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.

The association between current smoking and binge drinking among adults: A systematic review and meta-analysis of cross-sectional studies.

Background: The substantial increasing trend of binge drinking is a global alarm. Our aim was to undertake a systematic review and meta-analysis of cross-sectional studies to explore the association of current smoking with binge drinking among adults. Methods: We systematically searched Web of Knowledge; PubMed; Scopus; Embase and Ovid (MEDLINE, EMBASE, PsycARTICLES, PsycINFO, PsycEXTRA, and PsycTests) (from inception to 27 May 2020) databases to identify cross-sectional studies of the association between current smoking and binge drinking. Study screening, data extraction, and methodological quality assessment were all carried out by two independent authors. Adjusted odds ratio (AOR) was pooled with 95% confidence intervals (CI) using random effects model in the meta-analysis, followed by the investigation of the heterogeneity via Q-test and I 2 statistic. We assessed publication bias using a funnel plot, the Egger's, and Begg's tests. Results: We identified 3,171 studies and included nine cross-sectional studies with 64,516 participants. A significant association was found between current smoking and binge drinking among both genders (AOR = 2.97; 95% CI = 1.98 to 4.45; I 2 = 90.5%). Subgroup analysis showed that this association among women, men, Caucasians, and Asians/Africans were (AOR = 3.68; 95% CI = 1.03 to 13.18; I 2 = 98.9%), (AOR = 2.53; 95% CI = 1.87 to 3.42; I 2 = 73.1%), (AOR = 1.36; 95% CI: 1.01-1.83, I 2 = 47.4%), and (AOR = 3.93; 95% CI: 2.99-5.17, I 2 = 61.3%), respectively. There was no evidence of publication bias. Conclusion: Current smoking is associated with binge drinking and can be used for identifying and screening binge drinkers. Moreover, this association is stronger among men, and Asians/Africans. This meta-analysis estimation was limited to English-language studies, and the full text of about 3.5% of reports for retrieval was not found, then generalization of the results should be done with caution.