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Phase 2 Completed N=351 Randomized Quadruple-blind Prevention

Safety and Immunogenicity With Two Different Serotype 2 Potencies of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Adults in Singapore

Dengue Fever
Source: ClinicalTrials.gov NCT02425098 ↗
Enrolled (actual)
351
Serious AEs
1.7%
Results posted
Aug 2019
Primary outcomePrimary: Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15 — 156.2; 110.2; 183.0; 117.6 Titer

Summary

The purpose of this study is to assess the post-vaccination neutralizing antibody response against each dengue serotype by vaccine group.

Outcome Measures

OutcomeResultp-value
PRIMARY
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15
156.2; 110.2; 183.0; 117.6; 113.5; 69.0
PRIMARY
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30
771.0; 470.5; 8640.3; 1992.7; 390.6; 250.8
PRIMARY
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90
376.5; 394.0; 4090.2; 1647.3; 266.5; 218.0
PRIMARY
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180
379.4; 312.2; 2585.5; 1235.0; 236.2; 161.0
PRIMARY
Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365
247.3; 264.1; 1726.0; 809.5; 163.2; 132.6
PRIMARY
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15
70.0; 72.4; 74.1; 65.9; 68.8; 62.4
PRIMARY
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30
97.1; 91.3; 98.8; 89.5; 89.0; 83.7
PRIMARY
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90
89.3; 89.5; 99.4; 92.6; 85.8; 86.4
PRIMARY
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180
93.4; 89.6; 98.2; 92.6; 88.0; 82.2
PRIMARY
Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365
84.4; 89.7; 98.8; 91.0; 79.4; 77.6
SECONDARY
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity
81; 91; 77; 84; 3; 6
SECONDARY
Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity
50; 61; 33; 40; 14; 18
SECONDARY
Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination
70; 78
SECONDARY
Number of Participants With Serious Adverse Events (SAEs)
3; 3
SECONDARY
Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status
1256.2; 675.2; 1603.0; 1057.4; 677.7; 376.0
SECONDARY
Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status
93.4; 98.9; 93.4; 95.7; 91.2; 91.4
SECONDARY
Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination
0; 0; 0; 0; 0; 0
SECONDARY
Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination
5.0; 4.0; 1.0; 1.0; 1.0
SECONDARY
Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination
3.73; 3.78; 2.82; 3.63; 3.63; 2.71

Eligibility Criteria

Inclusion Criteria

  • Participant signs and dates a written informed consent form where applicable, 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.
  • Is aged 21 to 45 years of age, inclusive.
  • Is 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.
  • Can comply with trial procedures and are available for the duration of follow-up.
  • Has self-declared as never having been vaccinated against Yellow Fever or Japanese Encephalitis Virus.

Exclusion Criteria

  • Has febrile illness (temperature ≥38°C or ≥100.4°F) or moderate or severe acute illness or infection at the time of enrollment.
  • Has history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial, including but not limited to:
  • Known hypersensitivity or allergy to any of the vaccine components.
  • Female participants who are pregnant or breastfeeding.
  • Individuals with any serious chronic or progressive disease according to judgment of the Investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome).
  • Known or suspected impairment/alteration of immune function, including:
  • i. 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 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
  • ii. 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 (Month 0).
  • iii. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
  • iv. Receipt of immunostimulants within 60 days prior to Day 1(Month 0).
  • v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
  • vi. Human immunodeficiency virus (HIV) infection and HIV-related diseases.
  • vii. Hepatitis C virus (HCV) infection.
  • viii. Genetic immunodeficiency.
  • Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0).
  • Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
  • Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine.
  • Is first-degree relative of individuals involved in trial conduct.
  • For 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 (Month 0).
  • Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy.
  • Acceptable birth control methods are defined as one or more of the following:
  • i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring).
  • ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse.
  • iii. Intrauterine device (IUD).
  • iv. Monogamous relationship with vasectomized partner (partner must have been vasectomized for at least six months prior to Day 1 [Month 0]).
  • Females of childbearing potential who are sexual
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02425098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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