tetano
Editor, Senior Moderator
Clin Infect Dis
. 2024 Aug 5:ciae365.
doi: 10.1093/cid/ciae365. Online ahead of print. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial
Rebecca Clark[SUP] 1 [/SUP], Sam Davies[SUP] 2 [/SUP], Jorge Labrador[SUP] 3 [/SUP], Paul Loubet[SUP] 4 [/SUP], Silvina Natalini Martínez[SUP] 5 [/SUP], Helena Moza Moríñigo[SUP] 6 [/SUP], Jean-François Nicolas[SUP] 7 [/SUP], Mercè Pérez Vera[SUP] 8 [/SUP], Mika Rämet[SUP] 9 [/SUP], Maria Henar Rebollo-Rodrigo[SUP] 10 [/SUP], Iván Sanz-Muñoz[SUP] 11 12 [/SUP], Nancy Dezutter[SUP] 13 [/SUP], Sophie Germain[SUP] 13 [/SUP], Marie-Pierre David[SUP] 13 [/SUP], Amulya Jayadev[SUP] 14 [/SUP], Hiwot Amare Hailemariam[SUP] 13 [/SUP], Shady Kotb[SUP] 13 [/SUP], Nadia Meyer[SUP] 13 [/SUP]
Affiliations
Background: We evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds.
Methods: This phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed.
Results: Overall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06-1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups.
Conclusions: Adjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine.
Clinical trials registration: NCT05568797.
Keywords: RSVPreF3 OA; adjuvanted seasonal influenza vaccine; concurrent administration; immunogenicity; safety.
. 2024 Aug 5:ciae365.
doi: 10.1093/cid/ciae365. Online ahead of print. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion F Protein Vaccine when Co-administered with Adjuvanted Seasonal Quadrivalent Influenza Vaccine in Older Adults: A Phase 3 Randomized Trial
Rebecca Clark[SUP] 1 [/SUP], Sam Davies[SUP] 2 [/SUP], Jorge Labrador[SUP] 3 [/SUP], Paul Loubet[SUP] 4 [/SUP], Silvina Natalini Martínez[SUP] 5 [/SUP], Helena Moza Moríñigo[SUP] 6 [/SUP], Jean-François Nicolas[SUP] 7 [/SUP], Mercè Pérez Vera[SUP] 8 [/SUP], Mika Rämet[SUP] 9 [/SUP], Maria Henar Rebollo-Rodrigo[SUP] 10 [/SUP], Iván Sanz-Muñoz[SUP] 11 12 [/SUP], Nancy Dezutter[SUP] 13 [/SUP], Sophie Germain[SUP] 13 [/SUP], Marie-Pierre David[SUP] 13 [/SUP], Amulya Jayadev[SUP] 14 [/SUP], Hiwot Amare Hailemariam[SUP] 13 [/SUP], Shady Kotb[SUP] 13 [/SUP], Nadia Meyer[SUP] 13 [/SUP]
Affiliations
- PMID: 39099085
- DOI: 10.1093/cid/ciae365
Background: We evaluated co-administration of adjuvanted seasonal quadrivalent influenza vaccine (FLU-aQIV) and respiratory syncytial virus (RSV) prefusion F protein-based vaccine (RSVPreF3 OA) in ≥65-year-olds.
Methods: This phase 3, open-label trial randomized ≥65-year-olds to receive FLU-aQIV and RSVPreF3 OA concomitantly (Co-Ad) or sequentially, 1 month apart (Control). Primary objectives were to demonstrate the non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration in terms of hemagglutination inhibition (HI) titers for each FLU-aQIV strain and RSV-A and RSV-B neutralization titers, 1 month post-vaccination. Reactogenicity and safety were also assessed.
Results: Overall, 1045 participants were vaccinated (Co-Ad: 523; Control: 522). Non-inferiority of FLU-aQIV and RSVPreF3 OA co-administration versus sequential administration was demonstrated in terms of HI titers for the A/Victoria(H1N1), B/Victoria, and B/Yamagata influenza strains and RSV-A neutralization titers (upper limits [ULs] of 95% confidence intervals [CIs] for adjusted geometric mean titer [GMT] ratios [Control/Co-Ad] ≤1.50) but not for A/Darwin(H3N2) HI titers (95% CI UL = 1.53). The immune response to A/Darwin(H3N2) was further assessed post-hoc using a microneutralization assay; the post-vaccination adjusted GMT ratio (Control/Co-Ad) was 1.23 (95% CI: 1.06-1.42, ie, UL ≤1.50), suggesting an adequate immune response to A/Darwin(H3N2) following co-administration. RSV-B neutralization titers were comparable between groups (95% CI UL for adjusted GMT ratio ≤1.50). Solicited adverse events were mostly mild or moderate and transient; unsolicited and serious adverse event rates were balanced between groups.
Conclusions: Adjuvanted FLU-aQIV and RSVPreF3 OA had acceptable reactogenicity/safety profiles when co-administered in ≥65-year-olds, without clinically relevant interference with the immune responses to either vaccine.
Clinical trials registration: NCT05568797.
Keywords: RSVPreF3 OA; adjuvanted seasonal influenza vaccine; concurrent administration; immunogenicity; safety.