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CompletedNCT00346086Updated Dec 13, 2018

DNA Vaccine for Ragweed Allergic Adults

A Phase 2 interventional study of AIC (Amb a 1 Immunostimulatory Conjugate) in Seasonal Allergic Rhinitis, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 1 month after the study started (first participant enrolled May 2001, registered Jun 2006).
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

Various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with IT. These approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic patients with seasonal rhinitis.

Read the detailed description

Evaluation of efficacy and safety of allergen-CpG oligonucleotide immunostimulatory conjugate in treatment of ragweed-induced seasonal allergic rhinitis. Study incorporates clinical outcomes (symptom diaries, medication diaries, visual analog scores, quality of life questionnaires), safety measurements, immunologic assays (antibody measurements, T-cell assays, cytokine assays, nasal provocation).

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Conditions studied

  • Seasonal Allergic Rhinitis

Keywords

  • CpG oligonucleotide vaccine
  • ragweed immunotherapy
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In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 25 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult men and women 18 to 60 years of age;
  • Who provide informed consent;
  • Have a history of fall, seasonal, allergic rhinitis consistent with ragweed allergy;
  • Exhibit a positive skin test to licensed , standardized, ragweed extract and a positive acute response to ragweed nasal challenge;
  • Are in general good health; and are available for the duration of the study.

Exclusion criteria

Exclusion Criteria:

  • Individuals with medical conditions or taking medications that might interfere with interpretation of the study results will be excluded.
  • Those with a history of severe symptoms of allergic rhinitis during the spring and summer grass pollen season will be excluded.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
25 participants (actual)

Interventions

  • DrugAIC (Amb a 1 Immunostimulatory Conjugate)
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What researchers measure

Primary outcomes

  1. Effect of treatment on nasal allergen challenge

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Study locations

1 site
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21224, United States
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References and documents

Publications

  • Creticos PS, Schroeder JT, Hamilton RG, Balcer-Whaley SL, Khattignavong AP, Lindblad R, Li H, Coffman R, Seyfert V, Eiden JJ, Broide D; Immune Tolerance Network Group. Immunotherapy with a ragweed-toll-like receptor 9 agonist vaccine for allergic rhinitis. N Engl J Med. 2006 Oct 5;355(14):1445-55. doi: 10.1056/NEJMoa052916. PubMed 17021320 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00346086
Lead sponsor
Johns Hopkins University
Responsible party
Sponsor
First posted
Jun 29, 2006
Start date
May 18, 2001
Primary completion
Aug 21, 2001
Completion
Aug 21, 2001
Last update
Dec 13, 2018

Study contacts

Peter S Creticos, M.D.
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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