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Virus Vaccine

V181 Vaccine for Dengue Fever

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28 post-vaccination
Awards & highlights

Study Summary

This trial is testing a low and mid potency vaccine for Dengue virus. The primary hypothesis is that the low potency vaccine is non-inferior to the mid potency vaccine.

Who is the study for?
Adults eligible for this trial must not be pregnant, breastfeeding, or planning to donate blood or sperm. They should agree to use contraception or abstain from heterosexual intercourse for 90 days post-vaccination. Exclusions include recent receipt of other vaccines, immunosuppressive therapies, blood transfusions, participation in another clinical study within the last 6 months, known immune system impairments like HIV, severe allergies to vaccine components, prior dengue vaccination or infection.Check my eligibility
What is being tested?
The trial is testing three different potency levels of a dengue vaccine (V181) against a placebo. It aims to compare the body's antibody response at day 28 after vaccination among these varying potencies and assess their safety and tolerability.See study design
What are the potential side effects?
While specific side effects are not listed here, common reactions may include pain at injection site, feverish symptoms similar to mild flu-like illness; allergic reactions could occur but are typically rare.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 post-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Secondary outcome measures
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Percentage of Participants With Solicited Systemic AEs

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: V181 Mid-Potency Level GroupExperimental Treatment1 Intervention
Participants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine.
Group II: V181 Low-Potency Level GroupExperimental Treatment1 Intervention
Participants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine.
Group III: V181 High-Potency Level GroupExperimental Treatment1 Intervention
Participants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive a single SC 0.5 mL dose of placebo.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,429 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,060,929 Total Patients Enrolled
22 Trials studying Dengue Fever
73,534 Patients Enrolled for Dengue Fever

Media Library

V181 High-Potency Level (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05507450 — Phase 2
Dengue Fever Research Study Groups: V181 Mid-Potency Level Group, V181 Low-Potency Level Group, V181 High-Potency Level Group, Placebo
Dengue Fever Clinical Trial 2023: V181 High-Potency Level Highlights & Side Effects. Trial Name: NCT05507450 — Phase 2
V181 High-Potency Level (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507450 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria that disqualify me from participating in this investigation?

"This clinical trial is targeting 1265 individuals between the ages of 18-50 that have been infected with dengue virus. Notably, males must either agree to abstain from heterosexual intercourse for 90 days or use contraception unless they are azoospermic. Females can only participate if not pregnant/breastfeeding and adhere to one of the following criteria: be non-childbearing potential (WOCBP); use highly effective contraception; or remain abstinent from sexual activity for 3 months post study intervention in accordance with local regulations."

Answered by AI

Does administering V181 Low-Potency Level pose any risks to patient safety?

"With Phase 2 trials backing its safety record, V181 Low-Potency Level was assessed as a ‘2’ on our organization’s 1 to 3 scale. Though evidence of efficacy is lacking at this stage, the drug's security has been established."

Answered by AI

Are there any vacancies left in this clinical investigation?

"Affirmative. Information furnished by clinicaltrials.gov confirms that the medical trial, which began on September 7th 2022, is actively seeking candidates. A total of 1265 participants need to be recruited from 10 different sites."

Answered by AI

What is the participant size of this clinical trial?

"To complete this clinical trial, 1265 patients conforming to the eligibility requirements must partake. The research is conducted at multiple locations including Diex Recherche Quebec Inc. ( Site 0022) in Quebec and Diex Recherche Joliette (Site 0023) in Saint-Charles-Borromée, California."

Answered by AI

Are there numerous locations in Canada conducting this research?

"Participants have the opportunity to join this trial at Diex Recherche Quebec Inc. ( Site 0022) in Quebec, Diex Recherche Joliette ( Site 0023) in Saint-Charles-Borromée, and Diex Recherche Victoriavile Inc. ( Site 0021) in Victoriaville as well as an additional 10 medical sites."

Answered by AI

Is the patient pool for this trial limited to individuals aged 25 or younger?

"This research is open to individuals between 18 and 50 years of age."

Answered by AI
~508 spots leftby Mar 2025