Table 2.
Step | Type of study | Possible study endpoints | Possible favorable outcomes |
---|---|---|---|
Step 0 | Therapeutic vaccination of allergic patients | Safety. Induction of allergen-specific IgG blocking antibodies. Boosting of allergen-specific IgE responses. Induction of allergic sensitization Reduction of symptoms |
Safe Induction of high levels of allergen-specific IgG without boosting allergen-specific IgE production. No induction of clinically relevant allergic sensitization. Reduction of symptoms |
Step 1 | Vaccination of non-allergic subjects | Safety. Induction of allergen-specific IgG blocking antibodies. Induction of allergic sensitization. Appearance of symptoms of allergy | Safe Induction of high levels of allergen-specific IgG inhibiting allergic patients IgE binding to allergens. No induction of clinically relevant allergic sensitization |
Step 2 | Secondary preventive vaccination of sensitized children | Safety. I Prevention of transition of mild allergic symptoms toward severe symptoms. Effects on symptoms II. Prevention of transition of clinically silent IgE sensitization to symptoms. Development of symptoms |
Safe. I. Prevention of progression of mild toward severe symptoms II. Prevention of progression of clinically silent IgE sensitization to symptoms of allergy |
Step 2 | Prenatal vaccination of mothers | Safety. Induction of allergen-specific IgG in mothers. Prevention of allergen-specific IgE sensitization in off-springs | Safe Induction of allergen-specific IgG in mothers. Prevention of allergen-specific IgE sensitization in off-springs |
Step 3 | Early postnatal primary preventive vaccination of not yet sensitized children | Safety. Prevention of allergen-specific IgE sensitization. Induction of allergen-specific IgG | Safe Induction of allergen-specific IgG capable of inhibiting IgE binding to allergen. No induction of clinically relevant allergic sensitization. Prevention of allergen-specific IgE sensitization |