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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high doses of virus content between 4.7~5.0 lgPFU | Experimental | live 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 |
|
| low doses of virus content between 4.7~5.0 lgPFU | Experimental | live 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 |
|
| high doses of virus content between 4.3~5.0 lgPFU | Experimental | live 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 |
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| middle doses of virus content between 4.3~5.0 lgPFU | Experimental | live 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 |
|
| low doses of virus content between 4.3~5.0 lgPFU |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the vaccine with high doses of virus content between 4.7~5.0 lgPFU | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | 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. |
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live 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 |
|
| placebo | Placebo Comparator | placebo in 100 adults aged 50-80 years old on day 0 |
|
| the vaccine with low doses of virus content between 4.7~5.0 lgPFU |
| Biological |
|
| the vaccine with high doses of virus content between 4.3~5.0 lgPFU | Biological |
|
| the vaccine with middle doses of virus content between 4.3~5.0 lgPFU | Biological |
|
| the vaccine with low doses of virus content between 4.3~5.0 lgPFU | Biological |
|
| placebo | Biological |
|
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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