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Overview of RSVPreF3 OA Vaccine

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Clinical Development Program

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Summary of Key Data

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GSK’s respiratory syncytial virus (RSV) older adult vaccine (RSVPreF3 OA)

The combination of RSVPreF3 (120 μg) and Adjuvant System 01E (AS01E) is designed to induce a robust humoral and cellular immune response, to help protect older adults and those with comorbidities.

RSVPreF3 OA vaccine

RSVPreF3 antigen (120 μg)

Engineered recombinant form of the RSV fusion glycoprotein (F protein), stabilized to preferentially maintain the pre-fusion conformation and display potent neutralizing epitopes to boost humoral immune response in older adults1,2

F Protein is highly conserved (≥90% homology) between RSV-A and RSV-B subtypes3

surface-representation-of-the-prefusion-conformation-of-the-rsv-f-glycoprotein.
ndasdk

AS01E adjuvant system

Helps boost cellular immune response and helps restore the RSVPreF3 CD4+ T-cell level in older adults2

Image of F protein reproduced from Graham BS et al. Curr Opin Immunol 2015;35:30–38, Copyright 2015, with permission from Elsevier

Clinical development program

As of July 10, 2023

Please refer to GSK Clinical Study Register or ClinicalTrials.gov for latest information.

Study
 Phase 1
 Phase 2
 Phase 3
Study 006: Pivotal efficacy, immunogenicity, and safety in ≥60 years of age4,5     NCT04886596
(ongoing)
Papi A, et al. N Engl J Med.2023
Study 004: Immunogenicity, safety, reactogenicity, persistence, and revaccination in ≥60 years of age6
     NCT04732871
(ongoing)
Study 007: Immunogenicity, safety and reactogenicity when co-administered with quadrivalent influenza vaccine (FLU-QIV) in ≥60 years of age7     NCT04841577
(completed)
Study 008: Immunogenicity, safety, and reactogenicity when co-administered with high-dose quadrivalent influenza vaccine (FLU-QIV-HD) in ≥65 years of age8     NCT05559476
(ongoing)
Study 017: Immunogenicity, safety, and reactogenicity when co-administered with adjuvanted quadrivalent influenza vaccine (FLU-aQIV) in ≥65 years of age9     NCT05568797
(ongoing)
Study 019: Immunogenicity, safety and reactogenicity when co-administered with pneumococcal conjugate vaccine 20 (PCV 20) in ≥60 years of age10     NCT05879107
(ongoing)
Study 018: Immunogenicity and safety in adults 50–59 years of age, including adults at increased risk of RSV-lower respiratory tract disease (LRTD), compared with adults ≥60 years of age11     NCT05590403
(ongoing)
Study 023: Immunogenicity and safety in adults ≥50 years of age who received lung or kidney transplant and are at increased risk of RSV-LRTD, compared with healthy adults ≥50 years of age12   NCT05921903
(ongoing)		  
Study 009: Lot-to-lot consistency in ≥60 years of age13     NCT05059301
(completed)
Study 011: (Extension of Study 002): Safety and immunogenicity of a revaccination dose in ≥60 years of age14   NCT04657198
(completed) 		  
Study 002: First-in-human safety, immunogenicity, formulation, and dose selection in adults 18–40 years of age and older adults 60–80 years of age2,15 NCT03814590 (completed)  
Leroux-Roels I, et al. J Infect Dis. 2023
Study 003: Safety, reactogenicity and immunogenicity in Japanese adults 60–80 years of age16 NCT04090658
(completed)		  

Summary of key data

Efficacy5,17
  • In Study 006, the first season analysis demonstrated that RSVPreF3 OA provides high and consistent efficacy against the full spectrum of RSV disease regardless of RSV subtype in adults ≥60 years of age
  • Efficacy over an entire RSV season (based on Season 1 analysis): 

82.6%

RSV-LRTD
(≥60 YOA)

94.1%

Severe RSV-LRTD
(≥60 YOA)

94.6%

RSV-LRTD
(≥1 comorbidity of interest*)
  • One dose of RSVPreF3 OA vaccine provides durable efficacy against RSVassociated LRTD for 2 full RSV seasons, including against severe RSV disease, in adults with underlying comorbidities, and across advancing ages
Immune Response17–19
  • RSVPreF3 OA induces a robust and persistent humoral and T-cell immune response
  • Co-administered with FLU-QIV, FLU-QIV-HD, or FLU-aQIV without evidence of clinically meaningful interference
Safety5,17,19,20
  • RSVPreF3 OA vaccine is well tolerated with an acceptable safety profile

