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

Primary Purpose

Yellow Fever Vaccine, Immunity

Status
Active
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
yellow fever vaccine
Sponsored by
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Yellow Fever Vaccine focused on measuring Yellow Fever Vaccine, immunity evolution

Eligibility Criteria

9 Months - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Ability to understand and sign the Informed Consent Term
  2. Acceptance in participate on the study after reading, understanding and signed the Informed Consent Term
  3. 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.
  4. 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.
  5. 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.
  6. Availability to follow the proposed activities throughout the study period.
  7. 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).
  8. Availability to follow the study protocol.
  9. Acceptance for serological testing for HIV.
  10. In adult women, it will be conduct pregnancy test (TIG).
  11. Being in good health with no significant medical history (such as those described in Exclusion criteria).
  12. Physical examination of screening with no significant clinical changes.

Exclusion Criteria:

  1. Previous vaccination against yellow fever.
  2. Presumed or confirmed pregnancy at any stage.
  3. Women who are breastfeeding.
  4. People in use, or have made use of immunosuppressants medicines.
  5. People with personal history of anaphylactic reaction to food, drugs or vaccines.
  6. People with personal history of allergy to egg ,erythromycin, kanamycin or gelatin.
  7. People with autoimmune diseases.
  8. Individuals seropositive for HIV.
  9. People with thymic disease history, such as thymoma, myasthenia due to thymectomy and thymoma.
  10. People who have received immunoglobulin, blood transfusions or derivatives in the last 60 days.
  11. 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.
  12. Individuals who have resided in an endemic area.
  13. People with acute febrile disease and a compromised general health.
  14. People immunosuppressed by disease (eg, cancer, AIDS, HIV infection with impaired immunity, etc.) or drugs (immunosuppressive drugs, radiotherapy, etc.).

Sites / Locations

  • Unidade de Saúde da Família Oiteiro I
  • Unidade Saúde da Família Mata Redonda 1
  • Unidade de Saúde da Família Cupissura I
  • Unidade de Saúde da Família Santo Antônio
  • Unidade de Saúde da Família N Sra da Conceição
  • Unidade de Saúde da Família N Sra das Neves

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

naive children and adults for yellow fever vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

Secondary Outcome Measures

Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

Full Information

First Posted
April 22, 2015
Last Updated
June 12, 2023
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02555072
Brief Title
Immunity Period After One Dose of Yellow Fever Vaccine in Adults and Children (Paraiba Study)
Official Title
Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2016 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a Phase IV study cohort, uncontrolled, composed of two segments: children and healthy adults. It will be included 2756 children and 2005 adults, evaluated initially in six different times (before vaccination, 30-45 days, 1 year, 4 years, 7 years and 10 years after vaccination). The Paraiba state was selected for the study because in this region there are no yellow fever virus dissemination and therefore no NIP recommendation for people's routine vaccination. However, the NIP indicate yellow fever vaccination for individuals who are moving to areas with virus circulation. The study will take place in six (6) Basic Health Units of three (3) municipalities (2 units per municipality) in the state of Paraíba. The selected municipalities are: Alhandra, Caaporã and Conde. The study target population consisted of healthy children and adults of both sexes. Children must be between 9 months and 4 years,11months and 29 days; adults between 18 and 50 years. It will be eligible for the study, people who have never received the yellow fever vaccine checked in vaccine design and history and who agree to participate. Not be included participants with any contraindication to vaccination against yellow fever and individuals who previously moved to risk areas for extended periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yellow Fever Vaccine, Immunity
Keywords
Yellow Fever Vaccine, immunity evolution

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4761 (Actual)

8. Arms, Groups, and Interventions

Arm Title
naive children and adults for yellow fever vaccine
Arm Type
Other
Arm Description
both sexes; ages between 9 months and 4 years, 11 months and 29 days old; 18 years to 50 years old
Intervention Type
Biological
Intervention Name(s)
yellow fever vaccine
Intervention Description
yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated
Primary Outcome Measure Information:
Title
Immune response evolution in children and adults for yellow fever vaccine
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
before vaccination (day 0)
Title
Immune response evolution in children and adults for yellow fever vaccine
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
30-45 days after vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
1 year after vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
4 years after vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
7 years after vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
10 years after vaccination
Secondary Outcome Measure Information:
Title
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Description
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Time Frame
before vaccination (day 0)
Title
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Description
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Time Frame
30-45 days after vaccination
Title
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Description
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Time Frame
1 year after vaccination
Title
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Description
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Time Frame
immediately before vaccination ( day 0 )
Title
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Description
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Time Frame
1 year after vaccination
Title
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Description
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Time Frame
4 years after vaccination
Title
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Description
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Time Frame
7 years after vaccination
Title
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Description
Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection.
Time Frame
10 years after vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
Immediately before vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
30-45 days after revaccination
Title
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
1 year after first vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
4 years
Title
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
7 years after first vaccination
Title
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Description
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time Frame
10 years after first vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Being in good health with no significant medical history (such as those described in Exclusion criteria). Physical examination of screening with no significant clinical changes. Exclusion Criteria: 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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Sergio S Sousa, MD
Organizational Affiliation
Universidade Federal da Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidade de Saúde da Família Oiteiro I
City
Alhandra
State/Province
Paraiba
ZIP/Postal Code
58320000
Country
Brazil
Facility Name
Unidade Saúde da Família Mata Redonda 1
City
Alhandra
State/Province
Paraiba
ZIP/Postal Code
58320000
Country
Brazil
Facility Name
Unidade de Saúde da Família Cupissura I
City
Caaporã
State/Province
Paraíba
ZIP/Postal Code
58326000
Country
Brazil
Facility Name
Unidade de Saúde da Família Santo Antônio
City
Caaporã
State/Province
Paraíba
ZIP/Postal Code
58326000
Country
Brazil
Facility Name
Unidade de Saúde da Família N Sra da Conceição
City
Conde
State/Province
Paraíba
ZIP/Postal Code
58322000
Country
Brazil
Facility Name
Unidade de Saúde da Família N Sra das Neves
City
Conde
State/Province
Paraíba
ZIP/Postal Code
58322000
Country
Brazil

12. IPD Sharing Statement

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

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