level: intermediate T he conclusion of this CMC Forum continued to focus on the latest developments in detection and characterization of protein aggregates (1). Afternoon sessions detailed the most recent experiments probing the role of protein aggregates in immunogenicity, with discussions on the best models to use and initial results. Topics included potential thresholds for immunogenicity, l...

Various strategies for dealing with COVID-19 have been carried out since the WHO declared as an international health emergency. One of preventive is development vaccines. vaccines developed worldwide. As April 13, 2021, there were 184 vaccine candidates in pre-clinical phase and 16 currently III clinical trials using several platforms, such inactivated viruses, vector protein subunits, mRNA. Cl...

Dengue vaccine development has been one of the strategies to reduce dengue incidence in the world alongside with other horizontal interventions such as vector control and the transgenic mosquito programmes. The objective of this paper is to evaluate the safety, reactogenicity and immunogenicity of dengue vaccine clinical trials for the last ten years systematically through a descriptive review....

Escherichia coli K100 produces an antigenic determinant similar to, or identical with, the capsular antigen of Haemophilus influenzae type b. Studies of the effects of heat on the immunogenicity, erythrocyte-modifying capacity, and antigenicity of this cross-reacting antigen (CRA) revealed the following findings. Immunization of rabbits with viable or formaldehyde-killed suspensions of E. coli ...

Neisseria meningitidis serogroup B is the most prevalent cause of invasive meningococcal disease in Europe and members of laboratories working on meningococci are at risk due to frequent handling. Recommendation for anti-meningococcal vaccination among these workers has been recently updated upon the licensure in Europe of Bexsero® vaccine. We tested the immunogenicity and safety of this vaccin...

INTRODUCTION The Biosimilars Forum conducted a survey through an independent organization from November 20, 2015 to January 4, 2016 in order to assess current levels of awareness, knowledge, and perceptions of biosimilars among US specialty physicians who already prescribe biologics. The survey was intended to provide a baseline level of knowledge about biosimilars and will be repeated in 2-3 y...

With the advancement of recombinant DNA techniques, a number of potent biologicals are available for the oral vaccination of free-ranging animals. Once oral immunogenicity and vaccine safety have been demonstrated, efficacy then becomes of paramount importance. Classical assessment of efficacy is conducted under carefully controlled laboratory conditions, whereas efficacy of oral wildlife rabie...

Synthesis of Trimethyl Chitosan Nanoparticles Containing Recombinant BLF1-stxB Protein Burkholderia Pseudomallei and Evaluation its Immunogenicity in Mice

BACKGROUND We assessed the persistence of hemagglutinin inhibition (HAI) antibodies and the vaccine efficacy (VE) of trivalent inactivated influenza vaccine (IIV3) following vaccination of a cohort of pregnant South African women during a second influenza season. METHODS A cohort of women who participated in a randomized placebo-controlled trial on the safety, immunogenicity and efficacy of I...