Immunogenicity and Safety of SpikoGen, an Adjuvanted Recombinant SARS-CoV-2 Spike Protein, as a Heterologous Third Booster Dose in Kidney Transplant Patients: A Single-arm Clinical Trial.

PURPOSE: Studies have found that immunocompromised patients have suboptimal responses to COVID-19 vaccines, leading to approval of a need for booster doses in this population. SpikoGen® is a subunit recombinant spike protein vaccine combined with Advax-CpG55.2™ adjuvant to protect against COVID-19. Previous clinical trials found this vaccine to be tolerable, immunogenic, and efficacious in reducing the risk of COVID-19, including severe disease. However, the effects of this vaccine have not been assessed in immunocompromised patients. This study sought to assess the immunogenicity and safety of the SpikoGen vaccine as a third booster dose in patients undergoing kidney transplant who were receiving immunosuppressive therapy and had received their primary vaccination based on an inactivated whole virus platform (Sinopharm). METHODS: This single-arm trial was performed with 43 patients undergoing kidney transplant. The participants received a single booster dose of the SpikoGen vaccine 1 to 3 months after primary vaccination with 2 doses of the Sinopharm vaccine. Immunogenicity assessments were performed at baseline and 30 days after the booster dose. The primary outcomes were seroconversion rates of anti-S1 and surrogate virus neutralizing antibodies. Safety outcomes included the incidence of solicited and unsolicited adverse events in the 7 days and 1 month after the booster dose, respectively. FINDINGS: The SpikoGen vaccine induced positive humoral and cellular responses 30 days after the booster dose in those patients who were seropositive or seronegative after 2 primary doses of the Sinopharm vaccine. Thirty days after the SpikoGen vaccine booster, seroconversion rates were 35.29% (95% CI, 19.75%-53.51%) to anti-S1 and 29.41% (95% CI, 13.27%-46.57%) to surrogate neutralizing antibodies. The most common local and systemic reported solicited adverse events were injection site pain and fatigue, which were largely mild and transient. No serious adverse events were reported. IMPLICATIONS: A single booster dose of SpikoGen vaccine given 1 to 3 months after primary vaccination with 2 doses of Sinopharm vaccine induced positive humoral and cellular immune responses in immunosuppressed patients undergoing renal transplant, thereby achieving spike antibody levels predictive of protection. This study was performed as a single-center study, and it will be important for future large multicenter studies to extend these results to other immunocompromised patient groups.

Corrigendum to "Development of IgY-Based Sandwich ELISA as a Robust Tool for Rapid Detection and Discrimination of Toxigenic Vibrio cholera".

[This corrects the article DOI: 10.1155/2018/4032531.].

Development of IgY-Based Sandwich ELISA as a Robust Tool for Rapid Detection and Discrimination of Toxigenic Vibrio cholerae.

BACKGROUND: The conventional methods for diagnosis of Vibrio cholerae are time consuming, complicated, and expensive. Development of rapid detection tests is critical for prevention and management of cholera. This study aimed to introduce two sensitive sandwich ELISAs based on avian antibodies (IgY) targeting outer membrane protein W (OmpW) and cytotoxin B (CtxB) antigens of V. cholerae. METHODS: The sequences of ompW and ctxB genes were cloned into pET28a vector. Escherichia coli BL21 (DE3) was transformed with the recombinant vectors, and gene expression was induced by IPTG. The expressed proteins were purified by affinity chromatography using Ni-NTA resins. Two groups of white Leghorn chickens were immunized by recombinant proteins, and the generated antibodies were purified from egg yolks of chickens by PEG precipitation. The antibodies were used for the development of α-OmpW and α-CtxB ELISAs. RESULTS: The expression and purification yielded 59 and 38 mg of recombinant OmpW and CtxB, respectively, per one liter of bacterial culture. PEG precipitation and purification of egg yolk antibodies yielded on average (±SD) 66.5 ± 1.80 and 50.9 ± 2.23 mg of purified α-OmpW and α-CtxB per egg, respectively. The analytical sensitivity of α-OmpW ELISA was 103 cfu/mL of V. cholerae and that of α-CtxB ELISA was 33 pg/mL of recombinant cytotoxin B. The two developed ELISAs did not show any cross-reactivity to any tested bacteria grown in common conditions. DISCUSSION: The current study is the first report on using IgY for detection of V. cholerae. The developed ELISAs were shown to have considerable analytical sensitivity and specificity. Therefore, the assays can be one of the convenient methods for sensitive and specific detection of toxigenic V. cholerae strains in clinical and environmental samples.

Application of the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) to patients with cataract.

OBJECTIVES: Cataract is a prevalent disease in the elderly, and negatively influences patients' quality of life. This study was conducted to study the application of the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) to patients with cataract. METHODS: In this cross-sectional study, 300 patients with cataract were studied in Neyshabur, Iran from July to October 2014. The Iranian version of the WHOQOL-BREF questionnaire was used to measure their quality of life. Cronbach's alpha coefficient, Pearson's correlation coefficient, the paired t-test, the independent t-test, and a linear regression model were used to analyze the data in SPSS version 16.0 (SPSS Inc., Chicago, IL, USA). RESULTS: The mean age of the participants was 68.11±11.98 years, and most were female (53%). The overall observed Cronbach's alpha coefficient for the WHOQOL-BREF was 0.889, ranging from 0.714 to 0.810 in its four domains. The total mean score of the respondents on the WHOQOL-BREF was 13.19. The highest and lowest mean scores were observed in the social relationship domain (14.11) and the physical health domain (12.29), respectively. A backward multiple linear regression model found that duration of disease and marital status were associated with total WHOQOL scores, while age, duration of disease, marital status, and income level were associated with domains one through four, respectively (p<0.05). CONCLUSIONS: The reliability analysis conducted in this study indicated that the WHOQOL-BREF scale exhibited an acceptable degree of internal consistency in the measurement of the quality of life of patients with cataract. It was also found that the patients with cataract who were surveyed reported a relatively moderate quality of life.