Treatment of Patients With Castration Resistant Prostate Cancer Using a Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines

Background:
Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want to develop vaccines to teach the immune system to target and kill cancer cells. They want to test three of these vaccines (ETBX-071, ETBX-061, and ETBX-051) against mCRPC.
Objective:
To test the safety of combination ETBX-071, ETBX-061, and ETBX-051 and to study their effects on the immune system.
Eligibility:
People ages 18 and older with mCRPC that has not responded to standard therapies
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Computed tomography (CT) or magnetic resonance imaging (MRI) scans
Bone scan
Participants will get the vaccines as shots under the skin every 3 weeks for 3 doses. They may then have the shots every 8 weeks for up to 1 year.
Participants will keep a diary to record any symptoms from the vaccines.
Participants will have blood tests each time they get the vaccines. They will also have scans and other tests to measure the effect the vaccines have on their tumors.
Participants will have a visit within 28 days after their last treatment. This includes a physical exam and blood and urine tests.
Participants will then be contacted by phone every 3 months for the first year, every 6 months for the next 2 years, and every 12 months for another 2 years.
Participants will be asked to join a long-term follow up study.

开始日期2018-07-24

申办/合作机构

National Cancer Institute

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项与 PSA targeted vaccine(Etubics Corp.) 相关的文献（医药）

2023-11-01·Research and Practice in Thrombosis and Haemostasis

Vaccine-induced immune thrombotic thrombocytopenia post COVID-19 booster vaccination in Brazil: a case series

Article

作者: Xavier, Janaína Reis ; Saraiva Pedro, Renata ; Mattos de Carvalho, Isis ; Burger, Marion ; Abreu, Debora Lima ; Bise Viegas, Anna Paula ; Bertollo Gomes Porto, Victor ; Zago, Luzia ; Takey, Paulo Roberto Gomes ; Nascimento Costa, Nathalya Macedo ; Júlio, Liliam Cristiana ; Kamoi, Tsukiyo Obu ; Fernandes, Eder Gatti ; Freire, Claudio Renato ; Vitiello Teixeira, Gabriellen ; Mouta Nunes de Oliveira, Patrícia ; Castro, Thalita da Matta de ; Ferreira, Rosane ; Palm, Cláudia Weingaertner ; Furtado, Barbara Emoingt ; Marques de Figueiredo, Risoleide ; Rodrigues, Juliana Vassalo ; Nunes, Gabriele Tantos ; Melo de Amorim Filho, Luiz ; Sousa Maia, Maria de Lourdes de ; Garcez, Tatiana ; Lignani, Letícia Kegele ; Jenifer da Silva Araújo Cunha, Juliana ; Mendes-de-Almeida, Daniela P. ; Filho, Rubens Costa ; Morgenstern, Georgia Karina ; Pietrowski Bertuol, Ana Paula ; Lima Frizzera, Renata Loss ; Pereira, Tainá dos Santos ; Greffe, Nadja ; Genuino de Souza, Thaina ; Ferreira, Diogenes Seraphim

BackgroundThe emergence of new variants of SARS-CoV-2 has led to the administration of different booster vaccines to mitigate COVID-19. Vaccines with adenoviral vectors have been rarely associated with vaccine-induced immune thrombotic thrombocytopenia (VITT).ObjectivesThis study aimed to describe 15 cases of VITT after the third and fourth doses of the COVID-19 vaccine in Brazil.MethodsCases were reported after all kinds of anti-SARS-CoV-2 booster vaccinations between October 17, 2021, and September 4, 2022.ResultsOf the 26 suspected cases, 15 cases of VITT were analyzed. Of these, 10 were classified as definite VITT, 2 as probable, 1 as possible, and 2 as unlikely. The estimated frequency of definite, probable, or possible VITT was 0.33 cases per million. Cases were assigned to ChAdOx1 (13 cases), Ad26.COV2.S (1 case), and BNT162b2 (1 case). None of the patients received an adenoviral vaccine as a primary vaccination. The average age of participants was 34 years, and symptoms usually appeared 8 days after vaccination. Headache was the most common symptom, and cerebral veins were the most affected thrombotic site. The overall mortality risk was 53%. Anti-platelet factor 4 enzyme-linked immunosorbent assay serology was positive in 11 out of 15 patients (73.3%), negative in 2 (13.3%), and missing in 2 (13.3%).ConclusionThe study confirms that VITT is linked to the first exposure to adenoviral vector vaccines. Since January 2023, Brazil has recommended preferably COVID-19 messenger RNA vaccines for individuals aged 18 to 39 years. We suggest that, in the current disease scenario, COVID-19 adenovirus vaccines should not be the first choice for individuals aged <50 years who have not received a previous dose of this type of vaccine.

2023-04-01·eBioMedicine

Adenoviral vectored vaccination protects against Crimean-Congo Haemorrhagic Fever disease in a lethal challenge model

Article

作者: Thomas, Kelly ; Spencer, Alexandra J. ; Graham, Victoria A. ; Belij-Rammerstorfer, Sandra ; Kennedy, Emma ; Morris, Susan ; Hewson, Roger ; Gilbert, Sarah C. ; Dowall, Stuart ; Saunders, Jack E. ; Lambe, Teresa ; Rayner, Emma ; Gilbride, Ciaran ; Ulaszewska, Marta

BACKGROUNDThe tick-borne bunyavirus, Crimean-Congo Haemorrhagic Fever virus (CCHFV), can cause severe febrile illness in humans and has a wide geographic range that continues to expand due to tick migration. Currently, there are no licensed vaccines against CCHFV for widespread usage.METHODSIn this study, we describe the preclinical assessment of a chimpanzee adenoviral vectored vaccine (ChAdOx2 CCHF) which encodes the glycoprotein precursor (GPC) from CCHFV.FINDINGSWe demonstrate here that vaccination with ChAdOx2 CCHF induces both a humoral and cellular immune response in mice and 100% protection in a lethal CCHF challenge model. Delivery of the adenoviral vaccine in a heterologous vaccine regimen with a Modified Vaccinia Ankara vaccine (MVA CCHF) induces the highest levels of CCHFV-specific cell-mediated and antibody responses in mice. Histopathological examination and viral load analysis of the tissues of ChAdOx2 CCHF immunised mice reveals an absence of both microscopic changes and viral antigen associated with CCHF infection, further demonstrating protection against disease.INTERPRETATIONThere is the continued need for an effective vaccine against CCHFV to protect humans from lethal haemorrhagic disease. Our findings support further development of the ChAd platform expressing the CCHFV GPC to seek an effective vaccine against CCHFV.FUNDINGThis research was supported by funding from the Biotechnology and Biological Sciences Research Council (UKRI-BBSRC) [BB/R019991/1 and BB/T008784/1].

2020-11-01·Journal of Stomatology, Oral and Maxillofacial Surgery4区 · 医学

Bone regeneration and mineralisation was promoted during distraction osteogenesis by human periostin gene in rabbit mandibular model

4区 · 医学

Article

作者: Jiang, X ; Chen, J ; Huang, H ; Chen, Y ; Peng, H

OBJECTIVETo study the effect of periostin gene on bone regeneration and mineralisation during distraction osteogenesis (DO) in a rabbit mandibular model.SUBJECTS AND METHODSA total of 54 New Zealand white rabbits underwent mandibular lengthening and were divided into group A and group B (n=27, each). At the end of the distraction, adenoviruses containing human POSTN/enhanced green fluorescent protein (Ad5-POSTN/EGFP) viruses or Ad5-POSTN viruses were injected into the distraction gaps in the group B or A, respectively. On the 4th and 8th week after distraction, eight samples, randomly selected from each group, were subjected to CT scanning and dual energy X-ray absorptiometry detection. All animals from each group were sacrificed for micro-CT, histology, and three-point bend testing eight weeks after DO.RESULTSThe CT images showed that callus in the distraction gap of group B was significantly better than that of group A. On the 4th and 8th weeks, the bone mineral densities (BMD) of the bone tissue in the distraction gap of the group B were 0.163±0.011g/cm² and 0.239±0.024g/cm², respectively, while the bone mineral contents (BMC) was 0.099±0.011g and 0.205±0.018g, respectively, which were significantly higher compared with group A. Histological sections showed that the trabecular bone in the distraction gap of group B was more coarse. On the basis of micro-CT images and micro-architecture parameters show that the microstructure of the distraction gap of the group B had more mature characteristics. The biomechanical strength of the distracted gap in the group B was 234.30±30.48N, which was 1.28 times higher than that in the group A (P=0.003).CONCLUSIONLocal transduction with human periostin gene would promote osteogenesis and mineralisation in a rabbit mandibular DO model. Periostin might be considered for clinical use if only there is a safe and effective administration method.

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适应症	最高研发状态	国家/地区	公司	日期
去势抵抗性前列腺癌	临床1期	美国	National Cancer Institute	2018-07-24
前列腺癌	临床1期	-	Etubics Corp.	-

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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


NCT03481816 (CTgov)	临床1期	去势抵抗性前列腺癌	18	ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 1/Dose De-Escalation)	淵網襯製構襯簾夢醖齋(艱遞膚觸壓簾網選獵襯) = 淵願鹹夢願蓋醖觸鬱願蓋積襯簾顧鏇衊積願夢 (鬱網淵鹹網築鹽鏇蓋糧, 襯繭遞襯憲衊襯鬱憲蓋 ~ 遞製蓋鹹壓憲艱繭廠壓) 更多	-	2020-12-22
				ETBX-061; adenoviral MUC1 vaccine+ETBX-071; adenoviral PSA vaccine+ETBX-051; adenoviral brachyury vaccine (Arm 2/Dose Expansion)	淵網襯製構襯簾夢醖齋(艱遞膚觸壓簾網選獵襯) = 襯獵簾簾襯觸網觸襯憲蓋積襯簾顧鏇衊積願夢 (鬱網淵鹹網築鹽鏇蓋糧, 艱衊醖襯築鬱膚襯繭廠 ~ 夢鏇鹹遞衊糧鏇襯艱鹹) 更多