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

Primary Purpose

Shingles, Herpes Zoster Infection, Human

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
Candidate 3: PF-07921186: VZV modRNA Suspension for Injection
Shingrix
Selected Vaccine Candidate group (Dose level, Schedule)
Shingrix - SSB
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shingles focused on measuring Shingles, Vaccine, RNA vaccine, modRNA vaccine, Herpes zoster

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Substudy A 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 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 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.

Sites / Locations

  • Tri-City CardiologyRecruiting
  • Aventiv Research Inc.Recruiting
  • Stanford University Medical CenterRecruiting
  • Diablo Clinical Research, Inc.Recruiting
  • Cardiology Associates of Fairfield County
  • Stamford Therapeutics Consortium
  • GW Medical Faculty AssociatesRecruiting
  • GW Vaccine Research UnitRecruiting
  • Proactive Clinical Research,LLCRecruiting
  • Acevedo Clinical Research AssociatesRecruiting
  • East-West Medical Research InstituteRecruiting
  • West Valley Cardiology ServicesRecruiting
  • Solaris Clinical ResearchRecruiting
  • University of IowaRecruiting
  • Johnson County Clinical TrialsRecruiting
  • Centennial Medical GroupRecruiting
  • Associates in Cardiology, PARecruiting
  • C.S. Mott Clinical Research Center (CRC)Recruiting
  • Ascension St. John HospitalRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Quality Clinical ResearchRecruiting
  • University of Nevada School of Medicine - RenoRecruiting
  • South Jersey Infectious DiseaseRecruiting
  • IMA Clinical ResearchRecruiting
  • NYU Langone Health
  • NYU Langone HealthRecruiting
  • Tisch HospitalRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Rochester Clinical Research, LLCRecruiting
  • Accellacare - WilmingtonRecruiting
  • Wilmington Health, PLLC (Cardiologist)Recruiting
  • CTI Clinical Research CenterRecruiting
  • Centricity Research Columbus Ohio MultispecialtyRecruiting
  • Columbus Cardiovascular Associates, Inc.Recruiting
  • Clinical Trials of Texas, LLCRecruiting
  • IMA Clinical Research San AntonioRecruiting
  • DM Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

SubStudy A (SSA): Group 1

SSA: Group 2

SSA: Group 3

SSA: Group 4

SSA: Group 5

SSA- Group 6

SSA: Group 7

SSA: Group 8

SSA: Group 9

SSA: Group 10

SSA: Group 11

Substudy B (SSB): Group 1

SSB: Group 2

Arm Description

Candidate 1, Dose Level 1, lyophilized, 0, 2 months schedule

Candidate 1, Dose Level 2, lyophilized, 0, 2 months schedule

Candidate 1, Dose Level 3, lyophilized, 0, 2 months schedule

Candidate 1, Dose Level 2, frozen, 0, 2 months schedule

Candidate 1, Dose Level 2, Frozen, 0, 6 months schedule

Candidate 2, frozen, 0, 2 months schedule

Candidate 3, Frozen, 0, 2 months schedule

Shingrix, 0, 2 months schedule

Shingrix, 0, 6 months schedule

Candidate 1, Dose level 4, lyophilized, 0, 6 months schedule

Candidate 1, Dose level 4, lyophilized, 0, 2 months schedule

Selected Vaccine candidate/dose-level/dosing schedule

Shingrix

Outcomes

Primary Outcome Measures

SSA: Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
SSA: Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
SSA: Percentage of participants reporting adverse events
As elicited by investigational site staff
SSA: Percentage of participants reporting serious adverse events
As elicited by investigational site staff
SSA: Percentage of participants reporting medically attended adverse event
As elicited by investigational site staff
SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments
As measured at the central laboratory
SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
SSA: Percentage of participants with abnormal troponin I laboratory values
as measured at the central laboratory
SSB: Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
SSB: Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
SSB: Percentage of participants reporting adverse events
As elicited by investigational site staff
SSB: Percentage of participants reporting serious adverse events
As elicited by investigational site staff
SSB: Percentage of participants reporting medically attended adverse events
As elicited by investigational site staff
Overall study: Percentage of participants from both substudies reporting local reactions
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
Overall study: Percentage of participants from both substudies reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
Overall study: Percentage of participants from both substudies reporting adverse events
As elicited by investigational site staff
Overall study: Percentage of participants from both substudies reporting serious adverse events
As elicited by investigational site staff
Overall study: Percentage of participants from both substudies reporting medically attended adverse events
As elicited by investigational site staff

Secondary Outcome Measures

SSA: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
As measured at the central laboratory
SSA: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
As measured at the central laboratory
SSA: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
As measured at the central laboratory
SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
As measured at the central laboratory
SSB: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
As measured at the central laboratory
SSB: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
As measured at the central laboratory
Overall study: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in evaluable immunogenicity participants in both substudies
As measured at the central laboratory
Overall study: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants from both substudies
As measured at the central laboratory
Overall study: Proportion of evaluable immunogenicity participants from both substudies with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
As measured at the central laboratory

