Immunogenicity and Safety of Co-administration of Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine With 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: A Randomized, Non-inferiority Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Respiratory syncytial virus (RSV) illness and pneumococcal disease present high disease burden and health risks to older adults. Vaccination against these 2 illnesses is a key strategy to reduce this burden, and co-administration of the 2 vaccines could enhance vaccine uptake. This study evaluated the immunogenicity, safety, and reactogenicity of co-administration of adjuvanted RSV prefusion F protein vaccine (adjuvanted RSVPreF3) with 20-valent pneumococcal conjugate vaccine (PCV20) in adults aged ≥60 years. METHODS: This phase III, open-label, randomized, non-inferiority trial was conducted across 38 centers in Belgium, Poland, Spain, and the United States. Participants (N = 1112) were randomized 1:1 to receive adjuvanted RSVPreF3 vaccine and PCV20 vaccine either concomitantly (Co-Ad group) or 1 month apart (Control group). The primary objectives were to assess immunogenicity as measured by RSV-A and RSV-B neutralizing titers and opsonophagocytic titers for the PCV20 serotypes. Safety and reactogenicity were assessed as secondary objectives. RESULTS: All primary immunogenicity objectives were met. The upper limit of the 95% confidence interval of the geometric mean titer ratios for RSV-A, RSV-B, and all 20 PCV20 serotypes was within the pre-defined non-inferiority margins. Safety profiles were similar across both groups, with most adverse events being mild to moderate in severity and of short duration. Serious adverse events and potential immune-mediated diseases were rare and unrelated to vaccination. CONCLUSIONS: Co-administration of adjuvanted RSVPreF3 vaccine and PCV20 vaccine in older adults is immunologically non-inferior to their sequential administration, with an acceptable safety profile. These findings support co-administration as a strategy to enhance vaccine uptake. CLINICAL TRIALS REGISTRATION: NCT05879107.
Source: Clinical Infectious Diseases
DOI: 10.1093/cid/ciag250
Authors: Isabel Leroux-Roels, Muriel Lins, Ronald Surowitz, Antoinette Pragalos, Paulia Kwo Ton Ge Jua, Dominique Wauters, Amulya Jayadev, Jacqueline Elaine Akite, Archana M Jastorff, Vicky Cárdenas, Marie Van der Wielen, RSV-019 study group, Abram Burgher, Adeyemi Gbohunmi, Agnieszka Jurek-Urbanowska, Bruce Rankin, Carlos Brotons Cuixart, Ewa Krecipro Nizinska, Fernando Cereto Castro, Jay Sandberg, Jean Benoit Martinot, Joseph Soufer, Katarzyna Wawrzyniec-Lis, Kathleen Jones, Klaas Vercruysse, Lina Perez Breva, Luc Capiau, Magda Dabrowska, Manuchehr Darani, Miguel Trevino, Patrick Dennis, Patrick Soentjens, Przemyslaw Borowy, Rachel Presti, Rica Santiago, Salma Saiger, Sander Gothard, Shital Upadhyay, Tatyana Miroshnikova, William Nixon, Madhavi Ampajwala
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,763
OpenAlex ID: W7154682136