Immunity Period After One Dose of Yellow Fever Vaccine in Adults and Children (Paraiba Study)

NCT02555072 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: ASCLIN 005/2014
• Study Type: interventional
• Target: 4,761
• Locations: 1 country
• Sites: 6

Brief Summary

The study main objective is to assess the immune status of children and adults who have never vaccinated, they will receive the first dose of 17DD yellow fever vaccine provided by the study and will be monitored for 10 years. Depending on the results of the analyzed of the data, the period of monitoring may be extended.

Conditions

Yellow Fever Vaccine; Immunity

Keywords

Yellow Fever Vaccine, immunity evolution

Outcome Measures

Primary Outcomes (6)

• Immune response evolution in children and adults for yellow fever vaccine

  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

  before vaccination (day 0)

• Immune response evolution in children and adults for yellow fever vaccine

  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

  30-45 days after vaccination

• Immune response evolution in children and adults for yellow fever vaccine

  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

  1 year after vaccination

• Immune response evolution in children and adults for yellow fever vaccine

  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

  4 years after vaccination

• Immune response evolution in children and adults for yellow fever vaccine

  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

  7 years after vaccination

• Immune response evolution in children and adults for yellow fever vaccine

  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

  10 years after vaccination

Secondary Outcomes (14)

• Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.

  before vaccination (day 0)

• Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.

  30-45 days after vaccination

• Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.

  1 year after vaccination

• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults

  immediately before vaccination ( day 0 )

• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults

  1 year after vaccination

Study Arms (1)

naive children and adults for yellow fever vaccine

OTHER

both sexes; ages between 9 months and 4 years, 11 months and 29 days old; 18 years to 50 years old

Biological: yellow fever vaccine

Interventions

yellow fever vaccine BIOLOGICAL

yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated

naive children and adults for yellow fever vaccine

Eligibility Criteria

• Age: 9 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ability to understand and sign the Informed Consent Term
• Acceptance in participate on the study after reading, understanding and signed the Informed Consent Term
• Participants of both sexes aged 9-4 years, 11 months and 29 days, after it was provided they have not received or have to receive the MMR or Tetraviral vaccine within 30 days or less.
• Healthy adults of both sexes aged between 18 and 50 years since they have not received or have to receive the MMR or Tetraviral vaccine within 30 days or less.
• Residence fixed in the municipality where the Basic Health Unit will held vaccination and collection of biological material samples (blood) for the study at the time of participant enrollment.
• Availability to follow the proposed activities throughout the study period.
• Agreement to provide name, address, telephone number and other information for personal contact is possible, if necessary (for example, event of failure to visit scheduled for follow-up).
• Availability to follow the study protocol.
• Acceptance for serological testing for HIV.
• In adult women, it will be conduct pregnancy test (TIG).

You may not qualify if:

• Physical examination of screening with no significant clinical changes.
• Previous vaccination against yellow fever.
• Presumed or confirmed pregnancy at any stage.
• Women who are breastfeeding.
• People in use, or have made use of immunosuppressants medicines.
• People with personal history of anaphylactic reaction to food, drugs or vaccines.
• People with personal history of allergy to egg ,erythromycin, kanamycin or gelatin.
• People with autoimmune diseases.
• Individuals seropositive for HIV.
• People with thymic disease history, such as thymoma, myasthenia due to thymectomy and thymoma.
• People who have received immunoglobulin, blood transfusions or derivatives in the last 60 days.
• People who have received live virus vaccines or against cholera in the last 30 days, or who plan to receive them within 30 days after vaccination against yellow fever.
• Individuals who have resided in an endemic area.
• People with acute febrile disease and a compromised general health.
• People immunosuppressed by disease (eg, cancer, AIDS, HIV infection with impaired immunity, etc.) or drugs (immunosuppressive drugs, radiotherapy, etc.).

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead
• Ministry of Health, Brazil: collaborator

Study Sites (6)

Unidade de Saúde da Família Oiteiro I

Alhandra, Paraíba, 58320000, Brazil

Location

Unidade Saúde da Família Mata Redonda 1

Alhandra, Paraíba, 58320000, Brazil

Location

Unidade de Saúde da Família Cupissura I

Caaporã, Paraíba, 58326000, Brazil

Location

Unidade de Saúde da Família Santo Antônio

Caaporã, Paraíba, 58326000, Brazil

Location

Unidade de Saúde da Família N Sra da Conceição

Conde, Paraíba, 58322000, Brazil

Location

Unidade de Saúde da Família N Sra das Neves

Conde, Paraíba, 58322000, Brazil

Location

MeSH Terms

Interventions

Yellow Fever Vaccine

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Eduardo Sergio S Sousa, MD

  Universidade Federal da Paraíba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: September 21, 2015
• Study Start: July 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

BR (6)