Phase 2
Completed N=1,364
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
Source: ClinicalTrials.gov NCT05710224 ↗
Enrolled (actual)
1,364
Serious AEs
1.6%
Results posted
Nov 2025
Primary outcomePrimary: Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) — 608.55; 703.19; 773.96; 109.05 Titer — p=<0.001
Summary
The purpose of this study was 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 was 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) |
608.55; 703.19; 773.96; 109.05; 179.97; 396.76 | <0.001 sig |
| PRIMARY Percentage of Participants Who Seroconverted, as Measured by VRNT |
98.6; 98.9; 99.2; 84.2; 95.3; 98.9 | <0.001 sig |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs) |
10.3; 6.0; 17.6; 17.8; 2.8; 2.2 | — |
| SECONDARY Percentage of Participants Who Experience Solicited Systemic AEs |
21.0; 22.1; 44.6; 46.8; 64.6; 67.7 | — |
Eligibility Criteria
Inclusion Criteria
- Male participants were eligible to participate if they agreed to the following for at least 90 days after administration of study intervention:
- Abstained from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agreed to remain abstinent; or agreed to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
- A female participant was eligible to participate if she was not pregnant or breastfeeding, and at least one of the following conditions applies:
- was NOT a woman of child-bearing potential (WOCBP); or
- was a WOCBP and using a contraceptive a highly effective method (with a failure rate of 10 kg) for ≥14 consecutive days and had not completed treatment at least 30 days before study entry or was expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days following receipt of study vaccine. (Note: topical and inhaled/nebulized steroids were permitted.)
- Had received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
- Had 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.
- Had 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.
- Had planned donation of blood, eggs, or sperm at any time from signing the informed consent through 90 days post-vaccination.
Data sourced from ClinicalTrials.gov (NCT05710224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.