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Evaluation of the Safety & Performance of 2 Intradermal Safety Devices

NCT02556047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-10-14

No results posted yet for this study

Summary

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).

Conditions

  • Syringe

Interventions

DEVICE

Star Intradermal Safety Device

Star Intradermal Safety Device 1.2mm needle length, Star Intradermal Safety Device 1.5mm needle length, Mantoux technique by N\&S

Sponsors & Collaborators

  • University of Surrey

    lead OTHER

Principal Investigators

  • David Lewis · University of Surrey

Study Design

Allocation
NA
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556047 on ClinicalTrials.gov