A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease

N/AActive Not RecruitingNCT06077968

Pfizer1 enrolled

Overview

The main purpose of this study is to learn about the effectiveness of Pfizer's ABRYSVO vaccine. This vaccine helps to prevent infections caused by Respiratory Syncytial Virus (RSV). RSV is a virus that can cause infections in the airways. These symptoms can be cold-like symptoms, but in some cases can lead to severe symptoms or hospitalization. This study uses only healthcare data that are already collected from routine visits to healthcare providers. This means that participants will not be actively enrolled in the study and there are no study treatments. The study will look at data for about two years. This study will look at patient information from: * Adults ages 60 years and older * Adults who are eligible to receive the ABRYSVO vaccination Substudy A: * This study will assess the duration of protection of ABRYSVO in adults ages 60 years and older after completion of the original study. * The substudy will look at data from subsequent RSV seasons after the first dose of ABRYSVO for about 3 years. Substudy B: * This study will assess vaccine effectiveness of ABRYSVO after revaccination in routine use, pending ACIP recommendation for revaccination. * The substudy will look at data for about 2 years after revaccination.

The overall research question asks how effective ABRYSVO® is against severe RSV disease in real-world populations. The primary objective of this study is to estimate the VE of Pfizer's ABRYSVO® vaccine against RSV-related LRTD hospitalizations among Kaiser Permanente Southern California members who are eligible for vaccination per current Advisory Committee on Immunization Practices (ACIP) recommendations. Key secondary objectives include determining ABRYSVO® VE against RSV-related LRTD hospitalizations among the immunocompetent and stratified by age group (60-74 years vs 75 years and older). Additional secondary objectives include assessment of ABRYSVO® VE stratified by RSV subgroup, against ARI endpoints, death, among high-risk subgroups, and against critical outcomes. A case control study with test negative design will be the primary analysis assessing RSV-related outcomes. An exploratory cohort design may also be used to assess all-cause outcomes and RSV-related outcomes. Standard-of-care specimens (e.g. stored remnant respiratory specimens) from patients who did not receive RSV testing, who tested negative for RSV via RSV-only test, or a had limited multiplex viral respiratory panel assay will be salvaged and tested using a full respiratory multiplex polymerase chain reaction (PCR) panel at KPSC. Further, all RSV positives will be tested for RSV A and RSV B.

Study Type

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. KPSC patients eligible to receive ABRYSVO® per current ACIP recommendations for adults ages 60 and older who are admitted to the hospital with ARI/LRTD, (defined using International Classification of Diseases (ICD) codes after start of study period, and who have had an RSV test, either through SOC testing or blinded study testing of remnant respiratory specimens. 2. For secondary objectives estimating VE against ED admission, the TND will include KPSC patients eligible to receive ABRYSVO® who present to the ED with ARI/LRTD after start of study period, and who have had an RSV test, either through standard of care testing or blinded study testing of remnant respiratory specimens. 3. For exploratory objectives estimating VE against RSV-related cardiac hospitalization, the TND will include KPSC patients eligible to receive ABRYSVO® who are hospitalized or present to the ED with cardiac events (defined using ICD codes) after start of study period, and who have had an RSV test, either through SOC testing or blinded study testing of remnant respiratory specimens. 4. We will include membership requirement of 1 year prior to index date, which is defined as the date of hospitalization or ED admission (allowing 45-day administrative gap), to facilitate accurate capture of comorbid conditions. Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: We will exclude patients who receive another licensed or investigational RSV vaccine prior to hospitalization or ED visit from the study population and analysis. Patients will be excluded if the index date is within certain time windows from vaccination date, outlined further in the exposure section below. SSA and SSB Eligibility Criteria: The inclusion criteria for Substudy A are described above for the Test Negative Design.

Outcomes

Primary Outcomes

1. Vaccine Effectiveness (VE) calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with ABRYSVO for RSV-related hospitalized LRTD cases and controls, multiplied by 100%.

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO against RSV-related LRTD hospitalizations

Time frame: Up to 2 years

Secondary Outcomes

Key Secondary 1: Among the immunocompetent, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related LRTD hospitalizations cases and controls, multiplied by 100%.

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations among the immunocompetent.

Time frame: Up to 2 years

Key Secondary 2: ABRYSVO® VE estimates stratified by age group

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by age group (60-74 years vs 75 years and older)

Time frame: Up to 2 years

Secondary 3: To further describe the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by RSV subgroup (A and B)

Adjusted for confounding factors using logistic regression. ABRYSVO® VE estimates stratified by virus subgroups

Time frame: Up to 2 years

Secondary 4: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related severe LRTD cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related severe LRTD.

Time frame: Up to 2 years

Secondary 5: ABRYSVO® VE estimates stratified by frailty index

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalization stratified by frailty index.

Time frame: Up to 2 years

Secondary 6: ABRYSVO® VE estimates stratified by chronic medical condition risk category

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations, stratified by chronic medical condition risk category (3 strata: not high-risk conditions, immunocompromising high-risk conditions, non-immunocompromising high-risk conditions).

Time frame: Up to 2 years

Secondary 7: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized LRTD cases and controls, multiplied by 100%, among those with CHF or COPD

Adjusted for confounding factors using logistic regression. Among those with congestive heart failure (CHF) or Chronic Obstructive Pulmonary Disease (COPD,) to estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations

Time frame: Up to 2 years

Secondary 8-1: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for ED (without subsequent hospitalization) cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against ED admission (without subsequent hospitalization)

Time frame: Up to 2 years

Secondary 8-2: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for hospitalized or ED visit (without subsequent hospitalization) cases and controls, multiplied by 100%.

