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

June 12, 2023 updated by: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4761

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraiba
      • Alhandra, Paraiba, Brazil, 58320000
        • Unidade de Saúde da Família Oiteiro I
      • Alhandra, Paraiba, Brazil, 58320000
        • Unidade Saúde da Família Mata Redonda 1
    • Paraíba
      • Caaporã, Paraíba, Brazil, 58326000
        • Unidade de Saúde da Família Cupissura I
      • Caaporã, Paraíba, Brazil, 58326000
        • Unidade de Saúde da Família Santo Antônio
      • Conde, Paraíba, Brazil, 58322000
        • Unidade de Saúde da Família N Sra da Conceição
      • Conde, Paraíba, Brazil, 58322000
        • Unidade de Saúde da Família N Sra das Neves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 months to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: naive children and adults for yellow fever vaccine
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
yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immune response evolution in children and adults for yellow fever vaccine
Time Frame: before vaccination (day 0)
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
Time Frame: 30-45 days after vaccination
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
Time Frame: 1 year after vaccination
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
Time Frame: 4 years after vaccination
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
Time Frame: 7 years after vaccination
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
Time Frame: 10 years after vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
10 years after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Time Frame: before vaccination (day 0)
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
before vaccination (day 0)
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Time Frame: 30-45 days after vaccination
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
30-45 days after vaccination
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Time Frame: 1 year after vaccination
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
1 year after vaccination
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time Frame: immediately before vaccination ( day 0 )
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.
immediately before vaccination ( day 0 )
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time Frame: 1 year after vaccination
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.
1 year after vaccination
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time Frame: 4 years after vaccination
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.
4 years after vaccination
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time Frame: 7 years after vaccination
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.
7 years after vaccination
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time Frame: 10 years after vaccination
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.
10 years after vaccination
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Time Frame: Immediately before vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Immediately before vaccination
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Time Frame: 30-45 days after revaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
30-45 days after revaccination
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Time Frame: 1 year after first vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
1 year after first vaccination
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Time Frame: 4 years
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
4 years
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Time Frame: 7 years after first vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
7 years after first vaccination
Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated.
Time Frame: 10 years after first vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
10 years after first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eduardo Sergio S Sousa, MD, Universidade Federal da Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASCLIN 005/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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