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.

Comparison of weight loss after Roux-en-Y gastric bypass in Helicobacter pylori-negative and Helicobacter pylori eradicated patients during five years follow-ups.

PURPOSE: Helicobacter pylori (HP) is the most common human infection that has affected up to 50% of the population worldwide. The relationship between HP eradication and weight loss is under debate. The present study aimed to compare weight loss outcomes after Roux-en-Y gastric bypass (RYGB) in HP-negative (HP-) and HP-eradicated (HPe) patients during five years follow-ups. METHODS: This retrospective cohort study was conducted on 305 patients aged 18 and more with severe obesity, who underwent primary RYGB from February 2014 to November 2017. The HP-negative and HP-eradicated patients were evaluated for weight loss outcomes during five years follow-ups. RESULTS: Patients' mean age, mean weight, and mean body mass index were 38.78 ± 9.9, 114.8 ± 13.6, and 43.37 ± 2.55, respectively. 27.2% of patients who were HP-positive were treated before RYGB. There was no significant difference between the HP- and HPe patients in terms of total weight loss percent (%TWL), 12 to 60 months after RYGB. Excess weight loss percent (%EWL) was higher in HPe patients compared to HP- patients (P = 0.04) at 12-month after RYGB. However, there was no difference in %EWL between these two groups of patients, 36 and 60 months after RYGB. CONCLUSION: The results of the present study showed that TWL% had no significant difference in HP- and HPe groups during five years follow-ups after RYGB. The %EWL was higher in HPe patients only at 12 months after RYGB and the difference did not persist over time.

Effect of anti-reflux suture on gastroesophageal reflux symptoms after one anastomosis gastric bypass: a randomized controlled trial.

PURPOSE: Gastroesophageal reflux disease (GERD) is an issue after one anastomosis gastric bypass (OAGB) and modification of OAGB with adding an anti-reflux system may decrease the incidence of postoperative GERD. This study aimed to compare the efficacy of the anti-reflux mechanism to treat preoperative GERD and prevent de novo GERD. METHODS: A prospective randomized clinical trial study was conducted on patients with a body mass index of 40 and more from August 2020 to February 2022. Patients undergoing one anastomosis gastric bypass with and without anti-reflux sutures (groups A and B, respectively). These patients had follow-ups for one year after the surgery. GERD symptoms were assessed in all the patients using the GERD symptom questionnaire. RESULTS: The mean age was 39.5 ± 9.8 years and 40.7 ± 10.2 years in groups A and B respectively. GERD symptoms remission occurred in 76.5% and 68.4% of patients in groups A and B, respectively. The incidence of de novo GERD symptoms was lower in group A, compared to group B (6.2% and 16.1% in groups A and B respectively), without any statistically significant difference (p-value: 0.239). CONCLUSION: GERD symptoms and de novo GERD after OAGB seems to be under-reported after OAGB. This study suggests that applying an anti-reflux suture can decrease de novo GERD symptoms.

The predictive relationship between early and long-term weight loss outcomes after one anastomosis gastric bypass.

BACKGROUND: Weight loss failure after bariatric surgery imposes great stress on patients and surgeons and great costs on healthcare systems. The literature review shows that weight loss failure is the most common cause of redo bariatric surgery. Therefore, identifying the predictors of weight loss failure in patients in the early stages can help bariatric surgeons. The present study aims to determine the association between primary weight loss and long-term weight loss outcomes. METHODS: This retrospective cohort study was conducted on 329 patients undergoing OAGB who were followed for 60 months. For the prediction of short-term (24 months) and long-term (60 months) successful weight loss and weight regain, we used %TWL and BMI at any regular follow-ups. RESULTS: In preoperative indices, age, sex, DLP, hypothyroidism, and HTN were not significant to predict successful short-term and long-term weight loss but %TWL at 12 months is a significant predictor of successful weight loss in short-term and long-term follow up. In the prediction of weight regain, preoperative indices (except BMI) were not significant but 12-month %TWL was a significant predictor. CONCLUSIONS: This index can help surgeons find these patients early and provide helpful instructions to manage their issues more promptly to reach better weight loss outcomes.

Prevention of malnutrition after one anastomosis gastric bypass: value of the common channel limb length.

