Production of Egg Yolk Antibody (IgY) Against Vibrio Cholerae O1: Protective Effect in Mice.

Background: Cholera is an acute intestinal infection caused by Vibrio cholera (V. cholera). The development of antibodies against specific V. cholerae may have a therapeutic effect. In the present research, we investigated the protective effect of egg yolk Immunoglobulin (IgY), which was produced by immunizing hens with formaldehyde-killed V. cholerae O1 and subsequently the isolated IgY was orally administrated to the V. cholerae O1 infected mice for evaluation of its immunizing capability. Methods: In the current study, hens were immunized three times with formaldehyde-killed V. cholerae O1 (1.5×107 CFU/ml) and an equal volume of adjuvant. The IgY was isolated from egg yolk by polyethylene glycol method. The validity and activity of isolated IgY were confirmed with SDS-PAGE and ELISA methods, respectively. Subsequently IgY was orally administered to suckling mice following challenge with V. cholerae O1. ELISA results showed high antibody titer in the serum and egg yolk. Also, SDS-PAGE analysis showed successful purification of IgY and anti-V. cholerae IgY prevented the death of mice infected with V. cholerae O1. The anti-V. cholera IgY was administered at 2, 4, 6 hr intervals after 3 hr of inoculation of mice with V. cholerae O1. Results: Results showed that the rate of surviving mice (2 mg/ml of IgY) were 60% after 4 hr and 40% after 6 hr and the rate of surviving mice (5 mg/ml of IgY) was 70% after 4 hr and 60% after 6 hr. Conclusion: The findings suggested the egg yolk-driven IgY as a natural antibacterial protein, could be effective in the prevention and treatment of cholera disease.

Safety and efficacy of the FAKHRAVAC compared with BBIBP-Corv2 against SARS-CoV-2 in adults: a non-inferiority multi-center trial.

BACKGROUND: We compared Fakhravac and BBIBP-Corv2 vaccines in a phase III trial. METHOD: We conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations assessing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. We started with two randomized double-blind arms and added two non-randomized open-label arms (based on participant preference) because of slow recruitment. The adult population received 0.5 ml (10 µg per dose) intramuscular injections of Fakhravac or BBIBP-Corv-2 vaccines 21 days apart. The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A 10% non-inferiority margin to the reported 72.8% efficacy of BBIBP-Corv2 was assumed. Cox proportional hazard modeling was used to estimate hazard ratios and their 95% confidence intervals. RESULT: We enrolled 24,056 adults in four groups (randomized-Fakhravac: 824, randomized-BBIBP-Corv2: 832; Non-randomized-Fakhravac: 19,429, Non-randomized-BBIBP-Corv2: 2971). All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed similar Serious Adverse Event (SAE) rates in the BBIBP-Corv2 (2.57, 95% CI 1.33-4.49) and Fakhravac (2.25, 95% CI 1.72-2.89) groups; none of which were related to the vaccines received. We recorded 9815 Medically Attendant Adverse Events (MAAE), 736 of which were categorized as somehow related. The rate of related MAAE in the Fakhravac was similar to the BBIBP-Corv2 groups (0.31 and 0.26 per 1000 person-day) in the randomized and considerably higher (0.24 and 0.07 per 1000 person-day) in the non-randomized arms. We observed 129 (35% of the 365 required by target sample size) events of PCR + symptomatic Covid-19 during four months of active follow-up in the randomized arm, demonstrating that those receiving the Fakhravac vaccine were significantly less likely (HR = 0.69; 95% CI 0.49-0.98) to be diagnosed with PCR + symptomatic Covid-19 compared with those receiving BBIBP-Corv2 vaccine. After adjusting for type I error using the O'Brien Fleming method, the Fakhravac vaccine was non-inferior to the BBIBP-Corv2 (assuming a 10% non-inferiority margin to the reported 72.8% BBIBP-Corv2 vaccine efficacy; HR < 1.35) (One-way test: HR = 0.66; 99.8% CI 0.38-1.15). In the non-randomized arm, the results were inconclusive (HR = 1.23; 95% CI 0.96-1.61). We observed 5 cases of hospitalized Covid-19 in the randomized arm, none of which occurred in the Fakhravac vaccine group. Those receiving the Fakhravac vaccine were four times less likely to go to the hospital because of a Covid-19 diagnosis (HR = 0.24; 95% CI 0.10-0.60). The vaccine efficacy of the Fakhravac vaccine is estimated to be 81.5% (95% CI 81-82.4%). CONCLUSION: Fakhravac inactivated SARS-CoV-2 vaccine has comparable safety and efficacy to the BBIBP-Corv2 vaccine. Trial registration This study was registered with the Iranian Registry of Clinical Trials ( www.irct.ir : IRCT20210206050259N3).

The Effect of Family-Centered Psycho-Education on Mental Health and Quality of Life of Families of Adolescents with Bipolar Mood Disorder: A Randomized Controlled Clinical Trial.

BACKGROUND: Bipolar Mood Disorder (BMD) is a type of mood disorder which is associated with various disabilities. The family members of the patients with BMD experience many difficulties and pressures during the periods of treatment, rehabilitation and recovery and their quality of life (QOL) is threatened. In the present study, we aimed to evaluate the effect of family-centered education on mental health and QOL of families with adolescents suffering from BMD. METHODS: In this randomized controlled clinical trial performed on 40 families which were mostly mothers of the adolescents with BMD referred to the psychiatric clinics affiliated to Shiraz University of Medical Sciences during 2012-13. They were randomly assigned to intervention and control groups. RESULTS: The results of single factor multivariate ANOVA/single-factor multivariate analysis of variance and Bonferroni post hoc tests showed that the interaction between the variables of group and time was significant (P<0.001). The mean of QOL and mental health scores increased in the intervention group, but it decreased in the control group at three measurement time points. CONCLUSION: The study findings confirmed the effectiveness of family-centered psychoeducation program on Mental Health and Quality of life of the families of adolescents with Bipolar Mood Disorder. TRIAL REGISTRATION NUMBER: IRCT201304202812N15.

The Effect of Stress Management Program Using Cognitive Behavior Approach on Mental Health of the Mothers of the Children With Attention Deficit Hyperactivity Disorder.

BACKGROUND: Attention deficit hyperactivity disorder is one of the most common psychiatric disorders in children. OBJECTIVES: The study aimed to evaluate the effectiveness of stress management program using cognitive behavior approach on mental health of the mothers of the children with attention deficit hyperactivity disorder. PATIENTS AND METHODS: In this interventional study, 90 mothers of the children with attention deficit hyperactivity disorder were randomly allocated into three intervention, placebo, and control groups. The general health questionnaire was used to measure mental health. Besides, stress was assessed through the depression-anxiety-stress scale. The two instruments were completed at baseline, immediately after, and one month after the intervention by the mothers. Afterwards, within group comparisons were made using one-sample repeated measurement ANOVA. One-way ANOVA was used for inter group comparisons. Mothers in the placebo group only participated in meetings to talk and express feelings without receiving any interventions. RESULTS: At the baseline, no significant difference was found among the three groups regarding the means of stress, anxiety, depression, and mental health. However, a significant difference was observed in the mean score of stress immediately after the intervention (P = 0.033). The results also showed a significant difference among the three groups regarding the mean score of mental health (P < 0.001). One month after the intervention, the mean difference of mental health score remained significant only in the intervention group (P < 0.001). CONCLUSIONS: The study findings confirmed the effectiveness of stress management program utilizing cognitive behavior approach in mental health of the mothers of the children with attention deficit hyperactivity disorder.