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

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: Active, not recruiting
• Conditions: Immunity; Yellow Fever Vaccine
• Intervention / Treatment: Biological: yellow fever vaccine

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: Interventional
• Enrollment (Actual): 4761
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before vaccination (day 0)
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.	30-45 days after vaccination
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.	1 year after vaccination
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.	immediately before vaccination ( day 0 )
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.	1 year after vaccination
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.	4 years after vaccination
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.	7 years after vaccination
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.	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.	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.	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.	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.	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.	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.	seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.	10 years after first vaccination

Collaborators and Investigators

• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Collaborators: Ministry of Health, Brazil
• Investigators: Principal Investigator: Eduardo Sergio S Sousa, MD, Universidade Federal da Paraíba

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimated): September 21, 2015

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Yellow Fever Vaccine, immunity evolution
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Body Temperature Changes; Hemorrhagic Fevers, Viral; Fever; Yellow Fever
• Other Study ID Numbers: ASCLIN 005/2014