Last updated 39 days ago
Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
997 patients around the world
Available in Brazil
The study aims to evaluate the non-inferiority of the immune response induced by the Dengue 1,2,3,4 (attenuated) vaccine in participants aged 60 - 79 years old (elderly) compared to participants aged 40 to 59 years on Day 42 + 7 days after vaccination. The primary analysis will include the immunogenicity cohort (n=460 participants, allocated 1:1). The primary outcome is the proportion of neutralizing antibody seroconversion measured by plaque reduction neutralization test (PRNT50), for each dengue serotype, of participants aged 60 - 79 years (elderly) compared with participants aged 40 to 59 years (adults), with or without previous exposure to dengue, on Day 42 + 7 days after vaccination. The primary safety outcome will be the frequency and intensity of solicited and unsolicited adverse reactions from vaccination to Day 22 post-vaccination among participants aged 60 - 79 years and in participants aged 40 to 59 years, with or without prior exposure to dengue. The study will last one year in order to assess the duration of the immune response and serious adverse events (SAE) and events of special interest (SIAE). Throughout the study period, there will be surveillance of suspected and confirmed cases of dengue, chikungunya fever and Zika virus fever. Therefore, if the null hypothesis is rejected, the immunogenicity and safety results of immunobridging will be used to expand the use of Dengue 1,2,3,4 (attenuated) for the age group of 60 - 79 years old.
Butantan Institute
1Research sites
997Patients around the world
This study is for people with
Dengue
Requirements for the patient
To 79 Years
All Gender
Medical requirements
- Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever.Agree to periodic contact by telephone, electronic means, and home visits and to the research center.Participants with reproductive potential must be using some effective contraceptive method at screening and continue using it for up to 90 days after the intervention, except in cases where the volunteer declares that she is not at risk of becoming pregnant, either by not engaging in sexual activities or by engaging in them in a non-reproductive manner, up to 90 days after vaccination.Demonstrate intent to participate in the study, documented by the participant's signature of the informed consent form, as well as the study procedures, including completing the Participant Diaries, blood collection, and being available for scheduled study visits and contacts.
- For female participants with reproductive potential: pregnancy confirmed by positive β-hCG test, breastfeeding or manifest intention to have sexual practices with reproductive potential without using a contraceptive method in the 90 days following vaccination.Planned donation of blood, semen or eggs in the 90 days following vaccination.Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease according to anamnesis or physical examination, at the discretion of the investigator.Diseases that compromise the immune system, including decompensated diabetes mellitus, active neoplasms or history of neoplasms in the last five years except basal cell carcinoma, congenital or acquired immunodeficiencies including HIV/AIDS, solid organ transplants or uncontrolled autoimmune diseases according to anamnesis or physical examination, as well as a history of liver failure, heart failure or terminal chronic kidney disease or dialysis.Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his/her medical representative, affects the potential participant's ability to understand and comply with the requirements of the study protocol.Any abuse of alcohol or drugs in the last 12 months prior to enrollment in the study that has caused medical, professional, or family problems, as indicated by the clinical history.History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine.History of asplenia.Participation in another clinical trial with administration of an investigational product during the six months prior to enrollment in the study or scheduled participation in another clinical trial in the 12 months following enrollment.Previous participation in a dengue vaccine evaluation study or previous exposure to dengue vaccine.Use of immunosuppressive therapies six months prior to enrollment in the study or their scheduled use in the 12 months following enrollment.Having received an immunosuppressive dose of corticosteroid in the last three months prior to inclusion in the study or administration of an immunosuppressive dose of corticosteroid for the 12 months following inclusion in the study.Having received blood products in the last three months prior to inclusion in the study, or scheduled administration of blood products or immunoglobulin in the 12 months following inclusion in the study.Fever, suspected or measured, in the 72 hours prior to vaccination or axillary temperature ≥ 37.8°C on the day of vaccination.Having received a live attenuated virus vaccine in the last 28 days or an inactivated vaccine in the last 14 days prior to inclusion in the study.Any other condition that, in the opinion of the principal investigator or his/her medical representative, may jeopardize the safety or rights of a potential participant or that prevents him/her from complying with this protocol.
Sites
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
StudyDEN-04-IB
SponsorButantan Institute
Study typeInterventional
Conditions
Dengue
Requirements
To 79 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06891950
