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OpenTrials
Completed

NCT Number: NCT06334744

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.

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Key information

Conditions

Oncologic Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irccs San Matteo Pavia

Pavia, PV, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Inability to sign informed consent

Treatment and study plan

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.

    Time frame: 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 outcomes

  1. 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

    Time frame: 0, 3, 26, 52 weeks

    The difference in antibody titers from time 0, at 3 and 26 weeks, up to week 52

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

    Time frame: 52 weeks

    The incidence will be expressed as patients per 100 people per year.

  3. 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.

    Time frame: 4 weeks

    The incidence will be expressed as patients per 100 people per year.

  4. 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.

    Time frame: 52 weeks

    The incidence will be expressed as patients per 100 people per year.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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