H. pylori - Ace Therapeutics
Safety Evaluation of H. pylori Vaccines
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Safety Evaluation of H. pylori Vaccines

Ace Therapeutics provides preclinical safety evaluation services for H. pylori vaccine antigens, H. pylori vaccine adjuvants, other supplemental components of the H. pylori vaccine, and the entire vaccine. We offer five types of safety evaluation tests, including acute toxicity testing, repeat-dose toxicity testing, reproductive and developmental toxicity testing, general pharmacology testing, and immunotoxicity testing. Please ensure that the samples you provide are of sufficient purity and are well packaged to ensure that they are not contaminated during shipment prior to the safety assessment.

Safety evaluation of H. pylori vaccines - Ace Therapeutics.Fig. 1 Safety evaluation of H. pylori vaccines - Ace Therapeutics.

Acute toxicity testing

The main purpose of the acute toxicity testing for the H. pylori vaccine is to examine the direct damage to the organism by the vaccine component itself as a toxic substance. We will select different animals (rats, mice, guinea pigs, and rabbits) for acute toxicity tests and test the relationship between dose, duration of administration, and toxicity.

Repeat-dose toxicity testing

People can be infected with H. pylori at any time in their lives, which requires long-term immunization to prevent H. pylori infection. Therefore, the evaluation of the dose and timing of repeat H. pylori vaccination is necessary, as is the evaluation of the safety and toxicity testing of repeat H. pylori vaccination. Depending on the delivery route of the H. pylori vaccine, our safety testing experts can assist you with the design of repeat dose toxicity testing, including species selection, treatment group size, treatment duration, and dosing frequency.

Reproductive and developmental toxicity testing

In areas with a high prevalence of H. pylori, it is necessary to vaccinate young children or adolescents with preventive vaccines and to vaccinate infected persons (including pregnant women) with therapeutic vaccines. Therefore, H. pylori vaccines need to be tested for reproductive and developmental toxicity. Ace Therapeutics offers preclinical reproductive and developmental toxicity testing for H. pylori vaccines and develops experiments specifically for each case. In addition, we provide to vaccinate pregnant model animals during the organogenesis period to focus on the possible embryotoxicity and teratogenicity of H. pylori vaccines.

General pharmacology testing

For H. pylori oral vaccines, the vaccine adjuvants and other supplemental components may be absorbed and metabolized. Therefore, Ace Therapeutics offers general pharmacological testing for H. pylori vaccine adjuvants and other supplemental components to make sure they are safe.

Immunotoxicity testing

Immunotoxicity can be divided into two categories, one referring to the adverse effects on the structure or function of the immune system, and the other referring to the adverse effects on other systems due to the dysfunction of the immune system. Ace Therapeutics offers general immune boosting or attenuation testing for H. pylori vaccines. We test for the possibility of causing an allergic reaction or autoimmune response.

For allergy testing, we use guinea pigs for active systemic anaphylaxis (ASA), passive cutaneous anaphylaxis (PCA), and active cutaneous anaphylaxis (ACA) to predict the possibility of allergy caused by the H. pylori vaccine and its components. In addition, we additionally provide a mouse local lymph node assay (LLNA) to predict allergic reactions. And we also have relevant assays for autoimmune responses.

For additional information on immunotoxicity testing, please contact us or refer to immunological testing of H. pylori vaccines.

※ All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.