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Completed

NCT Number: NCT01542632

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

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).

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heart Center of the Rockies, Fort Collins, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female at least 18 years and ≤ 45 years old at time of screening
  • In good health as determined by medical history, physical examination including height and weight
  • 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)].
  • Weight: Body Mass Index (BMI) ≤32
  • Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and Hepatitis B surface antigen

Exclusion criteria

  • Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator
  • Clinically significant ECG findings
  • History of any significant dermatologic disease in the last 6 months,
  • History of diabetes mellitus
  • History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines
  • Hypersensitivity to any vaccine
  • Receipt of any vaccine in the 4 weeks preceding the first vaccination
  • Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study
  • Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)
  • Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)
  • Seropositivity to dengue or West Nile (WN) virus
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
  • 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
  • Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination
  • 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)
  • Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
  • Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90
  • Females who are pregnant or lactating

Treatment and study plan

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

Biological

TDV subcutaneous injection

TDV New Formulation

Biological

TDV New Formulation subcutaneous injection

Placebo

Drug

Placebo subcutaneous injection

New Formulation Placebo

Drug

New Formulation placebo subcutaneous injection

Primary outcomes

  1. Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported

    Time frame: Day 0 to Day 104

    Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.

  2. Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose

    Time frame: For 30 days after each dose (Up to Day 120)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.

  3. Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose

    Time frame: For 30 days after each dose (Up to Day 120)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.

  4. Rate of Seroconversion to Each of Four Dengue Serotypes

    Time frame: Up to 30 days after the last immunization (Up to Day 120)

    Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.

Secondary outcomes

  1. Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations

    Time frame: various timepoints up to 30 days after each dose (Up to Day 120)

    Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.

  2. Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes

    Time frame: Days 30, 90 and 120 after 1st vaccination

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Randomized, Phase 1b Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers Between the Ages of 18 - 45 Years

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 2, 2012
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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