An observational study in Measles Vaccine, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Status unknown. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-10.
Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Observational
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.
In this project, the investigators propose:
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.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's planned enrollment of 190 is below the median of 282 across 26 observational studies indexed under Measles.
Browse Measles studies →The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy children, aged 8 to 9 years old, who will be contacted and invited to participate in the study, and who were part of the population that participated in the previous comparative study of immunogenicity after vaccination with the triple viral.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duration of immunity from the triple viral vaccine
The present study is expected to evaluate the duration of immunity from the triple viral vaccine over the years of life, specifically in this study in the age group of 8 to 9 years, from the capture of the cohort of vaccinated with the first dose applied to 12- 23 months in the 2012 study.
Time frame: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study
proportions of seropositive individuals with an enzyme immunoassay (ELISA), such as the Geometric Average Titles for measles
Both the proportions of seropositive individuals with an enzyme immunoassay (ELISA), as well as the Average Geometric Titles for measles, are higher than those observed after vaccination at 12 to 23 months of age, according to the results found in studies previously conducted in Brazil. In this study, the analysis of the agreement between the ELISA and PRNT methods will also be performed, for the evaluation of the serology of the measles component, and the agreement of the challenge test for the vaccine and wild measles strain.
Time frame: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)