Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older

被引:72
作者
Kerzner, Boris
Murray, Alexander V.
Cheng, Eric
Ifle, Rudy
Harvey, Peter R.
Tomlinson, Mark
Barben, Julie L.
Rarrick, Kimberly
Stek, Jon E.
Chung, Mi-Ok
Schoedel, Florian P.
Wang, William W. B.
Xu, Jin
Chan, Ivan S. F.
Silber, Jeffrey L.
Schlienger, Katia
机构
[1] Merck Res Labs, N Wales, PA 19454 USA
[2] Hlth Trends Res, Baltimore, MD USA
[3] PharmQuest, Greensboro, NC USA
[4] SUNY, Dept Family Med, Brooklyn, NY USA
[5] Behandelctr, Waterland Oost, Netherlands
关键词
concomitant use; safety; immunogenicity; influenza; zoster vaccine;
D O I
10.1111/j.1532-5415.2007.01397.x
中图分类号
R592 [老年病学]; C [社会科学总论];
学科分类号
03 ; 0303 ; 100203 ;
摘要
OBJECTIVES: To evaluate the safety and immunogenicity of ZOSTAVAX administered concomitantly with inactivated influenza vaccine or sequentially in adults aged 50 and older. DESIGN: Randomized, blinded, placebo-controlled study. SETTING: Thirteen U.S. and seven European study sites. PARTICIPANTS: Three hundred eighty-two concomitantly, 380 sequentially vaccinated subjects. INTERVENTION: 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. MEASUREMENTS: 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. CONCLUSION: 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.
引用
收藏
页码:1499 / 1507
页数:9
相关论文
共 22 条
[1]  
Dooley Samuel W., 2008, Morbidity and Mortality Weekly Report, V57, P1
[2]  
[Anonymous], CPMPBWP21496 EUR AG
[3]   Serum antibody responses after intradermal vaccination against influenza [J].
Belshe, RB ;
Newman, FK ;
Cannon, J ;
Duane, C ;
Treanor, J ;
Van Hoecke, C ;
Howe, BJ ;
Dubin, G .
NEW ENGLAND JOURNAL OF MEDICINE, 2004, 351 (22) :2286-2294
[4]  
Centers for Disease Control, NAT IMM PROGR AD IMM
[5]   Safety, tolerability, and immunogenicity of a two-dose regimen of high-titer varicella vaccine in subjects ≥ 13 years of age [J].
Diaz, Clemente ;
Dentico, Pietro ;
Gonzalez, Rocio ;
Mendez, Rafael G. ;
Cinquetti, Andro ;
Barben, Julie L. ;
Harmon, Anna ;
Chalikonda, Ira ;
Smith, Jeffrey G. ;
Stek, Jon E. ;
Robertson, Andrew ;
Caulfield, Michael J. ;
Biasio, Luigi R. ;
Silber, Jeffrey L. ;
Chan, Christina Y. ;
Vessey, Rupert ;
Sadoff, Jerald ;
Chan, Ivan S. F. ;
Matthews, Holly ;
Wang, William ;
Schlienger, Katia ;
Schodel, Florian P. .
VACCINE, 2006, 24 (47-48) :6875-6885
[6]  
EMEA Committee for Medical Products for Human Use, EMEA COMM MED PROD H
[7]  
*FDA, ADV COMM BACKGR DOC
[8]   PURIFICATION OF INDIVIDUAL VARICELLA-ZOSTER VIRUS (VZV) GLYCOPROTEIN-GPI, GLYCOPROTEIN-GPII, AND GLYCOPROTEIN-GPIII AND THEIR USE IN ELISA FOR DETECTION OF VZV GLYCOPROTEIN-SPECIFIC ANTIBODIES [J].
KELLER, PM ;
LONERGAN, K ;
NEFF, BJ ;
MORTON, DA ;
ELLIS, RW .
JOURNAL OF VIROLOGICAL METHODS, 1986, 14 (02) :177-188
[9]   Comparison of gpELISA and neutralizing antibody responses to Oka/Merck live varicella vaccine (Varivax(R)) in children and adults [J].
Krah, DL ;
Cho, IS ;
Schofield, T ;
Ellis, RW .
VACCINE, 1997, 15 (01) :61-64
[10]  
LAMONTAGNE JR, 1983, REV INFECT DIS, V5, P723