Immunogenicity of Yellow Fever Vaccine in a Pediatric Population Vaccinated at 12-23 Months of Age in Argentina

NCT05644145 | Active Not Recruiting

• 1 other identifier: IS003815
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 3

Brief Summary

Northern Argentina is a risk area for yellow fever (YF). Recent studies have suggested that immunity wanes in children vaccinated between 9 and 23 months of age. In 2015, a collaborative study conducted by the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) assessed the immunogenicity and safety of co-administration of YF and MMR vaccines in a pediatric population at 12-13 months of age. A total of 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. It is now four to seven years since this pediatric group received their YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. Contact information collected during the earlier study will be used to locate the children. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.

Conditions

Yellow Fever

Keywords

Antibodies response; Yellow Fever Vaccine

Outcome Measures

Primary Outcomes (1)

• The proportion of the pediatric population seropositive for yellow fever ≥ 4 years after yellow fever vaccination at 12-23 months of age in Argentina.

  The proportion of children with detectable neutralizing antibodies 4-7 years following yellow fever vaccination.

  4-7 years following vaccination

Secondary Outcomes (1)

• To assess the influence of simultaneous administration versus sequential administration 28 days apart of yellow fever and MMR vaccines on yellow fever seropositivity and neutralizing antibody titers four to seven years later.

  4-7 years following vaccination

Study Arms (1)

Yellow fever seropositive vaccinated pediatric population in Argentina

EXPERIMENTAL

Yellow fever seropositive pediatric population in Argentina after receiving the YF vaccine at 12-23 months of age.

Biological: Serological study after yellow fever vaccination

Interventions

Serological study after yellow fever vaccination BIOLOGICAL

It is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever.

Also known as: Immunogenicity after yellow fever vaccine

Yellow fever seropositive vaccinated pediatric population in Argentina

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children enrolled in the 2015 study received one dose of YF vaccine and had documented seroconversion regardless of the
• Healthy child, determined by clinical history
• Availability to perform a single blood draw
• Informed consent signed by the parents.

You may not qualify if:

• Children in the 2015 study received one dose of the Yellow Fever vaccine and had NO documented seroconversion.
• Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for different reasons, received a booster (minimum interval of one month between doses).
• Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but developed Yellow Fever
• Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but are participating in another clinical drug trial of a drug, vaccine, or medical device
• Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for various reasons, are immunocompromised:
• ● Any condition that, in the judgment of study personnel, poses a risk to the health of the participant or interferes with the assessment of response to the vaccine

Sponsors & Collaborators

• Ministry of Public Health, Argentina: lead
• Centers for Disease Control and Prevention: collaborator
• Pan American Health Organization: collaborator

Study Sites (3)

SAMIC Eldorado Hospital

Eldorado, Misiones Province, Argentina

Location

SAMIC Obera Hospital

Oberá, Misiones Province, Argentina

Location

Favoloro Hospital

Posadas, Misiones Province, Argentina

Location

Related Publications (6)

• Nascimento Silva JR, Camacho LA, Siqueira MM, Freire Mde S, Castro YP, Maia Mde L, Yamamura AM, Martins RM, Leal Mde L; Collaborative Group for the Study of Yellow Fever Vaccines. Mutual interference on the immune response to yellow fever vaccine and a combined vaccine against measles, mumps and rubella. Vaccine. 2011 Aug 26;29(37):6327-34. doi: 10.1016/j.vaccine.2011.05.019. Epub 2011 Jun 2.

  PMID: 21640779 BACKGROUND

• de Noronha TG, de Lourdes de Sousa Maia M, Geraldo Leite Ribeiro J, Campos Lemos JA, Maria Barbosa de Lima S, Martins-Filho OA, Campi-Azevedo AC, da Silva Freire M, de Menezes Martins R, Bastos Camacho LA; Collaborative Group for Studies of Yellow Fever Vaccine. Duration of post-vaccination humoral immunity against yellow fever in children. Vaccine. 2019 Nov 15;37(48):7147-7154. doi: 10.1016/j.vaccine.2019.09.051. Epub 2019 Oct 4.

  PMID: 31590934 BACKGROUND

• Campi-Azevedo AC, Reis LR, Peruhype-Magalhaes V, Coelho-Dos-Reis JG, Antonelli LR, Fonseca CT, Costa-Pereira C, Souza-Fagundes EM, da Costa-Rocha IA, Mambrini JVM, Lemos JAC, Ribeiro JGL, Caldas IR, Camacho LAB, Maia MLS, de Noronha TG, de Lima SMB, Simoes M, Freire MDS, Martins RM, Homma A, Tauil PL, Vasconcelos PFC, Romano APM, Domingues CM, Teixeira-Carvalho A, Martins-Filho OA. Short-Lived Immunity After 17DD Yellow Fever Single Dose Indicates That Booster Vaccination May Be Required to Guarantee Protective Immunity in Children. Front Immunol. 2019 Sep 26;10:2192. doi: 10.3389/fimmu.2019.02192. eCollection 2019.

  PMID: 31616412 BACKGROUND

• Domingo C, Fraissinet J, Ansah PO, Kelly C, Bhat N, Sow SO, Mejia JE. Long-term immunity against yellow fever in children vaccinated during infancy: a longitudinal cohort study. Lancet Infect Dis. 2019 Dec;19(12):1363-1370. doi: 10.1016/S1473-3099(19)30323-8. Epub 2019 Sep 19.

  PMID: 31543249 BACKGROUND

• Vaccines and vaccination against yellow fever. WHO position paper -- June 2013. Wkly Epidemiol Rec. 2013 Jul 5;88(27):269-83. No abstract available. English, French.

  PMID: 23909008 BACKGROUND

• Who. Vaccines and vaccination against yellow fever: WHO Position Paper, June 2013--recommendations. Vaccine. 2015 Jan 1;33(1):76-7. doi: 10.1016/j.vaccine.2014.05.040. Epub 2014 May 20.

  PMID: 24852721 BACKGROUND

Related Links

• PAHO-WHO Member States reports to Health Emergency Information \& Risk assessment Unit (HIM) PAHO Health Emergencies Departments, 2022. Data compilation, analysis and report production.
• Ropero Alba Maria, 2020. Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Carla Vizzotti

  Ministry of Public Health, Argentina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Each enrolled participant is coded, and whoever processes the sample does not know the identity of the children included
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medico pediatra infectologo

Model Details: It is a seroepidemiological study to evaluate the Immunization Program. It is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever.

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 9, 2022
• Study Start: December 6, 2022
• Primary Completion: September 7, 2023
• Study Completion: July 30, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: It will be available for three years, starting after publication.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. All variables deemed to be personally identifiable information will be categorized or removed. The information will be available from the lead contact upon request.

Locations

AR (3)