RecruitingPhase 3Phase 4ACTRN12624000294550

Intramuscular versus Subcutaneous COVID-19 needle length RCT

Randomized Controlled Trial of COVID-19 booster vaccine for intramuscular versus subcutaneous administration assessing immunogenicity and reactogenicity. in pharmacies/vaccination sites in Aotearoa, New Zealand.


Sponsor

Medical Research Institute of New Zealand (MRINZ)

Enrollment

400 participants

Start Date

Jul 1, 2024

Study Type

Interventional

Conditions

Summary

This study is a single blind, parallel group, 2-arm randomized controlled trial with 486 participants. The purpose of this study is to measure the immunogenicity and reactogenicity following Subcutaneous versus Intramuscular administration of the Pfizer Comirnaty COVID-19 booster vaccine in adults aged 18 - 75 years, who have previously received at least 2 doses of the COVID-19 vaccine and are eligible for the Pfizer Comirnaty COVID-19 booster vaccine, The study will be conducted within the New Zealand Pharmacy Research Network (PRN) and coordinated from the Medical Research Institute of New Zealand (MRINZ) research office located in the Wellington Regional Hospital. The primary outcome of this study is to assess the immunogenicity of Subcutaneous versus Intramuscular vaccine delivery, Participants will be recruited through social media platforms, pharmacies, GP and health clinics by staff members and investigators. They will be screened and enrolled remotely by study staff member from Medical Research Institute of New Zealand (MRINZ). Participants will be required to get blood drawn on three different occasions as well as attending a vaccination visit at a participating pharmacy/vaccination site in their area. They will need to complete online diaries from day 1 - day 7 after receiving the vaccine to record reactogenicity outcome. They will also have two additional surveys to complete on day 28 and 105. The primary outcome of this study is to assess the immunogenicity of Subcutaneous versus Intramuscular vaccine delivery,


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Most COVID-19 vaccines are given as an intramuscular (IM) injection — directly into the muscle. A subcutaneous (SC) injection goes into the layer of fat just under the skin. Some research suggests that SC injection might trigger an equivalent immune response to IM while potentially causing fewer side effects, and it may also be more practical for certain patients. This study through the Medical Research Institute of New Zealand is testing whether a COVID-19 booster (Pfizer Comirnaty) given subcutaneously produces the same immune response (immunogenicity) as the standard intramuscular injection, and how the side effects (reactogenicity) compare. Participants will be randomly assigned to one of the two injection methods and asked to complete online diaries about how they feel afterwards. You may be eligible if you are between 18 and 75 years old, have had at least 2 previous COVID-19 vaccinations, have a higher BMI (as this affects how far the needle needs to go), and have not had a COVID infection or vaccine in the past 6 months. People who are pregnant, immunosuppressed, or have allergies to vaccine components are not eligible. This research could help optimise vaccine delivery, especially for people for whom standard IM injection may not be ideal.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Pfizer Comirnaty Omicron XBB.1.5 or JN.1 COVID-19 booster vaccine administered by 12.7mm needle (subcutaneous), lateral upper arm. Single 0.3ml dose administered only once by a pharmacist/registered v

Pfizer Comirnaty Omicron XBB.1.5 or JN.1 COVID-19 booster vaccine administered by 12.7mm needle (subcutaneous), lateral upper arm. Single 0.3ml dose administered only once by a pharmacist/registered vaccinator.


Locations(1)

New Zealand

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