Evidence of the clinical efficacy of VALERGEN-DP vaccine in asthmatics

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000037
• Date of registration: 09/12/2010
• Primary sponsor: National Biopreparations Center (BIOCEN)
• Public title: Evidence of the clinical efficacy of VALERGEN-DP vaccine in asthmatics
• Scientific title: Clinical trial of Dermatophagoides pteronyssinus allergenic extract (VALERGEN-DP), for subcutaneous therapeutic use in asthmatic adults sensitive to this allergen.
• Date of first enrolment: 10/05/2006
• Target sample size: 40 patients (20 active, 20 placebo)
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000037-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Raul Castro Almarales
• Affiliation: National Biopreparations Center (BIOCEN)

• Name: Raul Castro Almarales
• Affiliation: National Biopreparations Center (BIOCEN)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Asthmatic allergic patients with positive responses during the preliminary survey in the following aspects: family and personal history of atopy, clinical symptoms only triggered when exposed to dust at home, mainly indoors, when getting up in the morning or going to bed at night. 2. Skin test positive to D. pteronyssinus allergenic extract, 20,000 BU/ml VALERGEN-DP. The response to the allergen under study is predominant when compared to that obtained with other mites. 3. Patients included in the study will be patients clinically diagnosed as extrinsic asthmatics who, in according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment. 4. Age between 16 and 45 years. 5. Any sex and race. 6. Patients expressing their consent in writing to participate in our trial.
Exclusion criteria: 1. Patients not giving their consent in writing (Model 6) to participate in our trial. 2. Patients on allergenic extract immunotherapy during the two preceding years. 3. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 4. Patients with a diagnosed autoimmune disease of any kind. 5. Generalized severe eczema. 6. Patients with diagnosed tumoral disease. 7. Patients on betablocker treatment. 8. Patients with psychiatric disorders. 9. Patients not cooperating with treatment. 10. Patients who, at least one year before the study, needed immunostimulant or immunosuppressor treatment (no corticosteroids), including interferon and cyclosporine A. 11. Pregnancy and breastfeeding. 12. Adrenalin-contraindicated patients (high blood pressure). 13. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules.

Age minimum: 16 years
Age maximum: 45 years
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchial asthma

Intervention(s)

(Active) study group: The study group was given subcutaneous injections in deltoid region, and increasing volumes of the researched vaccine at different doses (20, 200, 2,000 and 20,000 BU/ml) for 13 weeks during the incremental phase. Afterwards, during the maintenance phase, a fixed dose was administered (0.3ml (6,000BU) of the 20,000BU/ml dose, maximum permissible dose, 6,000BU), until reaching 12 months every 4 weeks. Control group (placebo): The control group was given the placebo, namely, a diluent solution for allergenic extracts (BIOCEN). The placebo dosage was identical to that administered to the active group.

Primary Outcome(s)

Score by symptoms, score by drug consumption, cutaneous reactivity (Ch10 value: relative allergen concentration causing in the patient a bump similar to the one caused by a 10 mg/ml HCL histamine solution (54.3 mmol/l base histamine). Measuring time: 6 months and 1 year.

Secondary Outcome(s)

General evaluation (depends on symptoms, medication, respiratory function, Ch10). Measuring time: 6 months and 1 year.

Secondary ID(s)

2006ALBARRANSC-DP07

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable