Table 1.
Effects of allergen-specific immunotherapy and anti-IgE (i.e., omalizumab) treatment on T cells in clinical trials in humans.
| Allergy to | Vaccination/intervention | Study design | Number of patients | Observation period | Outcome | Ref. |
|---|---|---|---|---|---|---|
| IMMUNOTHERAPY | ||||||
| Bee venom | SCIT with bee venom Alutard SQ | s.c. rush immunotherapy study | During SCIT (n = 10) After WD (n = 7) | 3 y SCIT2 y after WD | Bee venom SCIT: Inhibition of FAB ↑ After WD: no diff to pre-treatment | (107) |
| Birch pollen | SCIT with Birch or Grass Alutard SQ | s.c immunotherapy, controlled study | Birch SCIT (n = 14) Grass SCIT (n = 2) Birch allergic (n = 7) Non-Allergic (n = 2) | 3 to 30 m | Birch SCIT: Inhibition of FAP ↑, T cell line: ↓IL-4, IL-5, IL-10, IFN-γ, Inhibition of FAP by blocking antibodies | (27) |
| Birch pollen | SCIT with Birch Alutard SQ | Randomized, double-blind placebo-controlled study | Birch SCIT (n = 21) Placebo (n = 21) | 18–20 m | Birch SCIT: Inhibition of FAP ↑, Association between inhibition of FAP and reduction of Bet v 1- specific IgE/IgG4 ratio | (65) |
| Birch pollen | SCIT with Birch Alutard SQ | Randomized, double-blind placebo-controlled study | Birch SCIT (n = 21) Placebo (n = 21) | 18–20 m | Birch SCIT: Inhibition of FAB and FAP ↑ (1y>2y SCIT) Correlation of change in FAB and T cell proliferation | (108) |
| Birch pollen | SCIT with Bet v 1 trimer or fragments | Randomized, double-blind placebo-controlled study | Bet v 1 trimer (n = 14) Bet v 1 fragments (n = 11) Placebo (n = 21) | 5 m | Birch SCIT: Inhibition of FAB ↑ trimer>fragments (n.s.) Correlation of Bet v 1 spec IgG with degree of inhibitory activity in FAB | (109) |
| Birch Pollen | Birch ALK Depot SQ | s.c. immunotherapy study | Birch SCIT (n = 16) | 3 y SCIT1.5 y after WD | Birch SCIT: Inhibition of FAB↑ maximum at 3y SCIT, still inhibition 1.5 y after WD Th2 response PBMC cultures: ↓ 4.5 y | (110) |
| Grass pollen | SCIT with Grass Alutard SQ | Randomized, double-blind placebo-controlled study | Grass SCIT (n = 10) Placebo (n = 8) | 1 y | Grass SCIT: Inhibition of FAB and FAP ↑ Inhibition of FAB mediated by IgG Correlation of degree of allergen-IgE binding to B cells and T cell prolif | (111) |
| Grass pollen | SCIT with Grass Alutard SQ | Double-blind placebo-controlled study | Grass SCIT (n = 20) Placebo (n = 17) | 2 y | Grass SCIT: Inhibition of FAB ↑ after 2y SCIT IgG4 fraction mediates inhibition of FAB | (112) |
| Grass pollen | SCIT with Grass Alutard SQ | Randomized, double-blind placebo-controlled study | Grass SCIT (n = 12) Placebo (n = 6) | 1 y | Grass SCIT: Inhibition of FAB ↑ 6 weeks until 1 y SCIT Smaller early and late phase SPT responses | (113) |
| Grass pollen | SLIT with Soluprick SQ | Randomized, double-blind placebo-controlled study | Grass SLIT (n = 14) Placebo (n = 9) Non-atopic control (n = 8) | 12–18 m | Grass SLIT: Inhibition of FAB ↑ at 3 months and 15 months | (114) |
| Grass pollen | SCIT with Grass Alutard SQ | Randomized, double-blind placebo-controlled discontinuation study | Grass SCIT 4 y (n = 7) Grass SCIT/Placebo 2 y/2 y (n = 6) | 4 y SCIT2 y SCIT/2y Placebo | Grass SCIT: Inhibition of FAB ↑ also after 2y discontinuation Inhibition of FAB dependent on IgG4. IgG4 ↓ after end of SCIT but still inhibition of FAB ↑ Inverse correlation of magnitude of inhibition of FAB and SMS | (22) |
| Grass pollen | SCIT with Grass Alutard SQ | Dose-response randomized double-blind placebo- controlled study | 100 000 SQU (n = 112) 10 000 SQU (n = 53) Placebo (n = 55) | 8 m | Grass SCIT: Inhibition of FAB ↑ 100 000 SQU > 10 000 SQU Modest inverse correlation of change in FAB and combined SMS | (115) |
