Patients With CancerPhase 1/2NCT05273541
Safety and Immunogenicity of Prime-boost Vaccination of SARS-CoV-2 in Patients With Cancer
A Phase 1/2 study testing Coronavirus vaccination in people with Patients With Cancer and Vaccine Reaction, run by Beijing 302 Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With Cancer, Vaccine Reaction, COVID-19
- What is being tested?
- Coronavirus vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2022to 30 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
302 Hospital
Beijing, 100039
Fu-Sheng Wang, MD, 01066933328, fswang302@163.com
Fu-Sheng Wang, MD
About this study
Official title: Beijing 302 Hospital
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.
Read the detailed description
This study is a prospective, single-arm, open-label clinical trial. A total of 100 patients with different cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this heterologous prime-boost vaccination study. All of the patients will further accept 12 months follow-up study after prime-boost vaccination. Safety, reactogenicity and immunogenicity of the prime-boost vaccination in those patients will be carefully recorded and detected.
- Conditions
- Patients With Cancer, Vaccine Reaction, COVID-19
- Being tested
- Coronavirus vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronavirus vaccinationBiological
Patients in this trial need to accept a prime-boost vaccination against SARS-CoV-2 after 6 to 8 months of the first vaccination
| Study group | Role | What they receive |
|---|---|---|
| Prime-boost vaccination | Experimental | Patients in the experimental group need to accept the prime-boost vaccination regimen Receives: Biological: Coronavirus vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse effects after prime-boost vaccination
Safety of the prime-boost vaccine
Measured: Within 1 week after the prime-boost vaccination
Titers of anti-SARS-CoV-2 antibodies
Immunogenicity of prime-boost vaccine
Measured: Within 3 months after the prime-boost vaccination
Secondary outcomes (2)
Occurence of adverse effects after prime-boost vaccination
Safety of the prime-boost vaccine
Measured: Within 1 month after the prime-boost vaccination
Titers of anti-SARS-CoV-2 antibodies
Immunogenicity of prime-boost vaccine
Measured: Within 12 months after the prime-boost vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start11 Feb 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Patients With CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-juan Li, MD, Study director, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273541
- Sponsor's protocol ID
- ky-2021-7-9-2
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33045429Dai 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 32345594Monin 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 33930323Fendler 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.
PubMed 35121900Villarreal-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.
PubMed 34110371Wang 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.
PubMed 33905793
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing 302 Hospital
- ClinicalTrials.gov ID
- NCT05273541
- Acronym / sponsor ID
- ky-2021-7-9-2
- Conditions
- Patients With Cancer, Vaccine Reaction, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, single-arm, open-label clinical trial. A total of 100 patients with different cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer were included in this heterologous prime-boost vaccination study. All of the patients will further accept 12 months follow-up study after prime-boost vaccination. Safety, reactogenicity and immunogenicity of the prime-boost vaccination in those patients will be carefully recorded and detected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prime-boost vaccination | Experimental | Biological: Coronavirus vaccinationPatients in the experimental group need to accept the prime-boost vaccination regimen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronavirus vaccinationPatients in this trial need to accept a prime-boost vaccination against SARS-CoV-2 after 6 to 8 months of the first vaccination | Biological | Prime-boost vaccination |
Primary outcome
Occurrence of adverse effects after prime-boost vaccination
Time frame: Within 1 week after the prime-boost vaccination
Safety of the prime-boost vaccine
Titers of anti-SARS-CoV-2 antibodies
Time frame: Within 3 months after the prime-boost vaccination
Immunogenicity of prime-boost vaccine
2 secondary outcomes
Occurence of adverse effects after prime-boost vaccination
Time frame: Within 1 month after the prime-boost vaccination
Titers of anti-SARS-CoV-2 antibodies
Time frame: Within 12 months after the prime-boost vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 33045429Lai 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.
- Background: PubMed 32345594Dai 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.
- Background: PubMed 33930323Monin 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.
- Background: PubMed 35121900Fendler 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.
- Background: PubMed 34110371Villarreal-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.
- Background: PubMed 33905793Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-juan Li, MD study director
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coronavirus vaccination in people with Patients With Cancer and Vaccine Reaction, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu-Sheng Wang, MD (8610-66933332, fswang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse effects after prime-boost vaccination (time frame: Within 1 week after the prime-boost vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273541, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.