Efficacy and Safety of an Ad26.RSV.preF–RSV preF Protein Vaccine in Older Adults

Falsey, Ann R.; Williams, Kristi; Gymnopoulou, Efi; Bart, Stephan; Ervin, John; Bastian, Arangassery Rosemary; Menten, Joris; Paepe, Els De; Vandenberghe, Sjouke; Chan, Eric K. H.; Sadoff, Jerald C.; Douoguih, Macaya; Callendret, Benoît; Comeaux, Christy; Heijnen, Esther

doi:10.1056/nejmoa2207566

Cited by 88 publications

(94 citation statements)

References 44 publications

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“…A replication incompetent human adenovirus 26 vector expressing the RSV pre-F protein (Ad26.RSV.preF) has been developed by Janssen Vaccines & Prevention and was shown to induce large increases in RSV-specific neutralizing antibodies in a small Phase 1/2a clinical trial (NCT03303625) in adults (18–50 years) and RSV-seropositive children (12–24 months) [36]. A subsequent Phase 2b clinical trial (NCT03982199) in older adults (≥65 years) inoculated with Ad26.RSV.preF and RSV preF antigen resulted in RSV A2 neutralizing antibody titers increasing by a factor of 12.1 from baseline on day 15 post-infection along with concomitant reductions in RSV-mediated LRTI [37]. The efficacy of Ad26.RSV.preF (RT-qPCR) has also been validated in the human challenge model (NCT03334695) in which healthy adults aged 18–50 years received Ad26.RSV.preF or a placebo control before intranasal challenge at 28 days with RSV-A Memphis 37b [38].…”

Section: Vaccinesmentioning

confidence: 99%

Respiratory syncytial virus infection in the modern era

Ludlow

2023

Current Opinion in Infectious Diseases

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Purpose of reviewRespiratory syncytial virus (RSV) continues to be a major cause of severe lower respiratory tract infection in infants, young children, and older adults. In this review, changes in the epidemiology of RSV during the coronavirus disease 2019 (COVID-19) pandemic are highlighted together with the role which increased molecular surveillance efforts will have in future in assessing the efficacy of vaccines and therapeutics.Recent findingsThe introduction of nonpharmaceutical intervention (NPIs) strategies during the COVID-19 pandemic between 2020 and 2022 resulted in worldwide disruption to the epidemiology of RSV infections, especially with respect to the timing and peak case rate of annual epidemics. Increased use of whole genome sequencing along with efforts to better standardize the nomenclature of RSV strains and discrimination of RSV genotypes will support increased monitoring of relevant antigenic sites in the viral glycoproteins. Several RSV vaccine candidates based on subunit, viral vectors, nucleic acid, or live attenuated virus strategies have shown efficacy in Phase 2 or 3 clinical trials with vaccines using RSVpreF protein currently the closest to approval and use in high-risk populations. Finally, the recent approval and future use of the extended half-life human monoclonal antibody Nirsevimab will also help to alleviate the morbidity and mortality burden caused by annual epidemics of RSV infections.SummaryThe ongoing expansion and wider coordination of RSV molecular surveillance efforts via whole genome sequencing will be crucial for future monitoring of the efficacy of a new generation of vaccines and therapeutics.

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Section: Vaccinesmentioning

confidence: 99%

Respiratory syncytial virus infection in the modern era

Ludlow

2023

Current Opinion in Infectious Diseases

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“…Currently, there are only two RSV vaccines approved by the US Food and Drug Administration and studies in SOT are underway, summarized in Table 6 along with investigational vaccines and other passive immunization agents against RSV currently undergoing development [80,83–94].…”

Section: Prevention Of Rsvmentioning

confidence: 99%

“…Recent trials show benefit against medically attended RSV-associated LRI in at-risk preterm and healthy late preterm and term infants [81,82]. Currently, there are only two RSV vaccines approved by the US Food and Drug Administration and studies in SOT are underway, summarized in Table 6 along with investigational vaccines and other passive immunization agents against RSV currently undergoing development [80,[83][84][85][86][87][88][89][90][91][92][93][94].…”

Section: Prevention Of Rsvmentioning

confidence: 99%

Respiratory viral infections including COVID-19 in solid organ transplantation

Lo,

Kumar

2023

Current Opinion in Organ Transplantation

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Purpose of review Respiratory viral infections are prevalent and contribute to significant morbidity and mortality among solid organ transplant (SOT) recipients. We review updates from literature on respiratory viruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in the SOT recipient. Recent findings With the wider availability and use of molecular diagnostic tests, our understanding of the epidemiology and impact of respiratory viruses in the SOT population continues to expand. While considerable attention has been given to the coronavirus disease 2019 (COVID-19) pandemic, the advances in prevention and treatment strategies of SARS-CoV-2 offered valuable insights into the development of new therapeutic options for managing other respiratory viruses in both the general and SOT population. Summary Respiratory viruses can present with a diverse range of symptoms in SOT recipients, with potentially associated acute rejection and chronic lung allograft dysfunction in lung transplant recipients. The epidemiology, clinical presentations, diagnostic approaches, and treatment and preventive strategies for clinically significant RNA and DNA respiratory viruses in SOT recipients are reviewed. This review also covers novel antivirals, immunologic therapies, and vaccines in development for various community-acquired respiratory viruses.

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“…Two antigenically distinct RSV subtypes, A and B, (RSV-A and -B) cocirculate worldwide, with each subtype being composed of multiple genotypes (3,4). Several vaccine candidates were recently shown to be efficacious in protecting older adults against RSV-associated lower respiratory tract diseases in clinical trials (5)(6)(7). The RSVPreF3-AS01 vaccine has been very recently approved by the U.S. Food and Drug Administration and the European Medicines Agency for the prevention of lower respiratory tract diseases caused by RSV in individuals 60 years of age and older (8).…”

Section: Introductionmentioning

confidence: 99%

“…This was further supported by the observation that a stabilized preF antigen induced higher RSV-neutralizing responses than a postF antigen in mice ( 20 ). Consequently, the currently most advanced RSV vaccine candidates are preF based ( 5 – 7 , 9 , 11 ).…”

Section: Introductionmentioning

confidence: 99%

The RSVPreF3-AS01 vaccine elicits broad neutralization of contemporary and antigenically distant respiratory syncytial virus strains

Sacconnay,

De Smedt,

Rocha-Perugini

et al. 2023

Sci. Transl. Med.

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The RSVPreF3-AS01 vaccine, containing the respiratory syncytial virus (RSV) prefusion F protein and the AS01 adjuvant, was previously shown to boost neutralization responses against historical RSV strains and to be efficacious in preventing RSV-associated lower respiratory tract diseases in older adults. Although RSV F is highly conserved, variation does exist between strains. Here, we characterized variations in the major viral antigenic sites among contemporary RSV sequences when compared with RSVPreF3 and showed that, in older adults, RSVPreF3-AS01 broadly boosts neutralization responses against currently dominant and antigenically distant RSV strains. RSV-neutralizing responses are thought to play a central role in preventing RSV infection. Therefore, the breadth of RSVPreF3-AS01–elicited neutralization responses may contribute to vaccine efficacy against contemporary RSV strains and those that may emerge in the future.

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Efficacy and Safety of an Ad26.RSV.preF–RSV preF Protein Vaccine in Older Adults

Cited by 88 publications

References 44 publications

Respiratory syncytial virus infection in the modern era

Respiratory syncytial virus infection in the modern era

Respiratory viral infections including COVID-19 in solid organ transplantation

The RSVPreF3-AS01 vaccine elicits broad neutralization of contemporary and antigenically distant respiratory syncytial virus strains

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