Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military

Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) (Other)
Overall Status
Completed
CT.gov ID
NCT03338231
Collaborator
(none)
374
1
5.3
70.7

Study Details

Study Description

Brief Summary

Yellow fever is an acute viral disease transmitted by mosquitoes in South America, Central America and Africa. It is more prevalente in males gender and the age above 15 years due to the greater exposure in the wild endemic area of yellow fever.

According to the World Health Organization (WHO), a single dose of the yellow fever vaccine is sufficient to maintain protective immunity against yellow fever for a lifetime, therefore a booster dose is not required. This issue is difficult to evaluate because there is no serological correlate of protection against yellow fever and seropositivity is defined with several cut-off points. Although studies indicate that the duration of protection after vaccination is long, many studies have demonstrated a reduction of the antibody titrer over the years. Consequently, there is more concern about people who live in endemic areas. For this reason, Brazil recommends revaccinating once at least until additional studies are performed.

It is important to know the duration of immunity induced by lower doses of YF vaccine. In our knowledge, there is a lack of clinical studies evaluating the immunity duration of the yellow fever vaccine with lower doses. This information is relevant to subsidize the routine recommendation of YF vaccine fractional dose for adults.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is an observational study in young adult males who received the first dose of the yellow fever vaccine in 2009 when they participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    374 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military, Participants of "Dose-response Study of Yellow Fever Vaccine 17DD Produced by Bio-Manguinhos / Fiocruz" in 2009
    Actual Study Start Date :
    Mar 27, 2017
    Actual Primary Completion Date :
    Sep 4, 2017
    Actual Study Completion Date :
    Sep 4, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Number of seropositivity participants to YF vaccine as assessed by PRNT. [8 years after the 1 st dose of yellow fever vaccine]

      To evaluate the seropositivity by the means of the neutralizing antibody dosage in the participants of the "Dose-response study of the 17DD yellow fever vaccine produced by Bio-Manguinhos/Fiocruz" realized in 2009

    Secondary Outcome Measures

    1. Individual repertoire of immunoglobulins profile as assessed by the PEPperPRINT and phenotypic/functional anti-amaryl memory cell analyse. [8 years after the 1 st dose of yellow fever vaccine]

      To evaluate individual repertoire of immunoglobulins profile directed to amaryl epitopes by the PEPperPRINT (PEPperCHIPĀ® Yellow Fever Virus Proteome Microarrays) Guidelines and to evaluate the phenotypic and funcional profile of anti-yellow memory cell in the participants of the "Dose-response study of the 17DD yellow fever vaccine produced by Bio-Manguinhos/Fiocruz" realized in 2009

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:
    • Participated in the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" in 2009.

    • Not been revaccinated during the "Dose-response study of the yellow fever vaccine 17DD produced by Bio-Manguinhos / Fiocruz" of 2009.

    • Not having received another dose of the 17DD yellow fever vaccine after participating in the 2009 "Bio-Manguinhos / Fiocruz" 17DD yellow fever vaccine dose-response study.

    • Provide name, address, telephone and other information so that you can contact if necessary.

    • Ability to understand and sign the TCLE.

    Exclusion Criteria:
    • Impossibility or refusal to collect blood

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bio-Manguinhos/Fiocruz Rio de Janeiro Brazil 21040-360

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Reinaldo M Martins, PhD, Oswaldo Cruz Foundation (Fiocruz)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
    ClinicalTrials.gov Identifier:
    NCT03338231
    Other Study ID Numbers:
    • ASCLIN 001/2017
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    Nov 9, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2017