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.

Oncologic Complications Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06334744
• Other study ID #: COVAR
• Status: Completed
• Start date: November 17, 2021
• Est. completion date: June 8, 2023

Study information

• Verified date: March 2024
• Source: Fondazione IRCCS Policlinico San Matteo di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 8, 2023
• Est. primary completion date: January 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oncologic Complications

Locations

Country	Name	City	State
Italy	Irccs San Matteo Pavia	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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