Phase
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
Ages 50-69 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Substudy A: Group 1 to Group 10
Inclusion Criteria:
Male or female participants 50 through 69 years of age (inclusive) at the time ofconsent.
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.
Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.
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:
Male or female participants 50 through 69 years of age (inclusive) at the time ofconsent.
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.
Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.
Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the ICD and in this protocol.
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:
History of HZ (shingles).
History of Guillain-Barré syndrome.
Known infection with HIV, HCV, or HBV.
History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency, asdetermined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the investigator, contraindicate intramuscular injection.
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.
Women who are pregnant or breastfeeding.
Prior history of heart disease (eg, heart failure, recent coronary artery disease,cardiomyopathies, pericarditis/myocarditis).
Previous vaccination with any varicella or HZ vaccine.
Individuals who receive treatment with immunosuppressive therapy, includingcytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmunedisease, or planned receipt throughout the study.
Receipt of blood/plasma products or immunoglobulin, from 60 days before studyintervention administration or planned receipt throughout the study.
Any participant who has received or plans to receive an RNA vaccine 28 days prior toVaccination 1.
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.
Any screening hematology and/or blood chemistry laboratory value that meets thedefinition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin Ivalue.
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.
Participation or planned participation in strenuous or endurance exercise within 7days before or after each study intervention administration.
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;
History of HZ (shingles).
History of Guillain-Barré syndrome.
Known infection with HIV, HCV, or HBV.
History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency, asdetermined by history and/or laboratory/physical examination.
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.
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.
Women who are pregnant or breastfeeding.
Prior history of heart disease (eg, heart failure, coronary artery disease,cardiomyopathies, pericarditis/myocarditis, or uncontrolled hypertension).
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.
Previous vaccination with any varicella or HZ vaccine.
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.
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.
Any participant who has received or plans to receive an RNA vaccine 28 days prior toVaccination 1
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.
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.
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.
Participation or planned participation in strenuous or endurance exercise within 7days before or after each study intervention administration.
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:
Male or female participants 50 through 69 years of age (inclusive) at the time ofconsent.
Healthy participants who are determined by clinical assessment, including medicalhistory and clinical judgment of the investigator, to be eligible for inclusion inthe study.
Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.
Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the ICD and in this protocol.
Exclusion Criteria:
History of HZ (shingles).
History of Guillain-Barré syndrome.
History of severe adverse reaction associated with a vaccine and/or severe allergicreaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency, asdetermined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, inthe opinion of the investigator, contraindicate intramuscular injection.
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.
Women who are pregnant or breastfeeding.
Prior history of heart disease (eg, heart failure, recent coronary artery disease,cardiomyopathies, pericarditis, or myocarditis).
Previous vaccination with any varicella or HZ vaccine.
Individuals who receive treatment with immunosuppressive therapy, includingcytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmunedisease, or planned receipt throughout the study.
Receipt of blood/plasma products or immunoglobulin, from 60 days before studyintervention administration or planned receipt throughout the study.
Any participant who has received or plans to receive an RNA vaccine 28 days prior toVaccination 1.
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.
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
Connect with a study center
Tri-City Cardiology
Gilbert, Arizona 85233
United StatesSite Not Available
Aventiv Research Inc.
Mesa, Arizona 85206
United StatesSite Not Available
Stanford University Medical Center
Palo Alto, California 94304
United StatesSite Not Available
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
United StatesSite Not Available
Cardiology Associates of Fairfield County
Stamford, Connecticut 06905
United StatesSite Not Available
Stamford Therapeutics Consortium
Stamford, Connecticut 06905
United StatesSite Not Available
GW Medical Faculty Associates
Washington, District of Columbia 20037
United StatesSite Not Available
GW Vaccine Research Unit
Washington, District of Columbia 20037
United StatesSite Not Available
Proactive Clinical Research,LLC
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Acevedo Clinical Research Associates
Miami, Florida 33142
United StatesSite Not Available
East-West Medical Research Institute
Honolulu, Hawaii 96814
United StatesSite Not Available
Solaris Clinical Research
Meridian, Idaho 83646
United StatesSite Not Available
West Valley Cardiology Services
Meridian, Idaho 83642
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
Johnson County Clinical Trials
Lenexa, Kansas 66219
United StatesSite Not Available
Centennial Medical Group
Columbia, Maryland 21045
United StatesSite Not Available
Centennial Medical Group
Elkridge, Maryland 21075
United StatesSite Not Available
Associates in Cardiology, PA
Silver Spring, Maryland 20910
United StatesSite Not Available
C.S. Mott Clinical Research Center (CRC)
Detroit, Michigan 48201
United StatesSite Not Available
Ascension St. John Hospital
Grosse Pointe Woods, Michigan 48236
United StatesSite Not Available
Meridian Clinical Research, LLC
Norfolk, Nebraska 68701
United StatesActive - Recruiting
Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701
United StatesSite Not Available
Quality Clinical Research
Omaha, Nebraska 68114
United StatesSite Not Available
University of Nevada School of Medicine - Reno
Reno, Nevada 89557
United StatesSite Not Available
South Jersey Infectious Disease
Somers Point, New Jersey 08244
United StatesSite Not Available
IMA Clinical Research
Albuquerque, New Mexico 87109
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Tisch Hospital
New York, New York 10016
United StatesSite Not Available
Rochester Clinical Research, Inc.
Rochester, New York 14609
United StatesActive - Recruiting
Rochester Clinical Research, LLC
Rochester, New York 14609
United StatesSite Not Available
Accellacare - Wilmington
Wilmington, North Carolina 28401
United StatesSite Not Available
Wilmington Health, PLLC (Cardiologist)
Wilmington, North Carolina 28401
United StatesSite Not Available
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesSite Not Available
Aventiv Research Inc
Columbus, Ohio 43213
United StatesSite Not Available
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio 43213
United StatesSite Not Available
Columbus Cardiovascular Associates, Inc.
Columbus, Ohio 43213
United StatesSite Not Available
Clinical Trials of Texas, LLC
San Antonio, Texas 78229
United StatesSite Not Available
Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas 78229
United StatesSite Not Available
IMA Clinical Research San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77375
United StatesActive - Recruiting
DM Clinical Research - MDC
Tomball, Texas 77375
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.