tetano
Editor, Senior Moderator
J Infect Dis. 2017 Sep 26. doi: 10.1093/infdis/jix481. [Epub ahead of print]
[h=1]Immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine co-administered with seasonal influenza vaccine in adults aged 50 years and older.[/h] Schwarz TF[SUP]1[/SUP], Aggarwal N[SUP]2[/SUP], Moeckesch B[SUP]3[/SUP], Schenkenberger I[SUP]4[/SUP], Claeys C[SUP]5[/SUP], Douha M[SUP]5[/SUP], Godeaux O[SUP]6[/SUP], Grupping K[SUP]5[/SUP], Heineman TC[SUP]7[/SUP], Lopez Fauqued M[SUP]5[/SUP], Oostvogels L[SUP]5[/SUP], Van den Steen P[SUP]5[/SUP], Lal H[SUP]7[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] The immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine (HZ/su) when co-administered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years.
[h=4]Methods:[/h] Subjects were randomized 1:1 to receive either HZ/su (VZV glycoprotein E [gE]; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (Co-ad group), or IIV4 at month 0 and HZ/su at months 2 and 4 (Control group). Co-primary objectives were the HZ/su vaccine response rate (VRR) in the Co-ad group and the non-inferiority of the antibody responses to HZ/su and IIV4 in the Co-ad group compared to the Control group. Safety information was collected throughout the duration of the study.
[h=4]Results:[/h] 413 subjects were vaccinated in the Co-ad group and 415 in the control group. The HZ/su VRR in the Co-ad group was 95.8% (95% CI 93.3-97.6) and the anti-gE GMCCo-ad/Control ratio was 1.08 (95% CI 0.97-1.20). Co-primary non-inferiority objectives were met. No safety concerns were observed.
[h=4]Conclusions:[/h] No interference in the immune responses to either vaccine was observed when co-administered and no safety concerns were identified.
[h=4]Clinical Trials Registration:[/h] Clinicaltrials.gov NCT01954251.
[h=4]KEYWORDS:[/h] adjuvant; co-administration; herpes zoster; influenza; subunit vaccine
PMID: 29029224 DOI: 10.1093/infdis/jix481
[h=1]Immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine co-administered with seasonal influenza vaccine in adults aged 50 years and older.[/h] Schwarz TF[SUP]1[/SUP], Aggarwal N[SUP]2[/SUP], Moeckesch B[SUP]3[/SUP], Schenkenberger I[SUP]4[/SUP], Claeys C[SUP]5[/SUP], Douha M[SUP]5[/SUP], Godeaux O[SUP]6[/SUP], Grupping K[SUP]5[/SUP], Heineman TC[SUP]7[/SUP], Lopez Fauqued M[SUP]5[/SUP], Oostvogels L[SUP]5[/SUP], Van den Steen P[SUP]5[/SUP], Lal H[SUP]7[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]Background:[/h] The immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine (HZ/su) when co-administered with a quadrivalent seasonal inactivated influenza vaccine (IIV4) was investigated in a phase 3, open-label, randomized clinical trial in adults aged ≥50 years.
[h=4]Methods:[/h] Subjects were randomized 1:1 to receive either HZ/su (VZV glycoprotein E [gE]; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (Co-ad group), or IIV4 at month 0 and HZ/su at months 2 and 4 (Control group). Co-primary objectives were the HZ/su vaccine response rate (VRR) in the Co-ad group and the non-inferiority of the antibody responses to HZ/su and IIV4 in the Co-ad group compared to the Control group. Safety information was collected throughout the duration of the study.
[h=4]Results:[/h] 413 subjects were vaccinated in the Co-ad group and 415 in the control group. The HZ/su VRR in the Co-ad group was 95.8% (95% CI 93.3-97.6) and the anti-gE GMCCo-ad/Control ratio was 1.08 (95% CI 0.97-1.20). Co-primary non-inferiority objectives were met. No safety concerns were observed.
[h=4]Conclusions:[/h] No interference in the immune responses to either vaccine was observed when co-administered and no safety concerns were identified.
[h=4]Clinical Trials Registration:[/h] Clinicaltrials.gov NCT01954251.
[h=4]KEYWORDS:[/h] adjuvant; co-administration; herpes zoster; influenza; subunit vaccine
PMID: 29029224 DOI: 10.1093/infdis/jix481