Healthy Volunteers "Vaccination against Dengue Fever and co-administration with Hepatitis A vaccine" MedDRA version: 20.1 Level: LLT Classification code 10012312 Term: Dengue fever virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Tetravalent Dengue Vaccine Candidate (TDV)
Product Code: TAK-003
Pharmaceutical Form: Powder and solution for solution for injection
INN o
Sponsors
Takeda Vaccines, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is aged 18 to 60 years, inclusive. 2. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator. 3. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. Assent is obtained from the subject where required. 4. Individuals who can comply with trial procedures and are available for the duration of follow-up. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Individuals with an elevated oral temperature (=38°C or 100.4°F) within 3 days of the intended date of vaccination (consider whether applicable as an exclusion criterion or criterion for delay. 2. Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccines or placebo). 3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject’s ability to participate in the trial. 4. Individuals with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome). 5. Individuals with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the subject due to participation in the trial. 6. Known or suspected impairment/alteration of immune function, including: a. Chronic use of oral steroids (equivalent to 20 mg/day prednisone =12 weeks/=2 mg/kg body weight/day prednisone =2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed). b. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone =12 weeks/= 2 mg/kg body weight/day prednisone =2 weeks) within 60 days prior to Day 1 (M0). c. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial. d. Receipt of immunostimulants within 60 days prior to Day 1(M0). e. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0). f. Human immunodeficiency virus (HIV) infection or HIV-related disease. g. HAV infection. h. Hepatitis C virus infection. i. Genetic immunodeficiency. 7. Abnormalities of splenic or thymic function. 8. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 9. Individuals with any serious chronic or progressive disease according to judgment of the Investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 10. Individuals with body mass index (BMI) greater than or equal to 35 kg/m2 (=weight in kg/[height in meters2]). 11. Individuals participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intent to participate in another clinical trial at any time during the conduct of this trial. 12. Individuals who received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of trial vaccine administration. 13. Previous HAV vaccination (in a clinical trial or with an approved product). 14. Individuals involved in the trial conduct or their first degree relatives. 15. Individuals with history of substance or alcohol abuse within the past 2 years. 16. Female subjects who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate NI of the immune response to 1 dose of HAV vaccine in HAV/DENV-naive subjects 1 month following co-administration with 1 dose of TDV (Group 3) compared to 1 dose of HAV vaccine co-administered with placebo (Group 1).;Timepoint(s) of evaluation of this end point: Day 30 (Month 1 [M1]); Secondary Objective: Immunogenicity -To describe the immune response to TDV in HAV/DENV-naive subjects 1 month following a second dose of TDV given 3 months after a first dose of TDV co-administered with HAV vaccine (Group 3) or placebo (Group 2). - To describe the immune response to TDV in HAV/DENV-naive subjects 1 month following a first dose of TDV co-administered with HAV vaccine (Group 3) or placebo (Group 2). - To describe the immune response to the HAV vaccine in HAV/DENV-naive subjects 1 month following 1 dose of HAV vaccine co-administered with TDV (Group 3) or placebo (Group 1). Safety - To assess the safety profile after each vaccine injection in Groups 1, 2 and 3. ; Primary end point(s): Proportion of subjects HAV/DENV-naive at Baseline who are seroprotected against HAV at Day 30 (Month 1 [M1]) as measured by enzyme-linked immunosorbent assay (ELISA) (seroprotection rate) in a subset of 120 subjects in each group (immunogenicity subset). Seroprotection is defined as serum anti-HAV antibody levels =10 mIU/mL. Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels <10 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes <10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity (immunogenicity subset): - Geometric mean titers (GMT) of neutralizing antibodies (microneutralization test [MNT50]) for each of the 4 dengue serotypes at Day 30 (M1) and Day 120 (Month 4 [M4]) in subjects HAV/DENV-naive at Baseline. Proportion of subjects HAV/DENV-naive at Baseline who are seropositive for each of the 4 dengue serotypes at Day 30 (M1) and Day 120 (M4) (seropositivity rate). Seropositivity is defined as a reciprocal neutralizing titer =10. - Geometric mean concentrations (GMC) of anti-HAV antibodies on Day 30 (M1) in subjects HAV/DENV-naive at Baseline. Safety (all subjects): - Frequency and severity of solicited local (injection site[s]) adverse events (AE) for 7 days (day of vaccination + 6 subsequent days) and solicited systemic AEs for 14 days (day of vaccination + 13 subsequent days) after each trial vaccination. - Percentage of subjects with any unsolicited AEs for 28 days (day of vaccination + 27 subsequent days) after each trial vaccination. - Percentage of subjects with serious adverse events (SAE) throughout the trial. - Percentage of subjects with medically attended adverse events (MAAE) throughout the trial. ; Timepoint(s) of evaluation of this end point: Immunogenicity: Day 30 (M1) and Day 120 (Month 4 [M4]) Safety: Throughout the trial | — |
Countries
United Kingdom
Contacts
Public ContactAssoc. Dir., Program Physician
Takeda Pharmaceuticals International AG
Outcome results
None listed