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In search of protective correlation factors for dengue: Comparison of the effects caused by Dengue virus infection with the effects of the QDenga vaccine in different age groups

In search of protection correlations for Dengue (Dengue Protect study): Comparison of the effects from Dengue infection with the effects from the inoculation of Qdenga vaccine in different age groups - PROTECT Dengue Protection correlations for Dengue

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-7k3nv44
Enrollment
Unknown
Registered
2024-08-13
Start date
2023-11-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue

Interventions

Patients will be classified as infected of healthy based on presenting symptoms. 100 patients presenting symptoms, will be allocated in the infected cohort will be monitored and blood samples will be
D20.215.894.899.162

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Universidade Federal de Minas Gerais
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Vaccination cohort: Participants between 18 to 90 years of age who agree to participate in the study. Absence of an acute clinical condition at the time of vaccination. Infected cohort: Participants under 18 yeas old. Participants with more than 5 days of symptoms. Participants who do not agree to sign the informed consent form. Participants who are not available to carry out the planned study visits

Exclusion criteria

Exclusion criteria: Vaccination cohort: Participants under 18 years old. Participants who are not available to carry out the planned visits of the study. Participants who do not agree to sign the informed consent form. Positive beta Human Chorionic Gonadotropin on the day of vaccination, in the case of women of reproductive potential. Participants who are pregnant or planning to become pregnant within the next 3 months after the last vaccine dose. Participants breastfeeding. Participant with a known or suspected immune system defect that may influence the immunological response to the vaccine, such as participants with congenital or acquired immunodeficiency, including human immunodeficientcy virus infection, post-organ transplant status or immunosuppressive therapy within 4 weeks prior to Visit 1. Therapy Immunosuppressive is defined as chronic administration of prednisone (more than 14 days) or equivalent more or equal than 2 miligramas por kilo por dia in the 4 weeks prior to study entry, radiotherapy or immunosuppressive cytotoxic drugs or monoclonal antibodies in the 3 previous years, topical and inhaled steroids are permitted. Infected cohort: Participants with more than 5 days of symptoms. Participants who do not agree to sign the Informed consent form. Participants who are not available to carry out the planned study visits

Design outcomes

Primary

MeasureTime frame
Detailed description of the immune response induced after vaccination and infection in young or elderly adult participants previously exposed or not to dengue.

Secondary

MeasureTime frame
Identification of immune factors (cellular or humoral immunity) associated with protection antiviral drugs induced after vaccination.;Identification of virus-specific B cell clones expanded and maintained after vaccination, and isolation of monoclonal antibodies with greater capacity to viral neutralization.

Countries

Brazil

Contacts

Public ContactMauro Teixeira

Universidade Federal de Minas Gerais

mmtex.ufmg@gmail.com+55 (31) 99516 6160

Outcome results

None listed

Source: REBEC (via WHO ICTRP)