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

Phase 1

• Conditions: Vaccine Reaction; Patients With Cancer; COVID-19
• Interventions: Biological: Coronavirus vaccination

• Registration Number: NCT05273541
• Lead Sponsor: Beijing 302 Hospital

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.

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 Timeline

• Status Verified: 2022-02
• Study Start: 2022-02-11
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-10
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-18
• Primary Completion: 2022-12-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age above 18 years.
2. Patients with diagnosed cancers including breast cancer, hepatocellular carcinoma, lung cancer, esophageal cancer, gastric cancer and colorectal cancer.
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. Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.

3. Pregnant or lactating women.

4. 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.

5. Systemic cytotoxic drugs, cell therapies including NK cells, cytokine induced killer cells, Dendritic cells, CTL and stem cells infusion are required during vaccination.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prime-boost vaccination	Coronavirus vaccination	Patients in the experimental group need to accept the prime-boost vaccination regimen

Primary Outcome Measures

Name	Time	Method
Titers of anti-SARS-CoV-2 antibodies	Within 3 months after the prime-boost vaccination	Immunogenicity of prime-boost vaccine
Occurrence of adverse effects after prime-boost vaccination	Within 1 week after the prime-boost vaccination	Safety of the prime-boost vaccine

Secondary Outcome Measures

Name	Time	Method
Occurence of adverse effects after prime-boost vaccination	Within 1 month after the prime-boost vaccination	Safety of the prime-boost vaccine
Titers of anti-SARS-CoV-2 antibodies	Within 12 months after the prime-boost vaccination	Immunogenicity of prime-boost vaccine

Trial Locations

Locations (1)

302 Hospital; 🇨🇳 Beijing, China