Safety and immunogenicity of a candidate parvovirus B19 vaccine

• Published in: Vaccine Vol. 29; no. 43; pp. 7357 - 7363
• Main Authors: Bernstein, David I., Sahly, Hana M. El, Keitel, Wendy A., Wolff, Mark, Simone, Gina, Segawa, Claire, Wong, Susan, Shelly, Daniel, Young, Neal S., Dempsey, Walla
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 06.10.2011; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; adults; Allergy and Immunology; Antibodies, Neutralizing - biosynthesis; Antibodies, Viral - biosynthesis; Antibodies, Viral - immunology; Applied microbiology; B19; B19 virus; Biological and medical sciences; capsid; Capsid Proteins - immunology; Cell culture; Children & youth; Double-Blind Method; Drug dosages; enzyme-linked immunosorbent assay; erythema; Erythema Infectiosum - prevention & control; Exanthema - etiology; Female; Fundamental and applied biological sciences. Psychology; Hospitals; Humans; immune response; Immunogenicity; Injection; injection site; Licenses; Male; MF59; Microbiology; Middle Aged; Miscellaneous; Mortality; neutralizing antibodies; pain; Parvovirus; Parvovirus B19; Parvovirus B19, Human - immunology; pathogens; Primate erythroparvovirus 1; Proteins; Protoparvovirus; Safety; Vaccine; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Synthetic - adverse effects; Vaccines, Synthetic - immunology; Viral Vaccines - adverse effects; Viral Vaccines - immunology; Virology; VLP; Womens health; MF59; B19; Vaccine; Parvovirus; VLP; Virus; Immunogenicity; Parvoviridae; Erythrovirus; Virus B19; Parvovirinae
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2011.07.080

Parvovirus B19 is an important human pathogen causing erythema infectiosum, transient aplastic crisis in individuals with underlying hemolytic disorders and hydropsfetalis. We therefore evaluated a parvovirus B19 virus like particle (VLP) vaccine. The safety and immunogenicity of a 25μg dose of parvovirus B19 recombinant capsid; 2.5 and 25μg doses of the recombinant capsid given with MF59; and saline placebo were assessed in healthy adults. Because of 3 unexplained cutaneous events the study was halted after enrollment of 43 subjects and before any subject received their third scheduled dose. The rashes developed 5–9 days after the first or second injection and were seen in one placebo recipient (without an injection site lesion) and two vaccine recipients (with injection site reactions). No clear cause was established. Other safety evaluations revealed mostly injection site reactions that were mild to moderate with an increase in pain in subjects receiving vaccine and MF59. After dose 2 the majority of vaccine recipients developed ELISA and neutralizing antibody to parvovirus B19. Given the possible severe consequences of parvovirus B19 infection, further development of a safe and effective vaccine continues to be important.