Safety, Immunogenicity, and Antibody Persistence of COVID-19 Boosters in BBIP-CorV Immunized Individuals with Comorbidities (preprint)

Data on immunogenicity, immune response persistency, and safety of COVID-19 boosters in patients with comorbidities are limited. Therefore, we aimed to evaluate and compare three different boosters in individuals who received two doses of the BBIBP-CorV vaccine including underlying diseases and healthy cases as control. One hundred forty subjects including 63 ones with at least one of three underlying diseases (UD) (including obesity, hypertension, and diabetes mellitus) and 77 healthy ones (HC) who had received a booster dose (either PastoCovac Plus or PastoCovac or BBIBP-CorV) were enrolled. The presence of SARS-CoV-2 antibodies was assessed before the booster injection and 28, 60, 90, and 180 days after it. Moreover, the adverse events (AEs) were recorded on days 7 and 21 post-booster shot for evaluating safety outcomes. Significantly increased titers of anti-spike, anti-RBD, and neutralizing antibodies were observed in both UD and HC groups 28 days after the booster dose, although the titer rise of anti-spike IgG and anti-RBD IgG was insignificantly inferior in the UD group compared to the HC group. All antibodies’ titers declined, with no significant differences between the two groups over time. Notably, all specific antibodies persisted up to 180 days; particularly the neutralizing antibody in both groups. Furthermore, no significant difference in antibody levels was observed between each UD subgroup and the HC group, except for neutralizing antibodies in the hypertension sub-group. PastoCovac Plus and PastoCovac boosters induced higher antibodies’ fold rise in UD individuals than BBIBP-CorV booster recipients. Safety outcomes did not show any serious AEs after the booster injection. The overall incidence of AEs post the booster injection was higher in the UD group than the HC group. Furthermore, the highest systemic AEs rate was reported in the UD group receiving the BBIBP-CorV booster. In conclusion, administration of COVID-19 boosters can equally induce robust and persistent humoral immune responses in individuals with or without UD primarily vaccinated with 2-doses of the BBIBP-CorV. Protein-based boosters with higher antibodies' fold rise and lower AEs in individuals with comorbidities might be considered a better choice for these individuals.

A Landscape on Disorders Following Different COVID-19 Vaccination: A Systematic Review of Iranian Case Reports (preprint)

Vaccination against SARS-CoV-2 has significantly contributed to the recent pandemic control. COVID-19 vaccines are available with different platforms and the primary clinical trials results presented acceptable safety profile of the approved vaccines. Nevertheless, the long-term assessment of the adverse events or rare conditions need to be investigated. The present systematic review, aimed at classification of Iranian case reports following COVID-19 immunization. To achieve this goal, the related published case reports were explored via PubMed, Web of Science and Google scholar according to PRISMA guideline and available up to 14th Dec, 2022. Out of 437 explored studies, the relevant data were fully investigated which totally led to 40 studies including 64 case reports with a new onset of a problem. The cases were then classified according to the various items such as the type of adverse event manifestations and COVID-19 vaccine. The reported COVID-19 vaccines in the studied cases included Sinopharm, AstraZeneca, and COVAXIN. The results showed that the adverse events presented in 8 different categories from which cutaneous problems accounted as the most prevalent manifestations (43.7%) in which rare diseases were also screened such as Steven-Johnson syndrome, Morphea and Toxic Epidermal Necrolysis. Notably, almost 60% of the cases had no comorbidities. Moreover, the obtained data revealed nearly half of the incidences occurred after the first dose of injection and the mean duration of improvement after the symptom onset was 18.72±24.69 days. 73% of all the cases were either significantly improved or fully recovered. Although the advantages of COVID-19 vaccination is undoubtedly significant, the high risk individuals including those with a history of serious disease or comorbidities immunodeficiency conditions should be vaccinated with the utmost caution.

The Significant Contribution of Pasteur Institute of Iran to COVID-19 Pandemic Control: A Successful Map over the Obstacles (preprint)

Background The present study aims to show the comprehensive effort of Pasteur Institute of Iran and its scientists regarding COVID-19 chaos management, related studies, achievements and vaccine production though there were many imposed challenges. Methods The relevant literature review was done through the associated data from national and international databases, published and under review research articles and also through reports obtained from official meetings with the heads of the related departments. Results The taken strategy adopted by Pasteur Institute of Iran was based on six arms including COVID-19 laboratory network establishment, vaccine research and production, monitoring of SARS-CoV-2 variants, diagnostic tests production, conduction of applied and basic research, and community management and support which eventually utilized appropriate technology for facilitating vaccination as well as the pandemic control at the right time. Conclusion The COVID-19 pandemic which was going to be a real crisis, led to a precise and great performance of Pasteur Institute of Iran owing to the unity of the scientists and the staff. COVID-19 pandemic has been managed by COVID-19 laboratory network set up, approved vaccines in collaboration with Cuba, evaluation and validation system of diagnostic and immunological COVID-19 kits, community Support and careful SARS-CoV-2 Variants Screening. COVID-19 is not over yet and the role of Pasteur Institute of Iran in dealing with this pandemic is still pivotal. There are some other challenges to overcome such as preparation for any COVID-19 probable trend, data management and update, long-term safety and efficacy of the vaccines and providing supplies.

Higher Rate of Hyperbilirubinemia and Arrythmia in COVID-19 Cases Receiving Combination Therapy Atazanavir /ritonavir vs. Lopinavir /ritonavir (preprint)

Background: Many treatments for COVID-19 are currently under studying, such as combination therapies with hydroxychloroquine plus antiviral drugs. In this study, we compared the efficacy and side effects of two types of combination therapy including atazanavir /ritonavir (ATV/r) or lopinavir /ritonavir (LPV/r) plus hydroxychloroquine among COVID-19 patients. Methods: In a non-randomized clinical trial, 108 eligible patients with moderate and severe form of COVID-19 were divided into two groups. Each group consisted of 54 patients. One group received ATV/r plus hydroxychloroquine and the other group received hydroxychloroquine plus LPV/r. Then, the two groups were evaluated and compared for clinical symptoms, recovery rates and complications of treatment regimens. Results: The findings of this research showed a significant increase in bilirubin in ATV/r receiving group compared to LPV/r receivers (p<0.001). there was also a significant increase in arrhythmias in the LPV/r group compared to ATV/r group during the treatment period (p=0.019). Other findings including length of hospital stay, outcome, and treatment complications were not statistically significant. Conclusions: There is not statistically significant difference between protease inhibitor drugs including ATV/r and LPV/r in the treatment of COVID-19 regarding to progress and clinical outcomes. However, some side effects such as hyperbilirubinemia and arrhythmia was significantly different by application of atazanavir or lopinavir.

Clinical Characteristics of SARS-CoV-2 by Re-infection Vs. Reactivation: A Case Series From Iran (preprint)

Purpose: COVID-19 immunity in infected individuals may not be persistent. The specific response wanes in patients who have recovered from this infection. Nevertheless, it has not been fully understood whether true re-infection occurs or the viral reactivation.Methods: In this study, we investigated three COVID-19 patients who represented the symptoms after recovery. Chest CT scan was applied to assess the patients along with the viral samples from oropharyngeal/nasopharyngeal which were subjected to RT-PCR. The viral genome sequencing was applied where possible to distinguish possible re-infection or latent reactivation. Moreover, COVID-19 specific antibodies available data were evaluated in each incidence.Results: The second episode of SARS-CoV-2 infection was different among the investigated subjects who experienced an interval between positive PCR tests ranged between 63 and 156 days. The disease presentation was less or more severe in the second infection. All cases were found IgG positive in the re-infection phase. The sequencing of SARS-CoV-2 sample obtained from two cases revealed a D614G mutation of S gene from the second isolated sample strengthens the case for the re-infection. Conclusions: The possibility of re-infection and reactivation could have significant effect on clinical implications and also vaccination. Our data supports clear warning of SARS-CoV-2 continuous circulation potency among the populations in spite of herd immunity either with natural infection or vaccination. This issue is critical in term of the patients, clinical investigate and viral transmission.