Measles VaccineNCT05154097
Immunity Duration Study Eight Years After Vaccination of Children 12 to 23 Months With the Triple Viral Vaccine (Measles, Mumps and Rubella)
An observational study of Measles Vaccine, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz).
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. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Measles Vaccine
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2022to 25 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Refusal to collect blood.
- Skin lesions at venipuncture sites that prevent collection - in this case, postpone collection.
- Child subject to abnormal bleeding after injections.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Measles Vaccine
- Keywords
- Immunity duration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start4 Jan 2022 (estimated)
- Primary completion18 Apr 2022 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measles VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celia Menezes Cruz, Marques, Principal investigator, Municipal Health Secretariat of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154097
- Sponsor's protocol ID
- ASCLIN 001/2020
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunity Duration Study Eight Years After Vaccination of Children 12 to 23 Months With the Triple Viral Vaccine (Measles, Mumps and Rubella)
- ClinicalTrials.gov ID
- NCT05154097
- Acronym / sponsor ID
- ASCLIN 001/2020
- Conditions
- Measles Vaccine
- Keywords
- Immunity duration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Study start
- 4 Jan 2022 (estimated)
- Primary completion
- 18 Apr 2022 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal to collect blood.
- Skin lesions at venipuncture sites that prevent collection - in this case, postpone collection.
- Child subject to abnormal bleeding after injections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of immunity from the triple viral vaccine
Time frame: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study
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.
1 secondary outcome
proportions of seropositive individuals with an enzyme immunoassay (ELISA), such as the Geometric Average Titles for measles
Time frame: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Measles Vaccine
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
PDO Based Drug Sensitive Test in R/M HNSCC
Head and Neck Squamous Cell Carcinoma, Patient Derived Organoid
RecruitingObservational study
PDO Based Drug Sensitive Test in R/M SGC
Salivary Gland Cancers, Patient Derived Organoid
RecruitingPhase 2
Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
Adenoid Cystic Carcinoma
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia Menezes Cruz, Marques principal investigator
Municipal Health Secretariat of Rio de Janeiro
Questions about this trial
What is this clinical trial studying?
An observational study of Measles Vaccine, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia Menezes Cruz, Marques (+55 (21)31116681, celia.marques@smsdc.rio.rj.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of immunity from the triple viral vaccine (time frame: 8 years after the 1st dose of measles vaccine applied in the 2012 clinical study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.