PURPOSE: Hypoalbuminemia and anemia are commonly observed indications for one anastomosis gastric bypass (OAGB) reversal and remain significant concerns following the procedure. Sufficient common channel limb length (CCLL) is crucial to minimize nutritional complications. However, limited literature exists regarding the impact of CCLL on OAGB outcomes. This study aimed to assess the effect of CCLL on weight loss and nutritional status in patients who underwent OAGB. METHODS: A prospective cohort study was conducted from August 2021 to July 2022, involving 64 patients with a body mass index of 40-50 kg/m2. The standardized length of the biliopancreatic limb (BPLL) for all patients in this study was set at 175 cm. Additionally, the measurement of the common channel limb length (CCLL) was performed consistently by the same surgeon for all included patients. RESULTS: The mean age and BMI of the patients were 39.91 ± 10.03 years and 43.13 ± 2.43 kg/m2, respectively, at the time of surgery. There was a statistically significant negative correlation between CCLL and percent total weight loss (%TWL) at the 12-month mark after OAGB (P = 0.02). Hypoalbuminemia was observed in one patient (1.6%), while anemia was present in 17 patients (26.6%) at the one-year follow-up. Statistical analysis revealed no significant difference in the incidence of anemia and hypoalbuminemia between patients with CCLL < 4 m and those with CCLL ≥ 4 m. CONCLUSION: A CCLL of 4 m does not appear to completely prevent nutritional complications following OAGB. However, maintaining a CCLL of at least 4 m may be associated with a reduced risk of postoperative nutritional deficiencies.

Metabolic and bariatric surgery in patients with class I obesity; a two-year follow-up.

BACKGROUND: Patients with class I obesity may need metabolic and bariatric surgery (MBS) in the presence of obesity-associated medical problems, but MBS in this class of obesity is under debate. This study aimed to investigate the efficacy and safety of MBS in patients with class I obesity. METHODS AND MATERIALS: This study was a historical cohort carried out on 112 patients with class I obesity with body mass index (BMI) of 30-35 kg/m2 with a 24-month follow-up underwent MBS at Rasoul-e-Akram Hospital. The required data were extracted through the Iran National Obesity Surgery Database. The data required for the study consisted of demographic information such as age, gender, and obesity-associated medical problems like type-2 diabetes mellitus (T2DM), hypertension, obstructive sleep apnea, and dyslipidemia before surgery, 6, 12, and 24 months after surgery. RESULTS: Mean age of the patients was 38.10 ± 10.04 years; mean BMI was 32.96 ± 1.35 kg/m2 and 83.9% (n = 94) of patients were female. Out of 18 patients with T2DM, 11 patients (61.11%) had complete remission and seven patients (38.88%) had partial remission. Obstructive sleep apnea, hypertension, dyslipidemia, and gastroesophageal reflux disease were observed in 18 (16.07%), 23 (20.53%), 43 (38.39%), and 13 patients (11.60%) before surgery and resolved at 24-month follow-up. Post-operative complications during the 24-month follow-up were checked to assess safety and there were no De novo gastroesophageal reflux disease, intolerance, leakage, pulmonary thromboembolism, deep vein thrombosis, incisional hernia, hypoalbuminemia (Albumin < 3.5 g/dl), excessive weight loss (BMI < 18.5 kg/m2) at any time during 24-months follow-ups and mortality. Early complications occurred as splenic injury in one case (0.89%), wound infection in one patient (0.89%), and extra-luminal bleeding in 10 (8.92%) after surgery, without any mortality. CONCLUSION: MBS is safe and effective in class I obesity and can be considered in selected patients with obesity-associated medical problems.

The effect of antral resection start point on post sleeve gastrectomy gastroesophageal reflux symptoms and weight loss outcomes.

PURPOSE: Sleeve gastrectomy (SG) has gained worldwide popularity by surgeons due to acceptable results in weight loss and obesity-associated medical problems. Distance from the pylorus during antral resection in SG may be effective in decreasing the occurrence of gastroesophageal reflux disease (GERD). The aim of this study was to evaluate GERD symptoms and weight loss outcomes in two groups of SG patients with different start points of antral resection. METHODS: This is a prospective cohort study on 220 patients who underwent SG between June 2019 and July 2021, aged 18 and above, BMI ≥ 40 kg/m2, or BMI > 35 kg/m2 with at least one obesity-associated medical problem. According to the start point of antral resection the patients were divided in two groups (group A: from 2 cm of pylorus and group B: from 4 cm of pylorus). Evaluation of GERD was performed using GerdQ questionnaire at 12-month follow up. RESULTS: Mean age and BMI of all patients were 37.6 ± 10 year and 44.8 ± 5.7 kg/m2 at the time of SG. Totally 153(69.5%) of the patients were female. De novo GERD after 12 months in the groups A and B was found in 18 (20%) and 19 (21%) patients. TWL% at 12-month follow ups, were 33.9% and 32.5% in group A and B, respectively. CONCLUSION: Antral resection's start point has no statistically significant effect on the excess and total weight loss indices, resolution of the obesity-related medical problems and De novo GERD between 2 and 4 cm start point for antral resection during SG.

