SyringeNCT02556047
Evaluation of the Safety & Performance of 2 Intradermal Safety Devices
A study testing Star Intradermal Safety Device in people with Syringe, run by University of Surrey at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Syringe
- What is being tested?
- Star Intradermal Safety Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
- Body Mass Index ≥18.5 and <29.5.
- The volunteer is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
- The volunteer has signed the ICF and is willing to comply with study procedures.
- Available for follow-up for the duration of the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Clinical Research Centre
Guildford, Surrey, GU2 7XP
About this study
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).
Read the detailed description
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.
- Conditions
- Syringe
- Being tested
- Star Intradermal Safety Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Star Intradermal Safety DeviceDevice
Star Intradermal Safety Device 1.2mm needle length, Star Intradermal Safety Device 1.5mm needle length, Mantoux technique by N\&S
| Study group | Role | What they receive |
|---|---|---|
| Injections | Other | * Two injections of 0.1 ml sterile saline per injection using Star intradermal safety device 1.2mm needle length
* Two injections of 0.1 ml sterile saline per injection using Star intradermal safety device 1.5mm needle length
* Two injections of 0.1 ml saline per subject using Mantoux technique by N\&S Receives: Device: Star Intradermal Safety Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 2 minutes
Secondary outcomes (9)
Volume of fluid on skin following each injection
To obtain data on 'wetness' of injection
Measured: Within 1 minute
Weight of syringes pre filling
To obtain data on pre- and post-injection weight of injectate in the injection devices.
Measured: Within 4 hours
Weight of syringes post filling
To obtain data on pre- and post-injection weight of injectate in the injection devices.
Measured: Within 2 hours
Weight of syringes post injections
To obtain data on pre- and post-injection weight of injectate in the injection devices.
Measured: Within 2 hours
Number of adverse events recorded
Local and systemic safety events recorded. Local safety events will be skin reactivity (redness, hardness, swelling).
Measured: Within 24 hours
Visual Analogue Score for Pain
Intensity of and comparative perceived pain during injection.
Measured: Within 2 minutes of injections at visit 2a and visit 3a
Least painful injection
Following 3 injections on one arm the participant will be asked which was the least painful injection.
Measured: Within 4 minutes
Most painful injection
Following 3 injections on one arm the participant will be asked which was the most painful injection.
Measured: Within 4 minutes
Ease of Use Questionnaire
Limited qualitative data on ease of use from the research nurses.
Measured: Within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyringeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Lewis, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556047
- Sponsor's protocol ID
- CRC332
- Status last verified
- Oct 2015
- First submitted
- 17 Sep 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Evaluate the Safety and Performance of Two Star Intradermal Safety Device (IDSD) Syringes in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02556047
- Acronym / sponsor ID
- CRC332
- Conditions
- Syringe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injections | Other | Device: Star Intradermal Safety Device* Two injections of 0.1 ml sterile saline per injection using Star intradermal safety device 1.2mm needle length * Two injections of 0.1 ml sterile saline per injection using Star intradermal safety device 1.5mm needle length * Two injections of 0.1 ml saline per subject using Mantoux technique by N\&S |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
- 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.
- Body Mass Index ≥18.5 and <29.5.
- The volunteer is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
- The volunteer has signed the ICF and is willing to comply with study procedures.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Star Intradermal Safety DeviceStar Intradermal Safety Device 1.2mm needle length, Star Intradermal Safety Device 1.5mm needle length, Mantoux technique by N\&S | Device | Injections |
Primary outcome
Diameter of wheal following each injection
Time frame: Within 2 minutes
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)
9 secondary outcomes
Volume of fluid on skin following each injection
Time frame: Within 1 minute
Weight of syringes pre filling
Time frame: Within 4 hours
Weight of syringes post filling
Time frame: Within 2 hours
Weight of syringes post injections
Time frame: Within 2 hours
Number of adverse events recorded
Time frame: Within 24 hours
Visual Analogue Score for Pain
Time frame: Within 2 minutes of injections at visit 2a and visit 3a
Least painful injection
Time frame: Within 4 minutes
Most painful injection
Time frame: Within 4 minutes
Ease of Use Questionnaire
Time frame: Within 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Lewis principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Star Intradermal Safety Device in people with Syringe, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of wheal following each injection (time frame: Within 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.