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 50 through 85 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 10 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 was determined from data collected in Substudy A. Participants will be involved in this study for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
484
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Tri-City Cardiology
Gilbert, Arizona, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Stanford University Medical Center
Palo Alto, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
SSA: Percentage of participants reporting local reactions
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
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
Time frame: For 7 days after Vaccination 1 and Vaccination 2
SSA: Percentage of participants reporting adverse events
As elicited by investigational site staff
Time frame: From Vaccination 1 to 4 weeks after last vaccination
SSA: Percentage of participants reporting serious adverse events
As elicited by investigational site staff
Time frame: From Vaccination 1 to 6 months after the last study vaccination
SSA: Percentage of participants reporting medically attended adverse event
As elicited by investigational site staff
Time frame: From Vaccination 1 to 6 months after the last study vaccination
SSA: Percentage of participants with abnormal hematology and chemistry laboratory assessments
As measured at the central laboratory
Time frame: 3 days and 1 week after each vaccination
SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
Time frame: 3 days and 1 week after each vaccination
SSA: Percentage of participants with abnormal troponin I laboratory values
as measured at the central laboratory
Time frame: 3 days and 1 week after each vaccination
SSB: Percentage of participants reporting local reactions
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
SSB: Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain, and joint pain, as self-reported in electronic diaries
Time frame: For 7 days after Vaccination 1 and Vaccination 2
SSB: Percentage of participants reporting adverse events
As elicited by investigational site staff
Time frame: From Vaccination 1 to 4 weeks after last vaccination
SSB: Percentage of participants reporting serious adverse events
As elicited by investigational site staff
Time frame: From Vaccination 1 to 6 months after the last study vaccination
SSB: Percentage of participants reporting medically attended adverse events
As elicited by investigational site staff
Time frame: From Vaccination 1 to 6 months after the last study vaccination
SSA: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
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
SSA: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
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
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
Time frame: At baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in proportion of evaluable immunogenicity participant
As measured at the central laboratory
Time frame: At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination
SSB: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants
As measured at the central laboratory
Time frame: At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination
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
Time frame: At baseline (before vaccination 1), at 4-weeks after each vaccination and 6-months after last vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
West Valley Cardiology Services
Meridian, Idaho, United States
...and 25 more locations