Laparoscopic Management of Gastrocolic Fistula in a Patient with a History of an Unusual Loop Gastric Bypass-a Video Vignette.

Gastrocolic fistula (GCF) is defined as an abnormal pathological communication between the epithelialized mucosal layers of the stomach and colon. In rare cases, complications following gastric bypass surgery, such as leakage or complicated marginal ulcers, may contribute to the development of a GCF. The laparoscopic approach for managing GCF involves a one-stage procedure that includes resection of the fistula and reconstruction of the gastrointestinal tract.

Five-Year BAROS Score Outcomes for Roux-en-Y Gastric Bypass, One Anastomosis Gastric Bypass, and Sleeve Gastrectomy: a Comparative Study.

PURPOSE: Metabolic and bariatric surgery (MBS) has been shown to enhance the quality of life (QoL) in individuals with obesity. The Bariatric Analysis and Reporting Outcome System (BAROS) is a highly reliable scoring system utilized to assess weight loss, obesity-associated medical conditions, and QoL following MBS. This study aimed to assess the efficacy of sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one anastomosis gastric bypass (OAGB) in improving health outcomes for individuals with severe obesity, employing the BAROS questionnaire. METHODS: A retrospective study was conducted, enrolling 299 patients with a body mass index (BMI) of 40 or higher who had undergone primary MBS (RYGB, OAGB, or SG) and had a 5-year follow-up. Patients were evaluated using the BAROS scoring system, which included measures of % excess weight loss (%EWL), improvement and remission of obesity-related medical problems, and postoperative short-term and long-term complications. RESULTS: The mean age and pre-op BMI of the patients was 39.4 ± 9.4 years and 44.6± 6.5 kg/m2, respectively. The total BAROS score was significantly higher in patients who underwent OAGB compared to those who underwent RYGB and SG (P, 0.02). However, no significant differences were observed in other aspects of the BAROS score, such as QoL. CONCLUSION: This study demonstrated that all three common metabolic and bariatric surgical procedures (SG, RYGB, and OAGB) significantly improved the QoL after surgery. Furthermore, patients who underwent OAGB had a significantly higher total BAROS score at the 5-year follow-up compared to those who underwent RYGB and SG.

Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial.

Background: We conducted a phase III, non-inferiority trial comparing safety and efficacy of RCP recombinant spike protein Covid-19 vaccine to BBIBP (Sinopharm). Methods: Adult Iranian population received RCP or BBIBP in a randomized, double blind and an additional non-randomized open labeled trial arms. Eligible participants signed a written informed consent and received two intramuscular injections three weeks apart. In the randomized arm, an intranasal dose of vaccine or adjuvant-only preparation were given to the RCP and BBIBP recipients at day 51 respectively. Participants were actively followed for up to 4 months for safety and efficacy outcomes. Primary outcome was PCR + symptomatic Covid-19 disease two weeks after the second dose. The non-inferiority margin was 10% of reported BBIBP vaccine efficacy (HR = 1.36). Results: We recruited 23,110 participants (7224 in the randomized and 15,886 in the non-randomized arm). We observed 604 primary outcome events during 4 months of active follow-up including 121 and 133 in the randomized and 157 and 193 cases in the non-randomized arms among recipients of RCP and BBIBP respectively. Adjusted hazard ratios for the primary outcome in those receiving RCP compared with BBIBP interval were 0.91 (0.71-1.16) and 0.62 (0.49-0.77) in the randomized and non-randomized arms respectively. The upper boundary of 99.1% confidence interval of HR = 0.91 (0.67-1.22) remained below the margin of non-inferiority in the randomized arm after observing the early stopping rules using O'Brien Fleming method. Conclusion: Our study showed that the RCP efficacy is non-inferior and its safety profile is comparable to the BBIBP.

Effect of Metabolic and Bariatric Surgery on the Clinical Course of Multiple Sclerosis in Patients with Severe Obesity: a Systematic Review.

