Skip to main content
  • U.S. Department of Health & Human Services
National Institutes of Health (NIH) - Turning Discovery into Health
  • NIH Employee Intranet
  • Staff Directory
  • En Español

Site Menu

  • Home
  • Health Information
    • Health Info Lines
    • Find Health Services
    • HealthCare.gov
    • NIH Clinical Research Trials and You
    • Talking to Your Doctor
    • Science Education Resources
    • Community Resources
    • Clear Health A–Z
    • Publications List

    More »

    Quick Links

    • MedlinePlus Health Info
    • NIH News in Health
    • Wellness Toolkits
  • Grants & Funding
    • Grants Home Page
    • Find Funding
    • Due Dates
    • How to Apply
    • About Grants
    • Policy & Compliance
    • Grants News/Blog
    • Contracts
    • Loan Repayment

    More »

    Quick Links

    • RePORT
    • eRA Commons
    • NIH Common Fund
  • News & Events
    • News Releases
    • Digital Media Kits
    • Media Resources
    • Media Contacts
    • Images and B-roll
    • Events
    • Social Media

    More »

    Quick Links

    • NIH News in Health
    • NIH Research Matters
    • NIH Record
  • Research & Training
    • Medical Research Initiatives
    • Science Highlights
    • Science Education
    • Research in NIH Labs & Clinics
    • Training Opportunities
    • Library Resources
    • Research Resources
    • Clinical Research Resources
    • Safety, Regulation and Guidance

    More »

    Quick Links

    • PubMed
    • Stem Cell Information
    • OppNet
    • NIDB
    • NIH Blueprint for Neuroscience Research
  • Institutes at NIH
    • List of Institutes, Centers & Offices
    • NIH Office of the Director
    • Directors of NIH Institutes and Centers
    • NIH Institute and Center Contact Information

    More »

    Quick Links

    • NCI
    • NEI
    • NHLBI
    • NHGRI
    • NIA
    • NIAAA
    • NIAID
    • NIAMS
    • NIBIB
    • NICHD
    • NIDCD
    • NIDCR
    • NIDDK
    • NIDA
    • NIEHS
    • NIGMS
    • NIMH
    • NIMHD
    • NINDS
    • NINR
    • NLM
    • CC
    • CIT
    • CSR
    • FIC
    • NCATS
    • NCCIH
    • OD
  • About NIH
    • Who We Are
    • What We Do
    • Jobs at NIH
    • Visitor Information
    • Frequently Asked Questions
    • Contact Us

    More »

    Quick Links

    • The NIH Director
    • The NIH Almanac
    • NIH…Turning Discovery Into Health®
    • Impact of NIH Research
    • Science, Health, and Public Trust

 COVID-19 is an emerging, rapidly evolving situation.

  • Get the latest public health information from CDC »
  • Get the latest research information from NIH »
  • NIH staff guidance on coronavirus (NIH Only) »

You are here

Home » News & Events » News Releases

News Releases

News Release

Thursday, January 14, 2016

Dengue vaccine enters phase 3 trial in Brazil

Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.

Photo of female A. aegypti mosquito after blood meal.

A large-scale clinical trial to evaluate whether a candidate vaccine can prevent the mosquito-borne illness dengue fever has been launched in Brazil. The vaccine, TV003, was developed by scientists in the laboratory of Stephen Whitehead, Ph.D., at NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The Butantan Institute, a non-profit producer of immunobiologic products for Brazil, licensed the NIAID dengue vaccine technology and is sponsoring the placebo-controlled, multi-center Phase 3 trial using test vaccine produced in Sao Paulo.

Dengue fever is common in many parts of the tropics and subtropics and about half the world’s population is at risk of infection. The World Health Organization estimates that up to 400 million dengue infections occur annually, resulting in 500,000 hospitalizations. More than 1.5 million cases of dengue were reported in Brazil in 2015.

Dengue is caused by any of four related viruses, termed serotypes DEN-1, DEN-2, DEN-3 and DEN-4, which are transmitted to people by Aedes aegypti mosquitoes. A person exposed to one dengue virus type gains immunity to that type, but not to the other three. In fact, a second infection with a virus type that differs from the first can lead to a more severe course of disease.

“Researchers in NIAID’s Laboratory of Infectious Diseases spent many years developing and testing dengue vaccine candidates designed to elicit antibodies against all four dengue virus serotypes,” said NIAID Director Anthony S. Fauci, M.D. “Earlier clinical trials of this candidate conducted in the United States by NIAID showed that it could elicit a robust antibody and cellular immune response after just one dose,” he added. “Because the impact of dengue fever in Brazil is especially large and the country has an excellent health infrastructure, it is an ideal location to test the vaccine candidate.” 

The new trial aims to enroll almost 17,000 healthy people aged 2 to 59 years in 13 cities, beginning in Sao Paulo. Two-thirds of the volunteers will receive a single dose of the candidate vaccine, while one-third will receive an inactive placebo injection. Neither participants nor study staff will know which of the two groups a volunteer is in. All volunteers will be monitored for five years through a combination of in-person visits to the health clinic and telephone or text communications from the investigators. The goal of the trial is determine if the candidate vaccine prevents dengue fever and to provide additional information about its safety. Although the trial is scheduled to last five years, the investigators hope to have early indications of the potential efficacy of the vaccine in less than two years. The principal investigator is Alexander Precioso, M.D., Ph.D., of the Butantan Institute.

 Additional information about the trial is available at https://clinicaltrials.gov using the identifier NCT02406729. 

Learn more about dengue fever and NIAID’s research projects to treat and prevent it and about the development of TV003 vaccine.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®

###

Institute/Center

National Institute of Allergy and Infectious Diseases (NIAID)

Contact

Anne A. Oplinger
301-402-1663

Connect with Us

  • Subscribe to news releases
  • RSS Feed

Connect with Us

  • Contact Us
  • Twitter
  • Facebook
  • Instagram
  • YouTube
  • Flickr
  • More Social Media from NIH

Footer

  • NIH Home
  • En Español
  • Site Map
  • Visitor Information
  • Frequently Asked Questions
  • Web Policies and Notices
  • Freedom of Information Act
  • No Fear Act
  • Office of Inspector General
  • USA.gov – Government Made Easy

NIH…Turning Discovery Into Health®

National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892

U.S. Department of Health and Human Services

Back to Top