ChickenpoxNCT00921999
Immune Response to Varicella-Zoster Vaccination and Infection
An observational study of Chickenpox and Herpes Zoster, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chickenpox, Herpes Zoster
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2009to 8 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Group I Frequent Follow-up Group (N=110)
- 18 years of age or older
- Patients about to receive the varicella vaccine, or were vaccinated within the last 5 days (if stored blood is available).
- Both males and females
- Subjects must be able to sign the consent form and be willing to comply with study procedures.
- Subjects must be willing to have their blood samples stored.
Show all 24Show fewer
- Group II Infrequent Follow-up Group (N=30)
- 18 years of age of older
- Patient about to receive the varicella vaccine, or were vaccinated within the last 30 days (if stored blood is available).
- Both males and females
- Subjects must be able to sign the consent form and be willing to comply with study procedures.
- Subjects must be willing to have their blood samples stored.
- Group III Vaccine Recipients-Vaccinated in the Past (N=60)
- 18 years of age or older
- Patients were vaccinated with varicella vaccine at least 6 months previously and must provide written documentation of varicella vaccination
- Both males and females
- Subjects must be able to sign the consent form and be willing to comply with study procedures.
- Subjects must be willing to have their blood samples stored.
- Group IV Patients with Varicella or Zoster (N=110)
- 5 years or older<TAB>
- Patients presenting with varicella or zoster.
- Both males and females
- Subjects and/or parents/guardians must be able to sign the consent or assent form and be willing to comply with study procedures.
- Subjects must be willing to have their blood samples stored.
Who cannot join
- Study subjects will be excluded if they fulfill either of the following criteria:
- 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)
- History of chickenpox, zoster, or having received the zoster vaccine for patients in Groups I, II or III.
- Patients in group I found to have a hemoglobin <11 gm/dl will be reassigned to group II or terminated from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Immune Responses to Varicella-Zoster Virus Vaccination and Infection
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.
Read more
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.
Read the detailed 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.
- Conditions
- Chickenpox, Herpes Zoster
- Keywords
- Chickenpox, Shingles, Varicella, Zoster, Vaccine
- Medical subject headings
- Chickenpox, Herpes Zoster
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study start15 Jun 2009
- Study completion8 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ChickenpoxStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey I Cohen, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921999
- Sponsor's protocol ID
- 090170
- Other IDs
- 09-I-0170
- Status last verified
- 8 Jan 2015
- First submitted
- 16 Jun 2009
- Last updated
- 14 Feb 2018
- Results posted
- No
Publications
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. doi: 10.1086/501900.
PubMed 11428437Sharrar 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. doi: 10.1016/s0264-410x(00)00297-8.
PubMed 11115716Wasmuth 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. doi: 10.1002/jmv.1890320310.
PubMed 2177782Cohen JI, Ali MA, Bayat A, Steinberg SP, Park H, Gershon AA, Burbelo PD. Detection of antibodies to varicella-zoster virus in recipients of the varicella vaccine by using a luciferase immunoprecipitation system assay. Clin Vaccine Immunol. 2014 Sep;21(9):1288-91. doi: 10.1128/CVI.00250-14. Epub 2014 Jul 2.
PubMed 24990909
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses to Varicella-Zoster Virus Vaccination and Infection
- ClinicalTrials.gov ID
- NCT00921999
- Acronym / sponsor ID
- 090170
- Conditions
- Chickenpox, Herpes Zoster
- Keywords
- Chickenpox, Shingles, Varicella, Zoster, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Jun 2009
- Study completion
- 8 Jan 2015
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- Group I Frequent Follow-up Group (N=110)
- 18 years of age or older
- Patients about to receive the varicella vaccine, or were vaccinated within the last 5 days (if stored blood is available).
- Both males and females
- Subjects must be able to sign the consent form and be willing to comply with study procedures.
Key exclusion criteria (4 listed)
- 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)
- History of chickenpox, zoster, or having received the zoster vaccine for patients in Groups I, II or III.
- Patients in group I found to have a hemoglobin <11 gm/dl will be reassigned to group II or terminated from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 11428437Saiman 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. doi: 10.1086/501900.
- Background: PubMed 11115716Sharrar 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. doi: 10.1016/s0264-410x(00)00297-8.
- Background: PubMed 2177782Wasmuth 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. doi: 10.1002/jmv.1890320310.
- Derived from this study: PubMed 24990909Cohen JI, Ali MA, Bayat A, Steinberg SP, Park H, Gershon AA, Burbelo PD. Detection of antibodies to varicella-zoster virus in recipients of the varicella vaccine by using a luciferase immunoprecipitation system assay. Clin Vaccine Immunol. 2014 Sep;21(9):1288-91. doi: 10.1128/CVI.00250-14. Epub 2014 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey I Cohen, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chickenpox and Herpes Zoster, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921999, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.