A Study to Assess the Acceptability and Usability of a New Device for Intradermal Vaccination

NCT01963338 | Completed

• 1 other identifier: cev2012-vaxid
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess the acceptability and usability of a newly developed intradermal device in healthy adults

Conditions

Pain; Vaccination Adverse Event

Outcome Measures

Primary Outcomes (2)

• Acceptability (e.g. pain) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle

  Each of the volunteers was asked to complete two questionnaires: first questionnaire surveyed demographic parameters, including gender, age, health care related job or education, number of vaccinations and blood samples taken during the last 5 years, second questionnaire surveyed the experience of ID and/or IM injection, such as anxiety, pain during injection and duration of injection. Also the perception of the participant towards injections into the forearm, which could be perceived as an unnatural site for vaccination, and perception towards the need to undress for IM vaccination, i.e. preparing the upper arm for injection, was asked. The Visual Analogue Scale (1=no agreement; 10=full agreement) was used to score the statements.

  1 day (directly after the injections)

• Adverse events after an injection with an intradermal delivery device and/or intramuscular injection with syringe and needle

  Volunteers were asked to fill a daily electronic diary for 5 days after the injections. The diary surveyed the presence of local reactions (pain at injection site, redness, swelling, ecchymosis and hardening) and systemic adverse events (headache, malaise, chills, myalgia, arthralgia, weakness/fatigue and temperature). In case of local reactions, participants were asked to measure the size of the reaction (in mm). For this purpose, a transparent ruler was provided to the participants at the study day.

  during 5 days after the injections

Secondary Outcomes (1)

• Usability (e.g. handling) of an injection with an intradermal vaccine delivery device compared to an intramuscular injection with syringe and needle

  Within one day after administering the injections

Study Arms (2)

Intradermal group

EXPERIMENTAL

These group participants received two intradermal injections with the newly developed device, one in the forearm and one in the upper arm (deltoid region).

Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%); Device: Intradermal injection in the upper arm (0,1cc NaCl 0,9%)

Intramuscular group

EXPERIMENTAL

These group participants received one intramuscular injection in the upper arm(deltoid region) using needle and syringe and one intradermal injection in the forearm using the newly developed device.

Device: Intradermal injection in the forearm (0,1cc NaCl 0,9%); Drug: Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)

Interventions

Intradermal injection in the forearm (0,1cc NaCl 0,9%) DEVICE

This injection is conducted by the newly developed device.

Intradermal group; Intramuscular group

Intradermal injection in the upper arm (0,1cc NaCl 0,9%) DEVICE

This injection is conducted by the newly developed device in the upper arm (deltoid region).

Intradermal group

Intramuscular injection in the upper arm (0,5cc NaCl 0,9%) DRUG

This injection is conducted by needle and syringe in the upper arm (deltoid region).

Intramuscular group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults

You may not qualify if:

• people who have regular experience with needle injections, e.g. diabetic patients
• pregnant women

Sponsors & Collaborators

• Pierre Van Damme: lead

Study Sites (1)

University of Antwerp

Wilrijk, Antwerp, 2650, Belgium

Location

Related Publications (1)

• Van Mulder TJ, Verwulgen S, Beyers KC, Scheelen L, Elseviers MM, Van Damme P, Vankerckhoven V. Assessment of acceptability and usability of new delivery prototype device for intradermal vaccination in healthy subjects. Hum Vaccin Immunother. 2014;10(12):3746-53. doi: 10.4161/21645515.2014.979655.

  PMID: 25531808 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Injections, Intradermal; Injections, Intramuscular

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Pierre Van Damme, Prof.

  Universiteit Antwerpen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 16, 2013
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

BE (1)