Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04878796 |
| Other study ID # |
ASST CR-01-2021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 24, 2021 |
| Est. completion date |
May 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Azienda Socio Sanitaria Territoriale di Cremona |
| Contact |
MARGHERITA RATTI, MD |
| Phone |
+390372408035 |
| Email |
margherita.ratti[@]asst-cremona.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Based on recent data, COVID (COV) vaccination in cancer patients (pts) is strictly
recommended. For oncologic pts,2 types of m-RNA vaccines have been approved: BNT162b2
(Pfizer, Biontech) and mRNA-1273 (Moderna, NIAID). In immunocompetent population, the
administration of 2 doses confers 95% protection against COV. However, protection conferred
by vaccines, adverse events (AEs) and correlations with antiblastic treatments are unknown in
cancer pts.
Description:
Trial Design
This is a monocentric observational study conducted by the Oncology Unit of Cremona (CR)
Hospital, enrolling pts from Oncology, Hematology, Radiotherapy and Palliative Care of Cr
Hospital.
This trial aims to prospectively and retrospectively evaluate the effectiveness of mRNA
vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], the quantization of the antibodies
(Abs) response and the onset of AEs in a consecutive population of 300 cancer pts, undergoing
antiblastic treatment, starting from March 26Th,2021.
From March, 2021 a vaccination point was set up by Cr Hospital, specific for cancer pts.
Vaccine is administered at least 5 days after the last dose of intravenous or oral
chemotherapy treatment; the next course of therapy is not administered within the next 3
days. Target therapy and immunotherapy doesn't need interruptions.
- Primary endpoint: Evaluating the protection conferred by vaccination, by detecting the
number of symptomatic pts affected by COV, diagnosed 7-60 days after the 2nddose of vaccine.
Confirmed of COV infection is defined according to the Food and Drug Administration criteria
combined with a nasopharyngeal swab, positive for SARS-Cov-2, obtained during the symptomatic
period or within 4 days before or after it.
- Secondary endpoints: Measuring Abs variation at different timepoints compared to baseline.
LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level
of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of
vaccine;
Describing AEs; Evaluating the interference between vaccine and cancer treatments; Analysis
of the Abs subtypes; Duration of abs, up to 12 months after 2nd dose
Statistic Analysis The hypothesis of vaccine inferiority in the trial population is rejected
if a rate of protection conferred by the vaccine is observed in 89% of the sample size. The
null hypothesis will be rejected if out of a sample size of 300 patients at least 261 are
"protected".
The observed proportion of patients with protection will be described by absolute and
relative frequency, with Clopper-Pearson confidence intervals. The primary objective will be
tested by non-inferiority one-single proportion test, compared with the historical value of
95%. In order to describe the trend of antibody changes in the multiple detections, the ANOVA
test for repeated measurements will be used.
