–1.55), and arthralgia (RR 2.50, 95% CI: 1.67–3.76), all with p < 0.0001. Subgroup analysis revealed a dose-response trend for arthralgia, particularly at 135 μg and 180 μg doses. However, nausea (RR = 1.34, p = 0.10) and severe unsolicited AEs (RR = 1.22, p = 0.42) were not statistically significant, suggesting no meaningful increase in these risks. Immunogenicity outcomes consistently favored VLA15, showing elevated IgG levels, GMTs, and seroconversion rates.

Conclusion::

VLA15 exhibits strong immunogenicity and acceptable safety, despite an increased risk of mild-to-moderate adverse events. Continued research and monitoring are warranted to support its use in Lyme disease prevention.

2025-09-01·LANCET INFECTIOUS DISEASES

Immunogenicity and safety of different immunisation schedules of the VLA15 Lyme borreliosis vaccine candidate in adults, adolescents, and children: a randomised, observer-blind, placebo-controlled, phase 2 trial

Article

作者: Hegele, Lisa ; Obersriebnig, Michaela ; Hochreiter, Romana ; Maguire, Jason D ; Kadlecek, Vera ; Larcher-Senn, Julian ; Ghadge, Santhosh Kumar ; Wagner, Laura ; Bézay, Nicole ; Jaramillo, Juan Carlos ; Eder-Lingelbach, Susanne ; Derhaschnig, Ulla

BACKGROUND:

Increasing incidence rates, insufficient effectiveness of exposure prevention strategies, and the potential for serious outcomes despite antibiotic treatment highlight the need for a preventive vaccine against Lyme borreliosis. VLA15, an investigational Lyme borreliosis vaccine based on outer surface protein A (OspA) variants from clinically relevant Borrelia burgdorferi sensu lato genospecies in North America and Europe, has shown safety and immunogenicity in adults when administered with various three-dose schedules. We aimed to investigate the safety and immunogenicity of two-dose and three-dose schedules of VLA15 within a broader population, including children and adolescents, who are among those at increased risk of Lyme borreliosis.

METHODS:

This randomised, observer-blind, placebo-controlled phase 2 trial is taking place at 14 clinical study centres in Lyme borreliosis-endemic areas in the USA. Healthy, eligible participants aged 5-65 years were enrolled in a 2:1:1 ratio to age cohorts of 18-65 years, 12-17 years, and 5-11 years through a staggered age-descending enrolment process. Within each age cohort, participants were randomly assigned with an electronic data capture system in a 1:1:1 ratio to receive intramuscular injections of 180 μg VLA15 at months 0, 2, and 6 (VLA15 M0-2-6 group); 180 μg VLA15 at months 0 and 6, and placebo at month 2 (VLA15 M0-6 group); or placebo at months 0, 2, and 6. Unmasked individuals included site staff and clinical research associates involved in randomisation and handling the investigational product, as well as specific individuals, both internal and external to the sponsor, who regularly reviewed trial safety data (including statisticians preparing relevant tables). All other individuals were masked; unmasking after the database snapshot for month 7 analyses for each age cohort was limited to the trial sponsor, collaboration partner, and statisticians. The primary immunogenicity endpoint was OspA serotype (ST)-specific IgG geometric mean titres (GMTs) assessed by ELISAs at month 7 (ie, 1 month after the third vaccination) and was evaluated in the per-protocol analysis set. The primary safety endpoint was the frequency of solicited local and systemic adverse events occurring within 7 days after each and any vaccination and were assessed in the safety analysis set (ie, all individuals who received at least one vaccination). This report includes safety and immunogenicity data through to month 12. This trial is ongoing but no longer recruiting participants, and is registered with Clinicaltrials.gov (NCT04801420).

FINDINGS:

Between March 15, 2021, and Feb 24, 2022, 625 participants (321 [51%] female, 304 [49%] male) received one or more vaccinations and were included in the safety analysis set. Of these, 190 participants were included in the VLA15 M0-2-6 group, 187 were included in the VLA15 M0-6 group, and 208 were included in the placebo group; 40 additional VLA15 recipients could not be allocated to either VLA15 group because their vaccination schedules were non-compliant with both VLA15 groups due to missed or incorrect vaccinations; however, these individuals were included in safety analyses. OspA-specific ELISA IgG GMTs at month 7 in the overall population (aged 5-65 years) were significantly higher in the VLA15 M0-2-6 group (333·2 [95% CI 275·2-403·4; ST1] to 656·0 [560·2-768·2; ST2] units per mL) and VLA15 M0-6 group (197·3 [156·2-249·3; ST1] to 460·3 [370·6-571·8; ST2] units per mL) compared with the placebo group (21·9 [20·2-23·7; ST2] to 24·3 [22·1-26·7; ST6] units per mL; p<0·0001 for all comparisons); GMTs were also significantly higher in the VLA15 M0-2-6 group than in the VLA15 M0-6 group (all p<0·0001 except for ST2 [p=0·0010] and ST3 [p=0·011]). Among VLA15 recipients, GMTs were highest in children followed by adolescents and then adults. Solicited local adverse events after any vaccination occurred more frequently among VLA15 recipients (M0-2-6, 178 [94%; 95% CI 89-96] of 190; M0-6, 176 [94%; 90-97] of 187) than placebo recipients (71 [34%; 28-41] of 208; p<0·0001 for both comparisons); the same was true for solicited systemic adverse events (M0-2-6, 128 [67%; 95% CI 60-74] of 190, p=0·0015 vs placebo; M0-6, 128 [68%; 61-75] of 187, p=0·0007 vs placebo; placebo, 107 [51%; 45-58] of 208). Most solicited adverse events were mild or moderate in severity; none was grade 4. There were no significant differences in the frequencies of unsolicited adverse events, related unsolicited adverse events, unsolicited serious adverse events (serious adverse events), and adverse events of special interest across groups in the overall population. None of the severe unsolicited adverse events, serious adverse events, or adverse events of special interest were considered related to vaccination and no deaths occurred through to month 12 of the trial.

INTERPRETATION:

These findings confirm previously observed safety and immunogenicity profiles of VLA15 in adults and extend them to children aged 5 years and older and adolescents. The greater immunogenicity of VLA15 among children and adolescents might translate to increased flexibility in the real-world clinical setting.

FUNDING:

Pfizer and Valneva.

113

项与 VLA15 相关的新闻（医药）

2025-11-26

·EndPoints

Imfinzi's latest label expansion; FDA seeks more information on BiomX's nebulizer

Plus, news about Ming Yu Pharmaceutical, Elpiscience Biopharmaceuticals, Chengdu Olymvax Biopharmaceuticals and Valneva: 🚦 AstraZeneca’s Imfinzi approved for perioperative use in stomach cancers : The PD-L1 inhibitor may now be used alongside standard chemotherapy before and after surgery in patients with early-stage and locally advanced gastric and gastroesophageal junction cancers. In its pivotal trial in this setting, Imfinzi plus chemo cut patients’ risk of progression, recurrence or death by 29% compared with chemo alone, and demonstrated a 22% cut in the risk of death. — Elizabeth Cairns 📁 FDA requests more info on BiomX’s nebulizer : The agency maintains its clinical hold on BiomX’s Phase 2 cystic fibrosis study of its investigational asset, called BX004, due to issues with its drug delivery device. The FDA has been reviewing the device after issues were found at a third-party manufacturer. BiomX is “working closely” with that manufacturer to address the issues and expects US patient enrollment to resume. — Anna Brown 🇨🇳 Three more Chinese biotechs file for HKEX listing: The long queue for a listing on the Hong Kong Stock Exchange now also includes Ming Yu Pharmaceutical , cancer drug developer Elpiscience Biopharmaceuticals and commercial vaccine maker Chengdu Olymvax Biopharmaceuticals . Ming Yu has multiple autoimmune drugs in clinical testing and a large suite of antibody-drug conjugates in hot target areas. It also has a Phase 2 bispecific antibody in the rich area of PD-1xVEGF. Elpiscience is partnered with Astellas Pharma and has done licensing deals with Inhibrx and Compass Therapeutics. Elpiscience had tried for an HKEX listing in 2024 and earlier this year , but let its applications lapse both times. — Kyle LaHucik 🪲 Valneva’s Phase 2 Lyme disease vaccine data : The vaccine candidate, codenamed VLA15, increased patients’ antibody levels between 9.5-fold and 15.6-fold from baseline in the final readout of the 48-month trial. Antibody levels were assessed six months after patients were given a third dose of the shot, and there were no safety concerns, the French biotech said Wednesday. The Pfizer-partnered product is the most advanced Lyme disease vaccine in the clinic, though the readout of its pivotal Phase 3 study has been delayed by three months to allow safety monitoring and adjudication of potential Lyme cases from tick bites received during the 2025 season. Data should come in the first half of 2026, with launch slated for 2027 . Valneva’s stock ticked up 5% on the Paris exchange on Wednesday. — Elizabeth Cairns

疫苗临床2期临床结果上市批准临床3期

2025-10-31

·百度百家

2025年第四季度，生物制药行业将迎来哪些颠覆性突破？

2025年10月发布的《2025年第四季度生物制药行业展望报告》，由Biomedtracker、Citeline Commercial等机构联合发布，共计50页。该报告系统梳理了2025年第四季度全球生物制药领域的关键药物审批、临床数据读出以及重大并购交易，旨在为行业参与者提供前瞻性的市场洞察与决策参考。一、重点药物审批与数据读出 1.PDUFA审批关键药物 TransCon CNP（软骨发育不全）：首个一周一次注射疗法，挑战现有日注射药物。 Ziftomenib（AML）：针对NPM1突变的口服menin抑制剂，与Revuforj竞争。 Depemokimab（哮喘/鼻息肉）：GSK长效抗IL-5抗体，每6个月一次给药。 Aficamten（肥厚型心肌病）：Cytokinetics新一代心肌肌球蛋白抑制剂，对标Camzyos。 Reproxalap（干眼症）：新型RASP调节剂，第三次提交NDA，追求快速起效。 2.三期临床数据读出 CagriSema（肥胖）：Novo Nordisk组合疗法，头对头挑战Zepbound。 VLA15（莱姆病疫苗）：Valneva/Pfizer合作，有望成为20年来首款莱姆病疫苗。 mRNA-1647（巨细胞病毒疫苗）：Moderna mRNA疫苗，瞄准先天性感染预防。 Latozinemab（额颞叶痴呆）：首个进入三期针对GRN突变的疾病修饰疗法。 3.其他值得关注的领域神经科学：如Fasedienol（社交焦虑）、ND0612（帕金森）等，机制新颖。肿瘤学：Ziihera（胃癌）、Giredestrant（乳腺癌）等靶向疗法持续推进。代谢与罕见病：plozasiran（FCS）、Lerochol（HoFH）等填补治疗空白。二、行业并购与战略交易 1.大型药企收购动态 BioNTech收购PureVac：加强mRNA平台与肿瘤/传染病管线。 Sanofi收购Vicebio：拓展呼吸道病毒疫苗技术与产品组合。 Novartis收购Tourmaline：获得抗IL-6单抗，布局心血管疾病领域。 2.技术平台与早期资产整合 Kite Pharma收购Interius：布局体内CAR-T疗法，拓展细胞治疗边界。 XOMA收购Lava Therapeutics：聚焦双特异性抗体与γδ T细胞衔接器。三、市场趋势与行业态度审批加速：多个药物获FDA优先审评、突破性疗法认定，反映监管支持。差异化竞争：长效给药、新型机制、联合疗法成为企业突围关键。患者为中心：自我给药、居家治疗（如Cardamyst）趋势明显。并购活跃：大药企通过收购补充管线，聚焦mRNA、细胞治疗、疫苗等前沿领域。报告总结与启示本报告显示，2025年第四季度是全球生物制药行业的关键时间窗口，多个重磅药物有望获批或公布关键数据，涵盖肿瘤、代谢、神经、罕见病等多个领域。企业通过自主研发与外部并购双轮驱动，不断推进治疗手段的创新与升级。未来，随着更多突破性疗法上市，患者获益将显著提升，而药企也需在快速变化的市场中持续优化战略布局，以保持竞争力。报告节选三个皮匠报告AI译版

并购疫苗信使RNA细胞疗法免疫疗法

2025-10-07

·EndPoints

Adicet reveals Phase 1 data for lupus therapy; Arcus’ ‘best-in-class’ kidney cancer drug

Plus, news about AbbVie, BlueRock Therapeutics, MaaT Pharma, Valneva, Jade Biosciences, Affinia Therapeutics, DBV Technologies, Pharming Group and Gemma Bio: 📈 Adicet Bio shares lupus data, initiates stock sale: The company’s cell therapy candidate, called ADI-001, achieved renal responses in all seven lupus nephritis patients enrolled in a Phase 1 trial as of a cut-off in August. All patients also had “rapid and sustained” reductions on a symptom scale called the Systemic Lupus Erythematosus Disease Activity Index. Adicet plans to discuss the design of a pivotal Phase 2 trial with the FDA, which is set to start the study in the second quarter of 2026. Separately, the company announced plans to sell $80 million in shares. Adicet’s share price $ACET was up around 20% at Monday’s close, but dipped in premarket trading on Tuesday. — Ayisha Sharma 🧪 Arcus’ promising kidney cancer results: In a pooled analysis of four different doses, Arcus’ casdatifan saw median progression-free survival of 12.2 months and an overall response rate of 31%. Arcus observed one complete response and 37 partial responses. The median follow-up for the 121 patients was 15.2 months. Arcus’ stock $RCUS closed 8% higher on Monday. Leerink analyst Daina Graybosch described the drug as “best in class” after examining the data. — Max Gelman 💉 AbbVie’s Botox gets mid-stage win in essential tremor: Topline data from a Phase 2 trial showed the injected therapy beat placebo in treating upper limb essential tremor. On the Tremor Disability Scale-Revised scale, which measures patients’ ability to do tasks like holding a cup of tea and unlocking their front door, Botox-treated patients had a 2.61-point reduction at 18 weeks, versus -1.61 for placebo. The difference was statistically significant at p=0.029. The study also met all six of its secondary endpoints. Muscle weakness was the most common adverse event. It was seen in 24.5% of the Botox group versus 2.3% of the placebo patients. — Elizabeth Cairns 🧬 Bayer’s BlueRock touts long-term Parkinson’s disease data: The company said seven patients taking the high dose of its cell therapy, known as bemdaneprocel, saw reduced motor symptoms in the “off” state by an average of 17.9 points compared with baseline after 36 months. The low dose, administered to four patients, reduced “off” state motor symptoms by an average of 13.5 points compared to baseline. Motor symptom scores were measured using MDS-UPDRS Part III, a scale used in most Parkinson’s studies. — Max Gelman 🦠 MaaT’s microbiome therapy clears Phase 2 safety test: The French biotech said MaaT033 successfully completed the second planned interim safety analysis in a trial of patients undergoing an allogeneic stem cell transplant. The company’s share price crept up about 4% on the Paris exchange after disclosing the data. It’s expected to have the next safety analysis in the first quarter of 2026. — Ayisha Sharma 💰 Valneva updates its financial position: The French vaccine maker inked a new debt facility for up to $500 million from Pharmakon Advisors, including $215 million upfront to repay an existing debt facility with Deerfield and OrbiMed. Valneva can get the rest of the money for future business development. It said the Phase 3 Lyme disease vaccine with Pfizer is still on track. The company also lowered its revenue guidance in response to the FDA’s suspension of its Ixchiq product license . It also said it would spend less on R&D because of grant funding and tax credits. Its shares were down 7% on the Euronext Paris exchange. — Kyle LaHucik 💸 Jade Biosciences’ $135M PIPE: The biotech listed a range of investors, including Janus Henderson Investors, Fairmount and RA Capital Management. It also disclosed that it’s working on a monoclonal antibody that targets the B cell activating factor receptor for autoimmune diseases. — Jaimy Lee 🫀 Affinia gets $40M to enter the clinic: The Series C , led by New Enterprise Associates, is the first publicly disclosed financing for the Waltham, MA-based biotech since a $110 million Series B in 2021 . Eli Lilly is a new investor. Affinia scrapped its IPO plans in 2022. And earlier this year, it lost a collaboration with Vertex, Endpoints News reported in May. The biotech is now focused on a BAG3 dilated cardiomyopathy gene therapy called AFTX-201, with plans to start a Phase 1/2 trial in the first quarter of next year. — Kyle LaHucik 💵 DBV Technologies gets $30M: The French food allergy biotech sold American depositary shares to get gross proceeds of about $30 million. — Kyle LaHucik 💼 Pharming Group restructures: The Dutch biotech plans to cut 20% of its “non-commercial and non-medical headcount.” It had 404 employees at the end of 2024. — Jaimy Lee 🔬 Gemma Bio launches affiliate company: The startup , called Rare Therapeutics, will focus on developing gene therapies for ultra-rare diseases. Rare has a trio of lead programs designed to treat GM1 gangliosidosis, Krabbe disease and metachromatic leukodystrophy. — Max Gelman

