Clinical & Experimental Allergy

Double-blind study of tolerability and antibody production of unmodified and chemically modified allergen vaccines of Phleum pratense

Authors

  • M. Casanovas,

  • J. Sastre,

  • M. Fernández-Nieto,

  • M. Lluch,

  • J. Carnés,

  • E. Fernández-Caldas


In [1], on page 1380, column two, paragraph two (Specific antibody response), the first sentence should read as follows: “Group A experienced a significant increase in specific IgG1, and group B in IgG and specific IgG1 levels after 4 months.”

On page 1381, column two, the last sentence should read as follows: “The effect on specific IgG was significant for both groups.”

On pages 1380 and 1381, incorrect versions of Tables 2, 3 and 4 were published. The corrected versions of Tables 2, 3 and 4 are shown below.

Table 1. Table 2.  Quantity of allergen extract and IgE potency (HEPL) administered in each dose of the vaccine containing the negative extract (Group A), and data corresponding to the modified extract, describing the amount of modified allergen extract administered per dose injected, the original IgE potency (HEPL) before the process of chemical modification and the residual after this process (Group B)
DoseMLUnmodifiedModified
VialUnits (HEPL/mL)mcg/doseHEPL/doseBiological Potency (HEPL/mL)mcg/doseHEPL/dose
Before
modification
Residual after
modification
Before
modification
Residual after
modification
10.1110.310.11000.32.4010.003
20.3  0.920.3  7.2030.010
30.5  1.540.5  12.0050.017
40.12103.0811003.324.0100.033
50.3  9.243  72.0300.100
60.5  15.405  120.0500.167
70.1310030.801010 00033.32401000.333
80.3  92.4030  7203001.000
90.5  154.0050  12005001.667
100.5  154.0050  12005001.667
110.5  154.0050  12005001.667
   Total μg accumulated615.69   4797.6  
Table 2. Table 3.  Number and evaluation of clinically relevant adverse reactions distributed per vial of treatment
   Group AGroup B
VialVial
123123
  1. The grey-shadowed area corresponds to the vial of maximum concentration used in regular clinical practices.

LocalImmediate∅>5 cm001000
Delayed∅>10 cm021000
SystemicImmediateGrade 2001000
Grade 3001000
DelayedGrade 2013000
Grade 3004000
Table 3. Table 4.  Systemic reactions: description of the reactions, time of appearance (immediate or late), grade, dose that provoked the reaction, vial and quantity (mL) injected
Patient IDReactionGroupVisitVialmLGradeDescription
  • *

    The patients were invited to stop the participation in the study after the adverse reaction.

20298DelayedA830.11Unspecific symptoms
20298ImmediateA930.32Nasal-ocular symptoms, dyspnoea, dizziness and cough*
21895ImmediateA420.51Perioral itching
22687ImmediateA930.32Wheals and rhinoconjunctivitis*
25039DelayedB730.51Headache and nasal obstruction
33274DelayedA8 and 930.3 and 0.53Naso-ocular symptoms, abdominal pain, diarrhoea and headache
53278DelayedA930.52Rhinoconjunctivitis
61156ImmediateA730.13Wheals, rhinoconjunctivitis and bronchospasm*
65456ImmediateB1030.51Palatal itching
79508DelayedA830.33Pharyngeal discomfort, headache and generalized weals*
81767DelayedA1030.53Asthma, wheals, fatigue and dry cough*

Ancillary