Immunologic Effect and Tolerability of Intra-Seasonal Subcutaneous Immunotherapy With an 8-Day Up-Dosing Schedule to 10,000 Standardized Quality-Units: A Double-Blind, Randomized, Placebo-Controlled Trial

Background: Although local reactions (LR) to subcutaneous immunotherapy (SCIT) occur in 26‐86% of patients, there are no well-studied strategies to manage LRs. Objective: To complete a prospective, randomized, single-blind, controlled trial that compared pre-rinsing SCIT syringes with diphenhydramine, epinephrine, or placebo in patients who were receiving aeroallergen SCIT and experiencing LRs despite pretreatment with an antihistamine. Methods: Patients ages ≥5 years who were receiving aeroallergen SCIT per a conventional dosing schedule and who were experiencing LRs despite premedicating with an oral antihistamine were randomized to diphenhydramine, epinephrine, or placebo rinse, and were followed up for three subsequent visits. At each visit, the patients were asked (yes or no) if LRs improved. Results: A total of 490 patients were enrolled in the study. Seventy-four of the 490 patients (15.1%) experienced an LR despite pretreatment with an oral antihistamine and were randomized into an intervention group. At visit 1, an epinephrine rinse was strongly associated with decreasing LR compared with both diphenhydramine rinse and placebo (p < 0.001). There was no difference among the intervention groups at visits 2 and 3. In patients who reported a consistent outcome at all three visits, the epinephrine rinse was significantly associated with a decrease in LR compared with both diphenhydramine rinse and placebo rinse (p = 0.05). Conclusion: In patients who received aeroallergen SCIT per a conventional dosing schedule, an epinephrine rinse significantly decreased LR at the first visit, and also within a population that reported a consistent outcome at all three study visits. In patients already premedicating with an oral antihistamine, adding an epinephrine rinse is a safe and effective strategy to decrease LRs to aeroallergen SCIT.

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Immunogenicity and safety of a 12-valent pneumococcal conjugate vaccine in infants aged 6–10 weeks: a randomized double-blind active-controlled trial

Clinical and Experimental Pediatrics ◽

10.3345/cep.2019.01067 ◽

2020 ◽

Vol 63 (7) ◽

pp. 265-271 ◽

Cited By ~ 1

Author(s):

Jonghoon Shin ◽

Jamaree Teeratakulpisarn ◽

Thanyawee Puthanakit ◽

Tuangtip Theerawit ◽

Ji Hwa Ryu ◽

...

Keyword(s):

Adverse Events ◽

Booster Dose ◽

Controlled Trial ◽

Enzyme Linked Immunosorbent Assay ◽

Double Blind ◽

Dosing Schedule ◽

Phase 2 Trial ◽

Healthy Infants ◽

Pneumococcal Serotype ◽

Specific Igg

Background: Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates.Purpose: This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants.Methods: This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6–10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group.Results: After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 μg/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, <i>P</i>=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 μg/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; <i>P</i>=0.003).Conclusion: The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

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