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Complementary Study of the Duration of Post-vaccination Against Yellow Fever Immunity in Children

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ClinicalTrials.gov Identifier: NCT02990182
Recruitment Status : Unknown
Verified July 2017 by Olindo de Assis Martins Filho, Oswaldo Cruz Foundation.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Olindo de Assis Martins Filho, Oswaldo Cruz Foundation

Brief Summary:
In a previous study by the researchers' group, the researchers' investigate the duration of yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of age. However, in this study, samples of children in the pre-vaccine period, also known as unvaccinated children samples (NV) have not been investigated. It is believed that to seek evidence about the immune status in the medium and long term after vaccination against yellow fever is necessary to investigate paired samples of children not vaccinated (NV), with re-evaluation 30-45 days after primary vaccination. The proposed study is to consolidate aspects of humoral (neutralizing antibodies) and cellular (phenotypic and functional parameters of T cells and memory B) by means of complementary longitudinal investigation children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary vaccination.

Condition or disease
Yellow Fever

Detailed Description:

A sample of 60 children aged 9 to 23 months paired in the pre-vaccine period (NV) and 30-45 post-primary vaccination days will be selected at health facilities in the metropolitan region of Belo Horizonte.

Children whose mothers consent to participate in research, have collected blood and elements of past medical history recorded. Analyses of humoral and cellular biomarkers will be used in a comparative study with other post-vaccination periods previously analyzed in children during the first phase in study funded by the Ministry of Health.

specific objectives:

  1. Estimate and compare the proportion of positivity and the geometric mean plasma titers of neutralizing antibodies against yellow fever;
  2. Assess lymphocyte frequency T and B memory induced in vitro by the vaccine antigen 17DD substrains, and...
  3. Quantify the lymphocytes T CD8 + producers of intracytoplasmic cytokines induced in vitro by the vaccine antigen 17DD substrains in unvaccinated children and primed aged between 9 and 23 months, categorized according to the vaccination time 30-45 days.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Complementary Study of the Duration of Post-vaccination Against Yellow Fever Immunity in Children
Study Start Date : April 2015
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Vaccines




Primary Outcome Measures :
  1. Quantification of Humoral and cellular immunity after first yellow fever vaccination [ Time Frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever ]
    Consolidating aspects of humoral (quantification of neutralizing antibodies - >2.log10IU/mL) and cellular (Percentege of phenotypic and functional parameters of T cells and B memory) through a complementary longitudinal investigation in children aged 9 to 23 month old unvaccinated and 30-45 days after first vaccination .


Secondary Outcome Measures :
  1. Quantification of titers of neutralizing antibodies in plasma samples [ Time Frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever ]
    Quantify the titers of neutralizing antibodies against yellow fever immediately before and 30-45 days after primary vaccination against yellow fever in children 9-23 months of age without yellow fever vaccination history.

  2. Evaluate the frequency (percentage) of T cells and B memory induced in vitro by the vaccine antigen 17DD [ Time Frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever ]
    Evaluate the frequency (percentage) of T cells and B memory induced in vitro by the vaccine antigen 17DD immediately before and 30-45 days after primary vaccination against yellow fever in children 9-23 months old with no vaccination history against yellow fever.

  3. Evaluate the frequency (percentage) of T and B cells expressing intracytoplasmic cytokines in vitro induced by the vaccine antigen 17DD [ Time Frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever ]
    Evaluate the frequency (percentage) of T and B cells expressing intracytoplasmic cytokines (gama interferon; IL-5, alfa-TNF) CD8 + T lymphocytes, in vitro induced by the vaccine antigen 17DD immediately before and 30-45 days after primary vaccination against yellow fever, in children 9-23 months of age without yellow fever vaccination history.


Biospecimen Retention:   Samples Without DNA
whole blood and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study provides immunoassays paired before and after anti-yellow fever vaccination in children of both sexes, of any color, class or social group. This will be necessary 60 paired samples (pre-vaccine period and 30-45 days after primary vaccination) of children aged 9 to 23 months, living in areas where YF vaccine makes up the basic immunization calendar and will receive the vaccine in the routine of UBRs in the first two years of life. This study will be conducted with samples collected from children living in Ribeirão das Neves - Minas Gerais. It will be collected 7 mL of whole blood collected in Heparin Sodium. It will be allowed to make two attempts to collect only. These samples will be used for the realization of the humoral and cellular immunity study.
Criteria

Inclusion Criteria:

Will be eligible for the study:

  • children 9-23 months of age;
  • both sexes;
  • children who will be vaccinated against yellow fever, whose parents or guardians sign the consent form.

Exclusion Criteria:

  • children who received another vaccine within 30 days before or after the yellow fever vaccine;
  • children which have permanent or temporary immunosuppression, including those treated with corticosteroids at doses higher than 2 mg / kg, and those with disease autoimmune diseases, transient or permanent immunosuppression induced diseases (cancer, AIDS, etc.) or treatment (immunosuppressive drugs, radiotherapy, etc.). Corticosteroids (such as prednisone, dexamethasone) for less than two weeks, or by inhalation or topical use, do not indicate exclusion from the study, but must be registered in the questionnaire (Annex II);
  • children with hemoglobinopathies;
  • children with a history of blood transfusion or treatment with hyperimmune serum up to 90 days prior to blood collection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990182


Locations
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Brazil
Centro de Pesquisas René Rachou
Belo Horizonte, Minas Gerais, Brazil, 30190002
Sponsors and Collaborators
Oswaldo Cruz Foundation
Investigators
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Principal Investigator: Olindo A Martins-Filho, PhD Centro de Pesquisas René Rachou
Additional Information:
Publications of Results:
Collaborative Group for Studies with Yellow Fever; Camacho LAB. Immunogenicity of 17DD and WHO 17D -213/77 Yellow Fever Vaccines in Children less than 2 years old: a randomized, double-blind study. In: 5th World Congress of the World Society fo Pediatric Infectious Diseases, 2007, Bangkok, Tailandia. Book of Abstracts, 2007.
Monath TP, Cetron MS & Teuwen DE. Yellow fever vaccine. In Plotkin SA, Orenstein WA & Offit P. Organizadores. Vaccine. Philadelphia. Saunders Elsevier 2008. p. 959-1056.

Other Publications:
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Responsible Party: Olindo de Assis Martins Filho, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT02990182    
Other Study ID Numbers: CPqRR - M 02
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by Olindo de Assis Martins Filho, Oswaldo Cruz Foundation:
Yellow Fever Vaccine
Immunity, Humoral
Immunity, Cellular
children
Additional relevant MeSH terms:
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Yellow Fever
Fever
Body Temperature Changes
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral