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NCT Number: NCT03338231

Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Bio-Manguinhos/Fiocruz

Rio de Janeiro, 21040-360, Brazil

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of seropositivity participants to YF vaccine as assessed by PRNT.

    Time frame: 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 outcomes

  1. Individual repertoire of immunoglobulins profile as assessed by the PEPperPRINT and phenotypic/functional anti-amaryl memory cell analyse.

    Time frame: 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 (PEPperCHIP® 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2017
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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