ObjectivesWidespread vaccination is considered as one of the best methods in combating any pandemic including COVID-19. Gam-COVID-Vac also known as Sputnik V, is one of the first vaccines that was registered in 74 countries and received an emergency approval for immunization. Monitoring anti-SARS-CoV-2 antibodies over time is essential for evaluation of post-vaccination humoral immune response.To date, there are only a limited number of clinical studies regarding the analysis of immune response after Sputnik V administration. It is of crucial importance to report independently on safety and efficiency of this vaccine with the aim to speed up the process of its final approval by the WHO.MethodsHumoral immune response was monitored by seven immunoassays to analyze different classes of anti-SARS-CoV-2 Ig in five health workers after receiving the combined vector vaccination. This vaccine is based on two replication-deficient rAd26 and rAd5 viral vectors that carry the gene SARS-CoV-2 full-length glycoprotein S(rAd26-S and rAd5-S). Sputnik V was administered with a 21-day interval between the first and second dose. Venous blood was collected two hours before vaccination as a baseline, and then followed by 18 series up to 170-day post-vaccination.ResultsThe participants in this study used a self-report form in which they noted their observations on safety at 72 h post-immunization. One participant reported mild side effects, such as muscle pain and fever, while the other four individuals had no noticeable complications. Seroconversion was detected in all individuals at 28 days of post-vaccination. Plateau of seropositivity has been achieved by 50th day of vaccination, while titer values decreased after 6 months.ConclusionThis study provides some clinical data regarding the kinetics of antibody levels elicited after administration of heterologous rAd26-S and rAd5-S vaccine. Based on the preliminary data from this pilot study, it appears that Sputnik V vaccine generates a solid humoral immune response lasting at least 6 months after immunization.

2013-01-01·Veterinary Immunology and Immunopathology3区 · 农林科学

Time-dependent biodistribution and transgene expression of a recombinant human adenovirus serotype 5-luciferase vector as a surrogate for rAd5-FMDV vaccines in cattle

3区 · 农林科学

Article

作者: J. Arzt ; N.A. Montiel ; G. Smoliga

Replication-defective recombinant adenovirus 5 (rAd5) vectors carrying foot-and-mouth disease virus (FMDV) transgenes elicit a robust immune response to FMDV challenge in cattle; however mechanistic functions of vaccine function are incompletely understood. Recent efforts addressing critical interactions of rAd5 vectors with components of the bovine immune system have elucidated important aspects of induction of protective immunity against FMDV. In the current study, a rAd5-Luciferase (rAd5-Luc) surrogate vector was utilized for indirect assessment of rAd5-FMDV distribution during the first 48 hours post inoculation (hpi). To compare vector distribution dynamics and time-dependent transgene expression, bovine cells were inoculated in vitro with rAd5-FMDV and rAd5-Luc vectors. Superior transgene expression was detected in cells infected with rAd5-Luc compared to rAd5-FMDV. However, both vectors behaved remarkably similar in demonstrating elevated mRNA transcription at 24 and 48 hpi with peak occurrence of transgene expression at 48 hpi. Injection sites of cattle inoculated with rAd5-Luc contained mononuclear inflammatory infiltrates with hexon and transgene proteins associated with antigen-presenting cells. Luciferase activity, as well as microscopic detection of luciferase antigens, peaked at 24 hpi. Presence of viral mRNA also peaked at 24 hpi but unlike luciferase, remained strongly detected at 48 hpi. Cell-associated luciferase antigens were detected as early as 6 hpi at the cortical interfolicullar areas of local LN, indicating rapid trafficking of antigen-presenting cells to lymphoid tissues. This work provides mechanistic insights on rAd5-mediated immunity in cattle and will contribute to ongoing efforts to enhance rAd5-FMDV vaccine efficacy.

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床1期	-	GenVec, Inc.	-
HIV感染	临床1期	美国	-	-
HIV感染	临床1期	-	National Institute of Allergy & Infectious Diseases	-
HIV感染	临床1期	-	Vaccine Research Center	-