Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

Study Overview
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Brief Summary
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A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic injections of 2 different dose levels of the investigational short and tall ragweed product. Biomarkers will be assessed at baseline and at multiple time points post-treatment.

Official Title
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A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis

Conditions
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Allergic Conjunctivitis, Allergic Rhinitis

Intervention / Treatment
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* Biological: Dose Level 1
* Biological: Dose Level 2
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 16 and 65 years old Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed pollen Positive skin test reaction at screening visit to short ragweed extract Avoid disallowed medications Females of childbearing potential must have pregnancy test and must agree to use an acceptable method of birth control Have blood and urine analysis within normal limits Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen Have a specific IgE ≥ 0.70 kU/L to short ragweed Exclusion Criteria: Have ocular or nasal conditions that could affect subject safety or trial parameters Have a presence of an active sinus, nasal, or ocular infections Have had allergy immunotherapy to ragweed pollen Have a compromised lung function ≤80% of predicted

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Concentration 1: Short and Tall Ragweed Mix<br> | Biological: Dose Level 1<br>* Short and Tall Ragweed Mix<br>|
| Other: Concentration 2: Short and Tall Ragweed Mix<br> | Biological: Dose Level 2<br>* Short and Tall Ragweed Mix<br>|
| Other: Placebo: Saline with 0.4% Phenol<br> | Biological: Placebo<br>* Saline with 0.4% Phenol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (reported, elicited and observed) |  | 47 weeks | 
| Local Injection Site Tolerability and Reactivity; pain will be assessed using 0-4 scale |  | 47 weeks | 
| Local Injection Site Tolerability and Reactivity; tenderness will be assessed using 0-4 scale |  | 47 weeks | 
| Local Injection Site Tolerability and Reactivity; redness will be assessed using 0-4 scale |  | 47 weeks | 
| Local Injection Site Tolerability and Reactivity; swelling will be assessed using 0-4 scale |  | 47 weeks |