Yellow Fever VaccinePhase 4NCT02555072
Immunity Period After One Dose of Yellow Fever Vaccine in Adults and Children (Paraiba Study)
A Phase 4 study testing yellow fever vaccine in people with Yellow Fever Vaccine and Immunity, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 6 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 9 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever Vaccine, Immunity
- What is being tested?
- yellow fever vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,761 participants
- Where
- 6 sitesBrazil
- Study dates
- Jul 2016to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Unidade de Saúde da Família Oiteiro I
Alhandra, Paraíba, 58320000
Unidade Saúde da Família Mata Redonda 1
Alhandra, Paraíba, 58320000
Unidade de Saúde da Família Cupissura I
Caaporã, Paraíba, 58326000
Unidade de Saúde da Família Santo Antônio
Caaporã, Paraíba, 58326000
Unidade de Saúde da Família N Sra da Conceição
Conde, Paraíba, 58322000
Unidade de Saúde da Família N Sra das Neves
Conde, Paraíba, 58322000
About this study
Official title: 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.
Read the 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.
- Conditions
- Yellow Fever Vaccine, Immunity
- Being tested
- yellow fever vaccine
- Keywords
- Yellow Fever Vaccine, immunity evolution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yellow fever vaccineBiological
yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: yellow fever vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response evolution in children and adults for yellow fever vaccine
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 years after vaccination
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 years after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startJul 2016
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow Fever VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Sponsor
- Investigators
- Eduardo Sergio S Sousa, MD, Principal investigator, Universidade Federal da Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555072
- Sponsor's protocol ID
- ASCLIN 005/2014
- Status last verified
- Jun 2023
- First submitted
- 22 Apr 2015
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area
- ClinicalTrials.gov ID
- NCT02555072
- Acronym / sponsor ID
- ASCLIN 005/2014
- Conditions
- Yellow Fever Vaccine, Immunity
- Keywords
- Yellow Fever Vaccine, immunity evolution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,761 participants (actual)
- Lead sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| naive children and adults for yellow fever vaccine | Other | Biological: yellow fever vaccineboth sexes; ages between 9 months and 4 years, 11 months and 29 days old; 18 years to 50 years old |
Who may qualify
- Ages
- 9 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yellow fever vaccineyellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated | Biological | naive children and adults for yellow fever vaccine |
Primary outcome
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.
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.
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.
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.
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.
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.
14 secondary outcomes
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Time frame: 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
Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults.
Time frame: 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 )
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time frame: 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
Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults
Time frame: 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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Sergio S Sousa, MD principal investigator
Universidade Federal da Paraíba
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing yellow fever vaccine in people with Yellow Fever Vaccine and Immunity, run by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response evolution in children and adults for yellow fever vaccine (time frame: before vaccination (day 0)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.