Immunity Duration Study Eight Years After Vaccination of Children 12 to 23 Months With the Triple Viral Vaccine (Measles, Mumps and Rubella)

NCT05154097 | Unknown DMC

• 1 other identifier: ASCLIN 001/2020
• Study Type: observational
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Measles Vaccine

Keywords

Immunity duration

Outcome Measures

Primary Outcomes (1)

• 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.

  8 years after the 1st dose of measles vaccine applied in the 2012 clinical study

Secondary Outcomes (1)

• proportions of seropositive individuals with an enzyme immunoassay (ELISA), such as the Geometric Average Titles for measles

  8 years after the 1st dose of measles vaccine applied in the 2012 clinical study

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Children of both sexes, aged between 8 and 9 years and who have provenly participated in the previous 2012 study.
• Agreement by the father and / or mother, or the legal guardian, with the child's participation in the study, and signing of the Informed Consent Form (ICF) and the Informed Consent Form (TALE) by the minor.
• Willingness of the father or mother, or legal guardian, to provide name, address, telephone and other information so that they can be contacted if necessary.
• Responsible (s) able (S) to understand the risks of the experiment that, although minimal, exist.
• Child able to understand TALE and accept to participate in the study.
• Responsible to understand and sign the IC. If the guardian is not able to sign (eg illiterate), the IC can be signed by an impartial witness who has accompanied the entire procedure.
• Participation availability by performing blood collection for immunity assessment.

You may not qualify if:

• Refusal to collect blood.
• Skin lesions at venipuncture sites that prevent collection - in this case, postpone collection.
• Child subject to abnormal bleeding after injections.

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead

Study Officials

• Celia Menezes Cruz, Marques

  Municipal Health Secretariat of Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celia Menezes Cruz, Marques

CONTACT

+55 (21)31116681; celia.marques@smsdc.rio.rj.gov.br

Eliane Matos dos, Santos

CONTACT

+55 (21) 38829479; ematos@bio.fiocruz.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: December 10, 2021
• Study Start: January 4, 2022
• Primary Completion: April 18, 2022
• Study Completion: September 25, 2024
• Last Updated: December 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share