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J Infect Dis. 2017 Sep 26. doi: 10.1093/infdis/jix481. [Epub ahead of print]
Immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine co-administered with seasonal influenza vaccine in adults aged 50 years and older.
Schwarz TF1, Aggarwal N2, Moeckesch B3, Schenkenberger I4, Claeys C5, Douha M5, Godeaux O6, Grupping K5, Heineman TC7, Lopez Fauqued M5, Oostvogels L5, Van den Steen P5, Lal H7.
Author information
Abstract
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
No interference in the immune responses to either vaccine was observed when co-administered and no safety concerns were identified.
Clinical Trials Registration:
Clinicaltrials.gov NCT01954251.
KEYWORDS:
adjuvant; co-administration; herpes zoster; influenza; subunit vaccine
PMID: 29029224 DOI: 10.1093/infdis/jix481
Immunogenicity and safety of an adjuvanted herpes zoster subunit vaccine co-administered with seasonal influenza vaccine in adults aged 50 years and older.
Schwarz TF1, Aggarwal N2, Moeckesch B3, Schenkenberger I4, Claeys C5, Douha M5, Godeaux O6, Grupping K5, Heineman TC7, Lopez Fauqued M5, Oostvogels L5, Van den Steen P5, Lal H7.
Author information
Abstract
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
No interference in the immune responses to either vaccine was observed when co-administered and no safety concerns were identified.
Clinical Trials Registration:
Clinicaltrials.gov NCT01954251.
KEYWORDS:
adjuvant; co-administration; herpes zoster; influenza; subunit vaccine
PMID: 29029224 DOI: 10.1093/infdis/jix481