Healthy Adults and Healthy Children Dengue Vaccine, Live Attenuated Vaccine, Tetravalent Vaccine, KD-382, Dengue, Immunogenicity, Safety, Phase II, Randomized Controlled Trial, Double-Blind, Open-Label, Dose-Response Relationship, Age Factor, Adult, Children, Healthy Volunteer
Conditions
Interventions
KD 382 is a live attenuated TDV PDK15/PDK25/PGMK30PDK4/PDK40 and is composed of 4 live attenuated DENV serotypes 1 to 4 (DENV 1, 2, 3, and 4).
Mode of administration: Subcutaneous
The KD-382 vials wil
there are no globally approved DENV vaccines. As a result, placebo is considered the best comparator for KD-382.
Experimental Biological/Vaccine,Experimental Biological/Vaccine,Placebo Comparator Other
high-dose KD 382,Standard-dose KD-382,Placebo
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria Part 1: Healthy adults (both dengue virus antibody naive adults from Australia [Cohort 1.1] and non-naive adults from Thailand [Cohort 1.2]) - Cohorts 1.1 and 1.2: aged 18-64 years Part 2: Healthy children (both dengue virus antibody naive and non-naive children from Thailand) - Cohorts 2.1 and 2.2: aged 12-17 years - Cohorts 2.3 and 2.4: aged 6-11 years - Cohorts 2.5 and 2.6: aged 2-5 years Part 3: Healthy children (both dengue virus antibody naive and non-naive children from Thailand) - Cohort 3.1: aged 12-17 years - Cohort 3.2: aged 6-11 years - Cohort 3.3: aged 2-5 years Inclusion Criteria 1. The subject is aged 2 to 64 years, inclusive, at the time of informed consent/informed assent. 2. Individuals who are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator. 3. The subject or the subject's legally acceptable representative signs and dates a written informed consent or informed assent form where applicable, and any required privacy authorization prior to the initiation of any study procedures, after the nature of the study has been explained according to the local regulatory requirements. 4. Individuals who can comply with the study procedures and are available for the duration of the follow up. 5. For dengue virus antibody non-naive subjects in Parts 1, 2, and 3: serological test positive for any DENV serotype within 70 days before Day 1 or at the time of screening. 6. For dengue virus antibody naive subjects (adult and pediatric populations): immunologically naive to dengue as documented by serological testing at screening.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Any subject meeting any of the following criteria will be excluded from the study: 1. Febrile illness (temperature more than or equal to 38 degree C or more than or equal to100.4 degree F) or moderate or severe acute illness or infection at the time of enrollment (consider whether applicable as an exclusion criterion versus criterion for delayed study vaccine administration). 2. Previous medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the subject due to participation in the study, including but not limited to: a. Known hypersensitivity or allergy to any of the vaccine components. b. Individuals with any serious chronic or progressive disease according to judgment of the investigator (eg, insulin-dependent diabetes; cardiac, renal, or hepatic disease [eg, chronic viral hepatitis; nonalcoholic hepatic steatosis; alcohol induced chronic liver injury including cirrhosis]; neurologic or seizure disorder; or Guillain-Barre syndrome). c. Malignancies (subjects with multiple basal cell cancers but who had their last basal cell cancer removed [confirmed pathologically] are permitted to be entered into the study). d. Hematologic conditions that could lead to bleeding tendencies or abnormality in platelets, white blood cell count, and neutrophil count. e. Known or suspected impairment/alteration of immune function, including: i. Chronic use of high-dose oral or parenteral corticosteroids (equivalent to either more than or equal to 2 mg/kg body weight or more than or equal to 20 mg/day of prednisone or equivalent for persons who weigh more than 10 kg when administered for more than or equal to 14 consecutive days) within 60 days prior to Day 1. ii. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 or planned administration during the study. iii. Receipt of immunostimulants such as interleukins, interferons, and G-CSF within 60 days prior to Day 1. iv. Immunosuppressive therapy such as anticancer chemotherapy or radiation therapy within 6 months prior to Day 1. v. Blood tests positive for HIV antibodies, HBV surface antigen, or HCV antibodies vi. Genetic immunodeficiency. 3. Receipt of any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) of the study vaccine administration or planning to receive any vaccine within 28 days after the study vaccine administration. 4. Participation in any clinical study with another investigational product 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study. 5. Previous participation in any clinical study of a dengue candidate vaccine (eg, KD 382), or previous receipt of a dengue vaccine. 6. Receipt of antipyretic and/or anti-inflammatory (eg, NSAIDs) and/or analgesic medications within 24 hours prior to the study vaccine administration (consider whether applicable as an exclusion criterion or criterion to delay the study vaccine administration). 7. First-degree relatives of individuals involved in the study conduct. 8. Female subjects who are pregnant or breastfeeding. 9. Females of childbearing potential who are sexually active and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 and until 120 days after administration of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of KD-382 7 days post vaccination Incidence and severity of solicited local reactogenicity events through 7 days post vaccination.,To evaluate the safety and tolerability of KD-382 14 days post vaccination Incidence and severity of solicited systemic reactogenicity events through 14 days post vaccination.,To evaluate the safety and tolerability of KD-382 28 days post vaccination Incidence and severity of unsolicited AEs through 28 days post vaccination.,To evaluate the safety and tolerability of KD-382 throughout the study Incidence and severity of SAEs and MAAEs throughout the study.,To evaluate the immunogenicity of KD-382 Day 29 GMT of FRNT50 for all four dengue serotypes at Day 29. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess vaccine viremia post vaccination with KD-382 at each visit throughout the treatment period or until negative Proportion of subjects with TDV viremia caused by DENV1/03135, DENV2/99345, DENV3/16562, or DENV4/1036 as measured by RT qPCR at each visit throughout the treatment period or until negative.,To assess vaccine viremia post vaccination with KD-382 at each visit throughout the treatment period or until negative Proportion of subjects with TDV viremia caused by 1, any 2, any 3, and all 4 dengue serotypes as measured by RT-qPCR at each visit throughout the treatment period or until negative.,To assess vaccine viremia post vaccination with KD-382 at Day 8, Day 15, and Day 29 or until negative Change in viremia titers from baseline at Day 8, Day 15, and Day 29 or until negative.,To assess vaccine viremia post vaccination with KD-382 throughout the course of the study Incidence of AEs reported in subjects with vaccine positive viremia throughout the course of the study.,To evaluate vaccine viremia infectiousness The vaccine viremia infectiousness will only be assessed if viremia is positive. Cell viability and viral levels,To further evaluate the immunogenicity of KD-382 at Day 29 Seroconversion rate for all four dengue serotypes at Day 29.,To further evaluate the immunogenicity of KD-382 at Day 29 GMR of FRNT50 for all four dengue serotypes at Day 29.,To further evaluate the immunogenicity of KD-382 at Day 29 Proportion of subjects seropositive against 1, any 2, any 3, or all 4 serotypes at Day 29. | — |
Countries
Thailand
Contacts
Public ContactProf. Khuanchai Supparatpinyo
Research Institute for Health Sciences, Chiang Mai University
Outcome results
None listed