Immunity After Two Doses of Yellow Fever Vaccine

NCT02572518 | Completed DMC

• 1 other identifier: ASCLIN 003/2013
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the immune status of yellow fever in adults with a history of two or more doses of vaccine, having received the second dose for at least 1 year, compared to re-vaccinated individuals (second dose) after 30 days.

Conditions

Yellow Fever

Keywords

immunity yellow fever vaccine

Outcome Measures

Primary Outcomes (1)

• Access the change of the immune status to yellow fever in adults history of two or more doses of vaccine, having received the second dose for at least one year, compared to revaccinated individuals (second dose) after 30 days.

  30 days, 1-5 years, through study completion at least 6 years after second dose of yellow fever vaccine, with 3 doses at any age

Secondary Outcomes (1)

• Access the cellular immunity

  30 days, 1-5 years, through study completion at least 6 years after second dose of yellow fever vaccine, with 3 doses at any age

Other Outcomes (2)

• Access the cellular immunity

  30 days, 1-5 years,through study completion at least 6 years after second yellow fever vaccine, with 3 doses at any age

• Access the cross reaction humoral immune status (neutralizing antibody) and cellular (aspects functional and phenotypic)

  30 days, 1-5 years,through study completion at least 6 years after second yellow fever vaccine, with 3 doses at any age

Study Arms (1)

2 doses of yellow fever vaccine

30 days,1-5 years and 6 years or more after last dose

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target study population will consist of 440 adult who have previously received at least one dose of yellow fever 17DD vaccine. The volunteers who received two doses of vaccine will be distributed in subgroups 1-5 and 6 years old or more, relative to the date of the last dose received. Volunteers with just one dose and who have received the same for at least 10 years, constitute the reference group (control) for serological and immunological studies. These volunteers will be guided and directed to revaccination in rooms vaccine immunization program and 30 to 45 days after revaccination shall be subjected to serological testing.

You may qualify if:

• Will be eligible for the study volunteers with proof of vaccination in vaccine design or functional or health care records, and who agree to participate in the study.

You may not qualify if:

• Will not be included adults with a contraindication for vaccination against Yellow Fever (permanent or transient immunosuppression, severe adverse reaction after the first dose, severe allergy to chicken eggs), use of hyperimmune serum or vaccine within 30 days prior to collection blood, individuals without proof (s) of vaccination (s) above (ies) or individuals who have resided or traveled to endemic or considered risk areas by the Ministry of Health, regardless of length of stay in high-risk areas.

Sponsors & Collaborators

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

Study Sites (1)

Institute of Technology in Immunobiology Bio-Manguinhos/Fiocruz

Rio de Janeiro, Rio de Janeiro, 21040-900, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• T G N

  Institute of Technology in Immunobiology Bio-Manguinhos/Fiocruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 45 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: October 9, 2015
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

BR (1)