A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
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| ClinicalTrials.gov Identifier: NCT05703607 |
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Recruitment Status :
Recruiting
First Posted : January 30, 2023
Last Update Posted : May 23, 2023
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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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 9 groups in the study and will receive 2 doses of vaccine at different intervals.
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Shingles Herpes Zoster Infection Human | Biological: Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection Biological: Candidate 1: PF-07915234: VZV modRNA Suspension for Injection Biological: Candidate 2: PF-07921188: VZV modRNA Suspension for Injection Biological: Candidate 3: PF-07921186: VZV modRNA Suspension for Injection Biological: Shingrix Biological: Selected Vaccine Candidate group (Dose level, Schedule) Biological: Shingrix - SSB | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 900 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | SSA: Observer-blinded, Sponsor Open label SSB: Observer-blinded |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | January 25, 2023 |
| Estimated Primary Completion Date : | July 5, 2025 |
| Estimated Study Completion Date : | January 5, 2030 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Shingles
| Arm | Intervention/treatment |
|---|---|
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Experimental: SubStudy A (SSA): Group 1
Candidate 1, Dose Level 1, lyophilized, 0, 2 months schedule
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Biological: Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection |
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Experimental: SSA: Group 2
Candidate 1, Dose Level 2, lyophilized, 0, 2 months schedule
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Biological: Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection |
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Experimental: SSA: Group 3
Candidate 1, Dose Level 3, lyophilized, 0, 2 months schedule
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Biological: Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection
Intramuscular injection |
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Experimental: SSA: Group 4
Candidate 1, Dose Level 2, frozen, 0, 2 months schedule
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Biological: Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Intramuscular injection |
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Experimental: SSA: Group 5
Candidate 1, Dose Level 2, Frozen, 0, 6 months schedule
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Biological: Candidate 1: PF-07915234: VZV modRNA Suspension for Injection
Intramuscular injection |
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Experimental: SSA- Group 6
Candidate 2, frozen, 0, 2 months schedule
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Biological: Candidate 2: PF-07921188: VZV modRNA Suspension for Injection
Intramuscular injection |
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Experimental: SSA: Group 7
Candidate 3, Frozen, 0, 2 months schedule
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Biological: Candidate 3: PF-07921186: VZV modRNA Suspension for Injection
Intramuscular injection |
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Active Comparator: SSA: Group 8
Shingrix, 0, 2 months schedule
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Biological: Shingrix
Intramuscular injection |
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Active Comparator: SSA: Group 9
Shingrix, 0, 6 months schedule
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Biological: Shingrix
Intramuscular injection |
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Experimental: Substudy B (SSB): Group 1
Selected Vaccine candidate/dose-level/dosing schedule
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Biological: Selected Vaccine Candidate group (Dose level, Schedule)
Intramuscular injection
Other Name: Intramuscular injection |
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Experimental: SSB: Group 2
Shingrix
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Biological: Shingrix - SSB
Intramuscular injection
Other Name: Shingrix group |
Primary Outcome Measures :
- SSA: Percentage of participants reporting local reactions [ Time Frame: For 7 days after Vaccination 1 and Vaccination 2 ]Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
- SSA: Percentage of participants reporting systemic events [ Time Frame: For 7 days after Vaccination 1 and Vaccination 2 ]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 [ Time Frame: From Vaccination 1 to 4 weeks after last vaccination ]As elicited by investigational site staff
- SSA: Percentage of participants reporting serious adverse events [ Time Frame: From Vaccination 1 to 6 months after the last study vaccination ]As elicited by investigational site staff
- SSA: Percentage of participants reporting medically attended adverse event [ Time Frame: From Vaccination 1 to 6 months after the last study vaccination ]As elicited by investigational site staff
- SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments [ Time Frame: 2 days and 1 week after each vaccination ]As measured at the central laboratory
- SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 2 days and 1 week after each vaccination ]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 [ Time Frame: 2 days after each vaccination ]as measured at the central laboratory
- SSB: Percentage of participants reporting local reactions [ Time Frame: For 7 days after Vaccination 1 and Vaccination 2 ]Pain at the injection site, redness, and swelling as self-reported in electronic diaries.
- SSB: Percentage of participants reporting systemic events [ Time Frame: For 7 days after Vaccination 1 and Vaccination 2 ]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 [ Time Frame: From Vaccination 1 to 4 weeks after last vaccination ]As elicited by investigational site staff
- SSB: Percentage of participants reporting serious adverse events [ Time Frame: From Vaccination 1 to 6 months after the last study vaccination ]As elicited by investigational site staff
- SSB: Percentage of participants reporting medically attended adverse events [ Time Frame: From Vaccination 1 to 6 months after the last study vaccination ]As elicited by investigational site staff
- Overall study: Percentage of participants from both substudies reporting local reactions [ Time Frame: For up to 7 days following each vaccination ]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 [ Time Frame: For up to 7 days following each vaccination ]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 [ Time Frame: From vaccination 1 to 4 weeks after vaccination 2 ]As elicited by investigational site staff
- Overall study: Percentage of participants from both substudies reporting serious adverse events [ Time Frame: From vaccination 1 to 6 months after the last study vaccination ]As elicited by investigational site staff
- Overall study: Percentage of participants from both substudies reporting medically attended adverse events [ Time Frame: From vaccination 1 to 6 months after the last study vaccination ]As elicited by investigational site staff
Secondary Outcome Measures :
- SSA: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]As measured at the central laboratory
- SSA: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]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 [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]As measured at the central laboratory
- SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]As measured at the central laboratory
- SSB: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]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 [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]As measured at the central laboratory
- Overall study: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in evaluable immunogenicity participants in both substudies [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]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 [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]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 [ Time Frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination ]As measured at the central laboratory
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 69 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05703607
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Locations
Show 37 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT05703607 |
| Other Study ID Numbers: |
C5031001 |
| First Posted: | January 30, 2023 Key Record Dates |
| Last Update Posted: | May 23, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Pfizer:
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Shingles Vaccine RNA vaccine modRNA vaccine Herpes zoster |
Additional relevant MeSH terms:
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Herpes Zoster Varicella Zoster Virus Infection Herpesviridae Infections |
DNA Virus Infections Virus Diseases Infections |