Respiratory Syncytial Virus (RSV)Phase 4NCT06077149
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
A Phase 4 study testing RSV vaccine in people with Respiratory Syncytial Virus (RSV), run by University of Rochester at 1 site in United States.
Trial summary
This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- RSV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 1 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥60 years of age who live in skilled nursing facilities or reside independently in the community
- Life expectancy of >6 months, as assessed by the investigator
- Able to sign informed consent or to provide consent via a legally authorized representative (LAR)
Who cannot join
- History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
- History of hypersensitivity or reaction to any vaccine component
- Simultaneous administration of another vaccine (influenza, SARS-CoV-2) or within a 14-day window before or after intervention
- Previous receipt or intended receipt of an RSV vaccine outside the study
- Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
- Documented RSV infection within 2 months prior to study intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Comparison of Immunogenicity of Licensed RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) to Community-dwelling Older Adults
This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.
Read the detailed description
This was an open label non-inferiority study to evaluate immunogenicity where all participants received either the Pfizer RSV Vaccine (ABRYSVO) or GSK RSV Vaccine (AREXVY) as part of Standard of Care (SOC). Hereafter, vaccines will be referred to as Pfizer and GSK.
The study was conducted at the University of Rochester Medical Center (URMC) Infectious Disease Research Clinic (IDRC) and 2 local LTCFs. Vaccinations were carried out between November and December 2023. LTCF A provided GSK vaccine and LTCF B provided Pfizer vaccine to their residents as part of SOC. The community cohort was divided equally to receive Pfizer and GSK to mirror the Pfizer and GSK vaccinations in LTCF. The study was reviewed and approved by the University of Rochester Institutional Review Board and leadership at the local LTCFs. Participants or their legally authorized representative (LAR) signed written informed consent. Verbal consent by LAR was also accepted given the minimal risk nature of the study.
Participants:
Inclusion criteria were intended to be broad with relatively few exclusions to reflect a real-life population in LTCF and the older adults in the community. Inclusion criteria included: ≥60 years of age living LTCF or residing independently in the community, planning to receive a SOC RSV vaccine, life expectancy of >6 months, able to sign informed consent or to provide consent via a LAR. Exclusions included: history of a current immunosuppressive condition or medications, history of hypersensitivity or reaction to any vaccine component, any routine vaccination within a 14-day window before or planned after RSV vaccination, previous receipt or intended receipt of an RSV vaccine outside the study, receipt of blood/plasma products or immunoglobulin within 60 days before RSV vaccination, and documented RSV infection within 2 months prior to enrollment.
Study Procedures:
Prior to any study procedures informed consent was obtained from the participant or LAR. At enrollment demographic and medical history data were collected. A clinical assessment including vital signs and a symptom directed targeted physical exam was performed. Ten 10cc of blood was collected. Vaccination in LTCF were performed by the staff at each facility per SOC and the vaccine product and date of vaccination recorded. Vaccination of the community cohort was performed in the IDRC at enrollment visit. Visit two was scheduled 28 to 42 days following vaccination at which time a second 10cc blood sample was collected and participants were queried about any intercurrent illnesses. Results of any viral testing performed as part of standard of care were recorded. If a participant had an intercurrent RSV infection prior to RSV vaccination and vaccination was deferred, visit 2 was scheduled 28 -42 days after infection was documented.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- RSV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV vaccineBiological
All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly in the the non-dominant deltoid muscle.
Long-term care facility residents will get whichever vaccine is available at the facility as part of standard of care. Community cohort will be matched proportionally
| Study group | Role | What they receive |
|---|---|---|
| Long-term care facility residents | Experimental | Licensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC Receives: Biological: RSV vaccine |
| community dwelling adults | Active comparator | Licensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort Receives: Biological: RSV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Fold Rise Against RSV Fa Protein
Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV Fa protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.
Measured: 30 days
Geometric Mean Fold Rise Against RSV Fb Protein
Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV Fb protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.
Measured: 30 days
Geometric Mean Fold Rise Against RSV A2 Protein
Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV A2 protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.
Measured: 30 days
Secondary outcomes (1)
Ratio of Fold Response of RSV A2 Titer to Fa Titer
the ratio of fold response of RSV A2 neutralizing titer to Fa IgG binding titers was calculated as a measure of the relative proportion of functional F antibody produced
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start7 Nov 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Falsey, University of Rochester
- Investigators
- Ann Falsey, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077149
- Sponsor's protocol ID
- STUDY00008699
- Status last verified
- Oct 2025
- First submitted
- 4 Oct 2023
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Immunogenicity of Licensed RSV Vaccines in Residents of Long-Term Care Facilities (LTCF) to Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT06077149
- Acronym / sponsor ID
- STUDY00008699
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.
