Haemophilus influenzae vaccines (Crucell/Sanofi)

Acute epiglottis is a rapidly progressive, potentially life-threatening infection causing inflammation of the epiglottis and adjacent supraglottic structures.- Since the introduction of the Haemophilus influenzae vaccine, the incidence of pediatric cases has decreased dramatically while adult instances have increased. Likewise, the etiology has changed considerably with the increasing prevalence of other causative bacterial and viral pathogens.

We present a novel case of acute epiglottis secondary to infection with the severe acute respiratory syndrome coronavirus 2. This case report highlights the changing landscape of epiglottitis and the importance of airway assessment.

Present-day epiglottitis differs greatly from our traditional understanding. Numerous etiologies beyond Haemophilus influenzae now afflict adults predominately. As a clinically significant, novel complication of coronavirus disease 2019, acute epiglottitis is a life-threatening airway emergency. Emergency physicians must maintain a high index of suspicion, especially given the evolving clinical landscape. Early airway assessment with nasopharyngolaryngoscopic is critical.

Molecular size distribution of Haemophilus influenzae type b (Hib) conjugate vaccine is an important indicator for its immunogenicity and stability. Molecular size distribution was evaluated by High-Performance Protein Chromatography on Sepharose CL-4B column, and fractions were pooled. The use of high flow rate, incorporation of a calibration standard with the injected buffer and pooling method yielded a superior assay compared to conventional pharmacopeial method. The pools were analyzed for determination of distribution coefficient (K_D) of 0.2 and 0.5 using two validated techniques: High Performance Anion Exchange Chromatography with pulsed amperometric detection (HPAEC-PAD) for ribitol determination and an optimized colorimetric assay for phosphorus determination. Linearity was achieved over range of 0.10-10.0 μg/mL and 1.0-8.0 μg/mL with LOD of 0.03 and 0.28 μg/mL for HPAEC and colorimetric assays, respectively. The developed assays were successfully applied in quality control monitoring of Hib conjugate vaccine. The optimized colorimetric method had shortened the analysis time to 25 min compared to 3.5 h for the European pharmacopeial assay by modifying the burning process. HPAEC stability results revealed 40% decrease in MSD after stressed storage conditions. The proposed assays offer a reliable and economic platform for monitoring the quality attributes of Hib for biopharma industry.