Safety and immunogenicity of a recombinant parvovirus B19 vaccine formulated with MF59C.1.
A recombinant human parvovirus B19 vaccine (MEDI-491; MedImmune) composed of the VP1 and VP2 capsid proteins and formulated with MF59C.1 adjuvant was evaluated in a randomized, double-blind, phase 1 trial. Parvovirus B19-seronegative adults (n=24) received either 2.5 or 25 microg MEDI-491 at 0, 1, and 6 months. MEDI-491 was safe and immunogenic. All volunteers developed neutralizing antibody titers that peaked after the third immunization and were sustained through study day 364.
Ballou
W Ripley
WR
Clinical Development, MedImmune, Gaithersburg, Maryland 20878, USA. BallouW@MedImmune.com
Reed
Jennifer L
JL
Noble
William
W
Young
Neal S
NS
Koenig
Scott
S
D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002213:Capsid / Q000276:immunology*; D036022:Capsid Proteins; D004311:Double-Blind Method; D006801:Humans; D007115:Immunization Schedule; D007273:Injections, Intramuscular; D008875:Middle Aged; D009500:Neutralization Tests; D010322:Parvoviridae Infections / Q000097:blood / Q000517:prevention & control*; D017992:Parvovirus / Q000276:immunology*; D011136:Polysorbates / Q000008:administration & dosage*; D013185:Squalene / Q000008:administration & dosage*; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000276:immunology*
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D036022:Capsid Proteins; C089950:MF59 oil emulsion; D011136:Polysorbates; D014614:Vaccines, Synthetic; D014765:Viral Vaccines; C095547:capsid protein VP1, parvovirus B19; C095548:capsid protein VP2, parvovirus B19; D013185:Squalene