Evaluation of Efficacy Endpoints for a Phase IIb Study of a Respiratory Syncytial Virus Vaccine in Older Adults Using Patient-Reported Outcomes With Laboratory Confirmation.

Objectives: There are no approved vaccines for respiratory syncytial virus (RSV), and consensus on methods to assess RSV vaccine efficacy has not been established. In this study of an adjuvanted RSV vaccine, we evaluated an RSV disease endpoint using a patient-reported outcome instrument (the inFLUenza Patient-Reported Outcome instrument [FLU-PRO]) and molecular testing for virologic confirmation.

Methods: In a randomized, blinded efficacy study (NCT02508194), 1900 adult participants aged ≥60 years who had any respiratory symptom lasting ≥24 hours recorded symptoms in a FLU-PRO-based workbook for 21 days, self-collected nasal swabs on illness days 2 to 4, and had a site-collected swab obtained on (approximately) day 4.

The changing subtypes of hepatitis B surface antigen in Hungary and the lack of correlation with severity and chronicity of the disease.

Two hundred and twenty sera from asymptomatic carriers and 129 sera from acute hepatitis patients were subtyped. Subtype adw was found in a significantly higher percentage of asymptomatic carriers. The indices of disease severity and chronicity were compared in adw and ayw cases.

Distribution of ad and ay subtypes of hepatitis B surface antigen among hepatitis patients and symptomless carriers in Hungary.

A total of 176 HBsAg positive sera from acute and chronic hepatitis patients and symptomless carriers (blood donors) in Hungary were subtyped for ad and ay determinants. The distribution of ad and ay determinants in Hungary was found to be about the same. There were no significant differences among the groups tested.