A treatment study of 44 adult persons with injection of grass- and birch pollen in a lymph nodule with one month in between - for treatment of pollen allergy.

Phase 1

• Conditions: Allergic rhinoconjunctivitis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-003369-24-SE
• Lead Sponsor: Allergy Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-19
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Age 18-55 years.
Seasonal moderate to severe allergic symptoms for grass and birch during the two latest seasons.
Positive skin prick test and/or positive serum-IgE to birch and timothy.
Retrospective symptoms measured as RTSS >= 8.
Accepted and signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The presence of any of the following will exclude the potential study patient from entry into the study and will exclude the patient for the ILIT injections at visits 3, 4 and 5:

Pregnancy or nursing, or planning for that November 2017 until March 2018. Women with childbearing potential should use contraceptives. Condom only is not enough as contraceptive.
Adequate anticonception:

-Oral contraceptive, either combined or progestogen alone,
-Injectable progestogen,
-Implants or etenogestrel or levonogestrel,
-Sterilisation done by the fertile woman, or male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.
a.Also, has practiced adequate contraception for 30 days prior to the first ILIT injection
b.Has a negative pregnancy test on the day of vaccination
c.Has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Autoimmune or collagen disease
Known cardiovascular disease, i.e. not even NYHA class I.
Use of ACE-blockers. If ACE-blockers are used, they should be withdrawn after discussion with the Principal Investigator 2 weeks before first injection until 2 weeks after last injection
Pulmonary disease with FEV1 < 75 % of predicted
Pulmonary disease, perennial or seasonal with daily use of more than 800 microgram inhalated budesonide/ day (or equivalent) or treatment with omalizumab.
Unstable asthma, decided by the investigator or >12% reversibility in FEV1 in visit 2.
Concomitant infection with fever or other signs/symptoms of an acute or chronic infection at treatment.
Allergic reaction last 3-4 days or anaphylaxia last month before ILIT injections. Vaccination of any kind two weeks before to two weeks after the three times of ILIT injections.
Recent or on-going hepatic disease
Recent or on-going renal disease
All tumour diseases without non-melanoma skin cancers or in situ cervix cancer Increased bleeding tendency with or without abnormal platelets, PK-INR or APTT.
Any other than study medication with an effect of interfering with the immune response
Immuno- or chemotherapy last 15 years
Upper airway disease (non-allergic sinusitis, nasal polyps)
Depot steroid injection for treatment of allergic rhinoconjunctivitis
Chronic obstructive or restrictive lung disease
Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with beta-blockers)
Major metabolic disease
Known or suspected allergy to additives to the study product
Skin diseases with barrier defect in the inguinal areas
Alcohol, drug abuse or tobacco smoking
Mental incapability of coping with the study
Participation in another clinical study from visit one until last patient has been evaluated after the pollen season after treatment. Studies with pharmacological agents or studies that could otherwise disturb the study are not permitted after the first evaluation of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified