Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2017-04-29

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.

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Detailed Description

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Conditions

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Allergic Conjunctivitis Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Concentration 1: Short and Tall Ragweed Mix

Group Type OTHER

Dose Level 1

Intervention Type BIOLOGICAL

Short and Tall Ragweed Mix

Concentration 2: Short and Tall Ragweed Mix

Group Type OTHER

Dose Level 2

Intervention Type BIOLOGICAL

Short and Tall Ragweed Mix

Placebo: Saline with 0.4% Phenol

Group Type OTHER

Placebo

Intervention Type BIOLOGICAL

Saline with 0.4% Phenol

Interventions

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Dose Level 1

Short and Tall Ragweed Mix

Intervention Type BIOLOGICAL

Dose Level 2

Short and Tall Ragweed Mix

Intervention Type BIOLOGICAL

Placebo

Saline with 0.4% Phenol

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No