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.
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, gastric cancer and colorectal cancer were included in this heterologous prime-boost vaccination study. All of the patients will further accept 12 months follow-up study after prime-boost vaccination. Safety, reactogenicity and immunogenicity of the prime-boost vaccination in those patients will be carefully recorded and detected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients in this trial need to accept a prime-boost vaccination against SARS-CoV-2 after 6 to 8 months of the first vaccination
302 Hospital
Beijing, China
RECRUITINGOccurrence of adverse effects after prime-boost vaccination
Safety of the prime-boost vaccine
Time frame: Within 1 week after the prime-boost vaccination
Titers of anti-SARS-CoV-2 antibodies
Immunogenicity of prime-boost vaccine
Time frame: Within 3 months after the prime-boost vaccination
Occurence of adverse effects after prime-boost vaccination
Safety of the prime-boost vaccine
Time frame: Within 1 month after the prime-boost vaccination
Titers of anti-SARS-CoV-2 antibodies
Immunogenicity of prime-boost vaccine
Time frame: Within 12 months after the prime-boost vaccination
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