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.

NCT06334744 | Completed

• 1 other identifier: COVAR
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oncologic Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  0, 3, 26, 52 weeks

• Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine.

  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.

  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.

  52 weeks

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years or older, regardless of gender;
• Life expectancy (estimated by the treating doctor) ≥ 6 months;
• Histological diagnosis confirmed solid neoplasm;
• Under active treatment
• 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-)
• All participants subscribed and signed the informed consent form first of enlistment
• Patients with a positive history of a previous diagnosis are also enrolled laboratory confirmed COVID-19
• ECOG 0-2

You may not qualify if:

• \. Inability to sign informed consent

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Irccs San Matteo Pavia

Pavia, PV, 27100, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: March 28, 2024
• Study Start: November 17, 2021
• Primary Completion: January 8, 2023
• Study Completion: June 8, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

IT (1)