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Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military

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ClinicalTrials.gov Identifier: NCT03338231
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Tracking Information
First Submitted Date November 1, 2017
First Posted Date November 9, 2017
Last Update Posted Date November 9, 2017
Actual Study Start Date March 27, 2017
Actual Primary Completion Date September 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2017)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 7, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Study of Immunity Duration of Yellow Fever Vaccine in Military
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
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.

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 Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Yellow Fever Vaccine
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 7, 2017)
374
Original Actual Enrollment Same as current
Actual Study Completion Date September 4, 2017
Actual Primary Completion Date September 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03338231
Other Study ID Numbers ASCLIN 001/2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study Sponsor The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators Not Provided
Investigators
Principal Investigator: Reinaldo M Martins, PhD Oswaldo Cruz Foundation (Fiocruz)
PRS Account The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Verification Date November 2017