Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or Older.
Background
The immunogenicity and safety of an adjuvanted herpes zoster subunit (HZ/su) vaccine when coadministered 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 (varicella zoster virus glycoprotein E; AS01B Adjuvant System) and IIV4 at day 0 followed by a second HZ/su dose at month 2 (coadministration group), or IIV4 at month 0 and HZ/su at months 2 and 4 (control group). The primary objectives were the HZ/su vaccine response rate in the coadministration group and the noninferiority of the antibody responses to HZ/su and IIV4 in the coadministration compared with the control group. Safety information was collected throughout the duration of the study.


Results
A total of 413 subjects were vaccinated in the coadministration group and 415 in the control group. The HZ/su vaccine response rate in the coadministration group was 95.8% (95% confidence interval, 93.3%-97.6%) and the anti-glycoprotein E GMCControl/Coadmin ratio was 1.08 (.97-1.20). The primary noninferiority objectives were met. No safety concerns were observed.


Conclusions
No interference in the immune responses to either vaccine was observed when the vaccines were coadministered, and no safety concerns were identified.


Clinical Trials Registration
NCT01954251.
['Schwarz|Tino F|TF|', 'Aggarwal|Naresh|N|', 'Moeckesch|Beate|B|', 'Schenkenberger|Isabelle|I|', 'Claeys|Carine|C|', 'Douha|Martine|M|', 'Godeaux|Olivier|O|', 'Grupping|Katrijn|K|', 'Heineman|Thomas C|TC|', 'Fauqued|Marta Lopez|ML|', 'Oostvogels|Lidia|L|', 'Van den Steen|Peter|P|', 'Lal|Himal|H|']
D000276:Adjuvants, Immunologic D000277:Adjuvants, Pharmaceutic D000368:Aged D000914:Antibodies, Viral D000917:Antibody Formation D004338:Drug Combinations D064420:Drug-Related Side Effects and Adverse Reactions D005260:Female D006562:Herpes Zoster D053061:Herpes Zoster Vaccine D014645:Herpesvirus 3, Human D006801:Humans D007111:Immunity, Cellular D056724:Immunity, Humoral D000071497:Immunogenicity, Vaccine D007252:Influenza Vaccines D007251:Influenza, Human D008297:Male D008875:Middle Aged D012621:Seasons D014611:Vaccination D015164:Vaccines, Inactivated D022223:Vaccines, Subunit
adjuvant herpes zoster subunit vaccine influenza coadministration