title: Safety, tolerability, and immunogenicity of a two-dose regimen of high-titer varicella vaccine in subjects > or =13 years of age.
abstract: A new manufacturing process, known as process upgrade varicella vaccine (PUVV) was developed for a refrigerated formulation of varicella vaccine and for an investigational zoster vaccine. Safety and tolerability of a two-dose regimen of high-titered (approximately 50,000 PFU) PUVV were compared to a lower-titer formulation (approximately 5400 PFU) of VARIVAX; in 1366 healthy subjects > or =13 years old. Only one vaccine-related clinical serious adverse experience (pruritus; no hospitalization) was reported, in the VARIVAX group. Injection-site adverse experiences following any dose were higher in the PUVV group, 70.0%, than in the VARIVAX group, 56.2%, but generally were mild. Immunogenicity were similar in both groups in seronegative subjects. PUVV was generally well tolerated, and elicited an immune response similar to that induced by the marketed formulation of VARIVAX.
authors.affiliation: University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
authors.forename: Clemente
authors.initials: C
authors.lastname: Diaz
authors.forename: Pietro
authors.initials: P
authors.lastname: Dentico
authors.forename: Rocio
authors.initials: R
authors.lastname: Gonzalez
authors.forename: Rafael G
authors.initials: RG
authors.lastname: Mendez
authors.forename: Sandro
authors.initials: S
authors.lastname: Cinquetti
authors.forename: Julie L
authors.initials: JL
authors.lastname: Barben
authors.forename: Anna
authors.initials: A
authors.lastname: Harmon
authors.forename: Ira
authors.initials: I
authors.lastname: Chalikonda
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Smith
authors.forename: Jon E
authors.initials: JE
authors.lastname: Stek
authors.forename: Andrew
authors.initials: A
authors.lastname: Robertson
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Caulfield
authors.forename: Luigi R
authors.initials: LR
authors.lastname: Biasio
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Silber
authors.forename: Christina Y
authors.initials: CY
authors.lastname: Chan
authors.forename: Rupert
authors.initials: R
authors.lastname: Vessey
authors.forename: Jerald
authors.initials: J
authors.lastname: Sadoff
authors.forename: Ivan S F
authors.initials: IS
authors.lastname: Chan
authors.forename: Holly
authors.initials: H
authors.lastname: Matthews
authors.forename: William
authors.initials: W
authors.lastname: Wang
authors.forename: Katia
authors.initials: K
authors.lastname: Schlienger
authors.forename: Florian P
authors.initials: FP
authors.lastname: Schödel
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D000917:Antibody Formation / Q000276:immunology; D002644:Chickenpox / Q000276:immunology* / Q000517:prevention & control*; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D006562:Herpes Zoster / Q000276:immunology* / Q000517:prevention & control*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology; D007371:Interferon-gamma / Q000096:biosynthesis; D008297:Male
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D007371:Interferon-gamma