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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)

Primary Purpose

Dengue

Status
Active
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
V181
Butantan-DV
Sponsored by
Butantan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

V181

Butantan-DV

Arm Description

Participants will receive a single 0.5 mL subcutaneous (SC) injection of V181 on Day 1.

Participants will receive a single 0.5 mL SC injection of Butantan-DV on Day 1.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
January 24, 2023
Last Updated
August 31, 2023
Sponsor
Butantan Institute
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05710224
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
August 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butantan Institute
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
V181
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL subcutaneous (SC) injection of V181 on Day 1.
Arm Title
Butantan-DV
Arm Type
Experimental
Arm Description
Participants will receive a single 0.5 mL SC injection of Butantan-DV on Day 1.
Intervention Type
Biological
Intervention Name(s)
V181
Intervention Description
0.5 mL SC dose of V181
Intervention Type
Biological
Intervention Name(s)
Butantan-DV
Intervention Description
0.5 mL SC dose of Butantan-DV
Primary Outcome Measure Information:
Title
Dengue virus-neutralizing antibody titers as measured by virus reduction neutralization test (VRNT)
Description
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.
Time Frame
Day 28 post-vaccination
Title
Percentage of participants who seroconvert, as measured by VRNT
Description
Seroconversion rates for each of the 4 dengue serotypes (DENV1, DENV2, DENV3 and DENV4) as assessed by VRNT will be reported.
Time Frame
Day 28 post-vaccination
Title
Percentage of participants who experience vaccine-related serious adverse events (SAEs)
Description
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.
Time Frame
Up to 28 days post-vaccination
Secondary Outcome Measure Information:
Title
Percentage of participants who experience solicited injection-site adverse events (AEs)
Description
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.
Time Frame
Up to 5 days post-vaccination
Title
Percentage of participants who experience solicited systemic AEs
Description
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
Time Frame
Up to 28 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Hospital Tacchini (Site 0006)
City
Bento Gonçalves
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95700084
Country
Brazil
Facility Name
Fundação Universidade de Caxias do Sul (FUCS) - Instituto de Pesquisas em Saúde (IPS) (Site 0017)
City
Caxias do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95070560
Country
Brazil
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia (Site 0005)
City
Ijuí
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital São Vicente de Paulo-Education and Research Management (Site 0007)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Instituto Méderi de Pesquisa e Saúde (0020)
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-120
Country
Brazil
Facility Name
Hospital Escola da Universidade Federal de Pelotas (Site 0009)
City
Pelotas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96020-360
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa em Infectologia (Site # 003)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Núcleo de Pesquisa Clínica do Rio Grande do Sul (Site 0011)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
9043-0001
Country
Brazil
Facility Name
LMK Serviços Médicos S/S-Reumacenter (Site 0004)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Hospital Moinhos de Vento - Centro de Pesquisa Clínica (Site0021)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS-Centro de Pesquisa Clínica HSL-PUCRS (Site 0015)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Universidade Federal de Santa Maria (UFSM) - Hospital Univer-Unidade de Pesquisa Clínica-UPC (Site 0001)
City
Santa Maria
State/Province
Rio Grande Do Sul
ZIP/Postal Code
97105-900
Country
Brazil
Facility Name
Clínica Supera (Site 0019)
City
Chapecó
State/Province
Santa Catarina
ZIP/Postal Code
89812-211
Country
Brazil
Facility Name
Criciuma (Site 0008)
City
Passo Fundo
State/Province
Santa Catarina
ZIP/Postal Code
88811508
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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)

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