AzTrials
AzTrials

Herpes ZosterPhase 1/2NCT02526745

Safety and Immunogenicity Study of Live Attenuated Vaccine Against Herpes Zoster in Chinese Adults Aged 50 Years and Older

A Phase 1/2 study testing the vaccine with high doses of virus content between 4.7～5.0 lgPFU, the vaccine with low doses of virus content between 4.7～5.0 lgPFU and the vaccine with high doses of virus content between 4.3～5.0 lgPFU in people with Herpes Zoster, run by Beijing Chaoyang District Centre for Disease Control and Prevention.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged 50 years and older. Half of participants will receive high doses of the vaccine,while the other half will receive low doses of the vaccine in phase I clinical trial. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Herpes Zoster
What is being tested?
the vaccine with high doses of virus content between 4.7～5.0 lgPFU, the vaccine with low doses of virus content between 4.7～5.0 lgPFU and the vaccine with high doses of virus content between 4.3～5.0 lgPFU
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
No sites listed yet
Study dates
Dec 2015to Jul 2016
Phase
Phase 1/2
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 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults 50 years and older,no vaccine contraindications;
  • Subject to comply with the requirements of clinical trial programs;
  • No immune globulin vaccination history within a month, no vaccination history within 28 days;
  • Axillary temperature ≤37.0 ℃;
  • Patients with chronic diseases should be in stable ;
  • Postmenopausal or female subjects is no longer the possibility of pregnancy, or subjects pregnancy test was negative and has no pregnancy planner during the clinical trial period;
Show all 9Show fewer
  • The value of blood routine (WBC, RBC, Hb) is normal , or abnormal but meaningless by clinicians judgment ;
  • Alanine aminotransferase (ALT) values is normal, or abnormal but meaningless by clinicians judgment ;
  • Renal function (serum urea nitrogen) is normal, or abnormal but meaningless by clinicians judgment.

Who cannot join

  • Allergies, seizures, epilepsy, encephalopathy and other medical history or family history of mental illness;
  • Subjects who is allergic to any element of the vaccine,and have a history of severe allergy to any vaccine;
  • Subjects who is suffering from immune deficiency, receiving immunosuppressive therapy or immunocompromised due to HIV;
  • Subjects who had a history of herpes zoster five years ago;
  • Varicella or herpes zoster vaccination history;
  • Pregnant or lactating women;
Show all 18Show fewer
  • Women who are planning a pregnancy in the near future;
  • Any prior administration of vaccine in last 28 days or planned to vaccinate any vaccine during the observation period;
  • Suffering from acute febrile diseases, and infectious diseases;
  • Thrombocytopenia or other coagulation disorder history, which may cause subcutaneous taboo;
  • Accept any other investigational drug users within two months;
  • Subjects had high fever (axillary temperature ≥38.0 ℃) in the past three days ;
  • The value of blood routine (WBC, RBC, Hb) is abnormal and meaning by clinicians judgment ;
  • Alanine aminotransferase (ALT) values is abnormal and meaning by clinicians judgment ;
  • Renal function (serum urea nitrogen) is abnormal and meaning by clinicians judgment.
  • Blood pressure is abnormal after medication control;
  • Known or suspected diseases including: respiratory diseases, acute infection or chronic disease , and cardiovascular disease, kidney disease, skin disorders in the acute phase;
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

About this study

This study evaluates the safety and immunogenicity of live attenuated vaccine in adults aged 50 years and older. Half of participants will receive high doses of the vaccine,while the other half will receive low doses of the vaccine in phase I clinical trial. At the phase II clinical trial, participants will be distributed equally to four groups(low、middle, high doses of the vaccine and placebo).

Conditions
Herpes Zoster
Being tested
the vaccine with high doses of virus content between 4.7～5.0 lgPFU, the vaccine with low doses of virus content between 4.7～5.0 lgPFU, the vaccine with high doses of virus content between 4.3～5.0 lgPFU, the vaccine with middle doses of virus content between 4.3～5.0 lgPFU, the vaccine with low doses of virus content between 4.3～5.0 lgPFU
Keywords
vaccine, safety, immunogenicity
Medical subject headings
Herpes Zoster

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the vaccine with high doses of virus content between 4.7～5.0 lgPFUBiological

  • the vaccine with low doses of virus content between 4.7～5.0 lgPFUBiological

  • the vaccine with high doses of virus content between 4.3～5.0 lgPFUBiological

  • the vaccine with middle doses of virus content between 4.3～5.0 lgPFUBiological

  • the vaccine with low doses of virus content between 4.3～5.0 lgPFUBiological

  • placeboBiological

Study groups in NCT02526745
Study groupRoleWhat they receive
high doses of virus content between 4.7～5.0 lgPFUExperimentallive attenuated vaccine against herpes zoster with high doses of virus content between 4.7～5.0 lgPFU in 20 adults aged 50-80 years old on day 0
Receives: Biological: the vaccine with high doses of virus content between 4.7～5.0 lgPFU
low doses of virus content between 4.7～5.0 lgPFUExperimentallive attenuated vaccine against herpes zoster with low doses of virus content between 4.7～5.0 lgPFU in 20 adults aged 50-80 years old on day 0
Receives: Biological: the vaccine with low doses of virus content between 4.7～5.0 lgPFU
high doses of virus content between 4.3～5.0 lgPFUExperimentallive attenuated vaccine against herpes zoster with high doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0
Receives: Biological: the vaccine with high doses of virus content between 4.3～5.0 lgPFU
middle doses of virus content between 4.3～5.0 lgPFUExperimentallive attenuated vaccine against herpes zoster with middle doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0
Receives: Biological: the vaccine with middle doses of virus content between 4.3～5.0 lgPFU
low doses of virus content between 4.3～5.0 lgPFUExperimentallive attenuated vaccine against herpes zoster with low doses of virus content between 4.3～5.0 lgPFU in 100 adults aged 50-80 years old on day 0
Receives: Biological: the vaccine with low doses of virus content between 4.3～5.0 lgPFU
placeboPlacebo comparatorplacebo in 100 adults aged 50-80 years old on day 0
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the Rate of Adverse reactions of live attenuated Herpes zoster Vaccine in Chinese Adults.

    Adverse reactions associated with vaccine will be observed in Chinese Adults ( 50 years and older) after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

    Measured: 42 days

Secondary outcomes (1)

  1. Evaluate the seroconversion rate of anti-herpes zoster virus antibodies in serum of adults after vaccination.

    The seroconversion rate of anti-herpes zoster virus antibodies will be evaluated in serum of adults within the first 42 days after vaccination.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02526745
Sponsor's protocol ID
cycdc2015-1
Status last verified
Aug 2015
First submitted
12 Aug 2015
Last updated
15 Aug 2016
Results posted
No

Publications

  • de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

    PubMed 37781954

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing the vaccine with high doses of virus content between 4.7～5.0 lgPFU, the vaccine with low doses of virus content between 4.7～5.0 lgPFU and the vaccine with high doses of virus content between 4.3～5.0 lgPFU in people with Herpes Zoster, run by Beijing Chaoyang District Centre for Disease Control and Prevention.

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 9 inclusion and 18 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 15 Aug 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Evaluate the Rate of Adverse reactions of live attenuated Herpes zoster Vaccine in Chinese Adults. (time frame: 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02526745, which also lists 1 linked publication.

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 15 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in