Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00921999
Other study ID # 090170
Secondary ID 09-I-0170
Status Completed
Phase N/A
First received June 16, 2009
Last updated February 13, 2018
Start date June 15, 2009
Est. completion date January 8, 2015

Study information

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

Clinical Trial Summary

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.


Description:

Varicella-zoster virus (VZV) causes chickenpox (varicella) and shingles (zoster). Antibody is important for control of varicella as evidenced by the role of varicella immune globulin in limiting the severity of disease in immunocompromised persons. Limited information is available regarding the individual viral proteins to which antibodies are produced during primary infection with VZV or after vaccination. Furthermore, commercially available tests to determine seropositivity to VZV after vaccination have limited sensitivity, and improved assays are needed. We will obtain blood from persons with varicella, zoster, and those vaccinated with the varicella (not zoster) vaccine at the NIH Clinical Center and measure immune responses against specific viral proteins, look for virus in the blood, and in some cases measure immune responses against cellular proteins over time. Elucidation of these responses might help to develop more sensitive assays for VZV seropositivity after vaccination and determine how the varicella vaccine protects against varicella.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

See also
  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