Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and D… (NCT03746015) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and Dengue-Immune Adults
United States30 participantsStarted 2018-12-28
Plain-language summary
The purpose of this study is to assess the neutralizing antibody response against each dengue serotype post-vaccination.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Group 1 only: immunologically naïve to dengue, Zika, Yellow Fever (YF), Japanese Encephalitis (JE), West Nile (WN) (based on negative results for detection of anti-DENV, anti-Zika, anti-YF, anti-JE, anti-WN antibodies) as documented by serological testing performed by the trial center outside the scope of this trial (up to 70 days \[10 weeks\] prior to Day 1 \[Month 0\]).
✓. Group 2 only: serology consistent with primary infection with either DENV-1 or DENV-3 (defined as detectable neutralizing antibodies against DENV-1 or DENV-3 only, or titers for DENV-1 or DENV-3 ≥4-times higher than titers for the 2 other dengue serotypes) as documented by serological testing performed by the trial center outside the scope of this trial (up to 70 days \[10 weeks\] prior to Day 1 \[Month 0\]).
Exclusion criteria
✕. Has clinically active significant infection (as assessed by the investigator) or body temperature ≥38°C (100.4°F) within 3 days of the intended date of vaccination.
✕. Known or suspected impairment/alteration of immune function including:
✕. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks and/or ≥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).
✕. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks and/or ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0).
✕. Administration of immunoglobulins and/or any blood products within 3 months prior to Day 1 (Month 0) or planned administration during the trial.
✕. Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
✕. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
What they're measuring
1
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 15
Timeframe: Day 15
2
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 30 (Month 1)
Timeframe: Day 30 (Month 1)
3
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 60 (Month 2)
Timeframe: Day 60 (Month 2)
4
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 90 (Month 3)
Timeframe: Day 90 (Month 3)
5
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 105
Timeframe: Day 105
6
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 120 (Month 4)
Timeframe: Day 120 (Month 4)
7
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 150 (Month 5)