A protocol of development of a screening assay for evaluating immunological memory to vaccine-preventable infections: simultaneous detection of antibodies to measles, mumps, rubella and hepatitis B

Mazunina, Elena P.; Kleymenov, Denis A.; Manuĭlov, V. A.; Гущин, В.А.; Tkachuk, Artem P

doi:10.24075/brsmu.2017-05-04

Cited by 4 publications

(3 citation statements)

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“…Antibody IgG responses specific to GamTBvac vaccine subunits (Ag85a, ESAT6, CFP10, DBD, and their fusions, DBD-Ag85a and DBD-ESAT6-CFP10) were determined by a bead-based multiplex assay using xMAP technology (Luminex Corporation, Northbrook, IL, USA). Coupling antigens to microspheres (5–20 µg per 10 6 microspheres) was performed according to previous protocols [ 12 , 13 ]. The assay was described previously [ 8 ] and accomplished with some modifications.…”

Section: Methodsmentioning

confidence: 99%

Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

et al. 2020

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GamTBvac is a candidate tuberculosis vaccine with two fusion proteins, containing Ag85a, ESAT6, CFP10, and a dextran-binding domain (DBD). Phase II of a double-blind, randomized, multicenter, placebo-controlled study in parallel groups in healthy adults to evaluate the safety and immunogenicity of GamTBvac in 180 previously-vaccinated with Bacillus Calmette–Guérin vaccine (BCG) healthy volunteers without Mycobacterium tuberculosis (MTB) infection was conducted. The dose (0.5 mL) of either the study drug or a placebo was administered subcutaneously twice with an 8-week interval. At eight timepoints from 14 to 150 days, whole blood and sera were assayed. Antigen-specific T-cell responses were measured by an in-house interferon-gamma release assay (IGRA-test), the QuantiFERON (QTF) test, and intracellular cytokine staining (ICS). For antibody response detection, the bead-based multiplex immunoassay (MIA) was applied. The vaccine confirmed an acceptable safety profile previously shown in a first-in-human clinical study. After stimulation with both fusions, the highest median level of INF-γ was detected on day 21. The GamTBvac vaccine induced antigen-specific interferon-gamma release, Th1 cytokine-expressing CD4+ T-cells, and IgG responses and results support further clinical testing of GamTBvac.

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Section: Methodsmentioning

confidence: 99%

Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

et al. 2020

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“…An in-house interferon gamma release assay test (IGRA) was also used to assess IFN-γ expression after vaccination with GamTBvac. The assays were conducted as described previously [9,13]. In brief, 100 µL of whole blood was taken in a vacuum tube with lithium heparin (Vacuette TUBE, Greiner bio-one, Kremsmünster, Austria) that was supplied with 600 µL of growth medium (90% medium 199, 10% fetal bovine serum, 2 mM L-glutamine, 10 mM HEPES, 50 µg/mL gentamicin sulfate (PanEco, Moscow, Russia).…”

Section: Immunogenicity Assaysmentioning

confidence: 99%

“…For the serology-based quantification of antibodies to Ag85a, ESAT6, CFP10, and DBD, and their fusions, DBD-Ag85a and DBD-ESAT6-CFP10, 6 xMAP-based monoplex assays were used (Luminex Corporation, Northbrook, IL, USA). The optimal quantities of (fusion) antigens (5-20 µg per 10 6 microspheres) were coupled to six microsphere sets through carbodiimide reactions according to a protocol described previously [13,14]. An indirect serological assay was run as recommended in [14].…”

Section: Immunogenicity Assaysmentioning

confidence: 99%

First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessment

et al. 2019

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Tuberculosis is known to be the biggest global health problem, causing the most deaths by a single infectious agent. Vaccine-development efforts are extremely important. This paper represents the results of the first-in-human trial of recombinant subunit tuberculosis vaccine GamTBvac in a Phase I study. GamTBvac is a new BCG booster candidate vaccine containing dextran-binding domain modified Ag85a and ESAT6-CFP10 MTB antigens and CpG ODN adjuvant, formulated with dextrans. Safety and immunogenicity of GamTBvac were estimated in an open-label clinical trial on 60 Mycobacterium tuberculosis uninfected (MTB-uninfected) volunteers previously-vaccinated with Bacillus Calmette—Guérin vaccine (BCG). The candidate vaccine had an acceptable safety profile and was well-tolerated. Three different vaccine doses with a double-immunization scheme were assessed for immunogenicity and induced a significant increase in IFN-γ in-house IGRA response and IgG ELISA analysis. Among them, the half dose vaccine group (containing DBD-ESAT6-CFP10, 12.5 μg; DBD-Ag85a, 12.5 μg; CpG (ODN 2216), 75 μg; DEAE-Dextran 500 kDa, 250 μg; and Dextran 500 kDa, 5 mg) provided high, early and stable in time immune response specific to both protein antigen fusions and is proposed for the further studies.

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Development of a bead-based multiplex immunoassay for simultaneous quantitative detection of IgG serum antibodies against seven vaccine-preventable diseases

Bykonia

Kleymenov

Mazunina

et al. 2023

Journal of Immunological Methods

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A protocol of development of a screening assay for evaluating immunological memory to vaccine-preventable infections: simultaneous detection of antibodies to measles, mumps, rubella and hepatitis B

Cited by 4 publications

References 0 publications

Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

Safety and Immunogenicity of the GamTBvac, the Recombinant Subunit Tuberculosis Vaccine Candidate: A Phase II, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study

First-In-Human Trials of GamTBvac, a Recombinant Subunit Tuberculosis Vaccine Candidate: Safety and Immunogenicity Assessment

Development of a bead-based multiplex immunoassay for simultaneous quantitative detection of IgG serum antibodies against seven vaccine-preventable diseases

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