Detailed description
This was an open label non-inferiority study to evaluate immunogenicity where all participants received either the Pfizer RSV Vaccine (ABRYSVO) or GSK RSV Vaccine (AREXVY) as part of Standard of Care (SOC). Hereafter, vaccines will be referred to as Pfizer and GSK.
The study was conducted at the University of Rochester Medical Center (URMC) Infectious Disease Research Clinic (IDRC) and 2 local LTCFs. Vaccinations were carried out between November and December 2023. LTCF A provided GSK vaccine and LTCF B provided Pfizer vaccine to their residents as part of SOC. The community cohort was divided equally to receive Pfizer and GSK to mirror the Pfizer and GSK vaccinations in LTCF. The study was reviewed and approved by the University of Rochester Institutional Review Board and leadership at the local LTCFs. Participants or their legally authorized representative (LAR) signed written informed consent. Verbal consent by LAR was also accepted given the minimal risk nature of the study.
Participants:
Inclusion criteria were intended to be broad with relatively few exclusions to reflect a real-life population in LTCF and the older adults in the community. Inclusion criteria included: ≥60 years of age living LTCF or residing independently in the community, planning to receive a SOC RSV vaccine, life expectancy of >6 months, able to sign informed consent or to provide consent via a LAR. Exclusions included: history of a current immunosuppressive condition or medications, history of hypersensitivity or reaction to any vaccine component, any routine vaccination within a 14-day window before or planned after RSV vaccination, previous receipt or intended receipt of an RSV vaccine outside the study, receipt of blood/plasma products or immunoglobulin within 60 days before RSV vaccination, and documented RSV infection within 2 months prior to enrollment.
Study Procedures:
Prior to any study procedures informed consent was obtained from the participant or LAR. At enrollment demographic and medical history data were collected. A clinical assessment including vital signs and a symptom directed targeted physical exam was performed. Ten 10cc of blood was collected. Vaccination in LTCF were performed by the staff at each facility per SOC and the vaccine product and date of vaccination recorded. Vaccination of the community cohort was performed in the IDRC at enrollment visit. Visit two was scheduled 28 to 42 days following vaccination at which time a second 10cc blood sample was collected and participants were queried about any intercurrent illnesses. Results of any viral testing performed as part of standard of care were recorded. If a participant had an intercurrent RSV infection prior to RSV vaccination and vaccination was deferred, visit 2 was scheduled 28 -42 days after infection was documented.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term care facility residents | Experimental | Biological: RSV vaccineLicensed RSV vaccine IM x 1. Specific product to be determined availability at the facility as SOC |
| community dwelling adults | Active comparator | Biological: RSV vaccineLicensed RSV vaccine IM x1. The proportion of specific products will be matched to the LTCF cohort |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥60 years of age who live in skilled nursing facilities or reside independently in the community
- Life expectancy of >6 months, as assessed by the investigator
- Able to sign informed consent or to provide consent via a legally authorized representative (LAR)
Key exclusion criteria (6 listed)
- History of a current immunosuppressive condition or receipt of chemotherapy or other immunosuppressive or cytotoxic therapy, including chronic prednisone use of ≥ 20 mg/day for more than 14 days within 3 months of study vaccination
- History of hypersensitivity or reaction to any vaccine component
- Simultaneous administration of another vaccine (influenza, SARS-CoV-2) or within a 14-day window before or after intervention
- Previous receipt or intended receipt of an RSV vaccine outside the study
- Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV vaccineAll participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly in the the non-dominant deltoid muscle. Long-term care facility residents will get whichever vaccine is available at the facility as part of standard of care. Community cohort will be matched proportionally | Biological | Long-term care facility residents, community dwelling adults |
Primary outcome
Geometric Mean Fold Rise Against RSV Fa Protein
Time frame: 30 days
Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV Fa protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.
Geometric Mean Fold Rise Against RSV Fb Protein
Time frame: 30 days
Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV Fb protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.
Geometric Mean Fold Rise Against RSV A2 Protein
Time frame: 30 days
Microneutralization Assay (MNA): Serum neutralizing titers will be performed using an established microneutralization method for RSV A and B strains. Briefly, 2-fold serum dilutions are incubated with 75 plaque forming units of RSV for 30 min at room temperature followed by the addition of 104HEp-2cells in 96-well culture plates. After 3 days, the quantity of RSV antigen is determined by enzyme immunoassay using a monoclonal antibody to the RSV A2 protein. The geometric mean fold rise is the neutralizing antibody titer at day 30 divided by the neutralizing antibody titer at day 0. Calculated as the geometric mean of the fold rise (post-vaccination titer divided by baseline titer) across participants.
1 secondary outcome
Ratio of Fold Response of RSV A2 Titer to Fa Titer
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Falsey principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RSV vaccine in people with Respiratory Syncytial Virus (RSV), run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Fold Rise Against RSV Fa Protein (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.