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

Immunity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02555072
• Other study ID #: ASCLIN 005/2014
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4761
• Est. completion date: December 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 50 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Fever
• Immunity
• Yellow Fever
• Yellow Fever Vaccine

Intervention

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

Locations

Country	Name	City	State
Brazil	Unidade de Saúde da Família Oiteiro I	Alhandra	Paraiba
Brazil	Unidade Saúde da Família Mata Redonda 1	Alhandra	Paraiba
Brazil	Unidade de Saúde da Família Cupissura I	Caaporã	Paraíba
Brazil	Unidade de Saúde da Família Santo Antônio	Caaporã	Paraíba
Brazil	Unidade de Saúde da Família N Sra da Conceição	Conde	Paraíba
Brazil	Unidade de Saúde da Família N Sra das Neves	Conde	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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 )
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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