TY - JOUR
T1 - A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months
AU - Langley, Joanne M.
AU - Nolan, Terry M.
AU - Rämet, Mika
AU - Richmond, Peter C.
AU - Filho, Nelson Rosário
AU - Haazen, Wouter
AU - van den Berg, Sara P.H.
AU - Williams, Kristi
AU - Bastian, Arangassery Rosemary
AU - Omoruyi, Edmund
AU - Durkin, Joanna Williams
AU - Salisch, Nadine
AU - Van Geet, Gunter
AU - van Duijnhoven, Wilbert
AU - Heijnen, Esther
AU - Callendret, Benoit
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/9/1
Y1 - 2024/9/1
N2 - Background. Respiratory syncytial virus (RSV) causes serious illness in children. The Ad26.RSV.preF vaccine candidate was immunogenic with acceptable safety in a phase 1/2a study of RSV-seropositive children. Here, we assessed its safety and immunogenicity in RSV-seronegative children. Methods. In this randomized, observer-blinded, placebo-controlled, phase 1/2a study (NCT03606512; https://www. clinicaltrials.gov/ct2/show/NCT03606512), RSV-seronegative toddlers aged 12-24 months received Ad26.RSV.preF (2.5 × 1010 viral particles) or placebo on days 1, 29, and 57 (a meningococcal vaccine [Nimenrix] could substitute for day 57 placebo). Primary endpoints were solicited local and systemic adverse events (AEs; 7 days after each vaccination), unsolicited AEs (28 days postvaccination), and serious AEs (first vaccination until study end). Participants were monitored for RSV-respiratory tract infection to assess infection rates and for severe RSV-lower respiratory tract infection as an indication of enhanced disease. RSV- A2 neutralizing, RSV (A and B) preF binding, and RSV postF immunoglobulin G-binding antibodies were evaluated on days 1 (predose), 8, and 85, and after RSV season 1. Results. Thirty-eight participants were enrolled and vaccinated (Ad26.RSV.preF, n = 20; placebo, placebo/Nimenrix, n = 18). Solicited AEs were more common following Ad26.RSV.preF than placebo; most were mild/moderate. No vaccine-related serious AEs were reported. Five of 19 participants receiving Ad26.RSV.preF and 2/18 receiving placebo or placebo/Nimenrix had confirmed RSV-respiratory tract infection or RSV-associated otitis media; none were considered severe. At the final season 1 study visit, most Ad26.RSV.preF recipients had ≥2-fold increases from baseline in RSV-A2 neutralizing, RSV A and B preF binding, and RSV postF antibodies. Conclusions. Ad26.RSV.preF was well tolerated and immunogenic in RSV-seronegative toddlers.
AB - Background. Respiratory syncytial virus (RSV) causes serious illness in children. The Ad26.RSV.preF vaccine candidate was immunogenic with acceptable safety in a phase 1/2a study of RSV-seropositive children. Here, we assessed its safety and immunogenicity in RSV-seronegative children. Methods. In this randomized, observer-blinded, placebo-controlled, phase 1/2a study (NCT03606512; https://www. clinicaltrials.gov/ct2/show/NCT03606512), RSV-seronegative toddlers aged 12-24 months received Ad26.RSV.preF (2.5 × 1010 viral particles) or placebo on days 1, 29, and 57 (a meningococcal vaccine [Nimenrix] could substitute for day 57 placebo). Primary endpoints were solicited local and systemic adverse events (AEs; 7 days after each vaccination), unsolicited AEs (28 days postvaccination), and serious AEs (first vaccination until study end). Participants were monitored for RSV-respiratory tract infection to assess infection rates and for severe RSV-lower respiratory tract infection as an indication of enhanced disease. RSV- A2 neutralizing, RSV (A and B) preF binding, and RSV postF immunoglobulin G-binding antibodies were evaluated on days 1 (predose), 8, and 85, and after RSV season 1. Results. Thirty-eight participants were enrolled and vaccinated (Ad26.RSV.preF, n = 20; placebo, placebo/Nimenrix, n = 18). Solicited AEs were more common following Ad26.RSV.preF than placebo; most were mild/moderate. No vaccine-related serious AEs were reported. Five of 19 participants receiving Ad26.RSV.preF and 2/18 receiving placebo or placebo/Nimenrix had confirmed RSV-respiratory tract infection or RSV-associated otitis media; none were considered severe. At the final season 1 study visit, most Ad26.RSV.preF recipients had ≥2-fold increases from baseline in RSV-A2 neutralizing, RSV A and B preF binding, and RSV postF antibodies. Conclusions. Ad26.RSV.preF was well tolerated and immunogenic in RSV-seronegative toddlers.
KW - adenovirus serotype 26
KW - pediatric vaccination
KW - respiratory syncytial virus
KW - respiratory syncytial virus vaccine
UR - http://www.scopus.com/inward/record.url?scp=85202964016&partnerID=8YFLogxK
U2 - 10.1093/ofid/ofae453
DO - 10.1093/ofid/ofae453
M3 - Article
C2 - 39220658
AN - SCOPUS:85202964016
SN - 2328-8957
VL - 11
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 9
M1 - ofae453
ER -
