View clinical trials related to Allergic Rhinoconjunctivitis.
Filter by: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.
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks). The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes. A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.
This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant IgE-mediated allergic sensitization against birch pollen. The term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.
The purpose of this study is to assess the effect on various biomarkers of treatment with MK-8237 in participants with allergic rhinitis or rhinoconjunctivitis. In Part 1 of the study healthy participants undergo nasal allergen challenge (NAC) with house dust mite (HDM) extract in order to verify the operational performance of NAC and associated sample collection methods. Part 2, the main study, is a placebo controlled, double blind study of participants with HDM-induced allergic rhinitis or rhinoconjunctivitis. The primary hypotheses are that the changes from baseline in post-allergen challenge HDM-specific Immunoglobulin G4 (IgG4) and Immunoglobulin E blocking factor (IgE-BF) are greater after treatment with MK-8237 than after treatment with placebo.
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The majority are local allergic reactions within the mouth and/or throat, and most of these reactions are mild or moderate. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. So this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions.
This is a 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 research participants respond to the vaccine in various doses. 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. This is the first time that CryJ2-DNA-LAMP Plasmid vaccine is being given to humans. The purpose of this study is to evaluate the safety of an investigational vaccine intended to treat allergy to Japanese red cedar. The vaccine is composed of DNA, which is the material that cells use to provide instructions to make proteins. The DNA carries the information necessary to make a special protein which is a combination of a protein found in all cells, LAMP (lysosomal associated membrane protein), and the protein from Japanese red cedar that causes the allergy known as Cry J2. This vaccine is intended to help re-educate the immune system with respect to how it will respond to naturally occurring red cedar allergen and eliminate the allergic symptoms. Another purpose of this study will be to document the immune response to the vaccine Subjects that are eligible to participate in this study will be assigned by whether they are sensitive or non sensitive to CryJ2 or Mountain Cedar and chance (like flipping a coin) to one of 3 study vaccine groups: Group 1: will receive four (4) 4-milligram doses of the study vaccine. Group 2: will receive four (4) 2-milligram doses of the study vaccine. Group 3: will receive four (4) 4-milligram doses of the study vaccine. The study vaccine is administered as an intramuscular injection. Enrolled subjects will receive the study vaccine every 14 days (at day 0, 14, 28 and 42). Subjects will know their study vaccine assignment. Participants who are not allergic to Japanese red cedar will be assigned to Group 1. Participants who do have an allergy to Japanese red cedar or Mountain Cedar will have an equal chance of being assigned to Group 2 or 3. There will be between 18 to 30 men and women participating in the study at one location. Your participation in this study will last approximately 72 days.
The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum pratense based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Phleum pratense compared to placebo.
The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.
As part of the registration plan of our products and after performing a Phase I study the present trial has been designed to compare the efficacy of 5 different doses of subcutaneous immunotherapy in depot presentation.