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Study 006: Pivotal Efficacy and Safety of RSVPreF3 OA in Adults ≥60 Years of Age

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Study Design

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Study Results: Primary Objective and Efficacy

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Study Results: Safety

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Learn More About Study 006

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Study Design

Study 006 (AReSVi-006) is an ongoing Phase 3, randomized, placebo-controlled, observer-blind, multi-country study evaluating the efficacy of the RSVPreF3 OA vaccine in adults 60 years of age (YOA) or older.1-3

Immunogenicity, reactogenicity, and safety are also being evaluated.1-3

Study design3,4

figure-showing-the-study-design-for-AReSVi-006.-24,966-adults-aged-60-years-or-older-were-randomized-1-to-1-to-receive-1-dose-of-either-r-s-v-pre-f-3-o-a-vaccine-or-placebo-before-the-first-r-s-v-season.-the-AReSVi-006-study-is-an-ongoing-study.-prior-to-the-second-r-s-v-season-participants-who-initially-received-r-s-v-pre-f-3-o-a-were- randomized-1-to-1-to-receive--a-second-dose-of-rsv-pre-f-3-o-a,-for-the-annual-group,-or-placebo,-for-the-r-s-v-pre-f-3-o-a-single-dose-group,-at-12-months-post-dose-1.

Figure adapted with permission from Ison MG et al. A respiratory syncytial virus (RSV) prefusion F protein candidate vaccine (RSVPreF3 OA) is efficacious in adults ≥60 years of age (YOA). Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

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Primary objective1–3

To demonstrate the efficacy of RSVPreF3 OA in the prevention of RSV-LRTD in adults ≥60 years of age during the first season

Confirmatory secondary endpoint4

To demonstrate the efficacy of RSVPreF3 OA in the prevention of RSV-LRTD in adults ≥60 years of age over 2 seasons, following a single dose of RSVPreF3 OA and following annual revaccination dose

Key secondary objectives1,2

  • Efficacy against RSV-LRTD by:
    • RSV subtype (RSV-A and RSV-B)
    • Age category
    • Baseline comorbidities and frailty status
  • Efficacy against severe RSV-LRTD
  • Efficacy against RSV-acute respiratory infection (ARI)
  • Impact of RSV vaccine on Patient-Reported Outcomes
  • Immunogenicity/reactogenicity and safety

Case definitions1,4

figure-showing-the-case-definitions-for-r-s-v-in-terms-of-acute-respiratory-infection,-r-s-v-lower-respiratory-tract-disease,-and-r-s-v-severe-lower-respiratory-tract-disease.-acute-respiratory-infection-was-defined-as-a-presence-of-2-or-more-respiratory-symptoms-or-signs-for-24-or-more-hours,-or-at-least-1-respiratory-and-1-systemic-symptom-or-sign-for-at-least-24-hours.-lower-respiratory-tract-disease-was-defined-as-a-presence-of-2-or-more-lower-respiratory-symptoms-or-signs-including-1-or-more-respiratory-signs-for-at-least-24-hours,-or-3-or-more-lower-respiratory-symptoms-for-at-least-24-hours.-severe-lower-respiratory-tract-disease-was-defined-as-presence-of-2-or-more-lower-respiratory-signs-or-episode-preventing-normal,-everyday-activities.

Figure adapted with permission from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023
All RSV cases were confirmed by RT-PCR. All RSV-LRTD cases and severity of LRTD were assessed by independent external adjudication committee

Selected inclusion and exclusion criteria1

Key inclusion criteria

  • Males or females, ≥60 years of age at first RSV vaccination, who lived in the general community or a long-term care facility
  • Participants who, in the opinion of the investigator, could and would comply with the protocol
  • Written or witnessed informed consent
  • Participants with chronic conditions such as diabetes, hypertension or cardiac disease (with or without specific treatment), assessed as medically stable in the opinion of the investigator

Key exclusion criteria

  • Confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy
  • Serious or unstable chronic illness
  • Any history of dementia or any medical condition that moderately or severely impairs cognition
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
  • Administration of long-acting immune-modifying drugs, immunoglobulins and/or any blood products or plasma
  • Chronic administration (>14 consecutive days) of immunosuppressants or other immune-modifying drugs within 90 days of the first study vaccination

Demographic characteristics1,5

Demographic characteristics were balanced between study groups (exposed set)

table-showing-the-demographic-characteristics-of-the-participants-enrolled-in-the-AReSVi-006-study.-demographic-characteristics-were-similar-between-participants-who-received-the-r-s-v-pre-f-3-o-a-vaccine-and-those-who-received-placebo.

