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

COVID-19

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

Inclusion Criteria7

Adult aged 18 – 75 years.
BMI cutoff points will be determined by sex assigned at birth. Female with BMI >30.2 kg/m2 or male with BMI >37.3 kg/m2
Have received at least 2 previous COVID-19 vaccinations.
Be eligible to receive Pfizer Comirnaty COVID-19 booster vaccine.
Participant must be willing and able to provide written informed consent.
Access to a mobile phone and/or device with internet connectivity to complete remote diary entries and surveys.
Willing and able to comply with the study instructions.

Exclusion Criteria10

Positive COVID-19 infection within 6 months prior to screening.
Received COVID-19 vaccination within 6 months prior to screening.
History or anaphylaxis, allergic disease, severe reactions to COVID vaccine, or reaction likely to be exacerbated by any component or study participation.
Cognitive impairment that prevents the participant from understanding the study instructions, completing questionnaires, or providing informed consent.
Is acutely ill or febrile 72 hours prior to or at vaccination visit. Fever is defined as a body temperature greater than 38.0°C.
Individuals receiving treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planes receipt throughout the study. If systemic corticosteroids have been administered short term for treatment of acute illness, participants should not be enrolled into study until corticosteroid therapy has been discontinued for at least 28 days before study vaccine is administered. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Any contraindication to IM, SC injections or blood tests including but not limited to bleeding disorders.
Is pregnant.
Has received or plans to receive immunoglobulins or any blood products within 3 months before the study vaccination through to the end of the study.
Has received or plans to receive any non-study vaccinations within 14 days prior to screening or 28 days after dose of study vaccine.

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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