Allergic Rhinoconjunctivitis Clinical Trial
Official title:
A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated CryJ2-DNA-LAMP Vaccinated Subjects and the Safety of a Booster Vaccination
This is a continuing research study of a vaccine for allergy to Japanese Red Cedar. The
vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the
vaccine is tolerated and how previous Phase IA research participants respond to the vaccine
in a booster dose. CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not
approved for use by the United States Food and Drug Administration (FDA) but is available in
research studies like this one. The study is a Phase IB, prospective, three cohort, open
label study conducted on one cohorts of non-atopic subjects and two cohorts of subjects with
a history of allergic rhinitis symptoms to Japanese red cedar CryJ 2 pollen allergen that
participated in the previous Phase IA study (all the subjects participated in the previous
study). The study will be conducted at 1 study center. Subjects are enrolled in the trial
for a period of 80 days. The objectives of the statistical analyses are to establish the
safety and to explore the immunogenicity of the LAMP-vax vaccine. All statistical analyses
conducted on the data from this trial will be exploratory in nature.
The primary objective of this Phase IB Study is to evaluate the safety and immunological
responses of an additional dose of CryJ2-DNA-LAMP plasmid vaccine delivered intramuscularly
(IM) to subjects who previously received 4 doses of CryJ2-DNA-LAMP vaccine delivered IM
every 2 weeks in the previous Phase IA study.
A further safety assessment of the JRC sensitive and non-sensitive subjects who were in
Group 1, 2 and 3 of the Phase 1A study will be further assessed in terms of current skin
test reactivity, re-vaccination safety and continued safety.
Group 1: will receive 2 mg CryJ2-DNA-LAMP plasmid vaccine by intramuscular (IM) injection.
The dosing regimen for this group will be to receive one (1) booster dose. This group will
be followed for 80 days (+/- 10), assessing skin reactivity and immune response.
Group 2: will receive 2 mg CryJ2-DNA-LAMP plasmid vaccine by intramuscular (IM) injection.
The dosing regimen for this group will be to receive one (1) booster dose. This group will
be followed for 80 days (+/- 10), assessing skin reactivity and immune response.
Group 3: will receive 2 mg CryJ2-DNA-LAMP plasmid vaccine by intramuscular (IM) injection.
The dosing regimen for this group will be to receive one (1) booster dose. This group will
be followed for 80 days (+/- 10), assessing skin reactivity and immune response.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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