Full Information

First Posted
January 19, 2023
Last Updated
September 14, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05703607
Brief Title
A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
Official Title
A PHASE 1/2 RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST VARICELLA ZOSTER VIRUS IN HEALTHY INDIVIDUALS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
February 11, 2026 (Anticipated)
Study Completion Date
August 14, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 11 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles, Herpes Zoster Infection, Human
Keywords
Shingles, Vaccine, RNA vaccine, modRNA vaccine, Herpes zoster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
SSA: Observer-blinded, Sponsor Open label SSB: Observer-blinded
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SubStudy A (SSA): Group 1
Arm Type
Experimental
Arm Description
Candidate 1, Dose Level 1, lyophilized, 0, 2 months schedule
Arm Title
SSA: Group 2
Arm Type
Experimental
Arm Description
Candidate 1, Dose Level 2, lyophilized, 0, 2 months schedule
Arm Title
SSA: Group 3
Arm Type
Experimental
Arm Description
Candidate 1, Dose Level 3, lyophilized, 0, 2 months schedule
Arm Title
SSA: Group 4
Arm Type
Experimental
Arm Description
Candidate 1, Dose Level 2, frozen, 0, 2 months schedule
Arm Title
SSA: Group 5
Arm Type
Experimental
Arm Description
Candidate 1, Dose Level 2, Frozen, 0, 6 months schedule
Arm Title
SSA- Group 6
Arm Type
Experimental
Arm Description
Candidate 2, frozen, 0, 2 months schedule
Arm Title
SSA: Group 7
Arm Type
Experimental
Arm Description
Candidate 3, Frozen, 0, 2 months schedule
Arm Title
SSA: Group 8
Arm Type
Active Comparator
Arm Description
Shingrix, 0, 2 months schedule
Arm Title
SSA: Group 9
Arm Type
Active Comparator
Arm Description
Shingrix, 0, 6 months schedule
Arm Title
SSA: Group 10
Arm Type
Experimental
Arm Description
Candidate 1, Dose level 4, lyophilized, 0, 6 months schedule
Arm Title
SSA: Group 11
Arm Type
Experimental
Arm Description
Candidate 1, Dose level 4, lyophilized, 0, 2 months schedule
Arm Title
Substudy B (SSB): Group 1
Arm Type
Experimental
Arm Description
Selected Vaccine candidate/dose-level/dosing schedule
Arm Title
SSB: Group 2
Arm Type
Active Comparator
Arm Description
Shingrix
Intervention Type
Biological
Intervention Name(s)
Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Candidate 3: PF-07921186: VZV modRNA Suspension for Injection
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Shingrix
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Selected Vaccine Candidate group (Dose level, Schedule)
Other Intervention Name(s)
Intramuscular injection
Intervention Description
Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Shingrix - SSB
Other Intervention Name(s)
Shingrix group
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
SSA: Percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
Time Frame
For 7 days after Vaccination 1 and Vaccination 2
Title
SSA: Percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
Time Frame
For 7 days after Vaccination 1 and Vaccination 2
Title
SSA: Percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From Vaccination 1 to 4 weeks after last vaccination
Title
SSA: Percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From Vaccination 1 to 6 months after the last study vaccination
Title
SSA: Percentage of participants reporting medically attended adverse event
Description
As elicited by investigational site staff
Time Frame
From Vaccination 1 to 6 months after the last study vaccination
Title
SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments
Description
As measured at the central laboratory
Time Frame
2 days and 1 week after each vaccination
Title
SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities
Description
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Time Frame
2 days and 1 week after each vaccination
Title
SSA: Percentage of participants with abnormal troponin I laboratory values
Description
as measured at the central laboratory
Time Frame
2 days after each vaccination
Title
SSB: Percentage of participants reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
Time Frame
For 7 days after Vaccination 1 and Vaccination 2
Title
SSB: Percentage of participants reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
Time Frame
For 7 days after Vaccination 1 and Vaccination 2
Title
SSB: Percentage of participants reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From Vaccination 1 to 4 weeks after last vaccination
Title
SSB: Percentage of participants reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From Vaccination 1 to 6 months after the last study vaccination
Title
SSB: Percentage of participants reporting medically attended adverse events
Description
As elicited by investigational site staff
Time Frame
From Vaccination 1 to 6 months after the last study vaccination
Title
Overall study: Percentage of participants from both substudies reporting local reactions
Description
Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
Time Frame
For up to 7 days following each vaccination
Title
Overall study: Percentage of participants from both substudies reporting systemic events
Description
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
Time Frame
For up to 7 days following each vaccination
Title
Overall study: Percentage of participants from both substudies reporting adverse events
Description
As elicited by investigational site staff
Time Frame
From vaccination 1 to 4 weeks after vaccination 2
Title
Overall study: Percentage of participants from both substudies reporting serious adverse events
Description
As elicited by investigational site staff
Time Frame
From vaccination 1 to 6 months after the last study vaccination
Title
Overall study: Percentage of participants from both substudies reporting medically attended adverse events
Description
As elicited by investigational site staff
Time Frame
From vaccination 1 to 6 months after the last study vaccination
Secondary Outcome Measure Information:
Title
SSA: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
SSA: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
SSA: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
SSB: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
SSB: Proportion of evaluable immunogenicity participants with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
Overall study: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in evaluable immunogenicity participants in both substudies
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
Overall study: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants from both substudies
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Title
Overall study: Proportion of evaluable immunogenicity participants from both substudies with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
Description
As measured at the central laboratory
Time Frame
At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Substudy A 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 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Tri-City Cardiology
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85233
Country
United States
Individual Site Status
Recruiting
Facility Name
Aventiv Research Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiology Associates of Fairfield County
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Name
GW Vaccine Research Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Name
Proactive Clinical Research,LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Individual Site Status
Recruiting
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Recruiting
Facility Name
West Valley Cardiology Services
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Johnson County Clinical Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Recruiting
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Individual Site Status
Recruiting
Facility Name
Associates in Cardiology, PA
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Name
C.S. Mott Clinical Research Center (CRC)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension St. John Hospital
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Recruiting
Facility Name
Quality Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nevada School of Medicine - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States
Individual Site Status
Recruiting
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Clinical Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Clinical Research, LLC
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmington Health, PLLC (Cardiologist)
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Name
Centricity Research Columbus Ohio Multispecialty
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Cardiovascular Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of Texas, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Clinical Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C5031001
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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