What side effects are associated with this type of intervention?

The most common side effects of treatments for Dengue Fever, particularly vaccines like the V181 that induce immune responses by generating neutralizing antibodies, include local injection site reactions such as pain, erythema, and swelling. Systemic side effects may include fever, headache, fatigue, and muscle pain. These side effects are generally mild to moderate in severity and resolve on their own. Serious adverse effects are rare but can include severe allergic reactions.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Dengue Fever that work by inducing an immune response through the generation of neutralizing antibodies. The V181 vaccine, which is currently under study, aims to achieve this by generating neutralizing antibodies against all four dengue virus serotypes. Other treatments for Dengue Fever primarily focus on supportive care, such as hydration and pain relief, rather than targeting the virus directly.

What other types of research exist?

Promising alternatives to the V181 vaccine for Dengue Fever include the Dengvaxia (CYD-TDV) vaccine, which is already approved in several countries and targets all four dengue serotypes. Additionally, the TAK-003 (Dengue Tetravalent Vaccine) by Takeda has shown positive results in phase 3 trials, demonstrating efficacy against all four dengue serotypes. Another potential alternative is the TV003/TV005 vaccine developed by the National Institutes of Health (NIH), which has shown strong immunogenicity and safety profiles in clinical trials. These alternatives offer diverse approaches to inducing immunity against dengue virus and are worth considering for treatment in 2024.

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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

Summary

This trial is testing different strengths of a new dengue vaccine on people to see if a lower strength works as well as a medium strength by measuring the body's defense response.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28 post-vaccination

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)

Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)

Secondary study objectives

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

V181 Mid-Potency Level

2022

Completed Phase 2

~1280

V181 High-Potency Level

2022

Completed Phase 2

~1280

V181 Low-Potency Level

2022

Completed Phase 2

~1280

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Dengue Fever, such as the V181 vaccine, work by inducing the body's immune system to produce neutralizing antibodies against the dengue virus. These antibodies target and neutralize the virus, preventing it from infecting cells and replicating. This mechanism is crucial for Dengue Fever patients as it helps to reduce the severity of the infection, lowers the risk of complications, and can potentially prevent future infections by providing immunity against the virus. By enhancing the immune response, these treatments aim to control the spread of the virus within the body and improve patient outcomes.