Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05228912 |
| Other study ID # |
7 vaccines against COVID-19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 26, 2021 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Hospital Clinica Nova |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Background: Scarce information exists in relation to the comparison of seroconversion and
adverse events following immunization (AEFI) with different SARS-COV2 vaccines. Our aim was
to correlate the magnitude of the antibody response to vaccination with previous clinical
conditions and AEFI.
Methods: A multicentric comparative study where SARS-CoV-2 spike 1-2 IgG antibodies IgG
titers are being measured at baseline, 21-28 days after the first and second dose (when
applicable), six months and a year of the following vaccines: BNT162b2 mRNA, mRNA-1273,
Gam-COVID-Vac, Coronavac, ChAdOx1-S, Ad5-nCoV and Ad26.COV2. Mixed model and Poisson
generalized linear models will be performed for the analyses.
Description:
The aim of this study is to compare the seroconversion after the first and second dose (if
applicable) between BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac,
and Coronavac through the measurement of SARS-CoV-2 spike 1-2 IgG antibodies using the same
standardized assay.
Our secondary aims are to correlate the magnitude of the antibody response with previous
clinical conditions (medical history) and previous diagnosis of SARS-CoV-2.
Our tertiary aim will be to compare the change in antibody levels after a third or fourth
dose of any of the vaccines previously described
Also, we will investigate the differences across vaccines regarding adverse events after
vaccination and determine the best predictors of systemic and severe adverse events.
This is a multicentric observational study of volunteers who will receive an approved
complete scheme of BNT162b2 mRNA, mRNA-1273, ChAdOx1-S, Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac,
or Coronavac COVID-19 vaccine during 2021 in five hospital centers (Hospital Clinica Nova,
Humanitas Clinical and Research Center, Fundación San Francisco Xavier, Ternium Health Center
in Rio, Hospital Municipal San Jose, Hospital Interzonal de Agudos San Felipe) from four
different countries: Mexico, Italy, Brazil and Argentina.
The study was approved by each local Institutional Review Board and conducted per the Code of
Ethics of the World Medical Association (Declaration of Helsinki) for experiments that
involve humans.
The inclusion criteria are: workers/participants of both genders at relevant vaccination
places who consented to participate, planned to conclude the immunization regimen of any
vaccine and agreed to be followed-up for the duration of the study. The following vaccines
are available at sites at the time of the study: BNT162b2 mRNA, mRNA-1273, ChAdOx1-S,
Ad26.COV2, Ad5-nCoV, Gam-COVID-Vac, or Coronavac. The exclusion criteria is to have been
previously given any COVID-19 vaccine prior to study entry.
The vaccines available, the schedule of doses was defined by the Health System of each
country, so that the day and the type of vaccine that each volunteer received has been
assigned by the latter. At the vaccination day and prior to the vaccination, the research
team invited any subject who planned to receive any scheme of vaccine.
The participant will recieve an explanation of the project and asked to sign the informed
consent. Inclusion-exclusion criteria were applied and a plasma sample will be collected.
The baseline sample will be taken before receiving the first dose of any COVID-19 vaccine
(T0). After 21 days (+/- 7 days) of the first dose, Then, 21 days (+/- 7 days) after the
second dose (if applicable), six months, and a year after.
In case a patient receives a third or fourth dose of any vaccine, extra plasma samples for
the antibody measures will be performed 21 days (+/- 7 days) after the third or fourth dose
(if applicable), three months and six months after.
At each visit participants will have to answer a questionnaire.
The basal-sample questionnaire aimed at obtaining patients medical history and previous
SARS-CoV-2 infections. The questionnaires will be applied after the first and second doses of
vaccines to recognise adverse events and identify a potential SARS-CoV-2 infection after
receiving any vaccine dose. SARS-CoV-2 infection will be also monitored by the epidemiology
team through PCR test, which informed the research team of any new infection.
IgG determination To determine the amount of specific anti-S1 and anti-S2 IgG antibodies
against SARS-CoV-2 in plasma samples, the laboratory personnel will use a chemiluminescence
immunoassay (CLIA) developed by DiaSorin, which has a sensitivity of 97.4% (95% CI,
86.8-99.5) and a specificity of 98.5% (95% CI, 97.5-99.2). The results will be reported as
follows: <12.0 AU / ml was considered negative, 12.0 to 15.0 AU / ml was indeterminate, and >
15 AU / ml was positive. This kit is comparable with other commercial kits such as Euroimmun
and Roche, and has been used elsewhere.
The variables that will be analyzed are age, sex, personal medical history (for example the
presence of type 2 diabetes, hypertension, asthma, pulmonary obstructive disease, any heart
condition, obesity, cancer, liver steatosis, any autoimmune disease) including confirmed
SARS-CoV-2 diagnosis (confirmed either with a nasal swab or serologic tests before and after
vaccine shots), and adverse events after immunization (AEFI) caused by any dose of any
vaccine. We will focuse on the following systemic or severe adverse events: fever (>37.5°C),
adenopathy, diffuse rash, edema, facial paralysis, orthostatic hypotension, headache,
arthralgia, myalgia, nausea, vomit and diarrhea. The analyzed biochemical variables are
SARS-CoV-2 quantitative antibodies from baseline, 21-28 days post-first dose (S1), 21-28 days
post-second dose if applicable, six and 12 months after vaccine application.
Statistical Methods The researchers will review the quality control and the anonymization of
the database. Normality assumption will be evaluated with the Shapiro Wilk test, Kolmogorov
and frequency histograms. Descriptive statistics such as mean, standard deviation, median,
interquartile range, frequencies, and percentages will be computed. Mixed model and Poisson
generalized linear models will be performed for analysis. A sample size of 1870 patients is
calculated, according to the primary aim, by using a mixed model formula with an alpha of
0.05, power of 90%, the effect size of 0.15, and k=7. The analyses will be two-tailed. A
p-value less than 0.05 will be considered to be statistically significant.
