The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.
In this study, children and adults at multiple sites in Puerto Rico will be randomly allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by age group (a specific number of subjects in each of 4 age groups \[12 months to 50 years of age\] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures. Safety follow-up for dengue may require unscheduled visits and venipunctures.\> Multiple DEN virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for dengue. The results of this phase II study will provide a basis for identifying the vaccine formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a high proportion of vaccine recipients. The most immunogenic and well tolerated candidate formulation identified in this study will be considered for advancement to phase III development.\>
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
636
Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months
Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months
San Juan Batista Medical School
Caguas, Puerto Rico
Private Practice
Carolina, Puerto Rico
St Luke's Memorial Hospital
Ponce, Puerto Rico
Safety: Incidence of All and Grade 3 Solicited Local Symptoms
Incidence of all and grade 3 (prevents normal, everyday activities) solicited local and general symptoms within the 21-day follow-up period (Total vaccinated cohort)
Time frame: Within 21 days (days 0-20) f/up period after each vaccine dose
Safety: Summary of Unsolicited Adverse Events Within the 31-day Post-vaccination Period
Summary of unsolicited Adverse Events within the 31-day post-vaccination period by age group (total vaccinated cohort)
Time frame: Within the 31-day (days 0-30) follow-up period after each vaccine dose
Safety: Occurrence of Serious Adverse Events (SAEs)
Summary of SAEs, 6 months + 30 day follow-up period after last vaccine dose
Time frame: 6 months + 30 day follow-up period after last vaccine dose
Incidence of Suspected and Laboratory Confirmed Dengue
Incidence of suspected and confirmed dengue reported during the 31-day (Days 0-30) post-vaccination period and after the 31-day period
Time frame: 31-day (days 0-30) post-vaccination period and after 31-day period
GMTs for Antibody Titer Above the Assay Cut Off to Each DEN Serotype for Unprimed and Primed Subjects
Comparison of F17 and F19 formulations in terms of GMTs at month 7 (one month post dose 2) for each DEN type, -unprimed and primed subjects
Time frame: at month 7 (one month post dose 2)
Percent of Subjects With Neut. Antibody Titer Above the Assay Cut-off to All Dengue Serotypes
Monovalent, bivalent, trivalent and tetravalent response for DEN neut. antibodies for unprimed and primed subjects
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Caparra Internal Medicine Research Center
Rio Grande, Puerto Rico
Private Practice
Rio Piedras, Puerto Rico
RCMI Clinical Research Center
Rio Piedras, Puerto Rico
Torre Medica San Vicente de Paul
San German, Puerto Rico
Clinical Research PR
San Juan, Puerto Rico
Centro de Neumologia Pediatricia
San Juan, Puerto Rico
Private Practice
San Juan, Puerto Rico
...and 1 more locations
Time frame: Pre-vaccination, at post dose 1, months 3 and 6 and post dose 2, month 7
Percent of Subjects With Neut. Sero-response to Each DEN Serotype
Seropositivity rates for DEN neut. antibodies for unprimed and primed subjects
Time frame: Pre-accination, at post dose 1, months 3 and 6 and post dose 2, month 7
Vaccine Response to DEN Antibody at Post Dose 1, Month 3
Vaccine response for DEN-1, DEN-2, DEN-3 and DEN-4 antibody S- = seronegative subjects (antibody titer \<10 ED50 for DEN-1, 2, 3, and 4 prior to vaccination; S+ = Seropositive subjects (antibody titer \>10 ED50 for DEN-1, 2, 3 and 4 prior to vaccination; Total = subjects either seropositive or seronegative at pre-vaccination Vaccine response defined as: For initially seronegative subjects, antibody titer \>10 ED50 at PI(M3) and for initially seropositive subjects: antibody titer at PI(m3) \>4 fold the pre-vaccination antibody titer
Time frame: at month 3, post dose 1
Vaccine Response to DEN Antibody at Post Dose 2, Month 7
Vaccine response for DEN-1, DEN2, DEN-3, DEN-4 antibody at post dose 2, month 7
Time frame: at month 7, post dose 2