Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer

NCT05273541 | Unknown Phase 1 DMC

• 1 other identifier: ky-2021-7-9-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Cancer; Vaccine Reaction; COVID-19

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse effects after prime-boost vaccination

  Safety of the prime-boost vaccine

  Within 1 week after the prime-boost vaccination

• Titers of anti-SARS-CoV-2 antibodies

  Immunogenicity of prime-boost vaccine

  Within 3 months after the prime-boost vaccination

Secondary Outcomes (2)

• Occurence of adverse effects after prime-boost vaccination

  Within 1 month after the prime-boost vaccination

• Titers of anti-SARS-CoV-2 antibodies

  Within 12 months after the prime-boost vaccination

Study Arms (1)

Prime-boost vaccination

EXPERIMENTAL

Patients in the experimental group need to accept the prime-boost vaccination regimen

Biological: Coronavirus vaccination

Interventions

Coronavirus vaccination BIOLOGICAL

Patients in this trial need to accept a prime-boost vaccination against SARS-CoV-2 after 6 to 8 months of the first vaccination

Prime-boost vaccination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years.
• Patients with diagnosed cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer.
• 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.

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

302 Hospital

Beijing, 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: 33045429 BACKGROUND

• 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: 32345594 BACKGROUND

• 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: 33930323 BACKGROUND

• Fendler A, Au L, Shepherd STC, Byrne F, Cerrone M, Boos LA, Rzeniewicz K, Gordon W, Shum B, Gerard CL, Ward B, Xie W, Schmitt AM, Joharatnam-Hogan N, Cornish GH, Pule M, Mekkaoui L, Ng KW, Carlyle E, Edmonds K, Rosario LD, Sarker S, Lingard K, Mangwende M, Holt L, Ahmod H, Stone R, Gomes C, Flynn HR, Agua-Doce A, Hobson P, Caidan S, Howell M, Wu M, Goldstone R, Crawford M, Cubitt L, Patel H, Gavrielides M, Nye E, Snijders AP, MacRae JI, Nicod J, Gronthoud F, Shea RL, Messiou C, Cunningham D, Chau I, Starling N, Turner N, Welsh L, van As N, Jones RL, Droney J, Banerjee S, Tatham KC, Jhanji S, O'Brien M, Curtis O, Harrington K, Bhide S, Bazin J, Robinson A, Stephenson C, Slattery T, Khan Y, Tippu Z, Leslie I, Gennatas S, Okines A, Reid A, Young K, Furness AJS, Pickering L, Gandhi S, Gamblin S, Swanton C; Crick COVID-19 Consortium; Nicholson E, Kumar S, Yousaf N, Wilkinson KA, Swerdlow A, Harvey R, Kassiotis G, Larkin J, Wilkinson RJ, Turajlic S; CAPTURE consortium. Functional antibody and T cell immunity following SARS-CoV-2 infection, including by variants of concern, in patients with cancer: the CAPTURE study. Nat Cancer. 2021 Dec;2(12):1321-1337. doi: 10.1038/s43018-021-00275-9. Epub 2021 Oct 27.

  PMID: 35121900 BACKGROUND

• Villarreal-Garza C, Vaca-Cartagena BF, Becerril-Gaitan A, Ferrigno AS, Mesa-Chavez F, Platas A, Platas A. Attitudes and Factors Associated With COVID-19 Vaccine Hesitancy Among Patients With Breast Cancer. JAMA Oncol. 2021 Aug 1;7(8):1242-1244. doi: 10.1001/jamaoncol.2021.1962.

  PMID: 34110371 BACKGROUND

• Wang J, Hou Z, Liu J, Gu Y, Wu Y, Chen Z, Ji J, Diao S, Qiu Y, Zou S, Zhang A, Zhang N, Wang F, Li X, Wang Y, Liu X, Lv C, Chen S, Liu D, Ji X, Liu C, Ren T, Sun J, Zhao Z, Wu F, Li F, Wang R, Yan Y, Zhang S, Ge G, Shao J, Yang S, Liu C, Huang Y, Xu D, Li X, Ai J, He Q, Zheng MH, Zhang L, Xie Q, Rockey DC, Fallowfield JA, Zhang W, Qi X. Safety and immunogenicity of COVID-19 vaccination in patients with non-alcoholic fatty liver disease (CHESS2101): A multicenter study. J Hepatol. 2021 Aug;75(2):439-441. doi: 10.1016/j.jhep.2021.04.026. Epub 2021 Apr 24.

  PMID: 33905793 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shu-juan Li, MD

  Beijing 302 Hospital

  STUDY DIRECTOR

Central Study Contacts

Fu-Sheng Wang, MD

CONTACT

8610-66933332; fswang@163.com

Ruonan Xu, MD

CONTACT

8610-66933333; xuruonan2004@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 10, 2022
• Study Start: February 11, 2022
• Primary Completion: December 30, 2022
• Study Completion: July 30, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-02

Locations

CN (1)