Novel Drugs & Emergent Therapeutics | Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial
Published in Source Journal:1 August 2022
Type of article: Summary of Novel Drug Research
MedED Catalogue Reference: MIND003
Catalogue Tabs: Infectious Diseases | RSV Vaccine |Pneumococcal Conjugate Vaccine | Phase 3 Study
Sources: Clinical Infectious Disease
This study aimed to evaluate the safety and immunogenicity of vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion conformation of RSV fusion protein (RSVPreF3). The study included 48 young adults and 1005 older adults who received two doses of unadjuvanted or AS01-adjuvanted vaccine or placebo
The researchers found the following:
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The RSVPreF3 vaccines increased humoral and neutralizing antibody responses, with higher responses observed after the first dose.
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CD4+ T cell responses also increased after each dose, with higher responses in adjuvanted vaccine recipients.
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The immune responses persisted until the end of the follow-up period.
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Most adverse events were mild to moderate and transient, with no safety concerns identified for any of the vaccine formulations.
Based on the safety and immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 μg of RSVPreF3 was selected for further clinical development.
Clinical Trial Registration: NCT03760146.
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