VaricellaNCT06482216
Correlation of Protection Against Varicella in an Exploratory Study
An observational study of Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd..
Trial summary
This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after… Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Varicella vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 10 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: There was no inclusion/exclusion criteria in the retrospective cohort study. The inclusion/exclusion criteria were only applicable in the prospective cohort. Subjects in the retrospective cohort study aged 8-20 years were from a previous phase Ⅲ study. There is no limit to the sample size of the retrospective cohort, which is based on the number of final follow-up.
Who may be able to join
- 1-12 years children who were the siblings or children of the indicator varicella cases, or the deskmates/roommates of the indicator varicella cases;
- Having close contacts with the indicator varicella cases at least 2 days during the period from 5 days before the onset and 2 days after the onset;
- Without varicella vaccination history or having varicella vaccination history (the last dose of varicella was manufacured by Sinovac, with an interval of >30 days before enrollment)
- Subjects/legal guardian can understand and sign the informed consent;
- Being able to provide legal proof of identity.
Who cannot join
- Without varicella history;
- Body temperature ≥37.0℃ on the day of enrollment, or skin rash on the head, torso, and limbs;
- Having any confirmed or suspected immunodeficiency disorder, including tumor patients undergoing chemotherapy, human immunodeficiency virus (HIV) infection, continuous use of steroid hormones for more than 30 days (prednisone equivalent ≥2mg/kg days in children), or having other immunosuppressive disorder as determined by the clinician;
- The investigators considered that participation in this study was not appropriate for various other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.
Read the detailed description
Part 1 was based on a previous Phase Ⅲ, randomized, placebo-controlled clinical trial (NCT02981836) conducted from 2016 to 2017. The analysis data of part 1 was from historical serum, historical varicella cases and additional one year case monitoring conducted as an extension of the Phase III study.
Part 2 was conducted based on close contacts of varicella cases. All close contacts without varicella symptoms will be recruited and followed up for 14 days to monitor the occurrence of the varicella cases. Part 2 aimed to compare the differences of FAMA antibody titers in varicella breakthrough cases, non-breakthrough cases, and non-cases at the time of exposure to validate/calibrate the model established in part 1.
- Conditions
- Varicella
- Being tested
- Varicella vaccine
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella vaccineBiological
lyophilized powder,subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Vaccination group | The last dose of varicella vaccine given 30 days before enrollment was manufacture by Sinovac (Dalian) Vaccine Technology Co. LTD.,(Sinovac). Receives: Biological: Varicella vaccine | |
| Non-vaccination group | Without varicella vaccine history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective cohort: Varicella confirmed case
Varicella confirmed case during an additional year follow-up period (pooled with varicella confirmed case from previous phase Ⅲ study)
Measured: one year after enrollment
Retrospective cohort: Varicella antibody titer
Varicella antibody titer on Day 30 after vaccination (historical serum)
Measured: on Day 30 after vaccination
Prospective cohort: Varicella confirmed case
Varicella confirmed case during the 14-day follow-up period
Measured: Within 14 days after enrollment
Prospective cohort: Varicella antibody titer
Varicella antibody titer on exposure
Measured: Enrollment
Secondary outcomes (2)
Prospective cohort: Varicella antibody titer
Varicella antibody titer in the acute period of varicella confirmed case
Measured: Within 3 days after eruption
Prospective cohort: Varicella antibody titer
Varicella antibody titer in the convalescent period of varicella confirmed case
Measured: Within 14-21 days after eruption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start10 Oct 2025 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Liu, Principal investigator, Yunnan Center for Disease Control and PreventionZhiqiang Xie, Principal investigator, Henan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482216
- Sponsor's protocol ID
- PRO-VZV-4007
- Status last verified
- Jan 2025
- First submitted
- 25 Jun 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Protection Against Varicella in an Exploratory Study
- ClinicalTrials.gov ID
- NCT06482216
- Acronym / sponsor ID
- PRO-VZV-4007
- Conditions
- Varicella
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 1 Jul 2024 (actual)
- 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.
This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.
Detailed description
Part 1 was based on a previous Phase Ⅲ, randomized, placebo-controlled clinical trial (NCT02981836) conducted from 2016 to 2017. The analysis data of part 1 was from historical serum, historical varicella cases and additional one year case monitoring conducted as an extension of the Phase III study.
Part 2 was conducted based on close contacts of varicella cases. All close contacts without varicella symptoms will be recruited and followed up for 14 days to monitor the occurrence of the varicella cases. Part 2 aimed to compare the differences of FAMA antibody titers in varicella breakthrough cases, non-breakthrough cases, and non-cases at the time of exposure to validate/calibrate the model established in part 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination group | – | Biological: Varicella vaccineThe last dose of varicella vaccine given 30 days before enrollment was manufacture by Sinovac (Dalian) Vaccine Technology Co. LTD.,(Sinovac). |
| Non-vaccination group | – | –Without varicella vaccine history |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- There was no inclusion/exclusion criteria in the retrospective cohort study. The inclusion/exclusion criteria were only applicable in the prospective cohort. Subjects in the retrospective cohort study aged 8-20 years were from a previous phase Ⅲ study. There is no limit to the sample size of the retrospective cohort, which is based on the number of final follow-up.
Key inclusion criteria (5 listed)
- 1-12 years children who were the siblings or children of the indicator varicella cases, or the deskmates/roommates of the indicator varicella cases;
- Having close contacts with the indicator varicella cases at least 2 days during the period from 5 days before the onset and 2 days after the onset;
- Without varicella vaccination history or having varicella vaccination history (the last dose of varicella was manufacured by Sinovac, with an interval of >30 days before enrollment)
- Subjects/legal guardian can understand and sign the informed consent;
- Being able to provide legal proof of identity.
Key exclusion criteria (4 listed)
- Without varicella history;
- Body temperature ≥37.0℃ on the day of enrollment, or skin rash on the head, torso, and limbs;
- Having any confirmed or suspected immunodeficiency disorder, including tumor patients undergoing chemotherapy, human immunodeficiency virus (HIV) infection, continuous use of steroid hormones for more than 30 days (prednisone equivalent ≥2mg/kg days in children), or having other immunosuppressive disorder as determined by the clinician;
- The investigators considered that participation in this study was not appropriate for various other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicella vaccinelyophilized powder,subcutaneous injection | Biological | Vaccination group |
Primary outcome
Retrospective cohort: Varicella confirmed case
Time frame: one year after enrollment
Varicella confirmed case during an additional year follow-up period (pooled with varicella confirmed case from previous phase Ⅲ study)
Retrospective cohort: Varicella antibody titer
Time frame: on Day 30 after vaccination
Varicella antibody titer on Day 30 after vaccination (historical serum)
Prospective cohort: Varicella confirmed case
Time frame: Within 14 days after enrollment
Varicella confirmed case during the 14-day follow-up period
Prospective cohort: Varicella antibody titer
Time frame: Enrollment
Varicella antibody titer on exposure
2 secondary outcomes
Prospective cohort: Varicella antibody titer
Time frame: Within 3 days after eruption
Prospective cohort: Varicella antibody titer
Time frame: Within 14-21 days after eruption
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Xiaoqiang Liu principal investigator
Yunnan Center for Disease Control and Prevention
Zhiqiang Xie principal investigator
Henan Provincial Center for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
An observational study of Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd..
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 5 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: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqiang Liu (15911568282, lxq7611@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective cohort: Varicella confirmed case (time frame: one year after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2025.