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The development of a safe and effective vaccine is essential to protect populations against coronavirus disease 2019 (COVID‐19). There are several vaccine candidates under investigation with different mechanisms of action. In the present study, we have evaluated the safety and immunogenicity of a recombinant receptor‐binding domain (RBD)‐based protein subunit vaccine (Noora vaccine) against COVID‐19 in adults. This Phase 1 trial is a randomized, double‐blind, placebo‐controlled study to evaluate the safety and immunogenicity of the recombinant RBD‐based protein subunit vaccine (Noora vaccine) against COVID‐19 in healthy adults volunteers. Eligible participants were included in this study after evaluating their health status and considering the exclusion criteria. They were then randomized into three groups and received three doses of vaccine (80 µg, 120 µg, and placebo) on Days 0, 21, and 35. Primary outcomes including solicited, unsolicited, and medically attended adverse events were recorded during this study. Secondary outcomes including the humoral and cellular immunity (including anti‐RBD IgG antibody and neutralizing antibody) were measured on Days 0, 21, 28, 35, 42, and 49 by using the ELISA kit and the Virus Neutralization Test (VNT) was performed on day 49. Totally 70 cases were included in this Phase 1 trial and 60 of them completed the study. Safety assessments showed no severe adverse events. Local pain at the vaccine injection site occurred in 80% of the vaccinated volunteers. Induration and redness at the injection site were the other adverse reactions of this vaccine. There was no significant difference between the studied groups regarding adverse reactions. Anti‐RBD IgG antibody and neutralizing antibody assessment showed significant seroconversion in comparison to the placebo group (80%, and 100% respectively, p < 0.001). The cellular immunity panel also showed mild to moderate induction of TH1 responses and the VNT showed 78% of seroprotection. The results of this Phase 1 trial showed acceptable safety without serious adverse events and significant seroconversions in the humoral and cellular immunity panel. The dose of 80 µg is an appropriate dose for injection in the next phases of the trial. [ABSTRACT FROM AUTHOR]

Aim: Production of IgY antibodies against CfaB-EtpA-LTB (CEL) chimeric protein and evaluation of its protective effects against enterotoxigenic Escherichia coli (ETEC) by in vivo and in vitro investigation. Methods and results: Indirect ELISA and immunoblotting methods were applied to assess the immunogenicity and specificity of IgYs and also to evaluate the efficacy of IgYs in binding prevention and neutralizing the heat-labile (LT) toxin of ETEC bacteria. The results indicated that the anti-CEL IgY at a concentration of 2 mg ml−1 could decrease the bacterial adhesion to HT-29 cells by 74% compared to the control group. At a concentration of 750 μg ml−1, the IgY antibody managed to neutralize the disruptive LT toxin effect on the Y1 cell line. At a concentration of 2 mg ml−1, 81% reduction was observed in the fluid accumulation in the ileal loop assay. Conclusion: According to our findings, passive immunotherapy with anti-CEL IgY can prevent bacterial colonization and toxicity, thus facilitating in controlling the enteric diseases caused by ETEC infection. [ABSTRACT FROM AUTHOR]

Objective(s): The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), giving rise to the coronavirus disease 2019 (COVID-19), has become a danger to wellbeing worldwide. Thus, finding efficient and safe vaccines for COVID-19 is of great importance. As a basic step amid contamination, SARS-CoV-2 employs the receptor-binding domain (RBD) of the spike protein to lock in with the receptor angiotensin-converting enzyme 2 (ACE2) on host cells. SARS-CoV-2 receptor-binding domain (RBD) is the main human antibody target for developing vaccines and virus inhibitors, as well as neutralizing antibodies. A bacterial procedure was developed for the expression and purification of the SARS-CoV-2 spike protein receptor-binding domain. Materials and Methods: In this research study, RBD was expressed by Escherichia coli and purified with Ni-NTA chromatography. Then it was affirmed by the western blot test. The immunogenicity and protective efficacy of RBD recombinant protein were assessed on BALB/c mice. Additionally, RBD recombinant protein was tested by ELISA utilizing sera of COVID-19 healing patients contaminated with SARS-CoV-2 wild type and Delta variation. Results: Indirect ELISA was able to detect the protein RBD in serum of the immunized mouse expressed in E. coli. The inactive SARS-CoV2 was detected by antibodies within the serum of immunized mice. Serum antibodies from individuals recovered from Covid19 reacted to the expressed protein. Conclusion: Our findings showed that RBD is of great importance in vaccine design and it can be used to develop recombinant vaccines through induction of antibodies against RBD. [ABSTRACT FROM AUTHOR]

Objective(s): Vaccination using inactivated bacteria is one of the most effective ways to protect against EHEC infection. Escherichia coli O157:H7 infections are mainly influenced by Shiga toxins (Stx) and attaching/effacing factors. Among various factors, Stx2B is gaining much attention as a vaccine candidate. Formulating an inactivated bacteria with a suitable adjuvant increases vaccine efficacy and antibody production and can lead to a lasting immune response and protection against O157:H7. Materials and Methods: To assess vaccine efficacy, in this study, we have considered heat and formalin-inactivated bacteria along with chitosan-coated Stx2B/ Stx2B in a mouse model. Ionotropic gelation via tripolyphosphate anions was used to coat Stx2B on chitosan. Subcutaneous injection or oral gavage was used to immunize mice, which were then challenged with E. coli O157:H7. Results: Immunity and protection against E. coli O157:H7 were achieved by all forms of the vaccine. Inactivated E. coli O157:H7 formulated with chitosan-coated Stx2B effectively evoked humoral and mucosal immune responses. However, minimum shedding appeared with the mice groups orally immunized with formalin-inactivated bacteria sublimated with chitosan-coated Stx2B and heat-inactivated bacteria plus Stx2B in subcutaneous immunization. Conclusion: Administration of inactivated whole-cell and toxin was synergistic and increased the protection capacity with both parenteral and oral immunization routes. [ABSTRACT FROM AUTHOR]