*Included chronic obstructive pulmonary disease, asthma, any chronic respiratory/pulmonary disease, and chronic heart failure (cardiorespiratory), diabetes mellitus type 1 or type 2, and advanced liver or renal disease (endocrine or metabolic)

Click on a section below to learn more:

Pivotal Efficacy and Safety

RSVPreF3 OA Vaccine

Click here to learn about RSVPreF3 OA vaccine's

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Pivotal Efficacy and Safety

Pivotal Efficacy and Safety

Click here to learn about RSVPreF3 OA vaccine's pivotal efficacy and safety results

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Co-administration with Influenza vaccines

Co-administration with Influenza Vaccines

Click here to learn about RSVPreF3 OA vaccine co-administration studies with influenza vaccines

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Abbreviation

AS01E, adjuvant system 01E; F protein, RSV fusion glycoprotein; FLU-aQIV, adjuvanted quadrivalent influenza vaccine; FLU-QIV, quadrivalent influenza vaccine; FLU-QIV-HD, high-dose quadrivalent influenza vaccine; LRTD, lower respiratory tract disease; PCV, pneumococcal conjugate vaccine; RSV, respiratory syncytial virus; YOA, years of age.

References

  1. Graham BS, et al. Curr Opin Immunol. 2015;35:30-38.
  2. Leroux-Roels I, et al. J Infect Dis. 2023;227(6):761-772.
  3. McLellan JS, et al. Curr Top Microbiol Immunol. 2013;372:83–104
  4. ClinicalTrials.gov. NCT04886596. https://clinicaltrials.gov/study/NCT04886596. Accessed July 2023.
  5. Papi A, et al. N Engl J Med. 2023;388(7):595-608.
  6. ClinicalTrials.gov. NCT04732871. https://clinicaltrials.gov/study/NCT04732871. Accessed July 2023.
  7. ClinicalTrials.gov. NCT04841577. https://clinicaltrials.gov/study/NCT04841577. Accessed July 2023.
  8. ClinicalTrials.gov. NCT05559476. https://clinicaltrials.gov/study/NCT05559476. Accessed July 2023.
  9. ClinicalTrials.gov. NCT05568797. https://clinicaltrials.gov/study/NCT05568797. Accessed July 2023.
  10. ClinicalTrials.gov NCT05879107. https://clinicaltrials.gov/study/NCT05879107. Accessed July 2023.
  11. ClinicalTrials.gov. NCT05590403. https://clinicaltrials.gov/study/NCT05590403. Accessed July 2023.
  12. ClinicalTrials.gov NCT05921903. https://clinicaltrials.gov/study/NCT05921903. Accessed July 2023.
  13. ClinicalTrials.gov. NCT05059301. https://clinicaltrials.gov/study/NCT05059301. Accessed July 2023.
  14. ClinicalTrials.gov. NCT04657198. https://clinicaltrials.gov/study/NCT04657198. Accessed July 2023.
  15. ClinicalTrials.gov. NCT03814590. https://clinicaltrials.gov/study/NCT03814590. Accessed July 2023.
  16. ClinicalTrials.gov. NCT04090658. https://clinicaltrials.gov/study/NCT04090658. Accessed July 2023.
  17. ACIP June 2023 GSK Presentation. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/03-RSV-Adults-Friedland-508.pdf. Accessed July 2023
  18. Schwarz TF, et al. A candidate respiratory syncytial virus (RSV) prefusion F protein investigational vaccine (RSVPreF3 OA) is immunogenic when administered in adults ≥ 60 years of age: results at 6 months after vaccination. Presented at IDWeek; October 19−23, 2022; Washington, DC, USA.
  19. Chandler R, et al. Immunogenicity, reactogenicity and safety of a respiratory syncytial virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent influenza vaccine in older adults. Presented at IDWeek; October 19−23, 2022; Washington, DC, USA.
  20. Schwarz TF, et al. Safety and reactogenicity of an investigational respiratory syncytial virus (RSV) prefusion F protein vaccine for adults ≥ 60 years of age (RSVPreF3 OA): an interim analysis at 6 months after vaccination. Presented at IDWeek; October 19−23, 2022; Washington, DC, USA.

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©2023 GSK group of companies or its licensor. GlaxoSmithKline Biologicals SA. Rixensart, Belgium.

NX-GBL-RSA-WCNT-230001 | July 2023