ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02555072
Recruitment Status : Recruiting
First Posted : September 21, 2015
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Brief Summary:
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: Alhambra, 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. 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.

Condition or disease Intervention/treatment Phase
Yellow Fever Vaccine Immunity Biological: yellow fever vaccine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4761 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area
Study Start Date : July 2016
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : December 2027


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555072


Contacts
Contact: Luiz Antônio B Camacho, MD +552125982630 luiz.camacho@ensp.fiocruz.br
Contact: Severino R Lima, MD +5586393820288 delimaseverinoramos@gmail.com

Locations
Brazil
Unidade Saúde da Família Mata Redonda 1 Recruiting
Alhandra, Paraiba, Brazil, 58320000
Contact: Marilene MAG da Silva, Bsc    5581995158866    apolinariomarilene@gmail.com   
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Ministry of Health, Brazil
Investigators
Principal Investigator: Severino R Lima, MD Universidade Federal da Paraíba

Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT02555072     History of Changes
Other Study ID Numbers: ASCLIN 005/2014
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
Yellow Fever Vaccine, immunity evolution

Additional relevant MeSH terms:
Fever
Yellow Fever
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs