Currently, two live attenuated vaccines are available throughout the world. Many countries have included rotavirus vaccines in national immunization program to reduce the disease burden. However, due to low efficacy of the available vaccines, satisfactory outcome has not yet been achieved in developing countries such as Bangladesh. Poor economic, public health, treatment, and sanitation status of the low-income countries necessitate the need for the most effective rotavirus vaccines. Therefore, the present scenario demands the development of a highly effective rotavirus vaccine. In this regard, inactivated rotavirus vaccine concept holds much promise for reducing the current disease burden. Recent advancements in developing an inactivated rotavirus vaccine indicate a significant progress towards disease prophylaxis and control.

No abstract

Highlights Inhibition of IL-6 trans-signaling is crucial to rescue from cytokine storm. sgp130Fc selectively inhibit IL-6 trans-signaling. ADAM17/TACE prodomain inhibitor (TPD) effectively stop ADAM17 shedding activity. Combination of sgp130Fc and TPD have potentiality to reduce cytokine storm in COVID-19. Future trial may consider combination of sgp130Fc, TPD, anti-coagulant and antivirals for severe cases.

Aims Advixa is a monoclonal antibody manufactured as a biosimilar to adalimumab (Humira, Abbvie Inc.). The key objectives of this study were to use a healthy population group to assess pharmacokinetics (PK) and safety similarity between Advixa and Humira in healthy participants and to quantify the effects of potential covariates on adalimumab PK and safety to assess the impact of treatment with Advixa. Methods A group of healthy participants selected by screening aged between 18 and 45 years. According to the randomization table, each participant was given Adalimumab (Advixa and Humira) in the inpatient facilities in a hospital and observed for 72 hours. Several blood samples were collected from the participants at different time points up to day 64 to measure their Pharmacokinetics and biosimilarity. Results The serum concentration-time profiles for PK and safety were compared in this randomized, double-blinded study between Humira and Advixa. A review of the data for biosimilarity confirmed that these products are similar to each other regarding healthy participants. 90% confidence interval of the relative mean Cmax, AUC0-t, and AUCo-inf of the Advixa and Humira were found within the acceptance criteria. No differences in safety profiles were observed in these studies. Conclusion PK and safety are similar between Advixa and Humira in participants with healthy status demonstrated in this clinical trial (NCT05172817; Registration Date/Initial Release Date: 28/09/2021). Adalimumab PK was also similar to treatment with Humira and Advixa.