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)

Dengue Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05710224
• Other study ID #: V181-002
• Secondary ID: 25351.019896/202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 15, 2023
• Est. completion date: November 29, 2024

Study information

• Verified date: February 2024
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1364
• Est. completion date: November 29, 2024
• Est. primary completion date: January 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dengue

Intervention

Biological:
• V181
0.5 mL SC dose of V181
• Butantan-DV
0.5 mL SC dose of Butantan-DV

Locations

Country	Name	City	State
Brazil	Hospital Tacchini (Site 0006)	Bento Gonçalves	Rio Grande Do Sul
Brazil	Fundação Universidade de Caxias do Sul (FUCS) - Instituto de Pesquisas em Saúde (IPS) (Site 0017)	Caxias do Sul	Rio Grande Do Sul
Brazil	Clínica Supera (Site 0019)	Chapecó	Santa Catarina
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia (Site 0005)	Ijuí	Rio Grande Do Sul
Brazil	Criciuma (Site 0008)	Passo Fundo	Santa Catarina
Brazil	Hospital São Vicente de Paulo-Education and Research Management (Site 0007)	Passo Fundo	Rio Grande Do Sul
Brazil	Instituto Méderi de Pesquisa e Saúde (0020)	Passo Fundo	Rio Grande Do Sul
Brazil	Hospital Escola da Universidade Federal de Pelotas (Site 0009)	Pelotas	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento - Centro de Pesquisa Clínica (Site0021)	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital São Lucas da PUCRS-Centro de Pesquisa Clínica HSL-PUCRS (Site 0015)	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa em Infectologia (Site # 003)	Porto Alegre	Rio Grande Do Sul
Brazil	LMK Serviços Médicos S/S-Reumacenter (Site 0004)	Porto Alegre	Rio Grande Do Sul
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul (Site 0011)	Porto Alegre	Rio Grande Do Sul
Brazil	Universidade Federal de Santa Maria (UFSM) - Hospital Univer-Unidade de Pesquisa Clínica-UPC (Site 0001)	Santa Maria	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Butantan Institute	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dengue virus-neutralizing antibody titers as measured by virus reduction neutralization test (VRNT)	Dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) as assessed by VRNT will be reported.	Day 28 post-vaccination
Primary	Percentage of participants who seroconvert, as measured by VRNT	Seroconversion rates for each of the 4 dengue serotypes (DENV1, DENV2, DENV3 and DENV4) as assessed by VRNT will be reported.	Day 28 post-vaccination
Primary	Percentage of participants who experience vaccine-related serious adverse events (SAEs)	The safety and tolerability of V181 and Butantan-DV with respect to the percentage of participants experiencing vaccine-related serious adverse events (SAEs) will be reported.	Up to 28 days post-vaccination
Secondary	Percentage of participants who experience solicited injection-site adverse events (AEs)	The safety and tolerability of V181 and Butantan-DV with respect to the percentage of participants experiencing solicited injection-site AEs, including injection site pain, erythema and swelling will be reported.	Up to 5 days post-vaccination
Secondary	Percentage of participants who experience solicited systemic AEs	The safety and tolerability of V181 and Butantan-DV with respect to the percentage of participants experiencing solicited systemic AEs, including rash, headache, fatigue (tiredness), myalgia (muscle pain) and arthralgia (joint pain) will be reported	Up to 28 days post-vaccination