NCT05018078

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

August 18, 2021

Last Update Submit

June 24, 2023

Conditions

Patients With CancersCOVID-19Vaccine

Outcome Measures

Primary Outcomes (2)

  • Safety of coronavirus vaccine

    Occurence of adverse effects after COVID-19 vaccination

    Within 2 months after the first dose of coronavirus vaccine

  • Immunogenicity of coronavirus vaccine

    Titers of anti-SARS-CoV-2 antibodies

    Within 2 months after the first dose of coronavirus vaccine

Secondary Outcomes (2)

  • Safety of coronavirus vaccine

    Within 13 months after the first dose of coronavirus vaccine

  • Immunogenicity of coronavirus vaccine

    Within 13 months after the first dose of coronavirus vaccine

Study Arms (1)

Coronavirus vaccination

EXPERIMENTAL

Patients in the experimental need to accept the coronavirus vaccination

Biological: Coronavirus vaccine

Interventions

Coronavirus vaccineBIOLOGICAL

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

Coronavirus vaccination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with acute attack of chronic diseases.
  • 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.
  • Pregnant or lactating women.
  • 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.
  • Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 33045429BACKGROUND

  • 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.

    PMID: 32345594BACKGROUND

  • 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.

    PMID: 33930323BACKGROUND

  • 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.

    PMID: 33861303BACKGROUND

  • 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.

    PMID: 33563499BACKGROUND

  • 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.

    PMID: 33577086BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shu-juan Li, MD

    Beijing 302 Hospital

    STUDY DIRECTOR

Central Study Contacts

Fu-Sheng Wang, MD

CONTACT

8610-66933332fswang@163.com

Ruonan Xu, MD

CONTACT

8610-66933333xuruonan2004@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 24, 2021

Study Start

August 30, 2021

Primary Completion

August 30, 2023

Study Completion

October 30, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)