A Phase I clinical trial with subcutaneous immunotherapy vaccine of Timothy grass pollen extract according to EMA guidelines.
OBJECTIVE
A double-blind placebo-controlled study was conducted according to EMA guidelines, to evaluate safety, tolerability and short-term treatment effects of three up-dosing regimens of Phleum pratense subcutaneous immunotherapy.


METHODS
Forty-two patients were randomized to groups: A (6 weekly doses), B (8 weekly doses) or C (eight doses, two clustered increasing doses over 3 weeks).


RESULTS
The most frequent adverse events were local reactions. No serious adverse events were found. Higher number and more severe systemic reactions were reported in group C. A decrease in cutaneous responses and an increase of specific antibodies was shown in all active groups even at very short-term.


CONCLUSIONS
Phleum pratense subcutaneous immunotherapy in depot presentation exhibited good safety and tolerability. Group A seemed to show the best profile.
Allergy Department, Ramón y Cajal Hospital, Madrid, Spain.
Javier
J
Sola
Vanesa
V
Sánchez
Araitz
A
Landeta
Begoña
B
Madariaga
Alberto
A
Martínez
Emilio
E
Álvarez-Cuesta
D000328:Adult; D000485:Allergens / Q000276:immunology; D052179:Antigens, Plant / Q000276:immunology; D002985:Clinical Protocols; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D031784:Phleum / Q000276:immunology; D015990:Placebo Effect; D010936:Plant Extracts / Q000276:immunology; D011058:Pollen / Q000276:immunology; D017410:Practice Guidelines as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000276:immunology / Q000628:therapy*; D013030:Spain; D016896:Treatment Outcome; D014612:Vaccines / Q000008:administration & dosage* / Q000276:immunology; D055815:Young Adult
D000485:Allergens; D052179:Antigens, Plant; D010936:Plant Extracts; D014612:Vaccines
Phase I; SCIT; grass pollen; safety; tolerability