Safety, tolerability, and immunogenicity of a two-dose regimen of high-titer varicella vaccine in subjects > or =13 years of age.
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.
Diaz
Clemente
C
University of Puerto Rico School of Medicine, San Juan, Puerto Rico.
Dentico
Pietro
P
Gonzalez
Rocio
R
Mendez
Rafael G
RG
Cinquetti
Sandro
S
Barben
Julie L
JL
Harmon
Anna
A
Chalikonda
Ira
I
Smith
Jeffrey G
JG
Stek
Jon E
JE
Robertson
Andrew
A
Caulfield
Michael J
MJ
Biasio
Luigi R
LR
Silber
Jeffrey L
JL
Chan
Christina Y
CY
Vessey
Rupert
R
Sadoff
Jerald
J
Chan
Ivan S F
IS
Matthews
Holly
H
Wang
William
W
Schlienger
Katia
K
Schödel
Florian P
FP
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
D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D007371:Interferon-gamma