NCT02990182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

September 1, 2015

Last Update Submit

July 12, 2017

Conditions

Yellow Fever

Keywords

Yellow Fever VaccineImmunity, HumoralImmunity, Cellularchildren

Outcome Measures

Primary Outcomes (1)

  • Quantification of Humoral and cellular immunity after first yellow fever vaccination

    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 .

    Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever

Secondary Outcomes (3)

  • Quantification of titers of neutralizing antibodies in plasma samples

    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

    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 in vitro induced by the vaccine antigen 17DD

    Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever

Eligibility Criteria

Age9 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • children who received another vaccine within 30 days before or after the yellow fever vaccine;
  • children with hemoglobinopathies;
  • children with a history of blood transfusion or treatment with hyperimmune serum up to 90 days prior to blood collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Pesquisas René Rachou

Belo Horizonte, Minas Gerais, 30190002, Brazil

Location

Related Publications (11)

  • Vasconcelos PF. [Yellow Fever]. Rev Soc Bras Med Trop. 2003 Mar-Apr;36(2):275-93. doi: 10.1590/s0037-86822003000200012. Epub 2003 Jun 10. Portuguese.

    PMID: 12806465BACKGROUND

  • ANDERSON CR, GAST-GALVIS A. Immunity to yellow fever five years after vaccination. Am J Hyg. 1947 May;45(3):302-4. doi: 10.1093/oxfordjournals.aje.a119138. No abstract available.

    PMID: 20240017RESULT

  • Belmusto-Worn VE, Sanchez JL, McCarthy K, Nichols R, Bautista CT, Magill AJ, Pastor-Cauna G, Echevarria C, Laguna-Torres VA, Samame BK, Baldeon ME, Burans JP, Olson JG, Bedford P, Kitchener S, Monath TP. Randomized, double-blind, phase III, pivotal field trial of the comparative immunogenicity, safety, and tolerability of two yellow fever 17D vaccines (Arilvax and YF-VAX) in healthy infants and children in Peru. Am J Trop Med Hyg. 2005 Feb;72(2):189-97.

    PMID: 15741556RESULT

  • Camacho LA, Freire Mda S, Leal Mda L, Aguiar SG, Nascimento JP, Iguchi T, Lozana Jde A, Farias RH; Collaborative Group for the Study of Yellow Fever Vaccines. Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial. Rev Saude Publica. 2004 Oct;38(5):671-8. doi: 10.1590/s0034-89102004000500009. Epub 2004 Oct 18.

    PMID: 15499438RESULT

  • 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.

    RESULT

  • Collaborative Group for Studies with Yellow Fever Vaccine. Randomized, double-blind, multicenter study of the immunogenicity and reactogenicity of 17DD and WHO 17D-213/77 yellow fever vaccines in children: implications for the Brazilian National Immunization Program. Vaccine. 2007 Apr 20;25(16):3118-23. doi: 10.1016/j.vaccine.2007.01.053. Epub 2007 Jan 22.

    PMID: 17316925RESULT

  • FOX JP, FONSECA DA CUNHA J, KOSSOBUDZKI SL. Additional observations on the duration of humoral immunity following vaccination with the 17D strain of yellow fever virus. Am J Hyg. 1948 Jan;47(1):64-70. doi: 10.1093/oxfordjournals.aje.a119186. No abstract available.

    PMID: 18921440RESULT

  • Hepburn MJ, Kortepeter MG, Pittman PR, Boudreau EF, Mangiafico JA, Buck PA, Norris SL, Anderson EL. Neutralizing antibody response to booster vaccination with the 17d yellow fever vaccine. Vaccine. 2006 Apr 5;24(15):2843-9. doi: 10.1016/j.vaccine.2005.12.055. Epub 2006 Jan 18.

    PMID: 16494976RESULT

  • 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.

    RESULT

  • Niedrig M, Lademann M, Emmerich P, Lafrenz M. Assessment of IgG antibodies against yellow fever virus after vaccination with 17D by different assays: neutralization test, haemagglutination inhibition test, immunofluorescence assay and ELISA. Trop Med Int Health. 1999 Dec;4(12):867-71. doi: 10.1046/j.1365-3156.1999.00496.x.

    PMID: 10632996RESULT

  • Poland JD, Calisher CH, Monath TP, Downs WG, Murphy K. Persistence of neutralizing antibody 30-35 years after immunization with 17D yellow fever vaccine. Bull World Health Organ. 1981;59(6):895-900.

    PMID: 6978196RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and plasma

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Olindo A Martins-Filho, PhD

    Centro de Pesquisas René Rachou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 1, 2015

First Posted

December 13, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

BR(1)