COVID-19 vaccination safety and immune response in cancer patients
The Fifth Medical Center of Chinese PLA General Hospital
This study is testing how safe the COVID-19 vaccine is and how well it works for people with different types of cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05018078 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and immunogenicity of COVID-19 vaccination in patients diagnosed with various types of cancer, including hepatocellular carcinoma, breast cancer, lung cancer, esophageal cancer, gastric cancer, and colorectal cancer. A total of 300 participants will receive the vaccine and will be monitored for safety and immune response over a 12-month follow-up period. The study is designed as a prospective, single-arm, open-label trial to gather data on how well the vaccine works in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with specific types of cancer and are in a stable condition.
Not a fit: Patients with acute chronic diseases, serious cardiovascular conditions, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and effectiveness of COVID-19 vaccines for cancer patients, potentially improving their protection against the virus.
How similar studies have performed: While there is limited data on COVID-19 vaccination in cancer patients, similar studies have shown the importance of understanding vaccine responses in immunocompromised populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- The Fifth Medical Center of PLA General Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Fu-Sheng Wang, MD
- Email: fswang@163.com
- Phone: 8610-66933332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.