Tags

Type your tag names separated by a space and hit enter

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

Abstract

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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Health Trends Research, Baltimore, Maryland, USA.

    , , , , , , , , , , , , , ,

    Source

    MeSH

    Antibodies, Bacterial
    Antibodies, Viral
    Drug Administration Schedule
    Endpoint Determination
    Female
    Herpes Zoster Vaccine
    Humans
    Influenza A Virus, H1N1 Subtype
    Influenza A Virus, H3N2 Subtype
    Influenza B virus
    Influenza Vaccines
    Male
    Middle Aged

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    17908055

    Citation

    Kerzner, Boris, et al. "Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and Older." Journal of the American Geriatrics Society, vol. 55, no. 10, 2007, pp. 1499-507.
    Kerzner B, Murray AV, Cheng E, et al. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc. 2007;55(10):1499-507.
    Kerzner, B., Murray, A. V., Cheng, E., Ifle, R., Harvey, P. R., Tomlinson, M., ... Schlienger, K. (2007). Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. Journal of the American Geriatrics Society, 55(10), pp. 1499-507.
    Kerzner B, et al. Safety and Immunogenicity Profile of the Concomitant Administration of ZOSTAVAX and Inactivated Influenza Vaccine in Adults Aged 50 and Older. J Am Geriatr Soc. 2007;55(10):1499-507. PubMed PMID: 17908055.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. AU - Kerzner,Boris, AU - Murray,Alexander V, AU - Cheng,Eric, AU - Ifle,Rudy, AU - Harvey,Peter R, AU - Tomlinson,Mark, AU - Barben,Julie L, AU - Rarrick,Kimberly, AU - Stek,Jon E, AU - Chung,Mi-Ok, AU - Schödel,Florian P, AU - Wang,William W B, AU - Xu,Jin, AU - Chan,Ivan S F, AU - Silber,Jeffrey L, AU - Schlienger,Katia, PY - 2007/10/3/pubmed PY - 2007/11/9/medline PY - 2007/10/3/entrez SP - 1499 EP - 507 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 55 IS - 10 N2 - 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. SN - 0002-8614 UR - https://www.unboundmedicine.com/medline/citation/17908055/Safety_and_immunogenicity_profile_of_the_concomitant_administration_of_ZOSTAVAX_and_inactivated_influenza_vaccine_in_adults_aged_50_and_older_ L2 - https://doi.org/10.1111/j.1532-5415.2007.01397.x DB - PRIME DP - Unbound Medicine ER -