Around 39% of participants in each group had ≥1 pre-existing comorbidity of interest‡ associated with an increased risk of severe RSV disease

Figure was independently created for GSK from the original data from Papi A et al. N Engl J Med 2023;388(7):595–608

*Includes Native American, Alaska Native, Native Hawaiian and other Pacific Islanders; †assessed by a gait speed test; ‡COPD, asthma, any chronic respiratory/pulmonary disease, and chronic heart failure (cardiorespiratory condition), diabetes mellitus type 1 or type 2, advanced liver or renal disease (endocrine or metabolic condition)

Study Results: Primary Objective and Efficacy

The primary objective was met: a single dose of RSVPreF3 OA vaccine is highly efficacious in the prevention of RSV-LRTD during the first RSV season.1

Primary objective

forest-plot-showing-the-primary-endpoint,-vaccine-efficacy-against-r-s-v-related-lower-respiratory-tract-disease,-in-adults-60-years-or-older-during-the-first-r-s-v-season.-the-criterion-for-meeting-the-primary-objective-was-a-lower-limit-of-the-confidence-interval-around-the-efficacy-estimate-of-greater-than-20-percent.-the-primary-objective-was-met-with-a-vaccine-efficacy-against-r-s-v-lower-respiratory-tract-disease-of-82.6-percent-during-the-first-r-s-v-season.

Figure adapted with permission from Ison MG et al. A respiratory syncytial virus (RSV) prefusion F protein candidate vaccine (RSVPreF3 OA) is efficacious in adults ≥60 years of age (YOA). Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

*LRTD defined as ≥2 lower respiratory symptoms/signs for ≥24 hours including ≥1 lower respiratory sign, or ≥3 lower respiratory symptoms for ≥24 hours. All RSV cases confirmed by RT-PCR

Consistently high efficacy was observed across a broad spectrum of RSV-associated disease, in subgroups at increased risk of developing severe RSV-LRTD including adults with ≥1 comorbidity of interest, and across RSV-A and RSV-B subtypes.1

RSVPreF3 OA demonstrated consistently high VE across a broad spectrum of RSV-associated disease1,3

forest-plot-showing-vaccine-efficacy-across-a-broad-spectrum-of-r-s-v-associated-disease.-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-82.6-percent-against-r-s-v-related-lower-respiratory-tract-disease,-94.1-percent-against-severe-r-s-v-related-lower-respiratory-tract-disease,-and-71.7-percent-against-r-s-v-related-acute-respiratory-infection-among-adults-aged-60-years-or-older-during-the-first-r-s-v-season.-the-r-s-v-pre-f-3-o-a-vaccine-demonstrated-consistently-high-vaccine-efficacy-across-a-spectrum-of-r-s-v-associated-disease.

Figure adapted with permission from Ison MG et al. A respiratory syncytial virus (RSV) prefusion F protein candidate vaccine (RSVPreF3 OA) is efficacious in adults ≥60 years of age (YOA). Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

*ARI defined as ≥2 respiratory symptoms/signs for ≥24 hours, or ≥1 respiratory symptom/sign + 1 systemic symptom/sign for ≥24 hours. LRTD defined as ≥2 lower respiratory symptoms/signs for ≥24 hours including ≥1 lower respiratory sign, or ≥3 lower respiratory symptoms for ≥24 hours. Severe LRTD defined as LRTD with ≥2 lower respiratory signs, or an LRTD episode assessed as severe by the investigator. All RSV cases confirmed by RT-PCR

One dose of RSVPreF3 OA produces durable vaccine efficacy against RSV-LRTD and severe RSV-LRTD over 2 full seasons4

column-graph-depicting-durable-vaccine-efficacy-of-a-single-dose-of-r-s-v-pre-f-3-o-a-against-r-s-v-related-lower-respiratory-tract-disease-over-both-one-season-and-two-seasons.-a-single-dose-of-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-82.6-percent-during-season-1-and-67.2-percent-across-seasons-1-and-2.
column-graph-depicting-durable-vaccine-efficacy-of-a-single-dose-of-r-s-v-pre-f-3-o-a-against-severe-r-s-v-related-lower-respiratory-tract-disease-over-both-one-season-and-two-seasons.-a-single-dose-of-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-94.1-percent-during-season-1-and-78.8-percent-across-seasons-1-and-2.

