Key result
In a preclinical animal model, the combined inactivated HAV and EV71 vaccine demonstrated a good safety profile with no obvious clinical symptoms, abnormal body weight, or allergic reactions.
Why the study?
A combination HAV and EV71 vaccine could reduce vaccinations and costs, but its toxicity and adverse reactions required investigation under Good Laboratory Practice conditions.
Does a combined inactivated HAV and EV71 vaccine demonstrate a safe toxicity and adverse reaction profile in preclinical models?
Does a combined inactivated HAV and EV71 vaccine demonstrate a safe toxicity and adverse reaction profile in preclinical models?
Answers are grounded in this paper and cite their sources.
A combined inactivated HAV and EV71 vaccine demonstrates a favorable preclinical safety profile, supporting future clinical development.
Since 2007, Hepatitis A (HAV) vaccination has been a part of the National Immunization Program of China. Recognizing enterovirus 71 (EV71) as the most important pathogen in severe hand, foot and mouth disease, an inactivated EV71 vaccine was successfully marketed in 2015. Based on the concept of one vaccine preventing two diseases and owing to similarities in vaccine preparation and the overlap of the eligible population, a combination of the inactivated HAV vaccine and inactivated EV71 vaccine is theoretically feasible and desirable. However, the optimal vaccinationschedule for this combination vaccine has yet to be optimized. Use of this combined vaccine would not only decrease the number of vaccinations, but also lower associated cost. This study aimed to investigate the toxicity and adverse reactions of the combined HAV-EV71 vaccine under Good Laboratory Practice conditions to provide a reference for clinical studies/applications in the future. CD®(Sprague Dawley) IGS rats were employed for single-dose toxicity testing using a high dose, and repeated-dose toxicity testing using high, as well as low doses. Animals that received only a single dose showed no obvious clinical symptoms nor abnormal body weight, and no significant gross pathological change at the experimental endpoint at necropsy. In the rats injected with three doses, phagocytosis of basophilic granules by macrophages was observed in the inguinal, mesenteric, and local lymph nodes, besides irritation at the administration site. At 56 days after the last dose, no significant histopathological change was observed in the lymph nodes, and local irritation gradually faded. Further, systematic allergy testing was performed in guinea pigs. After systemic sensitization and challenge with the HAV-EV71 vaccine, animals showed normal weight gain and no allergic reactions. This study, therefore, confirmed a good safety profile of the inactivated HAV and EV71 combined vaccine.
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Yang et al. (2021) studied Hepatitis A and enterovirus 71 prevention. Combined inactivated HAV and EV71 vaccine was evaluated on Toxicity and adverse reactions (clinical symptoms, body weight, gross pathological change, allergic reactions). In a preclinical animal model, the combined inactivated HAV and EV71 vaccine demonstrated a good safety profile with no obvious clinical symptoms, abnormal body weight, or allergic reactions.
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