Syringe Clinical Trial
Official title:
A Clinical Investigation to Evaluate the Safety and Performance of Two Star Intradermal Safety Device (IDSD) Syringes in Healthy Adult Volunteers
Several vaccinations are administered by the intradermal (ID) method where the vaccine is
injected between layers of skin. The current technique required to do this can be difficult
to learn and perform accurately, is slower to deliver than subcutaneous or intramuscular
injections, and there is a risk that the injection will be given to too-deep skin layers or
to underlying tissues, which might change the immune response. There is increasing interest
in using ID administration for vaccines as it may be possible to achieve the same immune
response with a smaller dose of vaccine. This could increase access to vaccines that are
expensive or are only available in small quantities and therefore could have global health
benefit for vaccine programs for diseases such as yellow fever and polio.
Because of the potential global-health benefits of being able to give ID injections of
vaccines easily, quickly and with relatively little training or experience, several novel
devices are currently being developed to allow easy ID administration. Star Syringe have
developed two novel intradermal safety devices that differ only in the length of the needle
used. The current study will assess how the two new devices perform, compared to the
traditional Mantoux test, using injections of saline into the upper arm. Twenty volunteers
(18-60 years, male and female) will be recruited and attend a screening visit (1), an
injection visit (2a) and have a follow up telephone call (2b). At the injection visit they
will receive 3 injections in each arm (Mantoux and 2 device injections) and measurements
will be performed.
A subset of volunteers will be invited back to attend an additional visit (3a) which will be
a repeat of visit 2 but with an ultrasound image taken of each injection site. There will be
a follow up telephone call 24 hours later (3b).
Volunteers will be asked to attend Surrey CRC for two visits with a follow up telephone
call. A subset of volunteers will be aske to attend an additional visit and follow up call.
Visit 1 - Screening Visit (Day - 28 to -1) Visit 1 will take place up to 28 days prior to
the injections being administered (Visit 2). At this visit consent will be taken and the
following procedures performed: demography, medical history and concomitant medication,
vital signs (blood pressure, heart rate, oral temperature), symptoms-directed physical
examination including assessment of deltoid area, measurement of height and weight, blood
sample taken for haematology and coagulation screen, completion of a medical health
questionnaire. Inclusion/exclusion criteria will be assessed and volunteers that continue to
be eligible will be invited back to attend Visit 2a.
Visit 2a - Injection (Day 0) At Visit 2a, continuing eligibility will be assessed and both
adverse events and concomitant medication will be recorded. Vital signs will be measured and
if the volunteer is still eligible then they will be randomised onto the study.
The volunteer will receive a total of 6 injections, 3 in each upper arm. In each arm there
will be one Mantoux injection and 2 device injections (the same device or different). In
total they will receive 2 Mantoux injections and 2 injections from each device. To maintain
the blind of the study the volunteers will be asked to wear a blindfold during the
injections. After each injection a number of measurements will be performed including
assessing wheal size and wetness at the injection site as well as subjectively assessing
pain. In addition the devices will be weighed before and after use.
Following the injections, vital signs will be recorded again and volunteers will be
discharged and provided with a diary card to complete over the following 24 hours. They
should record side effects and any medications taken, including over the counter medications
as well as any skin reactions.
Visit 2b - Mandatory Follow Up telephone call (Day 1) The volunteer will be telephoned by a
member of the study team 24 hours after the injection visit and both adverse events and
concomitant medication will be recorded. Volunteers will be asked to return their diary
cards to the CRC in the mail.
A subset of volunteers will be invited back to attend Visits 3a and 3b.
Visit 3a - Injection (Within days 7 to 28) At Visit 3a, continuing eligibility will be
assessed and both adverse events and concomitant medication will be recorded. Vital signs
will be measured and if the volunteer is still eligible then they will be randomised onto
the study.
The volunteer will receive a total of 6 injections, 3 in each upper arm. In each arm there
will be one Mantoux injection and 2 device injections (the same device or different). In
total they will receive 2 Mantoux injections and 2 injections from each device. To maintain
the blind of the study the volunteers will be asked to wear a blindfold during the
injections. After each injection a number of measurements will be performed including
assessing wheal size and wetness at the injection site as well as subjectively assessing
pain. At this visit, ultrasound echography will be performed for each injection site. In
addition the devices will be weighed before and after use.
Following the injections, vital signs will be recorded again and volunteers will be
discharged and provided with a diary card to complete over the following 24 hours. They
should record side effects and any medications taken, including over the counter medications
as well as any skin reactions.
Visit 3b - Follow Up telephone call (24 h after Visit 3a) The volunteer will be telephoned
by a member of the study team 24 hours after the injection visit and both adverse events and
concomitant medication will be recorded. Volunteers will be asked to return their diary
cards to the CRC in the mail.
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Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)