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.

Completed

• Conditions: Oncologic Complications

• Registration Number: NCT06334744
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-17
• Primary Completion: 2023-01-08
• Study Completion: 2023-06-08
• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-27
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3 weeks	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

Secondary Outcome Measures

Name	Time	Method
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	The difference in antibody titers from time 0, at 3 and 26 weeks, up to week 52
Evaluation of the incidence of virologically confirmed cases of VOC after administration of the third dose of vaccine.	52 weeks	The incidence will be expressed as patients per 100 people per year.
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	The incidence will be expressed as patients per 100 people per year.
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	The incidence will be expressed as patients per 100 people per year.

Trial Locations

Locations (1)

Irccs San Matteo Pavia; 🇮🇹 Pavia, PV, Italy