Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older.
OBJECTIVE
To evaluate the safety and immunogenicity of ZOSTAVAX administered concomitantly with inactivated influenza vaccine or sequentially in adults aged 50 and older.


METHODS
Randomized, blinded, placebo-controlled study.


METHODS
Thirteen U.S. and seven European study sites.


METHODS
Three hundred eighty-two concomitantly, 380 sequentially vaccinated subjects.


METHODS
The concomitant vaccination group received influenza vaccine and ZOSTAVAX at separate injection sites on Day 1 and placebo at Week 4. The nonconcomitant vaccination group received influenza vaccine and placebo at separate injection sites on Day 1 and ZOSTAVAX at Week 4.


METHODS
Primary safety endpoints: vaccine-related serious adverse experiences (AEs) within 28 days postvaccination (PV); and diary card-prompted local and systemic AEs. Primary immunogenicity endpoints: geometric mean titer (GMT) and geometric mean fold rise (GMFR) from baseline of varicella-zoster virus (VZV) antibody (Ab) at 4 weeks PV according to glycoprotein enzyme-linked immunosorbent assay (gpELISA) and GMT of influenza Ab for the three vaccine strains (2005-2006 influenza season) at 4 weeks PV according to hemagglutination inhibition assay. Secondary immunogenicity endpoint: influenza seroconversion rates (SCRs).


RESULTS
No serious AEs related to ZOSTAVAX were observed during the study. VZV Ab GMTs 4 weeks PV for the concomitant and sequential groups were 554 and 597 gpELISA U/mL, respectively. The estimated VZV Ab GMT ratio was 0.9 (95% confidence interval (CI)=0.8-1.0), indicating noninferior (P<.001 for the null hypothesis of GMT ratio <0.67) responses. Estimated VZV Ab GMFR from baseline in the concomitant group was 2.1 (95% CI=2.0-2.3), indicating acceptable fold rise. Estimated GMT ratios (concomitant/sequential) for influenza strains A(H1N1), A(H3N2), and B were 0.9 (95% CI=0.8-1.1), 1.1 (95% CI=0.9-1.3), and 0.9 (95% CI=0.8-1.1), respectively, and SCRs were comparable across both groups, with more than 85% achieving titers of 1:40 or greater, meeting regulatory criteria.


CONCLUSIONS
ZOSTAVAX and influenza vaccine given concomitantly are generally well tolerated in adults aged 50 and older. Ab responses were similar whether ZOSTAVAX and influenza vaccine were given concomitantly or sequentially.
Kerzner
Boris
B
Health Trends Research, Baltimore, Maryland, USA.
Murray
Alexander V
AV
Cheng
Eric
E
Ifle
Rudy
R
Harvey
Peter R
PR
Tomlinson
Mark
M
Barben
Julie L
JL
Rarrick
Kimberly
K
Stek
Jon E
JE
Chung
Mi-Ok
MO
Schödel
Florian P
FP
Wang
William W B
WW
Xu
Jin
J
Chan
Ivan S F
IS
Silber
Jeffrey L
JL
Schlienger
Katia
K
D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004334:Drug Administration Schedule; D023381:Endpoint Determination / Q000379:methods; D005260:Female; D053061:Herpes Zoster Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology; D009981:Influenza B virus / Q000276:immunology; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D008297:Male; D008875:Middle Aged
D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D007252:Influenza Vaccines