Clinical trial NCT06890416: A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults
Official title: A PHASE 3, MULTICENTER, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH HERPES ZOSTER SUBUNIT VACCINE IN ADULTS ≥50 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: RSV
Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 526
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.


Eligibility criteria: Inclusion Criteria

• Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions

Exclusion Criteria

* Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-confirmed HZ within the past 12 months.
* Prior history of any subtype of Guillain Barré syndrome of any etiology.
* Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination, and medication list
* Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt of a nonstudy RSV vaccine during study participation.
* Previous vaccination with any licensed recombinant adjuvant zoster vaccine (Shingrix) at any time prior to enrollment, or planned receipt of a nonstudy licensed VZV vaccine (Shingrix) during study participation.
* History of previous vaccination with live HZ vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation.
* Previous vaccination with any investigational VZV vaccine at any time prior to enrollment, or planned receipt of a nonstudy investigational VZV vaccine during study participation.
* Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids (defined as ≥20 mg/day of prednisone or equivalent for ≥14 days), eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration, or planned receipt throughout the study.

Primary outcomes:
measure: Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone
timeFrame: 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
measure: Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
timeFrame: 1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group
measure: Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination
timeFrame: Within 7 Days after each vaccination (Vaccination on Day 1)
measure: Percentage of Participants with Systemic Events Within 7 Days after Vaccination
timeFrame: Within 7 Days after each vaccination (Vaccination on Day 1)
measure: Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination
timeFrame: Within 1 Month after last vaccination
measure: Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
timeFrame: Within 4 Months after first study vaccination (Vaccination on Day 1)
Secondary outcomes:
measure: NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
timeFrame: Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
measure: NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
timeFrame: Before vaccination and 1 month after vaccination with RSVpreF
measure: NTs for RSV A and RSV B expressed as seroresponse rate
timeFrame: 1 month after vaccination with RSVpreF
measure: Anti-gE antibody concentrations expressed as GMCs
timeFrame: Before vaccination and 1 month after the second dose of HZ/su
measure: Anti-gE antibody concentrations expressed as GMFRs
timeFrame: Before vaccination and 1 month after the second dose of HZ/su
measure: Anti-gE antibody concentrations expressed as seroresponse rate
timeFrame: 1 month after the second dose of HZ/su
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Mobile
country: United States
facility: AMR Clinical
state: Alabama
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Miami
country: United States
facility: De La Cruz Research Center, LLC
state: Florida
city: Columbus
country: United States
facility: Centricity Research Columbus Georgia Multispecialty
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc.
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Silver Spring
country: United States
facility: Jadestone Clinical Research
state: Maryland
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Warren
country: United States
facility: IMA Clinical Research Warren
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugar Land
state: Texas
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: