METHODS
Study Design. COVID-19 Vaccination in Adolescents and Children
(COVAC; NCT04800133) is a non-randomized study aimed at investigating
the immunogenicity of BNT162b2 and CoronaVac, in healthy children and
immunocompromised patients as previously
described.15,23,24 The study was approved by the
University of Hong Kong (HKU)/Hong Kong West Cluster Hospital Authority
Institutional Review Board (UW21-157).
Participants. This prespecified interim analysis included
patients aged 3 years and above who were diagnosed with IEIs and
received at least one dose of COVID-19 vaccine. Participants with no
known history of IEIs were excluded from this analysis.
Procedures. Potential participants were IEI patients diagnosed
by the Department of Paediatrics and Adolescent Medicine, Queen Mary
Hospital, The University of Hong Kong. YLL and JSRD obtained informed
consent from participants aged 18 years or above. Underage participants
provided informed assent, and consent was obtained from their parents or
legally acceptable representatives. Patients were free to elect a
homologous intramuscular primary series, a homologous intradermal
primary series, or a heterologous primary series with 2 doses of
intramuscular vaccine followed by intradermal dose 3. Three doses of
0.3ml BNT162b2 or 0.5 ml CoronaVac were administered via the
intramuscular route to the deltoid or anterolateral thigh, or by an
intradermal inoculator (MicronJet600, NanoPass Technologies, Nes Ziona,
Israel) to the deltoid. Doses 2 and 3 were given at least 14 and 28 days
after the preceding dose.