LIVE POLIO IRUS VACCINES

358
Efficacy-Laboratory Evidence
TABLE 1. ST. CLOUD REFORMATORY STUDY, 1959
PARTICIPANTS
No. M EX\ AGE
SALK VACCINE STATUS
OxE TVwo THREE FIOUR IMo.
NoNE DOSE DOSES DOSES DOSES UNO.
VACCINE
FOR\I AND DOSE
MAIN OBJECTIVES
Effect of feedings
in relation to meals
Adults all male 165 2:3.5 years
156 2
l
fi
Liquid-Trivalent
6.1 logs cach type
Pharyngeal recovery
of virus
Viremia
other four groups. Observation of all groups
extended from day "O" through day "28." Stool
specimens were collected from each participant
on days, -1 or -2, and on day "O" the first
blood for antibody titration was collected before
vaccine or placebo was given to the participant.
Blood specimens for viremia studies and throat
swabs for isolation of virus from the pharynx
were collected on the third, fifth, and seventh
day after ingestion of the placebo or vaccine.
Blood collections for viremia studies were made
from one half of each group of participants on
the third and seventh day, and from all participants
on the fifth day after ingestion of vaccine.
A second stool specimen was collected from each
participant during the period, days 14-21, and
blood specimens for antibody titrations were
collected on the 28th day after the ingestion of
placebo or vaccine. On day 28, which was July
13, all placebo-fed participants were given the
liquid vaccine. Some of these received the trivalent
vaccine in a single 2 ml. dose and some received
each of the virus types in separate vials
containing 6.1 logs of virus in 2 ml. of liquid.
The individuals receiving the monovalent form
of the vaccine drank the individual virus types in
rapid succession. Blood for antibody titrations
were collected from this group 30 days after
ingesting the vaccine.
Only one person on the project team knew the
identity of the placebo control and vaccine virusfed
individuals. Although members of the project
team responsible for feeding the vaccine knew
that group B was receiving placebo, the participants,
the reformatory physician, other reformatory
personnel, and the laboratory personnel
doing the antibody titrations and virus isolation
did not have this knowledge. Accordingly, there
TABLE 2. ST. CLOUD REFORMATORY STUDY, 1959
CELL HOUSE
Day -1 and -2
Day O
DayO
Day3
Day 3
Day 5
Day 5
Day 7
Day 7
Day 14-21
Day 28
Day 28
Day 58
A
( LIQUID )
(BEFORE I,UrCH»)
Stool
Blood
Vaccine*
Throat Swab
Blood on half
of participants
Throat Swab
Blood
Throat Swab
Blood on other half
of participants
B
Stool
Blood
Placebo
Throat Swab
Blood (token)
Throat Swab
Blood (token)
Throat Swab
Blood (token)
OPERATING PLAN
C
( CAPSULES )
(AFTER LuNCH)
Stool
Blood
Vaccine*
Throat Swab
Blood on half
of participants
Throat Swab
Blood
Throat Swab
Blood on other half
of participants
D
( LiQUID )
(AFTER LUNCH)
Stool
Blood
Vaccine*
Throat Swab
Blood on half
of participants
Throat Swab
Blood
Throat Swab
Blood on other half
of participants
Stool
Blood
Stool
Blood
Stool
Blood
Stool
Blood
Vaccine feeding to all placebo-fed participants.
Blood specimen on placebo-fed participants who were fed vaccine on day 28.
* Some placebo feedings were scattered among the participants in these cell houses.
E
( CAPSULES )
(BEroRE LUNCH)
Stool
Blood
Vaccine*
Throat Swab
Blood on half
of participants
Throat Swab
Blood
Throat Swab
Blood on other half
of participants
Stool
Blood