title: Immunopathogenesis associated with formaldehyde-inactivated RSV vaccine in preclinical and clinical studies.
abstract: Respiratory syncytial virus (RSV) infection is responsible for one-third of deaths of acute lower respiratory infection in children less than one-year-old. The formaldehyde-inactivated RSV vaccine trial conducted in the 1960s predisposed the vaccinees to more serious RSV infection instead of protection. Better understanding of the underlying mechanism is of critical importance for better designing of safe and effective RSV vaccines. Areas covered: PubMed was searched to review immunopathology induced by RSV vaccines. We intend to dissect the differences in clinical and pathological manifestations of enhanced respiratory disease (ERD) in different animal models in comparison with humans. Formaldehyde-inactivated RSV vaccine causes ERD in both humans and animals, while RSV vaccine without formaldehyde treatment could also induce similar disease in animals, suggesting multiple pathways may be involved. Expert commentary: Identification of biomarkers pertinent to clinical evaluation should be further explored for safety assessment of RSV vaccines in human trials.
authors.affiliation: a Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate , Health Canada and WHO Collaborating Center for Standardization and Evaluation of Biologics , Ottawa , ON , Canada.|c Department of Biochemistry, Microbiology and Immunology , University of Ottawa , Ottawa , ON , Canada.
authors.forename: Abenaya
authors.initials: A
authors.lastname: Muralidharan
authors.affiliation: b Department of Viral Vaccine III , National Institutes for Food and Drug Control and WHO Collaborating Center for Standardization and Evaluation of Biologicals , Beijing , PR China.
authors.forename: Changgui
authors.initials: C
authors.lastname: Li
authors.affiliation: c Department of Biochemistry, Microbiology and Immunology , University of Ottawa , Ottawa , ON , Canada.
authors.forename: Lisheng
authors.initials: L
authors.lastname: Wang
authors.affiliation: a Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate , Health Canada and WHO Collaborating Center for Standardization and Evaluation of Biologics , Ottawa , ON , Canada.|c Department of Biochemistry, Microbiology and Immunology , University of Ottawa , Ottawa , ON , Canada.
authors.forename: Xuguang
authors.initials: X
authors.lastname: Li
mesh_terms: D000818:Animals; D004195:Disease Models, Animal; D005557:Formaldehyde / Q000737:chemistry; D006801:Humans; D018357:Respiratory Syncytial Virus Infections / Q000209:etiology / Q000276:immunology* / Q000517:prevention & control; D022261:Respiratory Syncytial Virus Vaccines / Q000009:adverse effects* / Q000737:chemistry / Q000276:immunology; D018113:Respiratory Syncytial Virus, Human / Q000276:immunology*; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology
chemical_list: D022261:Respiratory Syncytial Virus Vaccines; D015164:Vaccines, Inactivated; D005557:Formaldehyde
keywords: Formaldehyde-inactivated vaccine; RSV; animal models; immunopathogenesis; vaccine enhanced disease