Céline Maréchal1, Himal Lal2, Airi Poder3, Murdo Ferguson4, Igwebuike Enweonye5, Thomas C Heineman6, Caroline Hervé7, Paul Rheault8, Jaak Talli9, Dominique Wauters10, Lidia Oostvogels11. 1. Business and Decision Life Sciences for GSK, Wavre, Belgium. Electronic address: celine.x.marechal@gsk.com. 2. GSK, King of Prussia, PA, USA. Electronic address: himallal@pfizer.com. 3. Clinical Research Center, Tartu, Estonia. Electronic address: airi@std.ee. 4. Colchester Research Group, Truro, Nova Scotia, Canada. Electronic address: MFtruroclinics@eastlink.ca. 5. GSK, Amsterdam, The Netherlands. Electronic address: igwebuike.x.enweonye@gsk.com. 6. GSK, King of Prussia, PA, USA. Electronic address: thomas.heineman@genocea.com. 7. GSK, Wavre, Belgium. Electronic address: caroline.c.herve@gsk.com. 8. Medicor Research Inc., Sudbury, Ontario, Canada. Electronic address: paul_rheault@sympatico.ca. 9. Innomedica Medical Center, Tallinn, Estonia. Electronic address: jaak.talli@innomedica.ee. 10. GSK, Wavre, Belgium. Electronic address: dominique.wauters@gsk.com. 11. GSK, Wavre, Belgium. Electronic address: cornelia.oostvogels@orange.fr.
Abstract
BACKGROUND: This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) when the first dose was co-administered with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) in adults aged ≥50 years. METHODS: In this open label, multi-center study (NCT02045836), participants were randomized 1:1 to receive either the first dose of RZV and PPSV23, co-administered at Day 0 and the second dose of RZV at Month 2 (Co-Ad group), or PPSV23 at Day 0, the first dose of RZV at Month 2 and second dose of RZV at Month 4 (Control group). Co-primary objectives were the RZV vaccine response rate (VRR) in the Co-Ad group and the non-inferiority of the antibody responses to RZV and PPSV23 in the Co-Ad group compared to the Control group. Reactogenicity and safety were also assessed. RESULTS:865 participants were vaccinated (Co-Ad: 432, Control: 433). VRRs to RZV were >98% in both groups. Humoral immune responses to co-administration of RZV and PPSV23 were non-inferior to sequential administration. All three co-primary immunogenicity objectives were met. Solicited local symptoms after the first RZV dose were reported by similar percentages of participants in both groups. Solicited general symptoms were more frequently reported when the first dose of RZV and PPSV23 were co-administered. No differences were apparent between groups after the second RZV dose. CONCLUSIONS: No immunologic interference was observed between RZV and PPSV23 when co-administered in adults ≥50 years. No safety concerns were raised.
RCT Entities:
BACKGROUND: This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) when the first dose was co-administered with the 23-valent pneumococcalpolysaccharide vaccine (PPSV23) in adults aged ≥50 years. METHODS: In this open label, multi-center study (NCT02045836), participants were randomized 1:1 to receive either the first dose of RZV and PPSV23, co-administered at Day 0 and the second dose of RZV at Month 2 (Co-Ad group), or PPSV23 at Day 0, the first dose of RZV at Month 2 and second dose of RZV at Month 4 (Control group). Co-primary objectives were the RZV vaccine response rate (VRR) in the Co-Ad group and the non-inferiority of the antibody responses to RZV and PPSV23 in the Co-Ad group compared to the Control group. Reactogenicity and safety were also assessed. RESULTS: 865 participants were vaccinated (Co-Ad: 432, Control: 433). VRRs to RZV were >98% in both groups. Humoral immune responses to co-administration of RZV and PPSV23 were non-inferior to sequential administration. All three co-primary immunogenicity objectives were met. Solicited local symptoms after the first RZV dose were reported by similar percentages of participants in both groups. Solicited general symptoms were more frequently reported when the first dose of RZV and PPSV23 were co-administered. No differences were apparent between groups after the second RZV dose. CONCLUSIONS: No immunologic interference was observed between RZV and PPSV23 when co-administered in adults ≥50 years. No safety concerns were raised.
Authors: Anna Mz Gagliardi; Brenda Ng Andriolo; Maria Regina Torloni; Bernardo Go Soares; Juliana de Oliveira Gomes; Regis B Andriolo; Eduardo Canteiro Cruz Journal: Cochrane Database Syst Rev Date: 2019-11-07
Authors: Katia J Bruxvoort; Lei Qian; Jun Wu; Ana Florea; Bradley Ackerson; Lina S Sy; Leticia Vega Daily; Harpreet Takhar; Hung Fu Tseng Journal: Open Forum Infect Dis Date: 2022-02-07 Impact factor: 3.835