Search

Ricin is a potent toxin and potential bioterrorism weapon for which no specific licensed countermeasures are available. We report the safety and immunogenicity of the ricin vaccine RVEc™ in a Phase 1 (N=30) multiple-dose, open-label, non-placebo-controlled, dose-escalating (20, 50, and 100μg), single-center study. Each subject in the 20- and 50-μg dose groups (n=10 for each group) received three injections at 4-week intervals and was observed carefully for untoward effects of the vaccine; blood was drawn at predetermined intervals after each dose for up to 1 year. RVEc™ was safe and well tolerated at the 20- and 50-μg doses. The most common adverse events were pain at the injection site and headache. Of the 10 subjects who received a single 100-μg dose, two developed elevated creatine phosphokinase levels, which resolved without sequelae. No additional doses were administered to subjects in the 100-μg group. Immunogenicity of the vaccine was evaluated by measuring antibody response using the well standardized enzyme-linked immunosorbent assay (ELISA) and toxin neutralization assay (TNA). Of the subjects in the 20- and 50-μg dose groups, 100% achieved ELISA anti-ricin IgG titers of 1:500 to 1:121,500 and 50% produced neutralizing anti-ricin antibodies measurable by TNA. Four subjects in the 50-μg group received a single booster dose of RVEc™ 20-21 months after the initial dose. The single booster was safe and well tolerated, resulting in no serious adverse events, and significantly enhanced immunogenicity of the vaccine in human subjects. Each booster recipient developed a robust anamnestic response with ELISA anti-ricin IgG titers of 1:13,500 to 1:121,500 and neutralizing antibody titers of 1:400 to 1:3200. Future studies will attempt to optimize dose, scheduling, and route of administration. This study is registered at clinicaltrials.gov (NCT01317667 and NCT01846104)., (Published by Elsevier Ltd.)

Background: Bochdalek hernia remains an entity carrying a high mortality. Because there are no published studies about prognostic factors for mortality in Bochdalek hernia in underdeveloped countries, we designed the present study. Our objective was to determine the prognostic factors related to mortality in Bochdalek hernia in countries such as Mexico., Methods: We designed a case (deceased)-control (alive) study during a 10-year period analyzing epidemiological and pre-, intra- and postoperative factors related to mortality. Our protocol is to operate when the patient is hemodynamically stable., Results: We analyzed 11 cases and 38 controls. There was pulmonary hypertension in 65% of the patients. Associated anomalies were not related to mortality. Low Apgar score (p = 0.016), the need for high frequency ventilation (p = 0.003) or having postoperative complications (p = 0.025) were related to mortality with pulmonary hypertension being the main cause. Odds ratios showed that immediate intubation, preoperative pulmonary hypertension (p = 0.05) and the necessity for preoperative stabilization (p = 0.043) increased mortality risk by 1.5 times. Using preoperative high-frequency ventilation increased the risk nine times and, when needed postoperatively, increases the risk 11 times., Conclusions: Factors related to mortality were low Apgar score, immediate intubation, need for stabilization, postoperative complications and need for high-frequency ventilation.