The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.
The vaccine being tested in this study is tetravalent dengue vaccine (TDV). The primary objective of this study is to evaluate the immune response and safety of a naturally aged (\>12 months stored at 2°C to 8°C) lot of TDV in a healthy adult population in country(ies) non-endemic for dengue. The assessment of a naturally aged lot of TDV in this clinical trial will provide an important contribution to data on TDV stability throughout the shelf life of the product. The study will enroll approximately 200 participants. Participants will be enrolled to the one treatment group: Tetravalent Dengue Vaccine (TDV) All participants will receive subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3). This multi-center trial will be conducted in the United States. The overall time to participate in this study is 9 months. Participants will make multiple visits to the clinic including a final visit at Day 270 (Month 9).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
200
TDV SC injection.
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Hutchinson Clinic
Hutchinson, Kansas, United States
Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: One month post second dose (Day 120)
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Time frame: One month and six months post second dose (Days 120 and 270)
Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity for multiple dengue serotypes was summarized in the following categories: tetravalent and at least trivalent.
Time frame: One month and six months post second dose (Days 120 and 270)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
GMTs of neutralizing antibodies were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
Time frame: Six months post second dose (Day 270)
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
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Solicited local adverse events (AEs) \[at injection site\] were collected by participants using diary cards within 7 days after each vaccination and included injection site pain \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\], injection site erythema \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\] and injection site swelling \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\]. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported.
Time frame: Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccination
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
Solicited systemic AEs were collected by participants using diary cards within 14 days after each vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). Fever is defined as body temperature greater than or equal to 38°C (100.4°F). Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. Only categories with at least 1 participant are reported.
Time frame: Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination
Percentage of Participants With Any Unsolicited Adverse Events Following Each Vaccination
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.
Time frame: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days)
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, leads to a congenital anomaly / birth defect in the offspring of a participant, or is an important medical event which may require intervention to prevent the items listed above or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Time frame: From first vaccination (Day 1) through end of study (Day 270)
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Time frame: From first vaccination (Day 1) through end of study (Day 270)