作者: García-Sastre, Adolfo ; Sánchez-Céspedes, Javier ; Pachón, Jerónimo ; Escalera, Alba ; Balsera-Manzanero, Maria ; Salamanca-Rivera, Celia ; Rojo-Fernandez, Amaya ; Aydillo, Teresa ; Cordero, Elisa ; Sánchez-Cordero, María José ; Del Mar Muñoz-García, María

Current clinical guidelines support the concomitant administration of seasonal influenza vaccines and COVID-19 mRNA boosters vaccine. Whether dual vaccination may impact vaccine immunogenicity due to an interference between influenza or SARS-CoV-2 antigens is unknown. We aimed to understand the impact of mRNA COVID-19 vaccines administered concomitantly on the immune response to influenza vaccines. For this, 128 volunteers were vaccinated during the 22-23 influenza season. Three groups of vaccination were assembled: FLU vaccine only (46, 35%) versus volunteers that received the mRNA bivalent COVID-19 vaccines concomitantly to seasonal influenza vaccines, FluCOVID vaccine in the same arm (42, 33%) or different arm (40, 31%), respectively. Sera and whole blood were obtained the day of vaccination, +7, and +28 days after for antibody and T cells response quantification. As expected, side effects were increased in individuals who received the FluCOVID vaccine as compared to FLU vaccine only based on the known reactogenicity of mRNA vaccines. In general, antibody levels were high at 4 weeks post-vaccination and differences were found only for the H3N2 virus when administered in different arms compared to the other groups at day 28 post-vaccination. Additionally, our data showed that subjects that received the FluCOVID vaccine in different arm tended to have better antibody induction than those receiving FLU vaccines for H3N2 virus in the absence of pre-existing immunity. Furthermore, no notable differences in the influenza-specific cellular immune response were found for any of the vaccination groups. Our data supports the concomitant administration of seasonal influenza and mRNA COVID-19 vaccines.

2024-06-01·American journal of ophthalmology case reports

Unilateral conjunctival Classic Kaposi Sarcoma following a COVID 19 booster

作者: White, Emily ; Finger, Paul T ; Fazio, Nicholas ; Sassoon, Jodi ; Keresztes, Roger ; Chou, Timothy ; Kaplowitz, Kevin ; Honkanen, Robert ; Tourmouzis, Konstantinos ; Ryu, Samuel

Purpose:

We describe a case of Classic Kaposi's sarcoma in a functionally monocular patient following a COVID19 vaccine booster and provide compelling evidence that suggests the booster was a relevant co-factor in the initiation of the disease process.

Observations:

The patient presented with red, irritated conjunctival area described as "bubbling" in her right eye. While her past medical history includes hypercholesterolemia and hypertension, she had no history of a compromised immune system. Her ophthalmologic history is more complex including treatment for glaucoma. The patient has 20/20 uncorrected vision OD and LP OS. Due to her ocular co-morbidities, the patient initially received interferon alpha 2-B qid for 6 weeks. However, topical therapy failed to decrease the size of the conjunctival lesions. After referral to Radiation Oncology, the right eye/orbit was treated with electron beam therapy for 1 month which caused a marked decrease in the size and vascularity of the conjunctival lesions. A slow improvement continued during followup.

Conclusion and importance:

In that the vaccine booster preceded the cancer, it appears etiologic to the appearance of Kaposi's sarcoma. The patient's monocular vision and glaucoma complicated her treatment. This case expands on current concepts of cofactors needed for the development of Kaposi's sarcoma in that vaccine booster administration was relevant to tumor progression and both clinical and mechanistic evidence is presented to support this hypothesis.

2024-01-28·Journal of microbiology and biotechnology

Comparative Biodistribution Study of Baculoviral and Adenoviral Vector Vaccines against SARS-CoV-2

Article

作者: Kim, Sehyun ; Lee, Hee-Jung ; Yoon, Doyoung ; Chun, Jungmin ; Aleksandra, Nowakowska ; Lee, Chanyeong ; Lee, Hyeon Dong ; Kim, Young Bong

Various types of vaccines have been developed against COVID-19, including vector vaccines. Among the COVID-19 vaccines, AstraZeneca's chimpanzee adenoviral vaccine was the first to be commercialized. For viral vector vaccines, biodistribution studies are critical to vaccine safety, gene delivery, and efficacy. This study compared the biodistribution of the baculoviral vector vaccine (AcHERV-COVID19) and the adenoviral vector vaccine (Ad-COVID19). Both vaccines were administered intramuscularly to mice, and the distribution of the SARS-CoV-2 S gene in each tissue was evaluated for up to 30 days. After vaccination, serum and various tissue samples were collected from the mice at each time point, and IgG levels and DNA copy numbers were measured using an enzyme-linked immunosorbent assay and a quantitative real-time polymerase chain reaction. AcHERV-COVID19 and Ad-COVID19 distribution showed that the SARS-CoV-2 spike gene remained predominantly at the injection site in the mouse muscle. In kidney, liver, and spleen tissues, the AcHERV-COVID19 group showed about 2-4 times higher persistence of the SARS-CoV-2 spike gene than the Ad-COVID19 group. The distribution patterns of AcHERV-COVID19 and Ad-COVID19 within various organs highlight their contrasting biodistribution profiles, with AcHERV-COVID19 exhibiting a broader and prolonged presence in the body compared to Ad-COVID19. Understanding the biodistribution profile of AcHERV-COVID19 and Ad-COVID19 could help select viral vectors for future vaccine development.

