Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
ConditionDengue
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-79
SponsorButantan Institute
About this trial
This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
a. Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever;
Disqualifiers
a. 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;
Trial design
Design model
Parallel
Treatments tested in this trial
Dengue 1,2,3,4 (attenuated) vaccine
Biological/VaccineEach 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.
Treatment groups
997 Participants
are divided into 3 treatment groupsGroup A: Dengue 1,2,3,4 (attenuated) vaccine in a single dose older adultExperimental treatment 1 intervention
Group B: Dengue 1,2,3,4 (attenuated) vaccine in a single dose adultExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Immunogenicity Primary
Proportion of neutralizing antibody seroconversion measured by PRNT50, for each dengue serotype, of participants aged 60 -79 years compared (elderly) with participants aged 40 to 59 years (adults), with or without previous exposure to dengue, on Day 42 + 7 days after vaccination.
Time frame
Day 42+7 days post-vaccination.2
Safety Primary 1.
Frequency and intensity of vaccine-related solicited (local and systemic) adverse events, from vaccination to Day 22 + 3 days post-vaccination, among participants aged 60 - 79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue.
Time frame
From vaccination to Day 22 + 3 days post-vaccination.3
Safety Primary 2.
Frequency and intensity of vaccine-related unsolicited adverse events, from vaccination to Day 22 + 3 days post-vaccination, in participants aged 60-79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue.
Time frame
From vaccination to Day 22 + 3 days post-vaccination.Secondary outcomes
1
Immunogenicity Secondary 1.
GMT of neutralizing antibodies, for each dengue serotype, of participants aged 60-79 years and of participants aged 40 to 59 years, with or without previous exposure to dengue, on Day 1, Day 42 + 7 days and Day 364 + 28 days after vaccination.
Time frame
Day 1, Day 42 + 7 days and Day 364 + 28 days after vaccination.2
Immunogenicity Secondary 2.
GMT ratio of neutralizing antibodies, for each dengue serotype, of participants aged 60-79 years compared with participants aged 40 to 59 years, with or without previous exposure to dengue, on Day 42 + 7 days after vaccination.
Time frame
Day 42 + 7 days after vaccination.3
Immunogenicity Secondary 3.
GMT ratio of neutralizing antibodies, for each dengue serotype, of participants aged 60-79 years compared with participants aged 40 to 59 years, with or without previous exposure to dengue, on Day 364 + 28 days after vaccination.
Time frame
Day 364 + 28 days after vaccination.4
Immunogenicity Secondary 4.
Valence or seropositivity rate for multiple dengue virus serotypes measured by PRNT50 in participants aged 60-79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue, on Days 42 + 7 days and Day 364 + 28 days after vaccination.
Time frame
Days 42 + 7 days and Day 364 + 28 days after vaccination.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Butantan Institute
Lead sponsor
Butantan Foundation
Collaborator
Source ClinicalTrials.gov