Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05154097 |
| Other study ID # |
ASCLIN 001/2020 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2022 |
| Est. completion date |
September 25, 2024 |
Study information
| Verified date |
September 2021 |
| Source |
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) |
| Contact |
Celia Menezes Cruz, Marques |
| Phone |
+55 (21)31116681 |
| Email |
celia.marques[@]smsdc.rio.rj.gov.br |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Several studies on the duration of immunity after the vaccine try to explain the cause of
susceptibility to the measles virus even after the administration of 2 doses of the viral
triple vaccine, based not only on the finding of low vaccine coverage.
In the recent measles epidemic that occurred in Brazil, beginning in 2018, we verified the
predominance of the D8 genotype, with different strains. The detection of these strains is an
important molecular marker to define different introductions of the same genotype, in the
same geographic area, enabling better knowledge and discussion of the control strategies
used.
Some news circulated in the press about a possible failure of the vaccine to protect the
vaccinated population against this D8 genotype.
Regarding the mumps and rubella components, analyzes of the duration of immunity will be
carried out for these 2 components, in addition to measles, since the children received in
2012 the triple viral vaccine, and there are data in the literature on the drop in antibodies
to mumps, over the years. For rubella, Brazil received the rubella virus elimination
certificate, and the results of duration of immunity from this study, may collaborate to know
the profile of duration of immunity to rubella, in this cohort vaccinated in 2012, and who is
living in a period without circulation of the wild virus.
Description:
In this project, the investigators propose:
- Evaluate the proportion of seropositive people for measles, mumps and rubella, in
relation to the doses of the triple viral vaccine administered, and recorded on the
vaccination card, and correlate with the time elapsed since the last dose, of the
children vaccinated at 12 months of age, in a study carried out in 2012, and which in
2020 will be 8 or 9 years old;
- Compare antibody titers in vaccinees, at 12 - 23 months of age, in 2012, in the study
that compared the mono x multidose presentations of the triple viral vaccine, evaluating
the serums collected at that time, in the post-vaccination post-vaccination samples (one
dose from triple viral), and stored in the biorepository, and the recent sera, from
samples that will be collected in 2020, 8 years later, against the vaccine virus and the
wild virus, strain D8;
- Evaluate cellular immunity to measles, rubella and mumps components, in samples
collected in 2020.
Children who participated in the study in 2012 received 1 dose of the triple viral vaccine at
12 - 23 months of age. After serology, IgG, using the immunoenzymatic assay (ELISA) method,
children who had not presented seroconversion to any of the components of the triple viral
vaccine received another dose of the vaccine. In 2012, the PNI recommended a 2nd dose of the
triple viral vaccine at 4 years of age. Probably, this year, 2020, children who are included
in the study will be able to register at least 2 doses of the triple viral vaccine, at 12
months as a participant in the 2012 study, and a 2nd dose of the triple viral vaccine, if
they were vaccinated. at the age of 4 as recommended by the PNI. In addition, these children
may have received more doses of triple viral vaccine, if they were vaccinated in a
vaccination campaign, blocking vaccination, because of the measles outbreak in Rio de
Janeiro.
