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Wise et al.

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Author Manuscript Author Manuscript Author Manuscript Author Manuscript TABLE IX.D.2-2. Study

design Study groups Clinical endpoint Conclusion

Improvement in primary endpoint for 2 higher doses but not the lower dose.

SLIT with rBet v 1 resulted in a significant decrease of symptom score and medication score vs placebo.

All dosing regimens were more effective than placebo.

Recombinant allergens safe and effective even at high protein levels.

Recombinant allergens were safe and effective for 2 seasons.

Recombinant allergens safe and effective over 2 grass seasons.

Symptom scores, IgG levels Both were safe and equally efficacious over 2 seasons.

Total nasal symptoms scores, ocular symptoms, skin tests

Symptom scores, medication scores

Symptom scores, change in IgG1 and IgG4

Primary: systemic allergic reactions; Secondary:

Improvement in symptoms, conjunctival provocation test

Symptoms, immunologic markers

Symptoms, medication use, RQLQ, immunologic markers, conjunctival provocation test

1 Study groups: 20 μ g, 40 μ g, 80 μ g, 120 μ g protein; 2 Placebo

Evidence for the use of recombinant, peptide, allergoid/polymerized, and adjuvant allergen immunotherapy Study Year LOE Klimek et al. 1585 2012 1b RDBPCT Recombinant Timothy grass antigens (Phl p 1, Phl p 2, Phl p 5a, Recombinant allergens Zieglmayer et al. 798 2016 1b RDBPCT 1 Recombinant peptide vaccine with grass epitopes at 3 doses; 2 Control Nony et al. 1584 2015 1b RDBPCT 1 12.5 μ g cGMP-grade rBet v 1 SLIT; 2 25 μ g cGMP-grade rBet v 1 SLIT; 3 50 μ g cGMP-grade rBet v 1 SLIT; 4 Placebo Meyer et al. 1063 2013 1b RDBPCT 1 rBet v 1-FV in multiple doses; 2 Placebo Phl p 5b, Phl p 6): Pauli et al. 1583 2008 1b RDBPCT 1 Recombinant birch pollen allergen; 2 Licensed birch pollen extract; 3 Natural purified birch pollen allergen; 4 Placebo

Jutel et al. 1586 2005 1b RDBPCT 1 Recombinant Timothy grass antigens (Phl p 1, Phl p 2, Phl p 5a, Phl p 5b, Phl p 6); 2 Placebo Klimek et al. 805 2015 2b Open RCT 1 Recombinant birch extract (rBet v 1-FV); 2 Native birch extract Peptide constructs

Int Forum Allergy Rhinol . Author manuscript; available in PMC 2020 June 10.