Clinical trial NCT05018078: Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer
Official title: The Fifth Medical Center of Chinese PLA General Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Cancers
COVID-19
Vaccine
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020. Patients with cancers may be at higher risk than those without cancer for coronavirus disease 2019 (COVID-19). At present, limited data are available on the safety and immunogenicity of COVID-19 vaccination for patients with cancer.

Detailed description: This study is a prospective, single-arm, open-label clinical trial. A total of 300 patients with different cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this vaccination study. All of the patients will further accept 12 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Eligibility criteria: Inclusion Criteria:

1. Age above 18 years
2. Patients with diagnosed cancers including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included .
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.
3. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
4. Pregnant or lactating women.
5. Sufferring serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
6. 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.
7. Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.

Primary outcomes:
measure: Safety of coronavirus vaccine
timeFrame: Within 2 months after the first dose of coronavirus vaccine
measure: Immunogenicity of coronavirus vaccine
timeFrame: Within 2 months after the first dose of coronavirus vaccine
Secondary outcomes:
measure: Safety of coronavirus vaccine
timeFrame: Within 13 months after the first dose of coronavirus vaccine
measure: Immunogenicity of coronavirus vaccine
timeFrame: Within 13 months after the first dose of coronavirus vaccine
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Shu-juan Li, MD
role: STUDY_DIRECTOR
References:
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