Immunogenicity and safety of RAZI recombinant spike protein vaccine (RCP) as a booster dose after priming with BBIBP-CorV: a parallel two groups, randomized, double blind trial.

BACKGROUND: The immunity induced by primary vaccination is effective against COVID-19; however, booster vaccines are needed to maintain vaccine-induced immunity and improve protection against emerging variants. Heterologous boosting is believed to result in more robust immune responses. This study investigated the safety and immunogenicity of the Razi Cov Pars vaccine (RCP) as a heterologous booster dose in people primed with Beijing Bio-Institute of Biological Products Coronavirus Vaccine (BBIBP-CorV). METHODS: We conducted a randomized, double-blind, active-controlled trial in adults aged 18 and over primarily vaccinated with BBIBP-CorV, an inactivated SARS-CoV-2 vaccine. Eligible participants were randomly assigned (1:1) to receive a booster dose of RCP or BBIBP-CorV vaccines. The primary outcome was neutralizing antibody activity measured by a conventional virus neutralization test (cVNT). The secondary efficacy outcomes included specific IgG antibodies against SARS-CoV-2 spike (S1 and receptor-binding domain, RBD) antigens and cell-mediated immunity. We measured humoral antibody responses at 2 weeks (in all participants) and 3 and 6 months (a subgroup of 101 participants) after the booster dose injection. The secondary safety outcomes were solicited and unsolicited immediate, local, and systemic adverse reactions. RESULTS: We recruited 483 eligible participants between December 7, 2021, and January 13, 2022. The mean age was 51.9 years, and 68.1% were men. Neutralizing antibody titers increased about 3 (geometric mean fold increase, GMFI = 2.77, 95% CI 2.26-3.39) and 21 (GMFI = 21.51, 95% CI 16.35-28.32) times compared to the baseline in the BBIBP-CorV and the RCP vaccine groups. Geometric mean ratios (GMR) and 95% CI for serum neutralizing antibody titers for RCP compared with BBIBP-CorV on days 14, 90, and 180 were 6.81 (5.32-8.72), 1.77 (1.15-2.72), and 2.37 (1.62-3.47) respectively. We observed a similar pattern for specific antibody responses against S1 and RBD. We detected a rise in gamma interferon (IFN-γ), tumor necrosis factor (TNF-α), and interleukin 2 (IL-2) following stimulation with S antigen, particularly in the RCP group, and the flow cytometry examination showed an increase in the percentage of CD3 + /CD8 + lymphocytes. RCP and BBIBP-CorV had similar safety profiles; we identified no vaccine-related or unrelated deaths. CONCLUSIONS: BBIBP-CorV and RCP vaccines as booster doses are safe and provide a strong immune response that is more robust when the RCP vaccine is used. Heterologous vaccines are preferred as booster doses. TRIAL REGISTRATION: This study was registered with the Iranian Registry of Clinical Trial at www.irct.ir , IRCT20201214049709N4. Registered 29 November 2021.

Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus.

BACKGROUND: The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV). DCV should be used at different doses to compensate for interactions with antiretroviral therapy (ART). Up to three pills a day might be required which will significantly add to the pill burden of these patients. In this study, we have used a single-tablet approach to treating HCV-HIV coinfection. METHODS: Patients coinfected with HIV and HCV were prospectively enrolled from 10 centers throughout the country. Patients received a single once-daily fixed dose combination (FDC) pill containing 400 mg SOF and 30, 60 or 90 mg DCV depending on the type of ART they were receiving for 12 or 24 weeks. (ClinicalTrials.gov ID: NCT03369327). RESULTS: Two hundred thirty-three patients were enrolled from 10 centers. Twenty-three patients were lost to follow-up and two patients died from causes unrelated to treatment. Two hundred eight patients completed the treatment course of which 201 achieved SVR (96.6%). CONCLUSION: Single-tablet combination of DCV and SOF is an effective and safe treatment for patients coinfected with HIV and HCV. The combination works well in patients on ART in which dose adjustment is required. Patients with cirrhosis, previous treatment failure and various genotypes respond identically. The expenses of genotyping can be saved.

Co-infection with bacterial and fungal endocarditis at scar tissue in an immunocompromised patient.

We present the case of a 65-year-old immunocompromised male with a history of kidney transplantation, diabetes, coronary artery bypass, and cardiac resynchronization therapy device implantation who was finally diagnosed with an unusual form of infective endocarditis due to co-infection of fungal and bacterial pathogens. He was afebrile at the time of admission and presented with decompensated heart failure and pneumonia. A spleen abscess was discovered incidentally and prompted us to search for a cardiac source of emboli. Culture of the suppurative fluid drained percutaneously from the abscess was positive for Enterococcus and Aspergillus species. Transthoracic and transesophageal echocardiography revealed a mobile vegetation attached to the scarred myocardium of anterior septum - an unusual location for intracardiac vegetations. With regard to the prohibitive risk for redo surgery, the patient was managed medically with broad spectrum antimicrobial therapy. Finally, the patient died with severe sepsis. .

The Diagnostic Value of Color Doppler Ultrasonography in Predicting Thyroid Nodules Malignancy.

BACKGROUND AND OBJECTIVE: Thyroid nodules are common medical and surgical problems. Although ultrasound has been proposed for evaluation of these nodules by many studies, but there is no consensus regarding its diagnostic accuracy and discriminatory cutoffs. We aimed to investigate the diagnostic value of Gray-scale and Color Doppler US in predicting thyroid nodules malignancy. METHOD: This is an analytical cross-sectional study which was conducted on 63 patients with thyroid nodules. The patients with nodular goiter were evaluated by Color Doppler and Gray scale US, fine needle aspiration and surgery was performed in all the subjects. The sensitivity, specificity, positive predictive value, and negative predictive value of the finding in US and their cut offs were calculated. Data were analyzed by Chi-square and Mann Whitney U test in SPSS19. P-value less than 0.05 considered as statistically significant. RESULTS: 63 patients consisting of 55 (87.3%) female and 8 (12.7%) male patients with the age range of 20-70 years were enrolled in this study. 14% of nodules were reported as malignant in pathology. Singularity, hypo echogenicity, irregular margin, and micro calcification were significantly correlated with malignancy in nodules (p<0.05). Micro calcification and hypo echogenicity of the nodule were the most and the least discriminator of malignancy in nodules (sensitivity 77%, specificity 76% vs. 24%, PPV 41% vs., 14% and NPV 94% vs. 86%) respectively. Pulsatility Index and Mean Systolic Velocity were the most and the least predictor factors of thyroid malignancy (PPV 62% vs. 23% and NPV 100% vs. 91%, respectively). There was a significant association between Resistive Index and Pulsatility Index with malignancy with a cutoff of RI ≥ 0.715 (P=0.005) and PI ≥ 0.945 (P=0.007), respectively. The combination of calcification, RI ≥ 0.715 with PI ≥ 0.945 had a very diagnostic yield for diagnose of malignancy (PPV 66.6% and NPV 98.4%). CONCLUSION: According to results, it seems that Grayscale US combined with Color Doppler are valuable modalities for evaluating thyroid nodules and can be used as a para-clinical method in order to assess the risk of malignancy in the patient with thyroid nodules.