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RecruitingNCT05018078Updated Jun 27, 2023

Safety and Immunogenicity of COVID-19 Vaccination in Patients With Cancer

An interventional study of Coronavirus vaccine in Patients With Cancers, COVID-19 and Vaccine, sponsored by Beijing 302 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by Beijing 302 Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Patients With Cancers
  • COVID-19
  • Vaccine

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Coronavirus vaccination

    Patients in the experimental need to accept the coronavirus vaccination

    Biological: Coronavirus vaccine

Interventions

  • BiologicalCoronavirus vaccine

    Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively

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What researchers measure

Primary outcomes

  1. Safety of coronavirus vaccine

    Occurence of adverse effects after COVID-19 vaccination

    Time frame: Within 2 months after the first dose of coronavirus vaccine

  2. Immunogenicity of coronavirus vaccine

    Titers of anti-SARS-CoV-2 antibodies

    Time frame: Within 2 months after the first dose of coronavirus vaccine

Secondary outcomes

  1. Safety of coronavirus vaccine

    Occurence of adverse effects after COVID-19 vaccination

    Time frame: Within 13 months after the first dose of coronavirus vaccine

  2. Immunogenicity of coronavirus vaccine

    Titers of anti-SARS-CoV-2 antibodies

    Time frame: Within 13 months after the first dose of coronavirus vaccine

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Study locations

1 of 1 sites recruiting
  • The Fifth Medical Center of PLA General Hospital
    Beijing, Beijing 100039, China
    • Fu-Sheng Wang, MD · Contact · fswang302@163.com · 01066933328
    • Fu-Sheng Wang, MD · Principal investigator
    Recruiting
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References and documents

Publications

  • Lai CC, Wang JH, Hsueh PR. Population-based seroprevalence surveys of anti-SARS-CoV-2 antibody: An up-to-date review. Int J Infect Dis. 2020 Dec;101:314-322. doi: 10.1016/j.ijid.2020.10.011. Epub 2020 Oct 9. PubMed 33045429 ↗
  • Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28. PubMed 32345594 ↗
  • Monin L, Laing AG, Munoz-Ruiz M, McKenzie DR, Del Molino Del Barrio I, Alaguthurai T, Domingo-Vila C, Hayday TS, Graham C, Seow J, Abdul-Jawad S, Kamdar S, Harvey-Jones E, Graham R, Cooper J, Khan M, Vidler J, Kakkassery H, Sinha S, Davis R, Dupont L, Francos Quijorna I, O'Brien-Gore C, Lee PL, Eum J, Conde Poole M, Joseph M, Davies D, Wu Y, Swampillai A, North BV, Montes A, Harries M, Rigg A, Spicer J, Malim MH, Fields P, Patten P, Di Rosa F, Papa S, Tree T, Doores KJ, Hayday AC, Irshad S. Safety and immunogenicity of one versus two doses of the COVID-19 vaccine BNT162b2 for patients with cancer: interim analysis of a prospective observational study. Lancet Oncol. 2021 Jun;22(6):765-778. doi: 10.1016/S1470-2045(21)00213-8. Epub 2021 Apr 27. PubMed 33930323 ↗
  • Herishanu Y, Avivi I, Aharon A, Shefer G, Levi S, Bronstein Y, Morales M, Ziv T, Shorer Arbel Y, Scarfo L, Joffe E, Perry C, Ghia P. Efficacy of the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia. Blood. 2021 Jun 10;137(23):3165-3173. doi: 10.1182/blood.2021011568. PubMed 33861303 ↗
  • Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6. PubMed 33563499 ↗
  • Fix OK, Blumberg EA, Chang KM, Chu J, Chung RT, Goacher EK, Hameed B, Kaul DR, Kulik LM, Kwok RM, McGuire BM, Mulligan DC, Price JC, Reau NS, Reddy KR, Reynolds A, Rosen HR, Russo MW, Schilsky ML, Verna EC, Ward JW, Fontana RJ; AASLD COVID-19 Vaccine Working Group. American Association for the Study of Liver Diseases Expert Panel Consensus Statement: Vaccines to Prevent Coronavirus Disease 2019 Infection in Patients With Liver Disease. Hepatology. 2021 Aug;74(2):1049-1064. doi: 10.1002/hep.31751. PubMed 33577086 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05018078
Lead sponsor
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Aug 24, 2021
Start date
Aug 30, 2021
Primary completion
Aug 30, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Jun 27, 2023

Study contacts

Fu-Sheng Wang, MD
Contact
fswang@163.com
8610-66933332
Ruonan Xu, MD
Contact
xuruonan2004@aliyun.com
8610-66933333
Shu-juan Li, MD
study director · Beijing 302 Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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