ClinicalTrials.gg
CompletedNCT03338231Updated Nov 9, 2017

Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military

An observational study in Yellow Fever Vaccine, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Completed at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-09.

Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
374
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Yellow Fever Vaccine

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Keywords

  • Immunity duration
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In context

Yellow Fever

52 studies on the registry are indexed under Yellow Fever; 10 are open to participants now.

Browse Yellow Fever studies →

Lead sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

Male adults 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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Impossibility or refusal to collect blood
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
374 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

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

    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

    Time frame: 8 years after the 1 st dose of yellow fever vaccine

Secondary outcomes

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

    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

    Time frame: 8 years after the 1 st dose of yellow fever vaccine

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Study locations

1 site
  • Bio-Manguinhos/Fiocruz
    Rio de Janeiro, 21040-360, Brazil
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References and documents

Publications

  • de Menezes Martins R, Maia MLS, de Lima SMB, de Noronha TG, Xavier JR, Camacho LAB, de Albuquerque EM, Farias RHG, da Matta de Castro T, Homma A; Collaborative Group for Studies on Duration of Immunity from Yellow Fever Vaccine. Duration of post-vaccination immunity to yellow fever in volunteers eight years after a dose-response study. Vaccine. 2018 Jun 27;36(28):4112-4117. doi: 10.1016/j.vaccine.2018.05.041. Epub 2018 May 18. PubMed 29784469 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Sep 2017, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2017
First posted
Nov 9, 2017
StartActual
Mar 27, 2017
Primary completionActual
Sep 4, 2017
CompletionActual
Sep 4, 2017
Last update
Nov 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03338231
Lead sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Mar 27, 2017
Primary completion
Sep 4, 2017
Completion
Sep 4, 2017
Last update
Nov 9, 2017

Study contacts

Reinaldo M Martins, PhD
principal investigator · Oswaldo Cruz Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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