Figures independently created for GSK from the original data from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

Modified exposed set. *Up to end of Season 1 in the Northern Hemisphere (April 2022 analysis); †from 15 days post-Dose 1 up to end of Season 2 in the Northern Hemisphere (March 2023 analysis); ‡the VE is estimated using a Poisson regression model adjusted using age and geographic region1; §the VE is estimated using a Poisson regression model adjusted using age, geographic region and season6; ǁ96.95% CI for VE against LRTD Season 1, 95% CI for VE against severe LRTD Season 1, 97.5% CI for Seasons 1 + 2

Revaccination after 12 months does not appear to confer additional efficacy benefit for overall population; future data will inform optimal timing of revaccination4

column-graph-showing-vaccine-efficacy-across-2-full-seasons-after-a-single-dose-and-after-two-doses-12-months-apart.-a-single-dose-of-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-67.2-percent-against-r-s-v-related-lower-respiratory-tract-disease-across-2-r-s-v-seasons.-revaccination-12-months-after-the-first-dose-had-an-efficacy-of-67.1-percent-against-r-s-v-related-lower-respiratory-tract-disease-across-2-r-s-v-seasons.

Figure was independently created for GSK from the original data from Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY). Presented at ACIP; June 21, 2023

Modified exposed set. *Up to end of Season 1 in the Northern Hemisphere (April 2022 analysis); †from 15 days post-Dose 1 up to end of Season 2 in the Northern Hemisphere (March 2023 analysis); ‡the VE is estimated using a Poisson regression model adjusted using age and geographic region1; §the VE is estimated using a Poisson regression model adjusted using age, geographic region and season6; ǁ96.95% CI for VE against LRTD Season 1, 97.5% CI for Seasons 1 + 2

RSVPreF3 OA had high and consistent VE against severe RSV-associated disease and in older adults1,3

forest-plot-showing-vaccine-efficacy-against-lower-respiratory-tract-disease-by-age-stratum.-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-82.6-percent-in-overall-participants-aged-60-years-or-older,-81.0-percent-in-participants-aged-60-to-69-years,-and-93.8-percent-in-participants-aged-70-to-79-years-during-the-first-r-s-v-season.

Figure adapted with permission from Ison MG et al. A respiratory syncytial virus (RSV) prefusion F protein candidate vaccine (RSVPreF3 OA) is efficacious in adults ≥60 years of age (YOA). Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

High VE against RSV-LRTD in older adults with ≥1 pre-existing comorbidity of interest and in older adults at increased risk1,3,7

forest-plot-showing-vaccine-efficacy-against-lower-respiratory-tract-disease-in-vulnerable-populations.-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-94.6-percent-in participants-with-at-least-one-comorbidity-of-interest,-92.1-percent-in-participants-with-at-least-one-cardiorespiratory-condition,-100-percent-in-participants-with-at-least-one-endocrine-metabolic-condition,-and-92.9-percent-in-pre-frail-participants-during-the-first-r-s-v-season.

Figure adapted with permission from Rizkalla B. RSVPreF3 Vaccine for Respiratory Syncytial Virus (RSV) in Older Adults. Presented at Vaccines and Related Biological Products Advisory Committee; March 1, 2023

*COPD, asthma, any chronic respiratory/pulmonary disease, diabetes type 1 or type 2, chronic heart failure, advanced liver or renal disease; †frailty was assessed by a gait speed test

Consistently high VE against RSV-A– and RSV-B–associated disease1,3,7

forest-plot-showing-vaccine-efficacy-against-lower-respiratory-tract-disease-by-r-s-v-subtype.-r-s-v-pre-f-3-o-a-vaccine-had-an-efficacy-of-84.6-against-r-s-v-a-subtype,-and-80.9-percent-against-r-s-v-b-subtype,-during-the-first-r-s-v-season.

Figure adapted with permission from Rizkalla B. RSVPreF3 Vaccine for Respiratory Syncytial Virus (RSV) in Older Adults. Presented at Vaccines and Related Biological Products Advisory Committee; March 1, 2023

*One case confirmed by local test without confirmation of subtype

Study Results: Safety

RSVPreF3 OA was well tolerated. Most solicited adverse events (AEs) were transient and mild-to-moderate in severity. Unsolicited AEs, serious AEs (SAEs), fatal SAEs, and potential immune-mediated diseases (pIMD) were balanced between groups.1–3

Reactogenicity and safety profiles of a second dose were in line with the first dose.4

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Most frequently reported solicited AEs were pain at the injection site, fatigue, myalgia, headache, and arthralgia.1,3

Solicited AEs reported within 4 days of vaccination with a single dose of RSVPreF3 OA (solicited safety set, n=1757)

column-graph-depicting-the-local-solicited-adverse-events-within-4-days-of-vaccination-in-participants-who-received-either the-r-s-v-pre-f-3-o-a-vaccine-or-placebo-in-the-AReSVi-006-study.-in-participants-who-received-the-r-s-v-pre-f-3-o-a-vaccine-the-most-frequently-reported-local-solicited-adverse-event-was-pain-at-the-injection-site.-most-solicited-reactions-were-of-mild-or-moderate-intensity-and-resolved-within-a-mean-duration-of-1-to-2-days.
column-graph-depicting-the-systemic-solicited-adverse-events-within-4-days-of-vaccination-in-participants-who-received-either the-r-s-v-pre-f-3-o-a-vaccine-or-placebo-in-the-AReSVi-006-study.-in-participants-who-received-the-r-s-v-pre-f-3-o-a-vaccine-the-most-frequently-reported-systemic-solicited-adverse-events-were-fatigue,-myalgia,-and-headache.-most-solicited-reactions-were-of-mild-or-moderate-intensity-and-resolved-within-a-mean-duration-of-1-to-2-days.

Figure adapted with permission from Ison MG et al. A respiratory syncytial virus (RSV) prefusion F protein candidate vaccine (RSVPreF3 OA) is efficacious in adults ≥60 years of age (YOA). Presented at IDWeek; October 19−23, 2022, Washington, DC, USA

Error bars show 95% CIs for total AEs

Unsolicited AEs, SAEs, fatal SAEs, and pIMDs were balanced between groups.1
The majority of unsolicited AEs were transient, mild-to-moderate in severity1,5

column-graph-showing-unsolicited-adverse-events,-serious-adverse-events,-fatal-serious-adverse-events,-and-potential-immune-mediated-diseases-in-participants-who-received-r-s-v-pre-f-3-o-a-vaccine-or-placebo.-in-the-solicited-safety-population,-the-incidence-of-unsolicited-adverse-events-within-30-days-after-injection-was-balanced-between-the-two-groups.-in-the-exposed-population,-33.0-percent-of-participants-in-the-vaccine-group-versus-17.8-percent-in-the-placebo-group-reported-unsolicited-adverse-events-within-30-days-post-vaccination.-overall-incidences-of-serious-adverse-events,-deaths-and-potential-immune-mediated-diseases-up-to-6-months-post-vaccination-were-similar-between-r-s-v-pre-f-3-o-a-vaccine-and-placebo-groups.

Figure adapted with permission from Rizkalla B. GSK RSV OA candidate vaccine clinical development. Presented at ACIP; October 20, 2022

*Follow-up is ongoing until the end of the study

In the exposed set, the RSVPreF3 OA group reported more unsolicited AEs within 30 days than placebo group. These unsolicited AEs were largely due to reactogenicity events, primarily in participants who were not included in the solicited safety set and thus reported reactogenicity events as unsolicited AEs.1

The independent data monitoring committee has not raised any safety concerns during their regular review of the unblinded safety data.1

Learn More About Study 006

Papi A et al. N Engl J Med 2023;388(7):595–608

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RSVPreF3 OA Overview

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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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Abbreviations

ACIP, Advisory Committee on Immunization Practices; AE, adverse event; ARI, acute respiratory infection; CI, confidence interval; COPD, chronic obstructive pulmonary disease; LL, lower limit; LRTD, lower respiratory tract disease; pIMD, potential immune-mediated disease; R, randomization; RSV, respiratory syncytial virus; RT-PCR, real-time polymerase chain reaction; SAE, serious adverse event; VE, vaccine efficacy; YOA, years of age.

References

  1. Papi A et al. N Engl J Med 2023;388(7):595–608
  2. ClinicalTrials.gov. NCT04886596. https://clinicaltrials.gov/study/NCT04886596 Accessed August 2023.
  3. Ison MG et al. A respiratory syncytial virus (RSV) prefusion F protein candidate vaccine (RSVPreF3 OA) is efficacious in adults ≥60 years of age (YOA). Presented at IDWeek; October 19–23, 2022, Washington, DC, USA.
  4. Friedland L. GSK’s RSVPreF3 OA Vaccine (AREXVY) Presented at ACIP; June 21, 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/03-RSV-Adults-Friedland-508.pdf Accessed August 2023.
  5. Rizkalla B. GSK RSV OA candidate vaccine clinical development. Presented at ACIP; October 20, 2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-10-19-20/02-RSV-Adults-Rizkalla-508.pdf. Accessed August 2023.
  6. GSK press release, June 2023. https://www.gsk.com/en-gb/media/press-releases/gsk-shares-positive-data-for-arexvy-its-respiratory-syncytial-virus-older-adult-vaccine-indicating-protection-over-two-rsv-seasons #:~:text=Cumulative%20efficacy%20over%20two%20seasons,benefit%20for%20the%20overall%20population Accessed August 2023.
  7. GSK. RSVPreF3 Vaccine for Respiratory Syncytial Virus (RSV) in Older Adults Presented at Vaccines and Related Biological Products Advisory Committee, March 1, 2023. https://www.fda.gov/media/165649/download Accessed August 2023.

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