Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
About this clinical trial
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States [US]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
At a glance
What medical conditions were being studied?
What was the clinical trial testing?
Placebo, Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
How many participants were enrolled?
365
When was the clinical trial conducted?
Nov 2019 - May 2024
Key requirements
Sex
All
Age
13-63 years
Healthy volunteers?
Yes
Inclusion Criteria:
1. Male or female participants (irrespective of serostatus at baseline in the parent trials
(DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]) who received at least one dose of
Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials and have data from
at least one blood draw post-vaccination.
Exclusion Criteria:
1. Participants with a prolonged period of habitation (≥1 year) in a dengue endemic area
within the 2 years prior to Visit 1 Day 1 (Month 0).
2. Previous and planned vaccination (during the trial conduct), against any flavivirus
including dengue (other than Takeda's TDV), yellow fever (YF), Japanese encephalitis
(JE) viruses or tick-borne encephalitis.
Booster Exclusion Criteria:
1. Participants for whom baseline serostatus is not defined in the parent trials (DEN-304
[(NCT03423173)] and DEN-315 [NCT03341637]).
2. Participants with any history of progressive or severe neurologic disorder, seizure
disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
3. Known or suspected impairment/alteration of immune function, including:
1. 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 Month 42 for
participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from
parent trial DEN-304 (US); use of inhaled, intranasal, or topical corticosteroids
is allowed.
2. 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 Month 42 for
participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from
parent trial DEN-304 (US).
3. Administration of immunoglobulins and/or any blood products within the 3 months
prior to administration of the TDV booster or placebo at Month 42 for
participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from
parent trial DEN-304 (US); consider whether applicable as an exclusion criterion
or criterion for delay.
4. Receipt of immunostimulants within 60 days prior to Month 42 for participants
from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial
DEN-304 (US).
5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
within 6 months prior to Month 42 for participants from parent trial DEN-315
(Mexico) / Month 15 for participants from parent trial DEN-304 (US).
6. Known human immunodeficiency virus (HIV) infection or HIV-related disease.
7. Hepatitis C virus infection.
8. Genetic immunodeficiency.
4. Abnormalities of splenic or thymic function.
5. Participants with a known bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time.
6. Participants with history of current or previous infection with a flavivirus such as
dengue, Zika, YF, JE, West Nile fever, tick-borne encephalitis or Murray Valley
encephalitis and participants with a prolonged period of habitation (≥1 year) in a
dengue endemic area during trial conduct.