Intramuscular versus Subcutaneous COVID-19 needle length RCT

Phase 3

• Conditions: COVID-19; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12624000294550
• Lead Sponsor: Medical Research Institute of New Zealand (MRINZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-21
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

1.Adult aged 18 – 75 years.
2.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
3.Have received at least 2 previous COVID-19 vaccinations.
4.Be eligible to receive Pfizer Comirnaty COVID-19 booster vaccine.
5.Participant must be willing and able to provide written informed consent.
6.Access to a mobile phone and/or device with internet connectivity to complete remote diary entries and surveys.
7.Willing and able to comply with the study instructions.

Exclusion Criteria

1.Positive COVID-19 infection within 6 months prior to screening.
2.Received COVID-19 vaccination within 6 months prior to screening.
3.History or anaphylaxis, allergic disease, severe reactions to COVID vaccine, or reaction likely to be exacerbated by any component or study participation.
4.Cognitive impairment that prevents the participant from understanding the study instructions, completing questionnaires, or providing informed consent.
5.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.
6.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.
7.Any contraindication to IM, SC injections or blood tests including but not limited to bleeding disorders.
8.Is pregnant.
9.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.
10.Has received or plans to receive any non-study vaccinations within 14 days prior to screening or 28 days after dose of study vaccine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the immunogenicity of subcutaneous (SC) versus intramuscular (IM) vaccine delivery [Fold change of Anti-S IgG antibodies against SARS-CoV-2 in bloods tests Day -14 prior vaccination and day 28 post vaccination ]