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Screening potential allergy vaccine components.

In vitro evaluation of the immune-skewing potential of different candidate building blocks for nanoparticle-based allergen immunotherapy for treatment of allergy. - Screening potential allergy vaccine components

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54501
Enrollment
90
Registered
2019-09-03
Start date
2022-05-09
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Hypersensitivity

Interventions

Products that are being used:Nanoparticles: Liposomes with different compositions will be used as well as PLGA nanoparticles, both as an alternative for aluminum hydroxide. Loading of liposomes/nanopa
• Purified house dust mite allergens Der p 1 and Der p 2 and house dust mite extract • Vitamin D3, retinoic acid and a TGFb mimetic peptide as candidate anti-inflammatory adjuvants • Nanoparticles: li
• Antibodies against receptors on DCs, for more effective targeting to the right antigen-presenting cells.Sialyalted allergens: Der p 1, Der p 2, Ara h 1, Ara h 2, Ara h 3, Ara h 6, and sialylated ver
• For house dust mite: purified Der p 1 and Der p 2, and sialylated versions thereof • For peanut: purified Ara h 1, Ara h

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Subjects with doctor-diagnosed allergic rhinitis or convincing history of  allergic rhinitis and a positive SPT and/or serum IgE levels for HDM, cat or  pollen allergens -Subjects with a doctor-diagnosed peanut allergy or a convincing history of  peanut allergy and positive SPT and/or serum IgE levels for peanut allergensSubjects with a doctor-diagnosed cashew and/or pistachio allergy or a convincing history of cashew nut/pistachio allergy and positive SPT and/or serum IgE levels for cashew nut/pistachio allergens Healthy subjects, defined as not having allergic or non-allergic rhinitis,  peanut allergy or other inflammatory non-communicable diseases such as  rheumatoid arthritis, type 2 diabetes, celiac disease, colitis ulcerosa,  Crohn*s disease, and multiple sclerosis.Age between 18-65Signed informed consent

Exclusion criteria

Exclusion criteria: Exclusion criteriaHistory of AIT (SCIT or SLIT) with any allergen within the past year of the  time of blood donation.Ongoing AIT (SCIT or SLIT) with any allergen at the time of blood donation.Vaccination within one week before blood donation.Immunosuppressive or biological medication (e.g. IL-5, anti-IgE therapy)  within the last six months prior to blood donation.Severe immune disorders (including auto-immune diseases) and/or diseases  requiring immunosuppressive drugs.Active malignancies or any malignant disease during the previous 5 years.Active inflammation or infection at the time of blood donation.Use of systemic steroids within 4 weeks before the blood donation.Treatment with systemic and local ß-blockers.Volunteers who are students or employees of one of the participating research  groups or 1st grade relatives or partners of the investigators.

Design outcomes

Primary

MeasureTime frame
Not applicable. Blood from patients will be used to isolate immune cells (PBMCs) and use them in fundamental in vitro experiments. The only value that will be determined directly from blood is the allergen-specific IgE titer to determine how severe the allergy from thet allergic patient is. 

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Contacts

Public ContactR. Ree

Amsterdam UMC

r.vanree@amsterdamum.nl020-5664964

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)