临床结果临床2期基因疗法疫苗临床1期

100 项与 VLA15 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
莱姆病	临床3期	美国	Valneva Sweden AB	2022-01-30
神经莱姆病	临床1期	美国	Pfizer Inc.	2017-01-31
神经莱姆病	临床1期	美国	VALNEVA Austria GmbH	2017-01-31
神经莱姆病	临床1期	比利时	VALNEVA Austria GmbH	2017-01-31
神经莱姆病	临床1期	比利时	Pfizer Inc.	2017-01-31

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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


NCT04801420 (VLA15-221, GlobeNewswire) 人工标引	临床2期	莱姆病	560	VLA15 (month 0-2-6)	願鹽網憲選壓構襯齋網(積獵觸夢積顧糧鹹獵糧) = 襯鑰憲憲鬱鹹憲築範餘觸壓餘蓋窪壓繭積膚鏇 (齋鏇繭餘築憲構壓襯齋 ) 更多	积极	2025-11-26
				VLA15 (month 0-6)	願鹽網憲選壓構襯齋網(積獵觸夢積顧糧鹹獵糧) = 襯積衊蓋鑰網鏇淵鹹夢觸壓餘蓋窪壓繭積膚鏇 (齋鏇繭餘築憲構壓襯齋 ) 更多
NEWS 人工标引	临床2期	莱姆病	560	VLA15	鑰夢壓餘壓蓋獵壓願膚(遞襯鹽製憲夢淵簾鹽蓋) = Seroconversion rates hit 100% for all outer surface protein A serotypes in all age groups 顧淵築積憲積鹹範膚餘 (醖築餘襯遞積簾構顧鬱 ) 更多	积极	2025-09-03
				placebo
NCT04801420 (VLA15-221, CTgov)	临床2期	莱姆病	625	VLA15 (Group 1: VLA15)	鬱窪遞淵積膚鏇鹹膚淵 = 窪膚積膚獵繭鏇選夢製壓鹽艱鏇憲壓鏇醖範獵 (遞衊鹹遞壓糧鏇醖觸願, 顧範糧襯願觸顧糧獵鬱 ~ 構壓顧繭鑰鹹鹽築築範) 更多	-	2023-06-07
				Placebo+VLA15 (Group 2: VLA15 + Placebo)	鬱窪遞淵積膚鏇鹹膚淵 = 遞獵製醖蓋網齋窪遞鹽壓鹽艱鏇憲壓鏇醖範獵 (遞衊鹹遞壓糧鏇醖觸願, 網憲積觸獵糧糧窪齋觸 ~ 繭鹹廠齋鬱夢鹽餘鹹願) 更多
NCT03970733 (CTgov)	临床2期	莱姆病	246	VLA15 (VLA15 With Alum Lower Dose)	遞鹽齋範廠願壓鏇壓醖(鹹積顧廠網觸齋網襯壓) = 觸願選觸積膚顧鬱醖淵齋繭願鬱鹽艱淵築齋鬱 (衊壓艱顧鬱願繭遞鏇範, 廠壓齋襯築獵鹹鹹夢壓 ~ 齋憲築製構範襯蓋廠壓) 更多	-	2021-07-08
				VLA15 (VLA15 With Alum Higher Dose)	遞鹽齋範廠願壓鏇壓醖(鹹積顧廠網觸齋網襯壓) = 鑰製獵鏇遞範鏇觸蓋積齋繭願鬱鹽艱淵築齋鬱 (衊壓艱顧鬱願繭遞鏇範, 醖願衊鹹鏇範夢衊壓艱 ~ 顧鬱遞襯鏇淵蓋襯繭鏇) 更多
NCT03769194 (CTgov)	临床2期	莱姆病	572	VLA15 (VLA15 Low Dose)	淵網選壓願鑰鬱膚簾淵(鑰夢觸簾糧衊衊繭廠獵) = 顧糧製廠網蓋艱構繭製選齋齋膚廠衊衊選鹹選 (醖鹹顧顧餘觸淵願餘鹽, 襯獵選鏇鏇廠窪簾築鏇 ~ 淵膚鹽鹽餘齋鑰壓襯積) 更多	-	2021-06-30
				VLA15 (VLA15 Medium Dose)	淵網選壓願鑰鬱膚簾淵(鑰夢觸簾糧衊衊繭廠獵) = 繭製願願齋願夢鏇憲構選齋齋膚廠衊衊選鹹選 (醖鹹顧顧餘觸淵願餘鹽, 築衊醖醖鑰鏇醖顧鹽範 ~ 窪繭廠遞夢繭繭遞遞衊) 更多