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| Column | Value |
|---|---|
| Trial registration number | NCT05273541 |
|
Full text link
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
fswang@163.com |
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Registration date
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
2022-03-10 |
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Recruitment status
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : April 20, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
inclusion criteria: age above 18 years. patients with diagnosed cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer. patients who have received local or systemic anti-cancer therapies according to the treatment guidelines previously or currently, and have a stable condition with the ecog score below 2. the functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination. |
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Exclusion criteria
Last imported at : April 20, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
patients with acute attack of chronic diseases. patients have history of convulsion, epilepsy, encephalopathy and psychosis. patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy. pregnant or lactating women. sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs. patients have severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. congenital or acquired angioedema / neuroedema. systemic cytotoxic drugs, cell therapies including nk cells, cytokine induced killer cells, dendritic cells, ctl and stem cells infusion are required during vaccination. |
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Number of arms
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Beijing 302 Hospital |
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Inclusion age min
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
70 |
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Countries
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
100 |
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primary outcome
Last imported at : April 20, 2022, 12:30 a.m. Source : ClinicalTrials.gov |
Occurrence of adverse effects after prime-boost vaccination;Titers of anti-SARS-CoV-2 antibodies |
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Notes
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
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Arms
Last imported at : March 12, 2022, midnight Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}] |