A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Substudy A: Group 1 to Group 10
Inclusion Criteria:
- Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
- Healthy participants who are determined by clinical assessment, including medical history and clinical judgment of the investigator, to be eligible for inclusion in the 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 study procedures.
- Capable of giving signed informed consent, which includes compliance with the requirements 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 of consent.
- Healthy participants who are determined by clinical assessment, including medical history and clinical judgment of the investigator, to be eligible for inclusion in the 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 study procedures.
- Capable of giving signed informed consent, which includes compliance with the requirements 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 screening visit.
Substudy A: Group 1 to Group 10
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 allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate 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, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- Any participant who has received or plans to receive an RNA vaccine 28 days prior to Vaccination 1.
- Participation in other interventional studies within 28 days prior to study entry or anticipated involvement through and including 6 months after the last dose of study intervention. Participation in observational studies is permitted.
- Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin I value.
- Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis/pericarditis or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
- Participation or planned participation in strenuous or endurance exercise within 7 days before or after each study intervention administration.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Substudy A: Group 11 to Group 14 Exclusion Criteria;
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History of HZ (shingles).
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History of Guillain-Barré syndrome.
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Known infection with HIV, HCV, or HBV.
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History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
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Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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Bleeding diathesis or condition associated with prolonged bleeding (including use of anticoagulant medications within 7 days prior to enrollment) that would contraindicate IM injection or imply treatment or prophylaxis of known cardiac or valvular disease.
Note: The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives from 7 days prior to enrollment through conclusion of study participation is exclusionary.
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Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. This includes a history of alcohol or drug abuse as determined by the investigator.
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Women who are pregnant or breastfeeding.
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Prior history of heart disease (eg, heart failure, coronary artery disease, cardiomyopathies, pericarditis/myocarditis, or uncontrolled hypertension).
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Participant with a history of autoimmune disease including, but not limited to, systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, multiple sclerosis, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, and/or insulin dependent diabetes mellitus.
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Previous vaccination with any varicella or HZ vaccine.
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Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
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Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
Note: Nonimmunosuppressive monoclonal antibodies are permitted.
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Any participant who has received or plans to receive an RNA vaccine 28 days prior to Vaccination 1
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Participation in other interventional studies within 28 days prior to study entry or anticipated involvement through and including 6 months after the last dose of study intervention. Participation in observational studies is permitted.
Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study.
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Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality; or any abnormal bilirubin or troponin I value.
Note: Any abnormal bilirubin or troponin I value above the ULN reference range is exclusionary. Participants with any stable Grade 1 abnormalities (according to the toxicity grading scale), except bilirubin and troponin I, may be considered eligible at the discretion of the investigator. (Note: A "stable" Grade 1 laboratory abnormality is defined as a report of Grade 1 on an initial blood sample that remains less than or equal to Grade 1 upon repeat testing on a second sample from the same participant during the screening period (prior to Visit 1). Please refer to the laboratory normal ranges (provided separately in the central laboratory manual) for grading scales for abnormalities.
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Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis/pericarditis or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. Participants with a screening 12-lead ECG that shows an average QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias should be excluded from study participation.
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Participation or planned participation in strenuous or endurance exercise within 7 days before or after each study intervention administration.
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Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
SubStudy B:
Inclusion Criteria:
- Male or female participants 50 through 69 years of age (inclusive) at the time of consent.
- Healthy participants who are determined by clinical assessment, including medical history and clinical judgment of the investigator, to be eligible for inclusion in the study.
- Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent, which includes compliance with the requirements 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 allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate 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, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
- Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
- Any participant who has received or plans to receive an RNA vaccine 28 days prior to Vaccination 1.
- Participation in other interventional studies within 28 days prior to study entry or anticipated involvement through and including 6 months after the last dose of study intervention is prohibited. Participation in observational studies is permitted.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Trial design
Primary purpose
Allocation
Interventional model
Masking
900 participants in 16 patient groups
Trial contacts and locations
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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