Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose

Launched by TAKEDA · Jun 25, 2019

Keywords

ClinConnect Summary

The vaccine tested in this study is Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV). This study will look at the long-term antibody persistence and safety of Takeda's TDV in healthy adolescents and adults and will assess the impact of a booster dose.

The study has enrolled 365 healthy participants. Participants who previously received TDV in two parent trials (DEN-304 \[NCT03423173\] and DEN-315 \[NCT03341637\]), will be invited to participate in this follow-up trial. Participants will be assessed for antibody persistence and safety from Baseline (Month 0) through Month 15 (fo...

Gender

ALL

Eligibility criteria

• 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.