V181 Vaccine for Dengue Fever
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine, V181, designed to protect against dengue fever, which is caused by four different virus types. The study compares three strength levels of the vaccine to determine which is most effective and monitors for side effects. Participants will receive one of these vaccines or a placebo, an inactive substance used for comparison. Ideal candidates have never had dengue or Zika infections and do not have serious diseases or medical conditions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important advancements in dengue prevention.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or immunosuppressive therapies, you may need to stop them before joining the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the V181 vaccine for dengue is safe. Studies found that participants generally tolerated all strength levels of this vaccine well. Most people experienced only mild side effects, such as soreness at the injection site or a mild fever, which are common with vaccines. No serious side effects were linked to the vaccine.
The V181 vaccine has been tested in low, medium, and high strengths. Across these versions, safety results remained consistent, with no major safety concerns reported. This is encouraging for those considering participation in trials for this vaccine.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the V181 vaccine for dengue fever because it offers a potentially groundbreaking approach to preventing the disease. Unlike existing vaccines, V181 is being tested in different potency levels—low, mid, and high—to optimize immune response and safety. This tailored approach could lead to a more effective vaccine that's adaptable to various populations and individual needs. Additionally, the V181 vaccine is administered as a single subcutaneous dose, which could simplify logistics and improve accessibility compared to multi-dose regimens of current treatments. By exploring these different potencies, researchers aim to develop a versatile and robust vaccine solution against dengue fever.
What evidence suggests that this trial's treatments could be effective for dengue fever?
Research has shown that the V181 vaccine for dengue fever looks promising. As a live-attenuated vaccine, it uses a weakened form of the virus and targets all four types of the dengue virus. Previous tests found that it was well-tolerated and generated strong immune responses. The vaccine's ability to combat the virus matched or exceeded that of earlier versions. In this trial, participants will receive one of three potency levels of the V181 vaccine or a placebo. Overall, early tests suggest that V181 could effectively prevent dengue infections.13456
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single 0.5mL SC dose of V181 vaccine or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- V181 High-Potency Level
- V181 Low-Potency Level
- V181 Mid-Potency Level
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University