A Phase 4 interventional study of Herpes Zoster Vaccine, Live and Placebo in Prevention of Herpes Zoster, sponsored by Changchun BCHT Biotechnology Co.. Not yet recruiting. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Changchun BCHT Biotechnology Co. · Phase 4, Interventional, and Prevention
To evaluate the immunogenicity 42 days after vaccination with the live attenuated herpes zoster vaccine.
To evaluate the safety of the live attenuated herpes zoster vaccine.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
This study's planned enrollment of 600 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →Changchun BCHT Biotechnology Co. is the lead sponsor of 22 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After reconstitution, 0.5 ml per bottle. The dose per person is 0.5 ml.
Biological: Herpes Zoster Vaccine, Live
After redissolving, 0.5 ml per bottle. The dose is 0.5 ml per dose for human and does not contain varicella-zoster live virus.
Biological: Placebo
assigned to the vaccine group and placebo group in a 2:1 ratio.
assigned to the vaccine group and placebo group in a 2:1 ratio.
Immunogenicity:
Geometric mean titer (GMT)at Day 0 and Day 42.
Time frame: Day 0 and Day 42
Immunogenicity:
geometric mean concentration (GMC) at Day 0 and Day 42.
Time frame: Day 0 and Day 42
Immunogenicity:
geometric mean fold increase (GMFI)at Day 0 and Day 42
Time frame: Day 0 and Day 42
Immunogenicity:
seroconversion/seroresponse rate (4-fold increase) at Day 0 and Day 42.
Time frame: Day 0 and Day 42
Adverse Events
1. Incidence, severity, and causality of solicited local，systemic adverse events within 14 days post-vaccination； 2. The incidence and severity of unsolicited adverse events within 42 days after vaccination and their association with vaccination； 3. Incidence of Serious Adverse events (SAE) within 42 days after vaccination。
Time frame: 42 days
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Jul 2025, 2 months later.
Of 19 phase 4 interventional studies under Herpes Zoster, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 45. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Herpes Zoster Vaccine
Changchun BCHT Biotechnology Co.