A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in Non-endemic Country(Ies) for Dengue
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Takeda
- Enrollment
- 900
- Locations
- 10
- Primary Endpoint
- Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous [SC] injection) and of hepatitis A virus (HAV) vaccine (intramuscular [IM] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.
Detailed Description
The vaccine tested in this study is TDV. TDV co-administered with HAV vaccine will be tested to assess immunogenicity and safety in healthy participants in non-endemic area(s) for dengue and HAV. The study will enroll approximately 900 patients. Participants will be randomly assigned to one of the three groups-which will remain undisclosed to the observer. Participants will be randomized in 1:1:1 ratio to receive: * Group 1: HAV vaccine (IM) and TDV placebo-matching injection (SC), co-administered at Day 1 (Month 0 \[M0\]); TDV placebo-matching injection (SC) administered at Day 90 (Month 3 \[M3\]) * Group 2: TDV (SC) and HAV placebo-matching injection (IM), co-administered at Day 1 (Month 0 \[M0\]); TDV (SC) administered at Day 90(Month 3 \[M3\]) * Group 3: TDV (SC) and HAV vaccine (IM), co-administered at Day 1 (Month 0 \[M0\]); TDV (SC) administered at Day 90 (Month 3 \[M3\]) This multi-center trial will be conducted in United Kingdom. The overall time to participate in this study is 270 days. Participants will have multiple visits to the clinic with a 6-months follow up after the last study administration, including a final visit at Day 270.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The participant is aged 18 to 60 years, inclusive.
- •Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
- •The participant signs and dates a written informed consent form 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.
- •Participants who can comply with trial procedures and are available for the duration of follow-up.
Exclusion Criteria
- •Participants with an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
- •Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccines or placebo).
- •Participants with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
- •Participants with any history of progressive or severe neurologic disorder, seizure disorder orneuro-inflammatory disease (eg, Guillain-Barré syndrome).
- •Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participant due to participation in the trial.
- •Known or suspected impairment/alteration of immune function, including:
- •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).
- •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).
- •Administration of immunoglobulins and/or any blood products within the 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).
Outcomes
Primary Outcomes
Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30
Time Frame: One month post first vaccination (Day 30)
Seroprotection is defined as serum anti-HAV antibody levels ≥12.5 mIU/mL, measured by enzyme-linked immunosorbent assay (ELISA). Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels \<12.5 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes \<10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Secondary Outcomes
- Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline(One month post first vaccination (Day 30) and one month post second vaccination (Day 120))
- Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120(One month post first vaccination (Day 30) and one month post second vaccination (Day 120))
- Geometric Mean Concentrations (GMC) of Anti-HAV Antibodies at Day 30 in Participants HAV/DENV-naive at Baseline(One month post first vaccination (Day 30))
- Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination(Within 7 days after each vaccination)
- Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination(Within 14 days after each vaccination)
- Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination(Up to 28 days (Day of Vaccination+27 Subsequent Days) after each vaccination)
- Percentage of Participants With Serious Adverse Events (SAEs)(From the first vaccination on Day 1 until the end of the trial (Day 270))
- Percentage of Participants With Medically Attended AEs (MAAEs)(From the first vaccination on Day 1 until the end of the trial (Day 270))