Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine (FAKHRAVAC®) in healthy adults aged 18-55 years: Randomized, double-blind, placebo-controlled, phase I clinical trial.

Background: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity. Methods and findings: In this double-blind, placebo-controlled, phase I trial, we randomly assigned 135 healthy adults between 18 and 55 to receive vaccine strengths of 5 or 10 µg/dose or placebo (adjuvant only) in 0-14 or 0-21 schedules. This trial was conducted in a single center in a community setting. The safety outcomes in this study were reactogenicity, local and systemic adverse reactions, abnormal laboratory findings, and Medically Attended Adverse Events (MAAE). Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels.The most frequent local adverse reaction was tenderness (28.9%), and the most frequent systemic adverse reaction was headache (9.6%). All adverse reactions were mild, occurred at a similar incidence in all six groups, and were resolved within a few days. In the 10-µg/dose vaccine group, the geometric mean ratio for neutralizing antibody titers at two weeks after the second injection compared to the placebo group was 9.03 (95% CI: 3.89-20.95) in the 0-14 schedule and 11.77 (95% CI: 2.77-49.94) in the 0-21 schedule. The corresponding figures for the 5-µg/dose group were 2.74 (1.2-6.28) and 5.2 (1.63-16.55). The highest seroconversion rate (four-fold increase) was related to the 10-µg/dose group (71% and 67% in the 0-14 and 0-21 schedules, respectively). Conclusions: FAKHRAVAC® is safe and induces a strong humoral immune response to the SARS-CoV-2 virus at 10-µg/dose vaccine strength in adults aged 18-55. This vaccine strength was used for further assessment in the phase II trial.Trial registrationThis study is registered with https://www.irct.ir; IRCT20210206050259N1.

Phase II randomized, double blind, placebo controlled, clinical trial of safety and immunogenicity of an inactivated SARS-CoV-2 vaccine FAKHRAVAC in adults aged 18-70 years.

BACKGROUND: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. METHODS: We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels. RESULTS: Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32-3.12, N:309) and (GMR = 5.51, 95% CI 3.94-8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5-4.47, N:142). CONCLUSIONS: FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18-70. A phase III trial is needed to assess the clinical efficacy. TRIAL REGISTRATION: Trial Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021).

Detection of Staphylococcus Enterotoxin B (SEB) Using an Immunochromatographic Test Strip.

BACKGROUND: Staphylococcus aureus is one of the most important microorganisms that causes various human diseases by secreting virulence factors known as staphylococcal super antigens (SAgs). Staphylococcal Enterotoxin B (SEB) is a bacterial antigen that is responsible for food poisoning in humans. Among SEB detection methods, a lateral flow device (LFD) is ideal for rapid immunochromatographic tests because it is easy to use, requires minimal time to produce results, and does not require personnel training. OBJECTIVES: In our laboratory, the production of an immunochromatographic test strip, for the detection of SEB using a sandwich assay and a competitive method, was described; the test can detect SEB with high sensitivity. MATERIALS AND METHODS: The strip assays were compared with PCR, a valid method for detection. For PCR, a specific sequence for SEB production was detected using primers designed according to GenBank sequences. RESULTS: In total, 80 food samples suspected of SEB contamination were assessed using the two methods. Fifty-four samples were contaminated based on the PCR technique and twenty-six of those were confirmed using the strip assay. CONCLUSIONS: The sensitivity of the sandwich method was approximately 10 ng/mL and that of the competitive method was approximately 250 ng/mL. In the LFD, a highly specific monoclonal antibody used for both the sandwich and competitive methods resulted in an increased sensitivity and accuracy for the detection of a minimal SEB concentration.

Clinicopathologic characterization of visceral gout of various internal organs--a study of 2 cases from a venom and toxin research center.

BACKGROUND: Gout is a metabolic disorder that results in hyperuricemia and the deposition of positively birefringent monosodium urate crystals in various parts of the body. The purpose of this study was to characterize the incidence and diagnostic features of visceral gout found at necropsy in two patients. CASE PRESENTATION: The authors present an unusual report of untreated gout leading to major structure destructions in visceral organs. Gross post-mortem examination revealed a white powdery substance and display needle-like crystalline symmetry under the macroscopic on the visceral surfaces. Microscopically, the presence of crystalline deposits (urate tophi) were detected in visceral organs, such as; kidney, liver, lung and mesentery. Irrespective of its location, gout was observed, by H&E, as intracellular and extracellular eosinophilic deposits that compressed surrounding tissues. Moreover, numerous necrotizing granulomas of multifarious sizes were observed that were compounded by large aggregations of eosinophilic material (gout), surrounded by epithelioid macrophages, lymphoplasmacytic cells, foreign body multinucleated giant cells, fibrosis, fibroplasia and few edema. On the other hand, our results revealed that granulomatous nodules in the mesentery and kidney contained large numbers of gout foci compared with lung and liver. Furthermore, the immediate cause of death in these cases were not identified, but appeared to result from multiple factors, including the visceral gout due to unsuitable environmental conditions. CONCLUSION: In summary, we have identified a valid histopathologic damage index for use in laboratory studies of visceral gout. This system provides a feasible method of representing visceral damage in gout, and may allow for better understanding of the natural history, pathophysiology and the management of acute attacks of gouty visceral in this disease. Finally, to the best of our knowledge, understanding of the distribution of monosodium urate crystals within the body can aid clinical diagnosis and further understanding of the resulting pathology. VIRTUAL SLIDES: The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1293547351151638 .

Evaluation of hepatitis B surface antibody and specific gamma interferon response in health care workers after vaccination.

BACKGROUND: Health care workers are at high risk of acquiring hepatitis B virus (HBV) infection through occupational exposure to blood or body fluids. Thus, the assessment of anti-HBs status after immunization is very important. OBJECTIVES: This study aimed to evaluate the measurement of HBsAb titer and specific gamma interferon response among the vaccinated health care workers in Golestan Hospital, Ahvaz, Iran. PATIENTS AND METHODS: The blood samples of 39 health care workers, including 13 general surgeons, 10 anesthesiologists, 5 neurosurgeons, 3 general physicians, 1 orthopedist, 2 urologist and 5 nurses were collected during June 2013. All the participants had received HBV vaccine. They had received last vaccine dose from 2 months to 14 years ago. Their sera were tested for anti-hepatitis B antibody and HBc-IgG by the ELISA. Also, the evaluation of specific interferon γ response against HBsAg was carried out using ELISA test. The age of health care workers were between 24 and 58 years with the mean age of 34.3 ± 7.4 y. RESULTS: Out of 39 sera, 22 (56.41%) had HBsAb titer above 100 IU/mL, 17 (43.6%) had titer below 100 IU/mL, 27 (69.2%) had positive specific HBsAg interferon γ, 8 (20.5%) cases had positive antibody response above 100IU, but negative for specific interferon γ and 3 (7.6%) cases were positive for HBc-IgG. CONCLUSIONS: Overall, 87.2% of the health care workers had immunity against HBV infection, which showed remarkable immunity response following HBV vaccination. Booster dose of HBV vaccine is recommended for those whose immunity are below 100 IU/mL.