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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. Has history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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).
Timeframe: Day 150 (Month 5)
8
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 180 (Month 6)
Timeframe: Day 180 (Month 6)
9
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 270 (Month 9)
Timeframe: Day 270 (Month 9)
10
GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 360 (Month 12)