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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.
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
1. Inability to sign informed consent
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs San Matteo Pavia | Pavia | PV | 27100 | Italy |
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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 |