ORCID ID
Pieter Jan de Kam
https://orcid.org/0000-0003-0859-4862
J.A. Bernstein https://orcid.org/0000-0002-3476-1196
U. Berger https://orcid.org/0000-0002-9265-2131
M. Berger https://orcid.org/0000-0001-8297-4412
M. Worm https://orcid.org/0000-0002-3449-1245
J. Matz https://orcid.org/0000-0002-3242-7979
E. Sher https://orcid.org/0009-0000-5524-7375
R. Möges https://orcid.org/0000-0002-1928-810X
M.H. Shamji https://orcid.org/0000-0003-3425-3463
L. DeBuske https://orcid.org/0000-0001-5013-8022
K. Oluwayi https://orcid.org/0009-0000-6832-7753
M.D. Heath https://orcid.org/0000-0002-6095-4098
M.F. Kramer https://orcid.org/0000-0002-3740-4733
M.A. Skinner https://orcid.org/0009-0008-4935-4316
This
randomized, double-blind, placebo-controlled study was designed to
evaluate the short-term efficacy of pre-seasonal subcutaneous
administration of PQ Grass compared to placebo during a single grass
pollen season. Separate long-term Phase III studies are being planned to
evaluate the long-term efficacy and safety of PQ Grass, as it is
generally accepted that the evaluation of a sustained efficacy response
requires three years of AIT treatment. During this study, the safety and
tolerability of PQ Grass was defined as a secondary endpoint and was
extensively evaluated during the study and included safety follow-up up
to 6 months after the last dose for all study participants. This aligns
with general regulatory requirements for the duration of safety
follow-up in short-term AIT studies. This study also applied an
intensive evaluation of solicited adverse events using a detailed
questionnaire after administering each subcutaneous injection. In
addition, subjects remained at the clinical sites for a minimum of 30
minutes after each dose to evaluate the occurrence of any local and
systemic AEs.
Furthermore, a telephone safety call was performed approximately 24
hours, 4 and 7 days after each injection to inquire about any adverse
events using a telephone script. Finally, safety was assessed three and
six months following the last injection. These intensive safety
monitoring procedures applied in the study have contributed to relative
high reported incidences of adverse events for both the active and
placebo treatment groups.
Furthermore, an extensive panel
of molecular, cellular and humoral biomarkers was evaluated as a part of
exploratory efficacy endpoints analysis in order to understand
underlying immunological mechanisms and their relationship to the
administered PQ grass allergen immunotherapy (AIT). A summary of the
main findings related to the molecular mechanism induced by PQ Grass AIT
are presented in the peer-reviewed manuscript “Peripheral blood
mononuclear cell transcriptome profile in a clinical trial with
subcutaneous, grass pollen allergoid immunotherapy” recently accepted
for publication in Clinical and Experimental Allergy [1].
Furthermore, as part of this study, a comprehensive biomarker analyses
was performed evaluating the cellular and humoral effects of PQ Grass
conventional and extended regimens vs placebo. A manuscript summarizing
these extensive biomarker findings is being finalized and will be
published shortly in a peer-reviewed journal.