项与 COVID19 vaccine(Vaxine Pty Ltd.) 相关的新闻（医药）

2024-01-22

·PRNewswire

CORBEVAX®, A COVID19 VACCINE DEVELOPED BY BIO E-INDIA BASED ON THE RBD PROTEIN ANTIGEN TECHNOLOGY FROM TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT, RECEIVES WORLD HEALTH ORGANIZATION EMERGENCY USE LISTING APPROVAL

The RBD antigen of SARS-CoV-2 producing yeast strain from Texas Children's Hospital / Baylor College of Medicine was used by Biological E Limited, India to develop & manufacture CORBEVAX ®, the COVID-19 vaccine and approximately 100 million doses have been administered to people in India HOUSTON, Jan. 22, 2024 /PRNewswire/ -- Texas Children's Hospital announces today that Biological E's CORBEVAX®, a traditional, recombinant protein-based COVID-19 vaccine has received World Health Organization (WHO) approval under Emergency Use Listing (EUL). CORBEVAX® is developed and commercialized by Biological E Limited, an established global vaccine supplier based in Hyderabad, India, using Pichia pastoris yeast strain expressing Receptor Binding Domain (RBD) protein of SARS-CoV-2 engineered by Texas Children's Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine (BCM), WHO's EUL procedure applies international standards to evaluate the acceptability of vaccine quality, safety and effectiveness in the context of a public health emergency. The mission of WHO pre-qualification is to work in close cooperation with national regulatory agencies and other partner organizations, such as UNICEF and other UN agencies, to make quality priority medical products available for those who urgently need them. "The latest approval of CORBEVAX® under WHO's EUL procedure is a testament to Texas Children's Hospital's established methodology to express important antigenic proteins which will help in the worldwide fight against COVID-19," said Mark A. Wallace, Chief Executive Officer of Texas Children's Hospital. "The recombinant yeast strains enable production of the RBD protein which can be further utilized by vaccine researchers globally to develop & manufacture effective and low-cost vaccines. By providing access to the yeast strains via non-exclusive licensing, we continue our mission to support global vaccine accessibility and availability." Texas Children's Hospital Center for Vaccine Development and BCM Ventures, Baylor College of Medicine's integrated commercialization arm, licensed the recombinant Pichia pastoris yeast strain that expresses the RBD protein of SARS-CoV-2 to Biological E Limited in 2020. Biological E subsequently developed large scale manufacturing technology for production of the RBD protein complying with Good Manufacturing Practices (GMP) as well as testing & characterization suitable for use as vaccine antigen. The RBD protein was then used as an antigen and formulated with optimized adjuvants (Alum and CpG1018) to develop a COVID-19 candidate vaccine. Biological E advanced the candidate vaccine through multiple clinical trials which led to the approval of CORBEVAX® in India under Emergency Use Authorization by Drugs Controller General of India (DCGI) in a two-dose regimen for the primary immunization. These approvals were first granted for adults (18+ years) in December 2021, followed by adolescents (12-18 Years) in February 2022 and then children (5-12 Years) in April 2022. In June 2022, CORBEVAX® received EUA from DCGI, for use as a heterologous booster for people over the age of 18 who received COVAXIN or COVISHIELD for their primary immunization. Over 100 million doses of CORBEVAX® have been administered to people in India so far. "Achieving approval under WHO's EUL procedure represents an important step toward our goal of helping development of low-cost vaccines for the world's most vulnerable populations," said Dr. Peter Hotez, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Countries around the world will rely on the WHO's EUL to CORBEVAX® and Biological E's established manufacturing and supply capacity to provide safe, effective inoculation against COVID-19." "WHO's recognition that CORBEVAX® qualifies under its EUL procedure will expedite the availability of a safe and effective COVID-19 vaccine developed using the RBD antigen of SARS-CoV-2 producing strain from Texas Children's Hospital," said Dr. Maria Elena Bottazzi, Co-Director of the Center for Vaccine Development at Texas Children's Hospital and Associate Dean of the National School of Tropical Medicine at Baylor College of Medicine. "Our team of scientists has worked diligently for years to bring effective and affordable technologies to those who have been overlooked, with the ultimate goal of providing global solutions to health emergencies." Ms. Mahima Datla, Managing Director, Biological E Limited, said: ``We are pleased to receive this significant endorsement from WHO for CORBEVAX®, our COVID-19 vaccine. This approval will provide us with an opportunity to get closer to complete the fight against COVID-19 and make our vaccine available worldwide." Biological E has also licensed a yeast strain expressing XBB.1.5 RBD variant of SARS-CoV-2 virus from BCM/CVD and has developed a candidate vaccine based on CORBEVAX® platform as per WHO TAG-CO-VAC guidelines for future COVID19 vaccines to address the currently circulating variants. Biological E has completed requisite pre-clinical studies and have received approval from the Central Drugs Standard Control Organization (CDSCO) to begin pivotal clinical trials in India Drs. Peter Hotez and Maria Elena Bottazzi and their team received the David and Beatrix Hamburg Award for Advances in Biomedical Research and Clinical Medicine for their vaccine technology development work from the National Academy of Medicine. In 2022, Drs. Hotez and Bottazzi were nominated for the 2022 Nobel Peace Prize and also named two of Fast Company's 2022 Most Creative People in Business for their work in bringing a safe, streamlined, low-cost vaccine technology to the world. ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. For more information, go to. Get the latest news by visiting the online newsroom and Twitter at twitter.com/texaschildrens. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved generic Injectables in its portfolio. In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market. SOURCE Texas Children's Hospital