| Grass pollen | SLIT with ALK Grazax | Randomized, double-blind placebo-controlled study | Grass SLIT (n = 316) Placebo (n = 318) | 3 y SLIT2 y WD | Grass SLIT: Inhibition of FAB ↑ max after 3y then decline but still present after 2 y WD | (12) |
| Grass pollen | SCIT with Grass Alutard SQ SLIT with ALK Grazax | Randomized, controlled study | Grass SCIT (n = 15) Grass SLIT (n = 15) Control group (n = 10) | 15 m | Grass AIT: FAB inhibition at 3 months: ↑ SCIT > SLIT FAB inhibition at 12 months: ↑ SCIT = SLIT | (116) |
| Grass pollen | SCIT with Grass Alutard SQ SLIT with ALK Grazax | Controlled s.c./SLIT study | SCIT (n = 14) SLIT (n = 12) SLIT/WD 3 y/1–2 y (n = 6) SAR (n = 24) Non-atopic (n = 12) | 1–3 y AIT1–2 y WD | Grass AIT: Inhibition of FAB ↑: SCIT > SLIT/WD > SLIT | (117) |
| Grass pollen | SCIT with recombinant B cell epitope-based vaccine BM32 | Randomized, double-blind placebo-controlled study | 40 μg BM32 (n = 17) 20 μg BM32 (n = 18) 10 μg BM32 (n = 17) Placebo (n = 18) | 19 w | Grass SCIT: ↓ T cell prolif to mix of recombinant Phl p 1, 2, 5, 6 in presence of post-SCIT serum | (87) |
| Grass pollen | SCIT with Lolium perenne peptides (LPP) | Dose escalation study | SCIT (n = 61) | 8 w | Grass SCIT: Inhibition of FAB ↑ after 5 and 8 weeks | (118) |
| Grass pollen | SCIT with Grass Alutard SQ SLIT with ALK Grazax | Randomized, double-blind placebo-controlled study | SLIT/Placebo SCIT (n = 36) Placebo SLIT/SCIT (n = 36) Placebo SLIT/Placebo SCIT (n = 34) | 2 y AIT1 y WD | Grass AIT: Inhibition of FAB ↑ for 2y IT and 1y WD (SLIT = SCIT) ↓Frequency of Ag-specific Th2 only for 2y IT (not for 1y after WD) | (106) |
| Grass pollen | SCIT with LPP with/without DnaK | Randomized, double-blind placebo-controlled study | LPP (n = 9) LPP/DnaK (n = 9) Placebo (n = 9) | 25 w | Grass AIT: Inhibition of FAB ↑at w25 in LPP group only | (119) |
| OMALIZUMAB | ||||||
| Cat Dander | Omalizumab s.c. | Randomized, double-blind placebo-controlled study | Oma (n = 12) Placebo (n = 4) | 15 w | Omalizumab: T-DC co-cultures post-treatment: 20-40% ↓ allergen-spec T cell prolif; ↓IL-5, IL-13, IL-10 in supernatants | (120) |
| N.A. | Omalizumab s.c. | Randomized, double-blind placebo-controlled study | Oma (n = 18) Placebo (n = 17) | 60 w | Omalizumab: Serum: ↓ levels of IL-13 (p < 0.01), IL-5 (trend but ns) 16 weeks after therapy | (121) |
| N.A. | Omalizumab, s.c. | Randomized, double-blind placebo-controlled study | Oma (n = 14) Placebo (n = 14) | 4 m | Omalizumab: In submucosa of bronchial biopsies: ↓CD3, CD4, CD8 cells, IL-4 and IgE | (122) |
| N.A. | Omalizumab s.c. | Randomized, double-blind placebo-controlled study | Oma (n = 12) Placebo (n = 12) | 12 w | Omalizumab: Skin biopsy after intradermal allergen challenge: ↓Late phase reaction >> early phase reaction | (123) |
| N.A. | Omalizumab, s.c. | Randomized, double-blind placebo-controlled study | Oma (n = 9) Placebo (n = 10) | 12 w Oma12 w WD | Omalizumab: In blood: ↓ IL-2+CD3+, IL-13+CD3*, CMSF+CD3+ lymphocytes after 12w treatment | (9) |
| Ragweed Pollen | Omalizumab s.c. Aqueous short ragweed extract ALK-Abello s.c. | Randomized, double-blind placebo-controlled study | Oma/SCIT (n = 7) Oma/Placebo (n = 11) Placebo/SCIT (n = 9) Placebo/Placebo (n = 9) | 64 w | Omalizumab/SCIT: During Treatment Inhibition of FAB ↑: Oma/SCIT or Oma/Placebo >> SCIT End study: Inhibition of FAB↑ only in Oma/SCIT group | (124) |