An adjuvanted influenza vaccine and an adjuvanted shingles vaccine can be safely administered together, a randomized, blinded clinical trial concludes.
Duke University researchers investigated the safety and response of simultaneous intramuscular vaccination with a quadrivalent (4-strain) inactivated adjuvanted influenza vaccine (allV4) and an adjuvanted recombinant shingles (shingles) vaccine (RSV). , compared with coadministration of RZV and shingles vaccine. Quadrivalent high-dose inactivated nonadjuvant influenza vaccine (HD-IIV4) vaccine.
allV4 or HD-IIV4 is recommended for adults age 65 and older, and the shingles vaccine is recommended for adults age 50 and older.
“Novel non-aluminum adjuvants are potent immunostimulants used in vaccine platforms to improve immunogenicity and efficacy,” the researchers wrote. “Vaccines containing new adjuvants are more reactogenic than vaccines without adjuvants, and there is a theoretical possibility that new adjuvants may activate immune-mediated disease in some individuals.”
The findings were published today in JAMA Network Open.
Vaccine administered to each arm
The research team will vaccinate 130 community-dwelling adults aged 65 and older with RZV and allV4 once in opposite arms during the 2021-22 and 2022-23 influenza seasons at two U.S. medical centers. 137 people were vaccinated with RSV and HD-IIV4 vaccines. Duke University and Johns Hopkins University Disease Control and Prevention (CDC) Immunization Safety Assessment (CISA) project site. Health-related quality of life (HRQoL) was assessed for 7 days after vaccination.
The second RZV dose was administered alone on day 60. The median age of participants was 71 years, 51.3% were male, and follow-up was approximately 3 months.
Outcomes of interest are vaccine recipients who experienced at least one serious local or systemic reaction in the 8 days after vaccination, and serious adverse events and clinically significant adverse events in the 43 days after vaccination. The percentage was
Slightly reduced serious reactions after adjuvant influenza vaccination
The proportion of participants who reported one or more severe reactions after co-vaccination with RZV and allV4 (11.5%) was non-inferior compared to co-vaccination with RZV and HD-IIV4 (12.5). Absolute difference, -1.0% (95% confidence interval ( CI), -8.9% to 7.1%).
From a safety perspective, this study supports co-administration of RZV and allV4 in older adults.
The proportion of participants with at least one severe local reaction was noninferior in the RZV and allV4 groups (6.2%) compared with the RZV and HD-IIV4 groups (4.4%) (absolute difference, 1.7 %, 95% CI, -4.0%) up to 7.8%). Additionally, the proportion reporting one or more serious systemic reactions was noninferior in the RZV and allV4 groups (5.4%) compared to the RZV and HD-IIV4 groups (9.6%) (absolute difference, -4.2%, 95% CI, -10.9%) to 2.5%).
Nine serious adverse events were reported over the study period (3.1% in the RZV and allV4 groups and 3.7% in the RZV and HD-IIV4 groups).
No participants sought medical attention for local or systemic reactions within 8 days after the first or second dose of RZV, and the pattern of severe reactions in participants aged 65 to 69 was similar to that in participants aged 70 and older. pattern was similar to that of
During the 43 days after vaccination, 0.8% of participants in the RZV and allV4 groups experienced serious adverse events, compared with 3.7% in the RZV and HD-IIV4 groups (difference between allV4 and HD-IIV4 groups). is -2.9%; 95)% CI, -6.4% to 0.6%). Changes in HRQoL scores during the 8 days following vaccination were minimal.
“Overall safety findings were similar between groups,” the study authors wrote. “From a safety perspective, this study supports co-administration of RZV and allV4 in older adults.”
