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
| Verified date | October 2015 |
| Source | University of Surrey |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: 1. Healthy male or female volunteers aged 18 to 60 years inclusive. Attempts will be made to achieve an equal gender ratio through appropriate screening procedures, but a failure to do so will not preclude analysis of the final data set. 2. The volunteer is, in the opinion of the investigator, healthy on the basis of self-reported medical history, vital signs, a physical examination (including the skin overlying the deltoids of the upper arms), and the results of routine haematology and coagulation laboratory tests, with no active disease process that could interfere with the study endpoints. 3. Body Mass Index =18.5 and <29.5. 4. The volunteer is able to read and understand the Informed Consent Form (ICF), and understand study procedures. 5. The volunteer has signed the ICF and is willing to comply with study procedures. 6. Available for follow-up for the duration of the study. Exclusion Criteria: - 1. Clinically significant psychiatric, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological (particularly myasthenia gravis), immunological, or haematological disease or abnormality, as determined by the study physician, which might interfere with consenting or self-recording of safety events. 2. Presence of large or dark tattoos or other marking or abnormal variation in skin pigmentation in the area of the deltoids that would preclude measurement of six injection site wheals. 3. Acute, self-reported needle phobia. 4. Regular use of anti-coagulant medication, non-steroidal anti-inflammatory drugs, topical or oral steroids, anti-histamines and opiates for longer than six months. 5. Pregnant or lactating at any point during the study from screening to final follow up. 6. Any condition that, in the investigator's opinion, compromises the volunteers' ability to meet protocol requirements or to complete the study. 7. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent. 8. Dermatological and other conditions likely to cause excessive soreness, bleeding or pain at the site of injection or subsequent scarring; these might include hyperkeratosis and bleeding disorders. 9. Peripheral neuropathy, which might interfere with pain perception. |
Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Surrey Clinical Research Centre | Guildford | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| University of Surrey |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Depth of dermis | Ultrasound echography of the wheal depth and diameter for two versions of an investigational intradermal safety device, compared with Mantoux N&S | Within 10 mins | No |
| Other | Thickness of dermis | Ultrasound echography of the wheal depth and diameter for two versions of an investigational intradermal safety device, compared with Mantoux N&S | Within 10 mins | No |
| Primary | Diameter of wheal following each injection | To obtain data on wheal size for two versions of an investigational intradermal safety device and compare this to the 'gold-standard' of the Mantoux technique with needle and syringe (referred to as Mantoux N&S) | Within 2 minutes | No |
| Secondary | Volume of fluid on skin following each injection | To obtain data on 'wetness' of injection | Within 1 minute | No |
| Secondary | Weight of syringes pre filling | To obtain data on pre- and post-injection weight of injectate in the injection devices. | Within 4 hours | No |
| Secondary | Weight of syringes post filling | To obtain data on pre- and post-injection weight of injectate in the injection devices. | Within 2 hours | No |
| Secondary | Weight of syringes post injections | To obtain data on pre- and post-injection weight of injectate in the injection devices. | Within 2 hours | No |
| Secondary | Number of adverse events recorded | Local and systemic safety events recorded. Local safety events will be skin reactivity (redness, hardness, swelling). | Within 24 hours | Yes |
| Secondary | Visual Analogue Score for Pain | Intensity of and comparative perceived pain during injection. | Within 2 minutes of injections at visit 2a and visit 3a | No |
| Secondary | Least painful injection | Following 3 injections on one arm the participant will be asked which was the least painful injection. | Within 4 minutes | No |
| Secondary | Most painful injection | Following 3 injections on one arm the participant will be asked which was the most painful injection. | Within 4 minutes | No |
| Secondary | Ease of Use Questionnaire | Limited qualitative data on ease of use from the research nurses. | Within 1 week | No |