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Neurovirulence tests of type 3 oral poliovirus vaccine manufactured by Lederle Laboratories, 1964-1988.

Abstract：

:Oral poliovirus vaccine (OPV) is tested for safety by evaluation of neurovirulence in rhesus and cynomolgus macaques. After intraspinal or intrathalamic injection of varying doses of vaccine, monkeys are followed for 17-21 days, killed, and a histopathological evaluation is made of the severity of poliomyelitis lesions in the spinal cord and brainstem. Each production lot of vaccine is compared with a type 1 OPV reference virus tested by the same method. Records of neurovirulence tests on production lots of type 3 OPV manufactured by Lederle Laboratories, during the period 1964-1988, have recently become available, together with the corresponding tests on type 1 reference vaccine. The cumulative data were collated, using a system under which each monkey was given a single grade according to the severity and spread of neuropathological poliomyelitis lesions. These raw data were assembled into frequency distributions ('neurovirulence profiles'), and used to compare type 3 OPV with the reference vaccine. These comparisons included monkeys injected by intraspinal injection (three vaccine dose levels) and intrathalamic injection (one vaccine dose level), and comprised independent tests conducted by the Food and Drug Administration and by the vaccine manufacturer. A total of 13 different comparisons were made, each one consisting of a pair of profiles, on type 3 OPV and reference vaccine, respectively. In total, these comparisons represented tests on more than 12,000 monkeys. Based on these neurovirulence profiles, the type 3 OPV appeared to be no more virulent than the reference vaccine.(ABSTRACT TRUNCATED AT 250 WORDS)

journal_name

Vaccine

journal_title

Vaccine

authors

Nathanson N,Horn SD

doi

10.1016/0264-410x(92)90396-2

subject

Has Abstract

pub_date

1992-01-01 00:00:00

pages

469-74

issue

7

eissn

0264-410X

issn

1873-2518

pii

0264-410X(92)90396-2

journal_volume

10

pub_type

杂志文章

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