V181 Vaccine for Dengue Fever

Recruiting at 32 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Systemic corticosteroids, Immunosuppressive therapies

Disqualifiers: Dengue or zika history, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1271 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the V181 treatment for dengue fever?

The V181 vaccine, a live-attenuated quadrivalent dengue vaccine, showed promising results in a study where it was well-tolerated and induced strong immune responses in participants, with high levels of antibodies against all four dengue virus serotypes. This suggests that V181 could be effective in preventing dengue disease. ^{1 2 3 4 5}

Is the V181 vaccine for dengue fever safe for humans?

The V181 vaccine for dengue fever has been tested in humans and is generally well-tolerated, with common side effects like headache, rash, fatigue, and muscle pain. No serious vaccine-related adverse events were reported in the studies. ^{2 3 6 7 8}

How is the V181 vaccine for dengue fever different from other treatments?

The V181 vaccine is unique because it is a live, attenuated (weakened) quadrivalent vaccine designed to protect against all four types of dengue virus with a single dose, which is different from other vaccines that may require multiple doses or use different formulations. ^{2 3 7 9 10}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

I am a male and will not have heterosexual intercourse or will use contraception for 90 days after treatment, unless I am sterile.

I am not pregnant or breastfeeding and will follow the study's birth control requirements.

Exclusion Criteria

Participation in another clinical study of an investigational product within specified timeframes

I have not taken immunosuppressive drugs recently.

Known or suspected impairment of immunological function

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single 0.5mL SC dose of V181 vaccine or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• V181 High-Potency Level
• V181 Low-Potency Level
• V181 Mid-Potency Level

Trial Overview 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.

Participant Groups

Group I: V181 Mid-Potency Level Group Experimental Treatment 1 Intervention

Participants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine.

Group II: V181 Low-Potency Level Group Experimental Treatment 1 Intervention

Participants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine.

Group III: V181 High-Potency Level Group Experimental Treatment 1 Intervention

Participants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive a single SC 0.5 mL dose of placebo.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

References

1. England pubmed.ncbi.nlm.nih.gov

A Tetravalent Sub-unit Dengue Vaccine Formulated with Ionizable Cationic Lipid Nanoparticle induces Significant Immune Responses in Rodents and Non-Human Primates. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naïve adults. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A phase I randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a live-attenuated quadrivalent dengue vaccine in flavivirus-naïve and flavivirus-experienced healthy adults. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Phase 1 Randomized Study of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults in the United States. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccination With a Single Consensus Envelope Protein Ectodomain Sequence Administered in a Heterologous Regimen Induces Tetravalent Immune Responses and Protection Against Dengue Viruses in Mice. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term safety assessment of live attenuated tetravalent dengue vaccines: deliberations from a WHO technical consultation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. [2022]

8. Malaysia pubmed.ncbi.nlm.nih.gov

Descriptive Review of Safety, Reactogenicity and Immunogenicity of Dengue Vaccine Clinical Trials, 2003 - 2013. [2019]

9. Thailand pubmed.ncbi.nlm.nih.gov

DENGUE VACCINES. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Prospects for a dengue virus vaccine. [2015]