       Document 0859
 DOCN  M9460859
 TI    Hepatitis B outbreak in a drug trials unit: investigation and
       recommendations.
 DT    9404
 AU    Vickers J; Painter MJ; Heptonstall J; Yusof JH; Craske J
 SO    Commun Dis Rep CDR Rev. 1994 Jan 7;4(1):R1-5. Unique Identifier :
       AIDSLINE MED/94154778
 AB    In autumn 1990 three young men developed acute hepatitis B. They
       belonged to a group of 24 young male volunteers who had taken part in a
       trial in a residential unit for drug trials in July and August 1990. A
       further case of acute hepatitis B and a carrier of hepatitis B e antigen
       (HBeAg) were detected by serological testing of the volunteers.
       Volunteers, in two groups of twelve, had occupied the unit at different
       times during the trial. The four cases occurred in the group that
       contained the HBeAg positive carrier. The carrier had also taken part in
       two trials on the unit in 1989. He was HBeAg positive then, but
       transmission of hepatitis B virus (HBV) did not occur. Although blood
       samples were taken in each of the three trials, intravenous cannulas
       were used only in the 1990 trial. It is likely that HBV was transmitted
       by blood to blood contact between volunteers when blood was sampled
       through cannulas during the trial. This outbreak might have been
       prevented. If an infection control policy had been applied to avoid
       hazardous practices, and volunteers had been screened for HBV before
       entry and the carrier excluded (as recommended by the Association of
       Independent Clinical Research Contractors), the outbreak would not have
       occurred. Volunteers for drug trials in residential units should be
       screened for HBV, human immune deficiency virus (HIV) and hepatitis C
       virus (HCV), and those found to be infected should not be
       accepted.(ABSTRACT TRUNCATED AT 250 WORDS)
 DE    *Clinical Trials  *Disease Outbreaks  England/EPIDEMIOLOGY  Hepatitis
       B/*EPIDEMIOLOGY/TRANSMISSION  Hepatitis B e Antigens/ANALYSIS  Human
       Male  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

