tetano
Editor, Senior Moderator
JAMA Netw Open
. 2024 Oct 1;7(10):e2440817.
doi: 10.1001/jamanetworkopen.2024.40817. Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial
Kenneth E Schmader[SUP] 1 2 [/SUP], Emmanuel B Walter[SUP] 3 4 [/SUP], Kawsar R Talaat[SUP] 5 [/SUP], Wes Rountree[SUP] 3 [/SUP], Marek Poniewierski[SUP] 3 [/SUP], Emily Randolph[SUP] 3 [/SUP], Sean X Leng[SUP] 6 7 [/SUP], Bettina Wunderlich[SUP] 5 [/SUP], Michael M McNeil[SUP] 8 [/SUP], Oidda Museru[SUP] 8 [/SUP], Karen R Broder[SUP] 8 9 [/SUP]
Affiliations
Importance: Quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) and adjuvanted recombinant zoster vaccine (RZV) contain novel adjuvants. Data are limited on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of the simultaneous administration of these vaccines.
Objective: To compare the safety and reactogenicity after simultaneous doses of RZV and aIIV4 administration (opposite arms) with simultaneous doses of RZV with quadrivalent high-dose inactivated influenza vaccine [HD-IIV4]).
Design, setting, and participants: This randomized blinded clinical trial was conducted during the 2021-2022 and 2022-2023 influenza seasons at 2 centers in the US among community-dwelling adults aged 65 years or older. Analysis was performed on an intention-to-treat basis.
Intervention: Simultaneous intramuscular administration of RZV dose 1 and aIIV4 or HD-IIV4 in opposite arms after age stratification (65-69 and ≥70 years) and randomization.
Main outcomes and measures: The primary outcome was the proportions of participants with 1 or more severe solicited reactions during days 1 to 8, using a noninferiority test (10% noninferiority margin). Additional measures included serious adverse events and adverse events of clinical interest during days 1 to 43 of the study period.
Results: A total of 267 adults (median age, 71 years [range, 65-92 years]; 137 men [51.3%]) were randomized; 130 received simultaneous RZV and aIIV4, and 137 received simultaneous RZV and HD-IIV4. The proportion of patients reporting 1 or more severe reactions after simultaneous administration of RZV and aIIV4 (15 of 115 [11.5%]) was noninferior compared with simultaneous RZV and HD-IIV4 (17 of 119 [12.5%]) (absolute difference, -1.0% [95% CI, -8.9% to 7.1%]). There were no significant differences in the number of serious adverse events or adverse events of clinical interest between the groups.
Conclusions and relevance: In this clinical trial of simultaneous doses of RZV and aIIV4 compared with simultaneous doses of RZV and HD-IIV4, overall safety findings were similar between groups. From a safety standpoint, this study supports the simultaneous administration of RZV and aIIV4 among older adults.
Trial registration: ClinicalTrials.gov Identifier: NCT05007041.
. 2024 Oct 1;7(10):e2440817.
doi: 10.1001/jamanetworkopen.2024.40817. Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial
Kenneth E Schmader[SUP] 1 2 [/SUP], Emmanuel B Walter[SUP] 3 4 [/SUP], Kawsar R Talaat[SUP] 5 [/SUP], Wes Rountree[SUP] 3 [/SUP], Marek Poniewierski[SUP] 3 [/SUP], Emily Randolph[SUP] 3 [/SUP], Sean X Leng[SUP] 6 7 [/SUP], Bettina Wunderlich[SUP] 5 [/SUP], Michael M McNeil[SUP] 8 [/SUP], Oidda Museru[SUP] 8 [/SUP], Karen R Broder[SUP] 8 9 [/SUP]
Affiliations
- PMID: 39446325
- DOI: 10.1001/jamanetworkopen.2024.40817
Importance: Quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) and adjuvanted recombinant zoster vaccine (RZV) contain novel adjuvants. Data are limited on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of the simultaneous administration of these vaccines.
Objective: To compare the safety and reactogenicity after simultaneous doses of RZV and aIIV4 administration (opposite arms) with simultaneous doses of RZV with quadrivalent high-dose inactivated influenza vaccine [HD-IIV4]).
Design, setting, and participants: This randomized blinded clinical trial was conducted during the 2021-2022 and 2022-2023 influenza seasons at 2 centers in the US among community-dwelling adults aged 65 years or older. Analysis was performed on an intention-to-treat basis.
Intervention: Simultaneous intramuscular administration of RZV dose 1 and aIIV4 or HD-IIV4 in opposite arms after age stratification (65-69 and ≥70 years) and randomization.
Main outcomes and measures: The primary outcome was the proportions of participants with 1 or more severe solicited reactions during days 1 to 8, using a noninferiority test (10% noninferiority margin). Additional measures included serious adverse events and adverse events of clinical interest during days 1 to 43 of the study period.
Results: A total of 267 adults (median age, 71 years [range, 65-92 years]; 137 men [51.3%]) were randomized; 130 received simultaneous RZV and aIIV4, and 137 received simultaneous RZV and HD-IIV4. The proportion of patients reporting 1 or more severe reactions after simultaneous administration of RZV and aIIV4 (15 of 115 [11.5%]) was noninferior compared with simultaneous RZV and HD-IIV4 (17 of 119 [12.5%]) (absolute difference, -1.0% [95% CI, -8.9% to 7.1%]). There were no significant differences in the number of serious adverse events or adverse events of clinical interest between the groups.
Conclusions and relevance: In this clinical trial of simultaneous doses of RZV and aIIV4 compared with simultaneous doses of RZV and HD-IIV4, overall safety findings were similar between groups. From a safety standpoint, this study supports the simultaneous administration of RZV and aIIV4 among older adults.
Trial registration: ClinicalTrials.gov Identifier: NCT05007041.