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. 2019 Nov 7;2019(11):CD008858. doi: 10.1002/14651858.CD008858.pub4

NCT02526745.

Trial name or title Safety and immunogenicity study of live attenuated vaccine against herpes zoster in Chinese adults aged 50 years and older
Methods Allocation: randomised
Intervention model: parallel assignment
Blinding: double‐blind (participant, investigator)
Primary purpose: prevention
Participants 440 participants. Aged 50 to 80 years, both genders, accepts healthy volunteers
Interventions

  1. Vaccine with low dose of virus content, between 4.7 and 5.0 lg pfu

  2. Vaccine with high dose of virus content, between 4.3 and 5.0 lg pfu

  3. Vaccine with middle dose of virus content, between 4.3 and 5.0 lg pfu

  4. Vaccine with very low dose of virus content, between 4.3 and 5.0 lg pfu

  5. Placebo
Outcomes Primary outcome measures:

  • Evaluate the rate of adverse reactions of live attenuated herpes zoster vaccine in Chinese adults. Time frame: 42 days.

  • 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, diarrhoea, decreased appetite, agitation (irritability, abnormal crying), fatigue, allergy.


Secondary outcome measures:

  • Evaluate the seroconversion rate of anti‐herpes zoster virus antibodies in serum of adults after vaccination. Time frame: 6 months.
Starting date November 2015
Contact information Beijing Chaoyang District Centre for Disease Control and Prevention
Notes Study evaluated the safety and immunogenicity of live attenuated vaccine in adults aged 50 years and over. Half of the participants received high doses of the vaccine, and the other half received low doses of the vaccine in phase I clinical trial. At the phase II clinical trial, participants were distributed equally into 4 groups (low, middle, high doses of the vaccine and placebo).
Completed, but no results posted on ClinicalTrials.gov and no publications identified
Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention