Clinical trial NCT05710224: Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan-DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181-002)
Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan-DV) in Healthy Adults 18 to 50 Years of Age in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-02-02
Enrollment: 1364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate that V181 is safe and well tolerated and elicits an immune response that is non-inferior to that of Butantan-DV at Day 28 post-vaccination in adults 18 to 50 years of age in Brazil. The primary hypothesis is that V181 is non-inferior to Butantan-DV for each of the 4 dengue serotypes based on geometric mean titers (GMTs) and seroconversion rates at Day 28 post-vaccination.


Eligibility criteria: Inclusion Criteria:

* Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention:

  * Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or
  * must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

  * Is NOT women of child-bearing potential (WOCBP); or
  * is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or
  * is abstinent from heterosexual intercourse as her preferred and usual lifestyle (abstinent on a long term and persistent basis), for at least 90 days after administration of study intervention.
  * Have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) before administration of study intervention
* Is dengue seronegative based on a pre-vaccination point of care (POC) dengue test.

Exclusion Criteria:

* Has a known history of dengue or Zika natural infection.
* Has an acute febrile illness (axillary temperature ≥37.8°C) occurring within 72 hours prior to receipt of study vaccine.
* Has a known hypersensitivity or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) to any component of the dengue vaccine, that required medical intervention.
* Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, systemic autoimmune or neurologic disorder.
* Has known or suspected impairment of immunological function, including but not limited to congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, hematologic malignancy, or treatment for autoimmune diseases.
* Has a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access
* Has received a dose of any dengue vaccine (investigational or approved) prior to study entry or plans to receive any dengue vaccine (investigational or approved) for trial duration.
* Has received a licensed non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed non-live vaccine within 28 days following receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered, but must be given at least 7 days before receipt of study vaccine or at least 28 days after receipt of study vaccine.
* Has received a licensed live vaccine within 28 days prior to receipt of study vaccine or is scheduled to receive any live vaccine within 28 days following receipt of study vaccine.
* Has received systemic corticosteroids (equivalent of ≥2 mg/kg/day of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days before study entry or is expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days following receipt of study vaccine. (Note: topical and inhaled/nebulized steroids are permitted.)
* Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
* Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, within 6 months prior to receipt of study vaccine, or plans to receive immunosuppressive therapies within 28 days following receipt of study vaccine.
* Has received a blood transfusion or blood products (including immunoglobulins) within 6 months prior to receipt of study vaccine or plans to receive a blood transfusion or blood products (including immunoglobulins) within 28 days following receipt of study vaccine.
* Has planned donation of blood, eggs, or sperm at any time from signing the informed consent through 90 days post-vaccination.

Primary outcomes:
measure: Dengue virus (DENV)-neutralizing antibody titers as measured by virus reduction neutralization test (VRNT)
timeFrame: Day 28 post-vaccination
measure: Percentage of participants who seroconvert, as measured by VRNT
timeFrame: Day 28 post-vaccination
measure: Percentage of participants who experience vaccine-related serious adverse events (SAEs)
timeFrame: Up to 28 days post-vaccination
Secondary outcomes:
measure: Percentage of participants who experience solicited injection-site adverse events (AEs)
timeFrame: Up to 5 days post-vaccination
measure: Percentage of participants who experience solicited systemic AEs
timeFrame: Up to 28 days post-vaccination
Other outcomes:
Locations:
city: Bento Gonçalves
country: Brazil
facility: Hospital Tacchini (Site 0006)
state: Rio Grande Do Sul
city: Caxias do Sul
country: Brazil
facility: Fundação Universidade de Caxias do Sul (FUCS) - Instituto de Pesquisas em Saúde (IPS) (Site 0017)
state: Rio Grande Do Sul
city: Ijuí
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia (Site 0005)
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo-Education and Research Management (Site 0007)
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde (0020)
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Hospital Escola da Universidade Federal de Pelotas (Site 0009)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa em Infectologia (Site # 003)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul (Site 0011)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S-Reumacenter (Site 0004)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento - Centro de Pesquisa Clínica (Site0021)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS-Centro de Pesquisa Clínica HSL-PUCRS (Site 0015)
state: Rio Grande Do Sul
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria (UFSM) - Hospital Univer-Unidade de Pesquisa Clínica-UPC (Site 0001)
state: Rio Grande Do Sul
city: Chapecó
country: Brazil
facility: Clínica Supera (Site 0019)
state: Santa Catarina
city: Passo Fundo
country: Brazil
facility: Criciuma (Site 0008)
state: Santa Catarina
Study officials:
References: