A Phase 1/2, First-Time-in Human (FTiH), Randomized, Observer-blind, Placebo-controlled, Dose Escalation Study to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Cytomegalovirus (CMV) Vaccine Comprising Recombinant Protein and Adjuvant When Administered Intramuscularly in Healthy Adults

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the candidate CMV recombinant protein subunit (CMVsu) vaccine consisting of a combination of glycoproteins B (gB) and pentamer antigens adjuvanted, regardless of baseline CMV sero-status. This FTiH study will be conducted in healthy adults 18 to 50 years of age, in which the 4 dose levels of the vaccine will be administered in a step-wise dose escalation manner, based upon safety adjudication.

开始日期2021-10-14

申办/合作机构

GSK Plc

NCT04225923 / Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

开始日期2020-06-01

申办/合作机构

Nobelpharma Co., Ltd.

NCT01357915 / CompletedN/A

A Follow-up Study to Evaluate the Long-term Persistence of GSK Biologicals' Candidate CMV Vaccine Administered to Male Adults

The purpose of this study is to evaluate the persistence of the vaccine induced immune responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses of GSK Biologicals' candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in naturally infected subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value (seropositive reference group). In addition, this study will continue to assess the occurrence of CMV infections as well as the continued development and validation of read-outs in the CMV project.
The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting (NCT00435396).

开始日期2011-06-24

申办/合作机构

GSK Plc

100 项与 CMV gB 相关的临床结果

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100 项与 CMV gB 相关的转化医学

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0 项与 CMV gB 相关的专利（医药）

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项与 CMV gB 相关的文献（医药）

2023-03-27·International journal of molecular sciences

Cytomegalovirus Glycoprotein B Genotype in Patients with Anterior Segment Infection.

Article

作者: Kang, Eugene Yu-Chuan ; Huang, Chu-Yen ; Hwang, Yih-Shiou ; Cheng, Yu-Chun ; Hsiao, Ching-Hsi

(1) The glycoprotein B (gB) on the viral envelope, encoded by the most widely characterised polymorphic gene, gpUL55, is responsible for cytomegalovirus (CMV) entry into the host and could serve as a potential marker of pathogenicity. The aim of the present study is to investigate the distribution of the CMV gB genotype in anterior segment infection in Taiwan and its correlation with clinical manifestations and outcomes. (2) Fifty-seven patients with CMV anterior segment infection were identified according to clinical features and positivity for CMV DNA in aqueous humour samples. CMV gB genotyping was performed through polymerase chain reaction assays. Patients' medical records were retrospectively reviewed. (3) Among the 57 aqueous humour samples tested for gB, 40 (70.28%) had multiple gB genotypes, and only 17 (29.82%) had a single gB genotype. Compared with single-genotype infection, multiple-genotype infection was correlated with higher CMV loads (p < 0.001) but not correlated with outcome. A higher proportion of patients with the gB3 genotype had received filtering surgery before antiviral treatment than those without the gB3 genotype (p = 0.046). (4) Multiple-genotype infection was highly prevalent in CMV anterior segment infection in Taiwan, and gB1 and gB3 were predominant. Multiple-genotype infection was correlated with higher CMV loads but not with specific clinical manifestations or prognostic outcomes. The gB3 genotype may be correlated with poor intraocular pressure control.

2023-03-01·Biochemistry and Biophysics Reports

Characterization of antigen adjuvant interactions in polyacrylate adjuvanted vaccines

Article

作者: Guinamand, Stéphanie ; Haensler, Jean ; Dinadayala, Premkumar ; Gleizal, Géraldine ; Bonifassi, Patrick

SPA09 is a polyacrylate-based clinical stage vaccine adjuvant that was found to exert a strong adjuvant effect on various vaccine antigens including recombinant cytomegalovirus glycoprotein B (CMV-gB). For the characterization of antigen-adjuvant interactions, which is a regulatory requirement and an important piece of information for the understanding of adjuvant mechanism of action, we developed a set of orthogonal techniques, comprising thermal analyses, biolayer interferometry and agarose gel migration assays. Here we apply these techniques to study the interaction between SPA09 and two recombinant proteins from the Sanofi new vaccine portfolio, CMV-gB and the Staphylococcus aureus chaperone protein, PrsA, that we used as model antigens. We believe that the techniques developed for this work could be useful to study the interactions between adjuvants and vaccine antigens in general and could be broadly applicable for the characterization of adjuvanted vaccine products.

2018-01-01·International journal of organ transplantation medicine

The Incidence of Cytomegalovirus Glycoprotein B Genotypes in Kidney Transplant Recipients in Iran.

Article

作者: Piroozmand, A ; Jafari, M ; Soleimani, A R ; Nikoueinejad, H ; Einollahi, B ; Akbari, H

BACKGROUNDCytomegalovirus (CMV) is the most common opportunistic viral infection in kidney transplant recipients. CMV classification is usually based on its glycoprotein B (gB) genotypes, which divides the virus into 4 strains (gB1-4).OBJECTIVETo determine the incidence of CMV genotypes in Iran and their relation to various clinical factors.METHODSWe studied 80 renal transplant recipients admitted to our transplant referral center between 2014 and 2015. All of the studied patients were monitored every 1-2 weeks for CMV infection by immunofluorescence method. There were 34 CMV-infected patients whose sera were studied with sequencing technique to identify the 4 CMV genotypes. All patients were followed up to 6 months after transplantation.RESULTSgB1 was the most common genotype (35.3%); it was followed by gB3 and gB4 (each with 17.6 %), gB2, and mixed gB1,3 and gB1,2 (each with 14.7%). Age (p=0.037), time of infection after transplantation (p=0.011), and biopsy-proven rejection (p=0.012) were associated with CMV genotype. After adjusting for covariates, significant associations were found between genotype gB1 and family relationship (p=0.047) as well as HLA mismatch (p=0.014); genotype gB3 and family relationship (p=0.011); and genotype gB4 and age (p=0.019).CONCLUSIONThe most common CMV gB genotype in CMV-infected kidney transplant recipients in Iran was gB1. We recommend considering related therapeutic applications in the management of such patients.