Status:
UNKNOWN
Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Patients With Cancer
Vaccine Reaction
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has caused a global pandemic since late 2019 that resulted in more than 360 million population infection. Patients with cancers m...
Detailed Description
This study is a prospective, single-arm, open-label clinical trial. A total of 100 patients with different cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, ga...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05273541
Start Date
February 11 2022
End Date
July 30 2023
Last Update
April 18 2022
Active Locations (1)
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1
302 Hospital
Beijing, China, 100039