Summary
A trial of pre-exposure immune serum globulin (ISG) vs. the prevailing policy of post-exposure ISG for the prevention of viral hepatitis was undertaken among 23,447 male and female military recruits in Israel, an endemic area for hepatitis A virus infection. We are reporting on the three-year follow-up of the incidence of non-B hepatitis among 12,835 male recruits, half of whom had been allocated to receive ISG on their first day of service, while the other half served as a non-vaccinated (“regular care”) control group. Over the three-year period the overall cumulative incidence in the intervention group was half that of the control group (3.6 per 1000 vs. 7.2 per 1000; p=0.0037). Protection was virtually absolute for up to nine months' follow-up. ISG may have provided prolonged partial protection well in excess of six to nine months. Between 10 to 18 months, half as many cases occurred in the intervention group as in the controls. By 18 months the difference in incidence between the study groups had reached a plateau and was highly significant (p=0.002). Between 19 and 36 months the case increment in the two groups was similar. The benefit of receiving pre-exposure ISG remained evident three years after inception of the trial in this indigenous military population living in an endemic area.
Zusammenfassung
23 447 männliche und weibliche Rekruten in Israel, einem Hepatitis-A-Endemiegebiet, wurden in eine Vergleichsstudie zur Immunglobulin(ISG)-Prophylaxe vor Exposition versus üblicher Immunglobulingabe nach Exposition einbezogen. Wir berichten über die Inzidenz der nicht-B-Hepatitis bei 12 835 männlichen Rekruten in einer Beobachtungszeit von drei Jahren; die eine Hälfte der Rekruten erhielten ISG am ersten Tag ihres Militärdienstes, die andere diente als nicht geimpfte „übliche“ Kontrollgruppe. Über den Zeitraum von drei Jahren war die kumulative Gesamtinzidenz an Hepatitis in der Prophylaxegruppe halb so hoch wie in der Kontrollgruppe (3,6 auf 1000 im Vergleich zu 7,2 auf 1000; p=0,0037). Neun Monate lang bestand praktisch vollkommener Schutz vor Hepatitis durch ISG, das möglicherweise über sechs bis neun Monate hinaus noch einen partiellen Schutz gewährte. In der Prophylaxegruppe traten 10–18 Monate nach Beginn der Studie nur halb so viele Fälle von Hepatitis auf wie in der Kontrollgruppe. Nach 18 Monaten hatte die unterschiedliche Inzidenz in den beiden Gruppen ein Plateau erreicht; die Differenz war hochsignifikant (p = 0,002). Im Zeitraum zwischen 19 und 36 Monaten nach Studienbeginn war die Zunahme von Krankheitsfällen in beiden Gruppen vergleichbar. Drei Jahre nach Beginn der Studie war der Nutzen einer ISG-Prophylaxe vor Exposition für diese in einem Hepatitis-A-Endemiegebiet lebende Militärbevölkerung noch eindeutig erkennbar.
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Kark, J.D., Witztum, E., Mazkin, H. et al. The three-year incidence of Non-B viral hepatitis morbidity in a controlled trial of pre-exposure immune serum globulin prophylaxis. Infection 12, 251–255 (1984). https://doi.org/10.1007/BF01645952
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DOI: https://doi.org/10.1007/BF01645952