Herpes Zoster Clinical Trial
Official title:
Immune Responses to Varicella-Zoster Virus Vaccination and Infection
Verified date | January 8, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- The common varicella-zoster virus causes both chickenpox and shingles. Both diseases
cause rashes, but they can also have complications such as bacterial infections of the
skin, pneumonia, or eye disease.
- By drawing and studying blood samples from people who have been infected with the
varicella-zoster virus or who are receiving or have received the varicella vaccine,
researchers hope to learn more about the immune system s response to the virus.
Objectives:
- To determine the immune system s response to the varicella virus, either in its existing
form or given as part of a vaccine.
Eligibility:
- Individuals 18 years of age and older who have had or are receiving the varicella
vaccine.
- Individuals 5 years of age and older who currently have chickenpox or shingles.
Design:
- Participants will visit the NIH Clinical Center for an initial physical examination, and
will provide blood samples for evaluation.
- Researchers will determine the number of samples to be taken and the amount of blood to
be drawn as needed based on the participants medical history and exposure to the
varicella-zoster virus.
Investigators in this study will not be giving subjects either the chickenpox or shingles
vaccine. They will only be looking at the response to the vaccine in persons who are
receiving or have received the vaccine from their health care provider.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 8, 2015 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years and older |
Eligibility |
- INCLUSION CRITERIA: Group I Frequent Follow-up Group (N=110) 1. 18 years of age or older 2. Patients about to receive the varicella vaccine, or were vaccinated within the last 5 days (if stored blood is available). 3. Both males and females 4. Subjects must be able to sign the consent form and be willing to comply with study procedures. 5. Subjects must be willing to have their blood samples stored. Group II Infrequent Follow-up Group (N=30) 1. 18 years of age of older 2. Patient about to receive the varicella vaccine, or were vaccinated within the last 30 days (if stored blood is available). 3. Both males and females 4. Subjects must be able to sign the consent form and be willing to comply with study procedures. 5. Subjects must be willing to have their blood samples stored. Group III Vaccine Recipients-Vaccinated in the Past (N=60) 1. 18 years of age or older 2. Patients were vaccinated with varicella vaccine at least 6 months previously and must provide written documentation of varicella vaccination 3. Both males and females 4. Subjects must be able to sign the consent form and be willing to comply with study procedures. 5. Subjects must be willing to have their blood samples stored. Group IV Patients with Varicella or Zoster (N=110) 1. 5 years or older<TAB> 2. Patients presenting with varicella or zoster. 3. Both males and females 4. Subjects and/or parents/guardians must be able to sign the consent or assent form and be willing to comply with study procedures. 5. Subjects must be willing to have their blood samples stored. EXCLUSION CRITERIA: Study subjects will be excluded if they fulfill either of the following criteria: 1. Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety (Groups I, II, IV who will be providing several blood samples) 2. History of chickenpox, zoster, or having received the zoster vaccine for patients in Groups I, II or III. 3. Patients in group I found to have a hemoglobin <11 gm/dl will be reassigned to group II or terminated from the study. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Saiman L, LaRussa P, Steinberg SP, Zhou J, Baron K, Whittier S, Della-Latta P, Gershon AA. Persistence of immunity to varicella-zoster virus after vaccination of healthcare workers. Infect Control Hosp Epidemiol. 2001 May;22(5):279-83. — View Citation
Sharrar RG, LaRussa P, Galea SA, Steinberg SP, Sweet AR, Keatley RM, Wells ME, Stephenson WP, Gershon AA. The postmarketing safety profile of varicella vaccine. Vaccine. 2000 Nov 22;19(7-8):916-23. — View Citation
Wasmuth EH, Miller WJ. Sensitive enzyme-linked immunosorbent assay for antibody to varicella-zoster virus using purified VZV glycoprotein antigen. J Med Virol. 1990 Nov;32(3):189-93. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03120364 -
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
|
Phase 3 | |
Completed |
NCT01165203 -
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
|
Phase 2 | |
Recruiting |
NCT06088745 -
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
|
Phase 3 | |
Completed |
NCT01385566 -
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
|
Phase 1 | |
Completed |
NCT01137669 -
ZOSTAVAX® in Renal Transplant Patients
|
Phase 1 | |
Completed |
NCT01911065 -
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
|
Phase 4 | |
Completed |
NCT00550745 -
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
|
Phase 4 | |
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 |
NCT00231816 -
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
|
Phase 3 | |
Completed |
NCT02852876 -
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
|
Phase 1 | |
Completed |
NCT05082688 -
Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)
|
Phase 2 | |
Completed |
NCT04099706 -
Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
|
N/A | |
Active, not recruiting |
NCT04091451 -
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles
|
Phase 3 | |
Completed |
NCT02519855 -
Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
|
Phase 3 | |
Completed |
NCT04523246 -
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
|
Early Phase 1 | |
Completed |
NCT05047770 -
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
|
Phase 3 | |
Completed |
NCT03314103 -
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
|
Phase 3 | |
Completed |
NCT01527370 -
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
|
Phase 3 | |
Completed |
NCT01954251 -
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
|
Phase 3 |