The purpose of this study is to evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh.
Dengue viruses (DENV) are the leading arboviral infection globally, with over 2 billion people at risk of infection worldwide. The first dengue fever outbreak in Bangladesh occurred in 2000, and since then, dengue fever has had a continued presence throughout Bangladesh. This study will evaluate the safety and immunogenicity of the recombinant live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults, adolescents, and children in Dhaka, Bangladesh. The study will enroll four cohorts of participants: adults, adolescents, children, and young children. Study researchers will evaluate study data for each cohort before enrolling the subsequent cohort. Participants will be randomly assigned to receive either TV005 vaccine or placebo at study entry (Day 0). Additional study visits will occur on Days 7, 14, 28, 56, 180, 360, 720, and 1080. Study visits will include blood collection, physical examinations, and clinical assessments. Participants will record and monitor their temperature and symptoms until Day 14. Study staff will contact participants daily until Day 14; after Day 14, study staff will contact participants weekly (and after Day 180, monthly) throughout the study for follow-up health monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
192
Delivered by subcutaneous injection; contains 10\^3 PFU of rDEN1Δ30, 10\^4 PFU of rDEN2/4Δ30(ME), 10\^3 PFU of rDEN3Δ30/31, and 10\^3 PFU of rDEN4Δ30.
Delivered by subcutaneous injection
International Centre for Diarrhoeal Disease Research, Bangladesh
Mīrpur, Dhaka Division, Bangladesh
Percentage of Study Participants With Each Solicited, Related Adverse Event Types of Any Severity.
Collected through daily home visits up to day 14, clinic visits for physical exam and hematological and blood chemistry labs, and weekly phone surveillance after day 14. Study staff record temperatures and AEs on the surveillance source document.
Time frame: Vaccine/placebo administration (study day 0) up to 28 days post vaccine/placebo administration
Percentage of Study Participants Who Are Seropositive Following Vaccination
Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 58, and 180 post vaccination. Seropositivity to each serotype as defined as PRNT50\>=10. Per protocol analysis includes participants meeting eligibility criteria, complying with defined visits and protocols, no elimination criteria, and immunogenicity data endpoints measures available.
Time frame: Study day 14 through study day 180
Proportion of Study Participants With Vaccine Virus Recovered Following Vaccination
Viremia in serum was determined both by amplification and direct titration using Vero cell monolayers. Each specific serotype was identified using monoclonal antibodies.
Time frame: Vaccine administration (study day 0) up to 14 days post vaccine administration
Percentage of Seropositive Study Participants Among Dengue Experienced and Dengue Naive Vaccinees.
Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, and 180 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.
Time frame: Study day 14 through study day 180
Durability of Seropositivity Post TV005 Vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Estimated percent seropositive, over 3 years by age group and serotype. Measured by serum plaque reduction neutralization titer, 50% (PRNT50) to DENV-1, DENV-2, DENV-3, and DENV-4 viruses at study day 14, 28, 56, 180, 360, 720, and 1080 post vaccination. Seropositivity to each serotype is defined as PRNT50 ≥ 10.
Time frame: Vaccine/placebo administration (study day 0) up to three years post vaccine/placebo administration (study day 1080).