A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults

Last updated: December 27, 2024
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

2

Condition

Herpes Simplex Infections

Chickenpox (Varicella Zoster Infection)

Shingles

Treatment

Shingrix

Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection

Selected Vaccine Candidate group (Dose level, Schedule)

Clinical Study ID

NCT05703607
C5031001
  • Ages 50-69
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this clinical study is to learn about the safety, extent of the side effects (reaction to vaccine), and immune response (your immune system's reaction) of the study vaccine called Varicella Zoster Virus modRNA (VZV modRNA). We are seeking for healthy participants who are between 50 and 69 years of age.

This study will be conducted in 2 substudies: Substudy A (Phase 1) and Substudy B (Phase 2).

Substudy A:

This substudy is the Phase 1 portion of the study. In this substudy, participants will receive 1 of 3 VZV modRNA vaccine candidates (different construct, different dose levels and different formulation [frozen or freeze dry powder]) or the approved shingles vaccine intramuscularly.

Participants will be assigned in 1 of 14 groups in the study. Vaccination will be given either as a 2-dose series using one of two dosing schedules (either 2-months apart or 6-months apart), or (in one of the groups), as a single VZV modRNA vaccine at the first vaccination visit and saline at the second vaccination visit.

Participants will take part in this study for 8 to 12 months depending on the group they are assigned to. Some group(s) will continue into persistence-of-immunity (overtime assessment of effect of vaccine) portion of the study. Those participants assigned to these selected groups will be involved in the study for up to 5 years.

Substudy B:

This substudy is the Phase 2 portion of the study. In this part of the study, participants will receive either VZV modRNA vaccine at selected dose level/schedule/formulation or approved shingles vaccine. This selection will be determined from Substudy A.

Participants will be involved in this study for up to 5 years.

Eligibility Criteria

Inclusion

Substudy A: Group 1 to Group 10

Inclusion Criteria:

  1. Male or female participants 50 through 69 years of age (inclusive) at the time ofconsent.

  2. Healthy participants who are determined by clinical assessment, including medicalhistory and clinical judgment of the investigator, to be eligible for inclusion inthe study. Note: Known infection with HIV, HCV or HBV is an exclusion in Substudy A.

  3. Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.

  4. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the ICD and in this protocol

Substudy A: Group 11 to Group 14

Inclusion Criteria:

  1. Male or female participants 50 through 69 years of age (inclusive) at the time ofconsent.

  2. Healthy participants who are determined by clinical assessment, including medicalhistory and clinical judgment of the investigator, to be eligible for inclusion inthe study. Note: Known infection with HIV, HCV or HBV is an exclusion in Substudy A.

  3. Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.

  4. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the ICD and in this protocol.

  5. Has a body mass index (BMI) between 18 and 35 (inclusive) kg/m2 at the screeningvisit.

Substudy A: Group 1 to Group 10

Exclusion

Exclusion Criteria:

  1. History of HZ (shingles).

  2. History of Guillain-Barré syndrome.

  3. Known infection with HIV, HCV, or HBV.

  4. History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the study intervention(s).

  5. Immunocompromised individuals with known or suspected immunodeficiency, asdetermined by history and/or laboratory/physical examination.

  6. Bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the investigator, contraindicate intramuscular injection.

  7. Other medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  8. Women who are pregnant or breastfeeding.

  9. Prior history of heart disease (eg, heart failure, recent coronary artery disease,cardiomyopathies, pericarditis/myocarditis).

  10. Previous vaccination with any varicella or HZ vaccine.

  11. Individuals who receive treatment with immunosuppressive therapy, includingcytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmunedisease, or planned receipt throughout the study.

  12. Receipt of blood/plasma products or immunoglobulin, from 60 days before studyintervention administration or planned receipt throughout the study.

  13. Any participant who has received or plans to receive an RNA vaccine 28 days prior toVaccination 1.

  14. Participation in other interventional studies within 28 days prior to study entry oranticipated involvement through and including 6 months after the last dose of studyintervention. Participation in observational studies is permitted.

  15. Any screening hematology and/or blood chemistry laboratory value that meets thedefinition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin Ivalue.

  16. Screening 12-lead ECG that, as judged by the investigator, is consistent withprobable or possible myocarditis/pericarditis or demonstrates clinically relevantabnormalities that may affect participant safety or interpretation of study results.

  17. Participation or planned participation in strenuous or endurance exercise within 7days before or after each study intervention administration.

  18. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.

Substudy A: Group 11 to Group 14 Exclusion Criteria;

  1. History of HZ (shingles).

  2. History of Guillain-Barré syndrome.

  3. Known infection with HIV, HCV, or HBV.

  4. History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the study intervention(s).

  5. Immunocompromised individuals with known or suspected immunodeficiency, asdetermined by history and/or laboratory/physical examination.

  6. Bleeding diathesis or condition associated with prolonged bleeding (including use ofanticoagulant medications within 7 days prior to enrollment) that wouldcontraindicate IM injection or imply treatment or prophylaxis of known cardiac orvalvular disease. Note: The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the useof other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors,or warfarin derivatives from 7 days prior to enrollment through conclusion of studyparticipation is exclusionary.

  7. Other medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study. This includes a history of alcohol or drug abuse asdetermined by the investigator.

  8. Women who are pregnant or breastfeeding.

  9. Prior history of heart disease (eg, heart failure, coronary artery disease,cardiomyopathies, pericarditis/myocarditis, or uncontrolled hypertension).

  10. Participant with a history of autoimmune disease including, but not limited to,systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoidarthritis, multiple sclerosis, idiopathic thrombocytopenia purpura,glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, and/orinsulin dependent diabetes mellitus.

  11. Previous vaccination with any varicella or HZ vaccine.

  12. Individuals who receive treatment with immunosuppressive therapy, includingcytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmunedisease, or planned receipt throughout the study. If systemic corticosteroids havebeen administered short term (<14 days) for treatment of an acute illness,participants should not be enrolled in the study until corticosteroid therapy hasbeen discontinued for at least 28 days before study intervention administration.Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)corticosteroids are permitted.

  13. Receipt of blood/plasma products or immunoglobulin, from 60 days before studyintervention administration or planned receipt throughout the study. Note: Nonimmunosuppressive monoclonal antibodies are permitted.

  14. Any participant who has received or plans to receive an RNA vaccine 28 days prior toVaccination 1

  15. Participation in other interventional studies within 28 days prior to study entry oranticipated involvement through and including 6 months after the last dose of studyintervention. Participation in observational studies is permitted. Note: This criterion does not apply to participants who are participating in afollow-up period for another study involving an investigational drug or vaccine, ifreceipt of the last dose was at least 6 months prior to consenting for this studyand there is no further dosing anticipated from the previous study during theparticipant's participation in this study.

  16. Any screening hematology and/or blood chemistry laboratory value that meets thedefinition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin Ivalue. Note: Any abnormal bilirubin or troponin I value above the ULN reference range isexclusionary. Participants with any stable Grade 1 abnormalities (according to thetoxicity grading scale), except bilirubin and troponin I, may be considered eligibleat the discretion of the investigator. (Note: A "stable" Grade 1 laboratoryabnormality is defined as a report of Grade 1 on an initial blood sample thatremains less than or equal to Grade 1 upon repeat testing on a second sample fromthe same participant during the screening period (prior to Visit 1). Please refer tothe laboratory normal ranges (provided separately in the central laboratory manual)for grading scales for abnormalities.

  17. Screening 12-lead ECG that, as judged by the investigator, is consistent withprobable or possible myocarditis/pericarditis or demonstrates clinically relevantabnormalities that may affect participant safety or interpretation of study results.Participants with a screening 12-lead ECG that shows an average QTcF interval >450msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction,ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AVblock, or serious bradyarrhythmias or tachyarrhythmias should be excluded from studyparticipation.

  18. Participation or planned participation in strenuous or endurance exercise within 7days before or after each study intervention administration.

  19. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.

SubStudy B:

Inclusion Criteria:

  1. Male or female participants 50 through 69 years of age (inclusive) at the time ofconsent.

  2. Healthy participants who are determined by clinical assessment, including medicalhistory and clinical judgment of the investigator, to be eligible for inclusion inthe study.

  3. Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.

  4. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

  1. History of HZ (shingles).

  2. History of Guillain-Barré syndrome.

  3. History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the study intervention(s).

  4. Immunocompromised individuals with known or suspected immunodeficiency, asdetermined by history and/or laboratory/physical examination.

  5. Bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the investigator, contraindicate intramuscular injection.

  6. Other medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.

  7. Women who are pregnant or breastfeeding.

  8. Prior history of heart disease (eg, heart failure, recent coronary artery disease,cardiomyopathies, pericarditis, or myocarditis).

  9. Previous vaccination with any varicella or HZ vaccine.

  10. Individuals who receive treatment with immunosuppressive therapy, includingcytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmunedisease, or planned receipt throughout the study.

  11. Receipt of blood/plasma products or immunoglobulin, from 60 days before studyintervention administration or planned receipt throughout the study.

  12. Any participant who has received or plans to receive an RNA vaccine 28 days prior toVaccination 1.

  13. Participation in other interventional studies within 28 days prior to study entry oranticipated involvement through and including 6 months after the last dose of studyintervention is prohibited. Participation in observational studies is permitted.

  14. Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.

Study Design

Total Participants: 900
Treatment Group(s): 8
Primary Treatment: Shingrix
Phase: 2
Study Start date:
January 25, 2023
Estimated Completion Date:
May 17, 2030

Connect with a study center

  • Tri-City Cardiology

    Gilbert, Arizona 85233
    United States

    Site Not Available

  • Aventiv Research Inc.

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Stanford University Medical Center

    Palo Alto, California 94304
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Cardiology Associates of Fairfield County

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • GW Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • GW Vaccine Research Unit

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Acevedo Clinical Research Associates

    Miami, Florida 33142
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • West Valley Cardiology Services

    Meridian, Idaho 83642
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Johnson County Clinical Trials

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075
    United States

    Site Not Available

  • Associates in Cardiology, PA

    Silver Spring, Maryland 20910
    United States

    Site Not Available

  • C.S. Mott Clinical Research Center (CRC)

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Ascension St. John Hospital

    Grosse Pointe Woods, Michigan 48236
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska 68701
    United States

    Active - Recruiting

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Quality Clinical Research

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • University of Nevada School of Medicine - Reno

    Reno, Nevada 89557
    United States

    Site Not Available

  • South Jersey Infectious Disease

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • IMA Clinical Research

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Tisch Hospital

    New York, New York 10016
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • Accellacare - Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Wilmington Health, PLLC (Cardiologist)

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Columbus Cardiovascular Associates, Inc.

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • IMA Clinical Research San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • DM Clinical Research - MDC

    Tomball, Texas 77375
    United States

    Site Not Available

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