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Duration of Immunity 10 Years After a Dose-response Study With Yellow Fever Vaccine - Complementary Study

NCT04416477 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2020-06-04

No results posted yet for this study

Summary

Yellow fever is an acute febrile infectious disease transmitted to man urban cycle by mosquitoes infected by an arbovirus of the genus Flavivirus family Flaviviridae. Its occurrence is recorded in South America Central America and Africa. In cities the yellow fever vector is the Aedes aegypti mosquito which also transmits dengue viruses zika and chikungunya. This disease is more frequent in males and the most affected age group is above fifteen years due to the greater exposure related to the penetration in wild areas of the endemic zone of yellow fever. Another risk group is unvaccinated people who live near wild environments where the virus circulates. According to the World Health Organization 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 question 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 there is considerable evidence in the literature that antibody titer falls over the years reaching levels considered as seronegative in at least a portion of the vaccinees. This is of more concern to people living in endemic areas who are exposed to the virus throughout their lives. For this reason Brazil recommended revaccinating once at least until additional studies were done. The need to increase Bio Manguinhos production capacity to meet the increased demand from Brazil and other countries is urgent. The occurrence of epidemics when millions of individuals need to be vaccinated in a short period of time exceeds production capacity and this is a recurrent problem. The current vaccine has a very high potency well above the thousand international units recommended by World Health Organization. But we need to generate additional evidence that very low doses of viral particles in the yellow fever vaccine are still immunogenic and that their immunogenicity can be maintained for at least ten years after vaccination. This evidence will support the rapid increase of their availability by the fractionation of doses or other alternatives.

Conditions

  • Yellow Fever Vaccine

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Akira Homma · Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos / FIOCRUZ

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04416477 on ClinicalTrials.gov