Multiple sclerosis (MS) is an autoimmune inflammatory condition affecting the central nervous system (CNS). A systematic review following the PRISMA guidelines was performed to explore the effect of metabolic and bariatric surgery (MBS) on the clinical course and outcomes in patients with multiple sclerosis. Eleven articles examining 394 patients were included in the final analysis. The mean MS duration at the time of surgery was 7.6 ± 4.6 years, and the mean postoperative follow-up was 35.5 ± 5.3 months. MBS leads to the same weight loss with the same complication rate as in patients without MS. Most of patients experienced improvement in clinical course of MS after MBS, compared to non-surgical group. However, there is a risk for MS exacerbation in a number of patients after MBS; they should not be disadvantaged from having MBS, since surgery leads to the same weight loss outcomes with the same complication rate as in patients without MS.

Safety and Efficacy of One Anastomosis Gastric Bypass in Children and Adolescents: a 5-Year Cohort Study.

BACKGROUND: Childhood obesity is an important worldwide issue of serious medical and social concern. One anastomosis gastric bypass (OAGB) is an approved, effective, and long-lasting procedure for weight loss and the remission of obesity-associated medical problems in the adult patients, but its efficacy and safety in children and adolescents are still on debate. This study aimed to evaluate safety and efficacy of OAGB compare to SG and RYGB during a 5-year follow-up. METHODS: A retrospective cohort study on children and adolescents with severe obesity who underwent primary OAGB, sleeve gastrectomy (SG), and Roux-e-Y gastric bypass (RYGB) at an academic hospital, between March 2016 and December 2020. RESULTS: Two hundred twenty-eight patients with 24 to 60 months of follow-up including 107 SG, 37 RYGB, and 84 OAGB were included in the final analysis. The mean age, preoperative weight, and BMI were 15.71 ± 2.09 years (range, 9-18 years), 126.3 ± 22.0 kg (74.5-215 kg), and 45.1 ± 6.9 kg/ m2 (36.4-79.3 kg/m2), respectively. The mean of follow-up was 30.05 ± 19.98 months. The mean of ∆BMI was 30.2 ± 5.1, 30.0 ± 5.4, and 31.1 ± 6.8 at 12th, 36th, and 60th months postoperative. At the 60-month follow-up, there were statistically significant differences in ΔBMI between SG and OAGB and SG and RYGB. CONCLUSION: OAGB is a safe and effective procedure for the treatment of obesity in children and adolescents in 24 to 60 months follow-ups.

Phase II, Safety and Immunogenicity of RAZI Cov Pars (RCP) SARS Cov-2 Vaccine in Adults Aged 18-70 Years; A Randomized, Double-Blind Clinical Trial.

BACKGROUND: This study explores the safety and immunogenicity of the Razi-Cov-Pars (RCP) SARS Cov-2 recombinant spike protein vaccine. METHOD: In a randomized, double-blind, placebo-controlled trial, adults aged 18-70 were randomly allocated to receive selected 10 µg/200 µl vaccine strengths or placebo (adjuvant). It included two intramuscular injections at days 0 and 21, followed by an intranasal dose at day 51. Immediate and delayed solicited local and systemic adverse reactions after each dose up to a week, and specific IgG antibodies against SARS Cov-2 spike antigens two weeks after the 2nd dose were assessed as primary outcomes. Secondary safety outcomes were abnormal laboratory findings and medically attended adverse events (MAAE) over six months follow up. Secondary immunogenicity outcomes were neutralizing antibody activity and cell-mediated immune response. RESULT: Between May 27th and July 15th, 2021, 500 participants were enrolled. Participants' mean (SD) age was 37.8 (9.0), and 67.0 % were male. No immediate adverse reaction was observed following the intervention. All solicited local and systemic adverse events were moderate (Grade I-II). Specific IgG antibody response against S antigen in the vaccine group was 5.28 times (95 %CI: 4.02-6.94) the placebo group with a 75 % seroconversion rate. During six months of follow-up, 8 SAEs were reported, unrelated to the study intervention. The participants sustained their acquired humoral responses at the end of the sixth month. The vaccine predominantly resulted in T-helper 1 cell-mediated immunity, CD8+ cytotoxic T-cell increase, and no increase in inflammatory IL-6 cytokine. CONCLUSION: RCP vaccine is safe and creates strong and durable humoral and cellular immunity. TRIAL REGISTRATION: (IRCT20201214049709N2).

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.