Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer

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 may be at higher risk of infection and severity than those without cancer. Mass vaccination has been carried out, but reinfection and vaccine breakthrough cases still occur. Now, the prime-boost regimen was identified safe and efficient, but the reactogenicity and immunogenicity of prime-boost vaccine strategy in cancer patients were not known.

Sex

All

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

1. Age above 18 years.
2. Patients with diagnosed cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer.
3. 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.
4. The functions of multi-organs were normal or basically normal, and there are no contraindications for vaccination.

Exclusion Criteria:

1. Patients with acute attack of chronic diseases.
2. 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.
3. Pregnant or lactating women.
4. 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.
5. 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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