A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

NCT ID: NCT01542632

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-01
• Study Completion Date: 2014-01-10

Brief Summary

A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine.

Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline [during the screening period or on day of vaccination (Day 0)], then on Days 30, 90 and 120.

The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group 1

Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and placebo, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.

Group Type: EXPERIMENTAL

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Intervention Type: BIOLOGICAL

TDV subcutaneous injection

Placebo

Intervention Type: DRUG

Placebo subcutaneous injection

Group 2

TDV, 0.5 mL, subcutaneous injection in one arm and TDV 0.5 mL, subcutaneous injection in the other arm on Day 0. Placebo, 0.5 mL, subcutaneous injection on Day 90.

Group Type: EXPERIMENTAL

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Intervention Type: BIOLOGICAL

TDV subcutaneous injection

Placebo

Intervention Type: DRUG

Placebo subcutaneous injection

Group 3

TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.

Group Type: EXPERIMENTAL

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Intervention Type: BIOLOGICAL

TDV subcutaneous injection

Group 4

TDV new formulation, 0.5 mL, subcutaneous injection in one arm and new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.

Group Type: EXPERIMENTAL

TDV New Formulation

Intervention Type: BIOLOGICAL

TDV New Formulation subcutaneous injection

New Formulation Placebo

Intervention Type: DRUG

New Formulation placebo subcutaneous injection

Group 5

TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.

Group Type: EXPERIMENTAL

TDV New Formulation

Intervention Type: BIOLOGICAL

TDV New Formulation subcutaneous injection

New Formulation Placebo

Intervention Type: DRUG

New Formulation placebo subcutaneous injection

Group 6

1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.

Group Type: EXPERIMENTAL

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Intervention Type: BIOLOGICAL

TDV subcutaneous injection

Interventions

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

TDV subcutaneous injection

Intervention Type: BIOLOGICAL

TDV New Formulation

TDV New Formulation subcutaneous injection

Intervention Type: BIOLOGICAL

Placebo

Placebo subcutaneous injection

Intervention Type: DRUG

New Formulation Placebo

New Formulation placebo subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female at least 18 years and ≤ 45 years old at time of screening

2. In good health as determined by medical history, physical examination including height and weight

3. Normal clinical safety laboratory examinations [Sodium (Na), Potassium (K), Glucose, Blood Urea Nitrogen (BUN), creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, White Blood Cell (WBC), neutrophil count, hemoglobin, platelets, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and urinalysis (by dipstick)].

4. Weight: Body Mass Index (BMI) ≤32

5. Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and Hepatitis B surface antigen

Exclusion Criteria

1. Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator

2. Clinically significant ECG findings

3. History of any significant dermatologic disease in the last 6 months,

4. History of diabetes mellitus

5. History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines

6. Hypersensitivity to any vaccine

7. Receipt of any vaccine in the 4 weeks preceding the first vaccination

8. Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study

9. Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)

10. Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)

11. Seropositivity to dengue or West Nile (WN) virus

12. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months

13. Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed

14. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination

15. Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)

16. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids

17. Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90

18. Females who are pregnant or lactating

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilad Gordon, MD

Role: STUDY_DIRECTOR

Inviragen Inc.

Locations

Heart Center of the Rockies

Fort Collins, Colorado, United States

University of Texas Medical Branch

Galveston, Texas, United States

Advanced Clinical Research

West Jordan, Utah, United States

Countries

United States

Other Identifiers

U1111-1177-8166

Identifier Type: REGISTRY

Identifier Source: secondary_id

INV-DEN-104

Identifier Type: -

Identifier Source: org_study_id