Related Experiment Video
Updated: Jun 28, 2026

08:52
Evaluation of Host-Pathogen Responses and Vaccine Efficacy in Mice
Published on: February 22, 2019
[New evaluation methods of vaccine safety]
Isao Hamaguchi1, Kazunari Yamaguchi
1Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases.
Nihon Rinsho. Japanese Journal of Clinical Medicine
|October 23, 2008
Summary
Pertussis and pandemic influenza vaccines significantly alter lung gene expression. New methods can detect vaccine toxicity using gene analysis, offering a novel approach to safety assessment.
Area of Science:
- Genomics
- Vaccinology
- Toxicology
Context:
- Vaccine development requires rigorous safety assessments.
- Understanding vaccine-induced molecular changes in lung tissue is crucial.
- Existing methods for detecting vaccine toxicity may have limitations.
Purpose:
- To investigate the impact of pertussis and pandemic influenza vaccines on lung gene expression.
- To develop and validate a gene expression-based method for detecting vaccine toxicity.
- To provide a novel approach combining experimental biology and genome science for vaccine safety evaluation.
Summary:
- Comprehensive gene expression analysis revealed that pertussis and pandemic influenza vaccines affect numerous lung genes.
- Specific gene sets (13 for pertussis, 76 for influenza) were identified at day 1 post-vaccination.
- Quantitative analysis using QuantiGene Plex methods successfully detected toxicity in samples with varying pertussis vaccine concentrations.
Impact:
- This study presents the first assessment of vaccine toxicity using a genome science approach.
- The findings offer a new methodology for evaluating vaccine safety and potential adverse effects.
- The developed methods can aid in the quality control and safety profiling of vaccines.
Related Concept Videos
Vaccinations
Overview
Vaccine Production
Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
Vaccines
Vaccines are among the most effective tools in preventive medicine, designed to prepare the immune system to recognize and combat infectious agents. By introducing antigens—substances that the immune system identifies as foreign—vaccines stimulate an adaptive immune response that leads to immunological memory. This immunological memory enables the body to mount a faster and more effective response upon future exposures to the actual pathogen.Vaccines can be categorized based on the type of...
Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...

