Clinical trial NCT01723254: A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis
Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Pharmacodynamic Response Of Ascending Dose Levels Of An Anti-ige Vaccine With Two Different Adjuvant Formulations (Pf-06444753 And Pf-06444752) In Generally Healthy Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: Vaccines
Phase 1
Allergic Rhinitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of different doses of PF-06444753 and PF-06444752 in subjects with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive,
* Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1 KU/L to at least one of the following common allergens: dust mite (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may compromise their ability to safely participate in the study.
* Evidence or history of clinically significant pulmonary disease (including allergic and non-allergic asthma, chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary fibrosis, pulmonary hypertension, or others).
* Evidence or history of clinically significant autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, or others).

Primary outcomes:
measure: Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
timeFrame: Within 14 days
measure: Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
timeFrame: Within 14 days
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
timeFrame: Baseline up to 336 days post study administration or at Early Termination
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to 336 days post last study drug administration or Early Termination
Secondary outcomes:
measure: Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
timeFrame: Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation
state: Ontario
city: Montreal
country: Canada
facility: Diex Research Montreal Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Appliquee en Allergie de Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: