Phase 2
Completed N=1,271
Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
Dengue Disease · Dengue
Source: ClinicalTrials.gov NCT05507450 ↗
Enrolled (actual)
1,271
Serious AEs
2.8%
Results posted
May 2025
Primary outcomePrimary: Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) — 326.31; 261.10; 184.85; 10.33 Titer
Summary
The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) |
326.31; 261.10; 184.85; 10.33; 815.79; 766.98 | — |
| PRIMARY Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) |
35.5; 21.7; 15.0; 1.7; 34.2; 19.7 | — |
| SECONDARY Percentage of Participants With Solicited Systemic AEs |
52.8; 48.6; 44.0; 33.9; 10.8; 7.6 | — |
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; or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of 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 or placebo. (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 before receipt of study vaccine or placebo, or plans to receive immunosuppressive therapies within 28 days following receipt of study vaccine or placebo.
- Has received a blood transfusion or blood products (including immunoglobulins) within 6 months before receipt of a study vaccine or placebo, or plans to receive a blood transfusion or blood products (including immunoglobulins) within 28 days following receipt of study vaccine or placebo.
- Has participated in another clinical study of an investigational product within 6 months before signing the informed consent, or plans to participate in another interventional clinical study at any time during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor.
- Has 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 (NCT05507450). 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.