Shingles Clinical Trial
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
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01132716 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
|
N/A | |
Completed |
NCT01132729 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
|
N/A | |
Completed |
NCT04099706 -
Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
|
N/A | |
Completed |
NCT04540081 -
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
|
N/A | |
Completed |
NCT01527370 -
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
|
Phase 3 | |
Completed |
NCT00534248 -
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
|
Phase 3 | |
Completed |
NCT01262300 -
Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care Residents
|
Phase 1 | |
Completed |
NCT00576108 -
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
|
Phase 2 | |
Completed |
NCT00109122 -
Safety, Tolerability, and the Body's Ability to Develop Resistance to an Investigational Vaccine for Shingles (V211-007)
|
Phase 2 | |
Completed |
NCT04047979 -
Systems Biology of Zoster Vaccine
|
Phase 2 | |
Active, not recruiting |
NCT05871541 -
A First-in-Human Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
|
Phase 1 | |
Completed |
NCT02114333 -
Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds
|
Phase 1 | |
Completed |
NCT00900783 -
A Study of FV-100 Versus Valacyclovir in Patients With Herpes Zoster
|
Phase 2 | |
Completed |
NCT01600079 -
ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)
|
||
Active, not recruiting |
NCT02444936 -
ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
|
Phase 4 | |
Recruiting |
NCT05554068 -
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
|
Phase 2 | |
Recruiting |
NCT06238726 -
Nudging Patients to Increase Shingles Vaccination
|
N/A | |
Completed |
NCT02704572 -
Optimal Timing of Zoster Vaccine After Zoster Illness
|
N/A | |
Completed |
NCT00300222 -
Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
|
Phase 3 | |
Terminated |
NCT02412917 -
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
|
Phase 3 |