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LIVE POLIO IRUS VACCINES

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13. MINNESOTA STUDIES WITH ORAL <strong>POLIO</strong>MYELITIS VACCINE.<br />

COMMUNITY SPREAD OF ORALLY ADMINISTERED<br />

ATTENUATED <strong>POLIO</strong>V<strong>IRUS</strong> VACCINE STRAINS*<br />

ANNE C. KIMBALL, PH.D., ROBERT N. BARR, M.D., HENRY BAUER, PH. D.,<br />

HERMAN KLEINMAN, M.D., EUGENE A. JOHNSON, PHD., AND<br />

MARION COONEY, M.S.t<br />

DR. KIMBALL (presenting the paper): In the<br />

1958 Minnesota study of orally administered attenuated<br />

poliovirus vaccine' the feeding of virus<br />

to only half of the participating families during<br />

the control period provided an opportunity to<br />

study the spread of these strains of poliovirus<br />

within the community to the participants who received<br />

placebos. Prior to this study, intrafamily<br />

2' "' and intra-institutional' spread of attenuated<br />

polio vaccine viruses had been reported.<br />

This study presents quantitative data in regard to<br />

the community spread of vaccine strains of poliovirus.<br />

The poliovirus vaccine strains used in this study<br />

were developed by Cox. No harmful effects were<br />

attributed to the use of these strains in the 1958<br />

Minnesota study nor in later studies conducted<br />

in Minnesota, Latin America and elsewhere.<br />

Natural human passage might be expected to<br />

produce changes in any property of these vaccine<br />

strains and intensive study of these passage<br />

strains is indicated. One crucial test for change<br />

is available from the medical history of the individuals<br />

receiving these strains by natural spread;<br />

a review of the detailed medical records of these<br />

individuals is presented. If after several natural<br />

passages in humans the strains do not show a<br />

persistent and progressive increase in virulence,<br />

the spread of these vaccine strains could have<br />

definite value; not only would some immunity be<br />

acquired by individuals not fed the vaccine<br />

strains but also the intermittent presence of these<br />

* This is one of a series of papers. Aided by grants<br />

from the Sister Elizabeth Kenny Foundation, Minneapolis,<br />

Minnesota and Lederle Laboratories, Division<br />

of the American Cyanamid Company, Pearl<br />

River, New York.<br />

t Dr. Kimball, Dr. Barr, Dr. Bauer, Dr. Kleinman<br />

and Miss Cooney (Minnesota Department of Health);<br />

Dr. Johnson (School of Public Health, University of<br />

Minnesota).<br />

strains in a community could provide booster<br />

stimulation to previously vaccinated individuals.<br />

The magnitude of interfamily or community<br />

spread of these strains can indicate the extent of<br />

added benefit that can be anticipated.<br />

MATERIALS AND METHODS<br />

Participants were married University of Minnesota<br />

students and their children who lived in e<br />

crowded university housing development in Minneapolis,<br />

known as Como Village.<br />

Design of the study, the vaccine strains used<br />

and the characteristics of the study population<br />

have been described.' All village residents (371<br />

families) were invited to participate, and 149<br />

fainilies (40 per cent) volunteered. Thus members<br />

of 20 per cent of the households were fed<br />

vaccine (group B) and specimens were available<br />

from an additional 20 per cent of the households<br />

for the measure of community spread of the vaccine<br />

strains. The division of the participants into<br />

group A (74 families) and group B (75 families)<br />

was on a random basis. During the study period<br />

the identity of these groups was known only to<br />

one member of the team (E.A.J.) who made the<br />

random division and distributed the vaccine and<br />

placebo capsules into envelopes labeled for each<br />

family. The identity of the blood serum and<br />

stool specimens were not known to the laboratory<br />

personnel at the time of testing.<br />

Three stool specimens were available from the<br />

control group (A) for isolation of each of the<br />

three respective poliovirus types. As can be observed<br />

in Table 1, showing the chronology and<br />

sequence of the feeding and collection of specimens,<br />

each participant submitted a total of six<br />

stool specimens. The first stool specimens<br />

were collected prior to the feeding of vaccine to<br />

either group. The second, third, and fourth<br />

161

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