疫苗上市批准紧急使用授权临床研究

2023-04-19

·GlobeNewswire-Health Care

Nykode Therapeutics announces positive final results from its Phase 2 trial of VB10.16 in combination with PD-L1 inhibitor atezolizumab in advanced cervical cancer

The results showed median overall survival greater than 25 months (not reached) and 6.3 months median progression free survival in PD-L1+ patientsVB10.16 was safe and well tolerated in combination with atezolizumabNykode plans to initiate a potentially registrational trial in PD-L1+ patients with HPV16-positive advanced cervical cancer in the U.S. in 4Q 2023 OSLO, Norway, April 18, 2023 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced positive final results from the Phase 2 VB-C-02 trial. The trial investigates the use of Nykode’s therapeutic cancer vaccine candidate VB10.16 in combination with Roche’s cancer immunotherapy Tecentriq® (atezolizumab) in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. The trial enrolled 52 patients, of which 48% had PD-L1+ tumors, who were treated for up to one year and followed for an additional 12 months. “We are extremely encouraged by the unprecedented data that indicates a doubling of the survival of PD-L1+ patients with advanced cervical cancer compared to treatment alternatives. Not only do we see patients on average live longer, but 7 of the 14 patients who received all treatments are still alive without signs of progression. This is a landmark day for VB10.16 and for Nykode’s technology and we are excited to move the cancer vaccine forward towards the market for the benefit of patients,” said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. As previously announced the company is planning an ambitious development strategy to take VB10.16 further in advanced cervical cancer and into head and neck cancer. The data announced today supports the next steps which focus on PD-L1+ patients with up to one prior line of systemic therapy. “The data give us confidence as we now plan to initiate a potentially registrational trial in the U.S. during 4Q this year in advanced cervical cancer and work to accelerate expansion of our VB10.16 program with the goal of reaching all addressable patient populations with HPV16-positive cancers,” said Klaus Edvardsen, Chief Development Officer of Nykode. “The unmet medical need in patients with advanced cervical cancer is still high,” said Professor Peter Hillemanns, Director of the Departments of Gynecology, Obstetrics and Breast Cancer at Hannover University Hospital, Germany and principal investigator of the C-02 trial. “These findings especially on median progression free survival and median overall survival indicate that VB10.16 may give meaningful added clinical benefit with prolonged responses and survival compared to existing standard of care in this setting.” The results showed a median overall survival of more than 25 months (median has not yet been reached) and a median progression free survival of 6.3 months in PD-L1+ patients. The median overall survival for the overall population, which also includes patients with PD-L1- tumors, was 16.9 months, while the median progression free survival was 4.1 months. With overall response rate (ORR) of 29% in PD-L1+ patients (19% in overall population) and disease control rate (DCR) of 75% in PD-L1+ (60% in overall population) the final analysis confirms the previously reported positive response rates from the interim analysis. The duration of response in the overall population was 17.1 months. In PD-L1+ patients with one prior line of systemic treatment ORR was 40% and DCR 80% with a median progression free survival of 16.9 months and median overall survival more than 25 months (not reached). VB10.16 in combination with atezolizumab was well-tolerated and has a safety profile comparable to checkpoint inhibitor monotherapy reported in literature. Webcast Investors and analysts are invited to join a webcast presentation of the updated results conducted by CEO Michael Engsig and other members of the management team tomorrow, April 19, 2023 at: 11 a.m. CET / 5 a.m. ET (in Norwegian) 4 p.m. CET / 10 a.m. ET (in English) The slide presentation is available in the Investors section of the Company’s website at https://nykode.com/investors. The live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website at https://nykode.com/investors/financial-reports-and-presentations. About the VB-C-02 trial VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in combination with the PD-L1 inhibitor atezolizumab in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer. Patients received treatment with VB10.16 in combination with atezolizumab for up to one year. The trial enrolled 52 patients at sites in Europe. Additional information about the VB-C-02 trial is available at clinicaltrials.gov (NCT04405349). About VB10.16VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody™ technology platform of targeting antigens to antigen presenting cells. The vaccine is currently in development for the treatment of HPV16-positive advanced cervical cancer. Nykode is planning a potentially registrational trial (VB-C-04) in advanced cervical cancer which will focus on patients who progressed after first line treatment including checkpoint inhibitor treatment. In addition, Nykode plans to expand into other HPV16-positive indications including first line HPV16-postive, recurrent or metastatic squamous cell head and neck where VB10.16 will be tested in combination with pembrolizumab. About Cervical CancerCervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma (arising from cells lining the bottom of the cervix) and most other patients have adenocarcinomas (arising from glandular cells in the upper cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread. About HPV16-Driven CancersOne of the emerging challenges within oncology is the virus-induced cancer types, with Human Papillomavirus (HPV) being one of the most prominent. There are several types of high-risk HPV-causing cancers, HPV16 being one of the most common, with more than 130,000 new cases in the U.S. and EU per year. Using a therapeutic cancer vaccine targeted specifically towards the HPV16 infected cells in the tumors, such as Nykode’s cancer vaccine VB10.16, represents a novel immunotherapeutic treatment option. By combining a therapeutic cancer vaccine with the checkpoint inhibitors and/or other general immune therapies, the tumors can be attacked by the cancer-specific T cells from several angles with the aim of improving patient outcomes. About Nykode TherapeuticsNykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for the treatment of cancer and infectious diseases. Nykode’s modular vaccine technology specifically targets antigens to Antigen Presenting Cells, which have been shown to induce broad, strong and long-lasting antigen specific immune responses which correlates with clinical responses. Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the treatment of human papilloma virus (HPV)-16 induced malignancies which demonstrated positive safety and efficacy results from its Phase 2 trial for the treatment of cervical cancer; and VB10.NEO, an individualized cancer neoantigen vaccine, which is exclusively out-licensed to Genentech, a member of the Roche Group. Additionally, Nykode is conducting a Phase 1/2 trial with next-generation COVID19 vaccine candidates. The Company’s partnerships include Genentech within oncology, a multi-target collaboration with Regeneron within oncology and infectious diseases and a collaboration with Adaptive Biotechnologies for COVID-19 T cell vaccine development. Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD). Further information about Nykode Therapeutics may be found at http://www.nykode.com. Forward-looking statements for Nykode Therapeutics This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Contact for Nykode Therapeutics ASA: Chief Business Officer, Agnete FredriksenNykode Therapeutics ASA IR@nykode.com Nykode Therapeutics ASA Oslo Science ParkGaustadalléen 21N-0349 Oslo, Norway

临床结果临床2期疫苗免疫疗法

100 项与 COVID19 vaccine(Vaxine Pty Ltd.) 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
冠状病毒感染	临床1期	澳大利亚	Vaxine Pty Ltd.	2020-06-30

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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


EADV2022	N/A	扁平苔藓	-	COVID-19 vaccine BIBP	鹹憲鏇選範衊窪積簾餘(鏇壓夢夢鬱網醖顧憲廠) = Lichen planus occurred in 4 patients after COVID-19 vaccination 獵壓襯餘窪顧鬱顧壓壓 (繭鏇鏇獵餘糧顧鹹餘築 )	-	2022-09-07
				COVID-19 mRNA vaccine
AACR2022	N/A	肿瘤	361	mRNA COVID19 vaccines (Vaccinated)	憲壓製鏇獵顧蓋選壓艱(窪鏇製淵簾淵網廠製壓) = 淵醖壓構淵鏇鏇窪鏇夢憲醖範顧餘醖願築膚艱 (繭襯簾衊鑰夢夢鬱襯鬱 ) 更多	积极	2022-06-15
				mRNA COVID19 vaccines (Unvaccinated)	糧夢廠壓憲鑰鹹窪膚觸(構獵膚構蓋廠醖網願積) = 窪襯膚築淵顧壓鬱繭糧觸膚願範鹹鏇鹹築觸範 (膚糧鏇壓繭獵壓蓋襯鏇 )