| Eligibility |
Inclusion Criteria:
1. Aged 18 to 50 years inclusive
2. Allergy to grass pollen allergen, defined by:
1. A history of moderate to severe symptoms of seasonal allergic rhinitis and/or
conjunctivitis due to grass pollen exposure that required repeated use of
antihistamines, nasal steroids, and/or leukotriene modifiers for relief of
symptoms, confirmed by the patient record if available.
2. A positive skin prick test for grass pollen allergen (wheal (longest diameter) of
= 5 mm greater than the negative control after skin prick testing) at Visit 1.
3. Specific IgE for grass pollen as documented by a specific IgE immunoassay, or
equivalent test, with class = 2 to grass pollen mix. Results from tests conducted
under a generalized screening protocol within the past six months may be used and
will not need to be repeated at V1 provided a copy of the test results is added
to the source file.
3. Positive skin prick test to histamine (wheal (longest diameter) = 3 mm greater than
the negative control)
4. Negative skin prick test to the negative control (redness with wheal = 2 mm is
acceptable)
5. For asthmatic patients: Forced expiratory volume (FEV) in 1 second (FEV1) = 80% of
National Health and Nutrition Examination Surveys (NHANES) predicted, with a
FEV1/Forced Vital Capacity (FVC) ratio = 70%
6. Obtain the minimum qualifying symptom scores by the final pre treatment EEC visit to
be enrolled into the study. Minimum qualifying TSS is at least 12 out of a possible 24
on at least one recording time, a TNSS score of at least 7 out of a possible 12 on at
least one recording time, and a rhinorrhea score of at least 2 on at least two diary
cards.
7. Observe the drug washout times for antihistamines, steroids etc. as specified in the
protocol prior to screening (Visit 1). The use of other medications will be permitted
if they are not expected to interfere with the ability of the patient to participate
in the study and provided they have been on a stable regimen (i.e., the same dosage
and administration) for six weeks prior to screening
8. Males or non pregnant, non lactating females who are:
1. Post menopausal (defined as at least 12 months natural spontaneous amenorrhea or
at least 6 weeks following surgical menopause, i.e. bilateral oophorectomy)
2. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral
tubal ligation with surgery at least 6 weeks prior to study initiation)
3. Of childbearing potential - with negative urinary and serological pregnancy test
and use at least one of the following contraception methods:
i. Stable hormonal contraceptive for = 90 days prior to Visit 1 and for at least 7
days after the final injection. If < 90 days prior to the study, additional use of a
double barrier method until 90 days reached is required.
ii. Placement of an intrauterine device (IUD) or intrauterine system iii. Use of
barrier methods of contraception (e.g., condom or occlusive cap) with spermicidal
foam/gel/film/cream/suppository iv. Use of double barrier methods of contraception
(e.g., male condom with diaphragm, male condom with cervical cap) v. Male
sterilization with the appropriate post vasectomy documentation of the absence of
sperm in the ejaculate of the sole partner vi. True abstinence, when in line with the
preferred and usual lifestyle of the patient; periodic abstinence, such as calendar,
ovulation, symptothermal, post ovulation methods, and withdrawal are not acceptable
methods of contraception.
9. Normally active and otherwise judged to be in good health on the basis of medical
history, physical examination and routine laboratory tests.
10. Willing and able to give written informed consent.
11. Able to understand and comply with study instructions.
12. Willing and able to attend required study visits.
Exclusion Criteria:
1. In the presence of symptoms outside the grass pollen season coupled with a positive
skin test to a perennial allergen, if as assessed by the Investigator the patient is
unable to avoid the offending allergen.
2. Concurrent disease that might complicate or interfere with investigation or evaluation
of the study medications or the skin prick test result, such as:
1. Nasal polyposis
2. Any ocular disorder (other than allergic conjunctivitis) including presumed
infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere
with the evaluation of the study medication
3. Rhinitis medicamentosa
4. Documented evidence of acute or significant chronic sinusitis or upper or lower
respiratory tract infection within 30 days before Visit 2 as determined by the
Investigator
5. Asthma, with the exception of mild asthma as, to lessen confounding by asthma
medications. Patients taking corticosteroids for asthma at doses higher than
budesonide MDI 400µg once a day or equivalent, as defined by the current GINA
guideline, will be excluded.
3. Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or
history of a life-threatening asthma attack ever
4. Presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria
factitia, or urticaria due to physical/chemical influence
5. Presence of secondary alterations at the affected organ (i.e., emphysema, and
bronchiectasis )
6. Current diagnosis of Type I diabetes. Patients with Type II diabetes will only be
allowed to participate at the discretion of the Investigator
7. Autoimmune disease (e.g., of liver, kidney, lung, thyroid, nervous system, rheumatoid
diseases) sarcoidosis, or NI disease (e.g., optic neuritis, multiple sclerosis or
other demyelinating disease, encephalitis or encephalomyelitis, myelitis/transverse
myelitis, myasthenia gravis, Guillain Barré syndrome, unexplained transitory
neurological events)
8. History of cancer (excluding basal cell carcinoma) or concomitant illness (e.g.,
cardiovascular, pulmonary, metabolic, renal, hepatic, gastrointestinal, dermatologic,
venereal, hematologic, neurologic, or psychiatric diseases or disorders) that, in the
opinion of the Investigator, would pose a safety risk or compromise the interpretation
of efficacy for this grass immunotherapy
9. Use of oral, intramuscular, intravenous corticosteroids, or potent or super-potent
topical corticosteroids, from 30 days prior to screening up to Visit 16
10. Any systemic disorder that could interfere with the evaluation of the study
medications
11. Presence of tattoos or other skin abnormalities in the upper arms which would prevent
an accurate assessment of local skin reaction, at Investigator's discretion
12. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the
study medication
13. Active or quiescent tuberculous infection of the respiratory tract, untreated local or
systemic fungal or bacterial or systemic viral infections (e.g., chickenpox or
measles) or parasitic or ocular herpes simplex
14. Experience of nasal septal ulcers, nasal surgery or nasal trauma within 90 days of
Visit 1
15. Clinical history of anaphylactic reactions to foods, insect venom, exercise, drugs or
idiopathic anaphylaxis
16. Clinical history of immunodeficiency, including those who are on immunosuppressant
therapy
17. Diseases with a pathogenesis interfering with the immune response and who have
received medication which could influence the results of the study
18. Clinical history of recurrent idiopathic angioedema
19. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria
20. ß blocker medication, including eye drops, for any indication
21. Monoamine Oxidase Inhibitor medication
22. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated)
23. Clinical history of drug or alcohol abuse which would, at the Investigator's
discretion, interfere with the patient's participation in the study
24. Clinical history, or evidence, of nasolacrimal drainage system malfunction
25. Any clinically significant abnormal laboratory value (as determined by the
Investigator) at Visit 1
26. Study site staff or immediate relatives of study site staff or other individuals who
would have access to the clinical study protocol or people considered as vulnerable or
institutionalized
27. Have undergone specific immunotherapy with comparable allergen extracts. An exception
will be allowed if prior immunotherapy with comparable allergen was successful,
symptoms reappeared sometime after stopping the immunotherapy, and the immunotherapy
was completed = 3 years before Visit 1
28. Treatment with a preparation containing MPL® within 6 months prior to Visit 1
29. Participation in a clinical research study with an investigational medicinal product
within 4 weeks of Visit 1 or concomitantly with this study, including the safety
follow-up period up to 12 months following the last injection.
|