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against ED (without subsequent hospitalization) or hospitalization

Time frame: Up to 2 years

Secondary 9: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related death cases and controls, multiplied by 100%.

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related death

Time frame: Up to 2 years

Secondary 10-1: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for hospitalized RSV-related ARI cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related ARI hospitalization

Time frame: Up to 2 years

Secondary 10-2: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related ARI ED visit (without subsequent hospitalization) cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related ARI ED visits (without subsequent hospitalization).

Time frame: Up to 2 years

TND Secondary 10-3: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for ED visit (without subsequent hospitalization) or hospitalized RSV-related ARI cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related hospitalization or ED visits (without subsequent hospitalization)

Time frame: 2 years

TND Secondary 11: Describe age, sex, race/ethnicity, clinical and laboratory characteristics, and disease severity (length of stay [LOS], intensive care unit [ICU] admission, respiratory support) of any patients who received ABRYSVO

To describe demographic, clinical, and laboratory characteristics and disease severity of any RSV events among vaccinated individuals as compared to unvaccinated

Time frame: Up to 2 years

Secondary 12: ABRYSVO® RSV-related VE estimates stratified by age group and chronic medical risk categories

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by age group and chronic medical risk categories.

Time frame: Up to 2 years

Secondary 13: ABRYSVO® VE estimates stratified by immunocompromised status

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations stratified by (1) immunocompromised vs immunocompetent, and separately (2) within those with immunocompromising condition, by severe vs moderate immunocompromised status.

Time frame: 2 years

Secondary 14: VE calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with ABRYSVO® for hMPV-related hospitalized ARI/LRTD cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against hMPV-related ARI/LRTD hospitalizations

Time frame: 2 years

Secondary 15: ABRYSVO® VE estimates stratified by age group.

Adjusted for confounding factors using logistic regression. To estimate ABRYSVO® VE against RSV-related LRTD hospitalizations by alternative age groups 60-69 years, 70-79 years, 80 years and older

Time frame: 2 years

Secondary 16: Among the immunocompetent, VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visits LRTD cases and controls, multiplied by 100%

Adjusted for confounding factors using logistic regression. To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) among the immunocompetent.

Time frame: 2 years

Secondary 17: ABRYSVO® VE estimates stratified by age group

Time frame: 2 years

SSA Primary: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using LRTD events from the 3rd season

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 3rd RSV season after a single dose

Time frame: Up to 3 years

SSA Secondary 1: VE calculated as 1 minus the OR comparing the odds of ABRYSVO® vaccination and timing compared with unvaccinated, stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from the 3rd season

To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) in the third season after a single dose by time since vaccination, defined in 3-month intervals up to 36 months

Time frame: Up to 3 years

SSA Secondary 2: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%*, using LRTD events from the 2nd season

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 2nd RSV season after a single dose

Time frame: Up to 2 years

SSA Secondary 3: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%, using LRTD events from the 4th season

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 4th RSV season after a single dose

Time frame: Up to 4 years

SSA Secondary 4: VE calculated as 1 minus the OR comparing the odds of being vaccinated with ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%*, using LRTD events from the 5th season

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED visits (without subsequent hospitalization) during the 5th RSV season after a single dose

Time frame: Up to 5 years

SSA Secondary 5: VE calculated as 1 minus the OR comparing the odds of ABRYSVO® vaccination and timing compared with unvaccinated, stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from the 2nd season

To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the second season after a single dose by time since vaccination, defined in 3-month intervals up to 24 months

Time frame: Up to 2 years

SSA Secondary 6: VE calculated as 1 minus the OR comparing the odds of ABRYSVO® vaccination and timing compared with unvaccinated, stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from the 4th season

To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the fourth season after a single dose by time since vaccination, defined in 3-month intervals up to 48 months

Time frame: Up to 4 years

SSA Secondary 7: VE calculated as 1 minus the OR comparing the odds of ABRYSVO® vaccination and timing compared with unvaccinated, stratified by time since vaccination, multiplied by 100%, using LRTD hospitalization/ED events from the 5th season

To estimate effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations/ED visits (without subsequent hospitalization) in the fifth season after a single dose by time since vaccination, defined in 3-month intervals up to 60 months

Time frame: Up to 3 years

SSB Primary: VE calculated as 1 minus the odds ratio comparing the odds of being vaccinated with two doses of ABRYSVO® vs not vaccinated with any dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 0 dose of ABRYSVO®, in the first season after revaccination

Time frame: Up to 2 years

SSB Secondary 1: VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs being vaccinated with one dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 1 dose of ABRYSVO®, in the first season after revaccination

Time frame: Up to 2 years

SSB Secondary 2: VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs not vaccinated with any dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%

Time frame: Up to 2 years

SSB Secondary 3: VE calculated as 1 minus the OR comparing the odds of being vaccinated with two doses of ABRYSVO® vs being vaccinated with one dose of ABRYSVO® for RSV-related hospitalized/ED visit LRTD cases and controls, multiplied by 100%

To estimate the effectiveness of ABRYSVO® against RSV-related LRTD hospitalizations or ED events (without subsequent hospitalization) after revaccination among those with 2 vs 1 dose of ABRYSVO®, in the second season after revaccination

Time frame: Up to 2 years

A Study to Learn About ABRYSVO Vaccine in Older Adults to Prevent Severe Respiratory Syncytial Virus (RSV) Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes