Ambispective Observational Multicenter Study on the Efficacy of the Third Dose of Vaccine Anti COVID-19 in Patients Suffering From Solid Tumors Undergoing Oncological Treatment Active.

To evaluate the serum neutralizing antibody titre in cancer patients undergoing active treatment against variants (VOC) before and after the third dose of BNT162b2 COVID-19 vaccine.

Study Overview

• Status: Completed
• Conditions: Oncologic Complications

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy, 27100
      • Irccs San Matteo Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This project includes subjects affected by solid tumors undergoing active treatment and subjected to the SARS-CoV-2 vaccine belonging to MAC oncology clinics starting from the start of the vaccination campaign in fragile patients.

Description

Inclusion Criteria:

1. Patients aged 18 years or older, regardless of gender;
2. Life expectancy (estimated by the treating doctor) ≥ 6 months;
3. Histological diagnosis confirmed solid neoplasm;
4. Under active treatment
5. Previous two doses of Pfizer anti-SARS-CoV-2 vaccine received (will be considered also patients who have completed the vaccination cycle with other mRNA vaccines - Modern-)
6. All participants subscribed and signed the informed consent form first of enlistment
7. Patients with a positive history of a previous diagnosis are also enrolled laboratory confirmed COVID-19
8. ECOG 0-2

Exclusion Criteria:

1. Inability to sign informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the change in neutralizing antibodies against SARS-CoV-2 (CLIA method) towards VOCs before the third dose of COVID-19 vaccine and 21 days after the same.	The immune response to viral variants will be evaluated by neutralization tests. In detail, previously titrated and characterized viral isolates representative of the alpha, beta, gamma and delta variants will be used. Any new variants relevant from a clinical and epidemiological point of view will subsequently be taken into consideration. A positive neutralizing titer is considered to be a titer equal to or greater than 1:10	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the kinetics of neutralizing antibodies and anti-SARS-CoV-2 IgG titer (CLIA method) up to 52 weeks after the third dose of COVID-19 vaccine	The difference in antibody titers from time 0, at 3 and 26 weeks, up to week 52	0, 3, 26, 52 weeks
Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine.	The incidence will be expressed as patients per 100 people per year.	52 weeks
Evaluation of the incidence of local and systemic adverse reactions (ARs), directly or indirectly linked to the vaccine, in an observation period up to 4 weeks later the third dose of vaccine.	The incidence will be expressed as patients per 100 people per year.	4 weeks
Evaluation of the incidence of "New onset" immune-related adverse events (IRAEs), such as immune-related pruritus, rashes, hypophysitis, hepatitis, pneumonia, diarrhoea, colitis in patients undergoing immunotherapy.	The incidence will be expressed as patients per 100 people per year.	52 weeks

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): January 8, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: COVAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No