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LIVE POLIO IRUS VACCINES

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Large-Scale Field Trial with Oral Cox-Lederle Vaccine in Dade County 439<br />

immunization, as well as other medical and<br />

social items. More reliable data than previously<br />

have been available concerning the immune<br />

status to poliomyelitis of a large metropolitan<br />

area will also be provided. The uncorrected<br />

interview survey data (Table 4) suggest that the<br />

percentage of the population that has received<br />

three or more injections of the Salk-type vaccine<br />

is about 83 per cent of the five-19-year-old-age<br />

group, 45 to 55 per cent in the 0-4 and 20-39-<br />

year-age group, and less than 20 per cent in the<br />

40-and-over-age group. The serologic results required<br />

to complete Table 5 are not yet available.<br />

Related Research. In addition to the actual<br />

field trial, we have undertaken or are cooperating<br />

in a series of related projects. These include<br />

the following:<br />

1. A study of polioviruses and other enteroviruses<br />

from sewage samples collected from<br />

representative points at weekly intervals before,<br />

during, and after the oral immunization program.<br />

2. An enterovirus surveillance program by<br />

Dr. A. Gelfand of the U. S. Public Health Service,<br />

based on rectal swabs submitted monthly<br />

from 100 Dade County infants and children.<br />

3. Studies by Dr. R. Murray and associates<br />

at the National Institutes of Health on polioviruses<br />

excreted by humans during the field<br />

trial and of vaccine potency.<br />

4. A prospective and retrospective multidisciplinary<br />

evaluation of the health education<br />

and other social factors, which contributed to<br />

the high degree of community acceptance and<br />

participation.<br />

ANTIBODY RESPONSE AND<br />

EFFECTIVENESS<br />

Although the final proof of the effectiveness<br />

of this and other polio vaccines depends on<br />

careful and prolonged epidemiologic surveillance<br />

for paralytic disease, it can be reasonably assumed<br />

that field effectiveness will parallel the<br />

antibody response to the vaccine.<br />

In order to determine the antigenic potency<br />

of the vaccine used, blood specimens were collected<br />

immediately prior to, and three to four<br />

weeks after, oral vaccination from approximately<br />

2,300 elementary school students and 850 infants<br />

and young adults. The elementary school students,<br />

aged six to 12 years, were volunteers,<br />

consisting of approximately 50 per cent of the<br />

student body of six representative elementary<br />

schools and a rather highly Salk-immunized<br />

group. The infants and young adults included<br />

university students, military personnel and their<br />

dependents, and Health Department clinic clientele,<br />

most of whom had received no prior Salktype<br />

polio vaccine.<br />

The poliovirus neutralizing antibody levels are<br />

being determined on paired sera in one of three<br />

laboratories: Variety Children's Research Foundation,<br />

directed by Dr. M. M. Sigel, Professor<br />

of Microbiology, University of Miami School of<br />

Medicine; Florida State Board of Health Laboratory,<br />

directed by Dr. N. J. Schneider; and by<br />

Microbiological Associates, Bethesda, a commercial<br />

laboratory with vast experience in this<br />

field. Microbiological Associates is using the<br />

metabolic inhibition (pH) test; the other laboratories<br />

are using the cytopathogenic effect (CPE)<br />

test. Specimens tested by the pH method which<br />

show absent or low titers by this technique<br />

and approximately 5 per cent of all other paired<br />

specimens, are being re-tested by one or more<br />

of the other laboratories by the different technique.<br />

All specimens are effectively coded, but<br />

by a system of unit packaging it is insured that<br />

all specimens from a given individual will be run<br />

simultaneously. Since this is not primarily a<br />

paper on laboratory technique and since the<br />

complete laboratory data are not yet available,<br />

the results here reported are those obtained from<br />

one laboratory using the pH test.<br />

As of this date, we have received the reports<br />

on the results of tests from approximately 2,500<br />

individuals. In this group there were 594 individuals<br />

who lacked measurable poliovirus<br />

neutralizing antibodies to one or more of the<br />

three types of poliovirus. The numbers of individuals,<br />

both by total and by broad age group,<br />

in each of the seven possible combinations of<br />

antibody gap to one or more types of poliovirus,<br />

are shown in Table 6. In this highly biased sample,<br />

the majority, 61 per cent, were in the age<br />

group of five through 14 years. Table 7 gives<br />

the Salk status of these 594 individuals. It will<br />

be noted that relatively few individuals lacking<br />

Type 2 antibodies had received three or more

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