Table 4. Representative egg oral immunotherapy clinical trials.
| Design & reference | Sample: size & age | Protocol: duration & daily maintenance dose | Outcome (by ITT) and other significant findings | Notable adverse events |
|---|---|---|---|---|
| Egg OIT, open-label | 7 subjects | 24 months | Among subjects without history of anaphylaxis, 24-month egg OIT induced 8 g-desensitization in 4 of 7, with good safety profile | No severe AE. No EAI. Mild AE during initial dose escalation; 1 reaction during build-up; none during maintenance |
| Buchanan et al. 2007 | 1–7 years | 0.3 g/day | ||
| Egg OIT in young children: see Staden et al. 2007 in Table 3 | ||||
| Egg OIT, open-label | 8 subjects | 18–40 months | Using a modified build-up protocol with IgE-de-pendent up-dosing, 75% achieved 3.9 g-desensitization achieved, with good safety profile | No severe AE. No EAI. Symptoms in 83% on initial dose escalation; 1 required SABA. No reactions on maintenance |
| Vickery et al. 2010 | 3–13 years | maximum 3.6 g/day | ||
| Egg OIT vs placebo, RCT | 40 active 15 placebo |
22 months | 55% on active vs 0 on placebo achieved 5 g-de-sensitization after 10 months OIT; After 22 months OIT, 75% achieved 10 g-desensitization; 28% achieved 2 month-SU |
No severe AE. No EAI. Symptoms with 25% of active vs 4% placebo. 5 AE-related withdrawals in active, vs 0 in placebo |
| Burks et al. 2012 | 5–11 years | 2 g/day | ||
| Egg OIT, long-term follow-up of Burks et al. 2012 | as above | Up to 4 years | With prolonged OIT, 50% of active subjects achieved 4 to 6-week SU to 10 g. 1 year after study conclusion, 64% of active and 25% of placebo were consuming egg (P=0.04) | No severe AE. No EAI. 12 of 22 active still reporting mild symptoms with egg at years 3 to 4 |
| Jones et al. 2016 | As above | |||
| Short-course open-label egg OIT vs placebo, RCT | 17 active 14 placebo |
4-month OIT with 5 months egg-containing diet | Abbreviated OIT protocol induced 4-g desensitization in 94% (compared to 1 of 14 in placebo), with 29% achieving 3-month SU | 1 EAI during desensitization phase. 1 reaction requiring SABA and steroid during maintenance |
| Caminiti et al. 2015 | 4–10 years | 4 g | ||
| Short-course open-label egg OIT, vs avoidance, | 30 active 31 avoidance |
3-month OIT | Abbreviated OIT protocol induced 2.8 g desensitization in 93%, with 1 month-SU in 37% (vs 1 of 31 placebo), with acceptable safety profile. All with SU were consuming at 36 months post-OIT | Symptoms with 5.9% of active doses. 5 episodes respiratory distress with 1 EAI in active group |
| Escudero et al. 2015 | 5–17 years | 1 undercooked egg (3.6 g) | ||
| Highly sensitized subjects, low-dose egg OIT vs avoidance, RCT | 21 active 12 avoidance |
12 months, with 5-day inpatient dose escalation | Among subjects with history of anaphylaxis or sIgE >30 kIU/L, a modified, low-dose protocol induced 2 week-SU to 0.2 g in 71% (vs 0 of 12 controls); and SU to 1.8 g in 33%, with acceptable safety profile | No severe AE. No EAI. Symptoms with 6.5% of home doses. 2 AE-related withdrawals |
| Yanagida et al. 2016 | 6–19 years | 0.1–0.2 g scrambled egg | ||
| High dose egg OIT vs placebo, RCT | 19 active 14 placebo |
5 months; with 5-day build-up | A high-dose, abbreviated protocol with inpatient build-up induced desensitization to 1 under-cooked egg in 89% of active subjects, vs 0 of placebo | During build-up, 2 episodes of anaphylaxis and 2 EAI. No severe AE during maintenance |
| Perez-Rangel et al. 2017 | Mean 10.4 years | 1 undercooked egg (=3.6 g powder)/48 hours | ||
AE, adverse event; EAI, epinephrine auto-injector; ITT, intention to treat; OIT, oral immunotherapy; RCT, randomized controlled trial; SU, sustained unresponsiveness.