Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NIH-Developed Candidate Dengue Vaccine Shows Promise in Early-Stage Trial

Published: Monday, April 29, 2013
Last Updated: Monday, April 29, 2013
Bookmark and Share
The trial results appeared in the April 1 issue of the Journal of Infectious Diseases.

A candidate dengue vaccine developed by scientists at the National Institutes of Health has been found to be safe and to stimulate a strong immune response in most vaccine recipients, according to results from an early-stage clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

Dengue fever, prevalent in many tropical and subtropical regions of the world, is caused by any of four related viruses - DENV-1, DENV-2, DENV-3 and DENV-4 - that are transmitted to humans by Aedes mosquitoes.

The World Health Organization estimates that every year, 50 million to 100 million cases of dengue occur worldwide, resulting in 500,000 hospitalizations of patients with severe disease, many of them in children.

Infection with one dengue virus results in immunity to that specific virus but not to the other three. Research shows that the likelihood of severe disease increases when a person is subsequently infected with a different dengue virus.

This observation suggests that the ideal dengue vaccine would be tetravalent - that is, protective against all four dengue viruses.

"The global burden of dengue is enormous - and it is growing," said NIAID director Anthony S. Fauci, M.D. "We are cautiously optimistic about these recent clinical trial results with this candidate tetravalent vaccine developed at NIAID; however, much more work still needs to be done."

The Phase I clinical trial (http://clinicaltrials.gov/ct2/show/NCT01072786), launched in July 2010 and led by principal investigator Anna Durbin, M.D., at Johns Hopkins Bloomberg School of Public Health in Baltimore, tested a single dose of each of four versions of the investigational dengue vaccine TetraVax-DV.

The vaccine was developed by scientists in NIAID's Laboratory of Infectious Diseases. It is a live-attenuated vaccine, which means that the viruses it contains are weakened enough such that they do not cause illness but still can induce an immune response. Each of the four vaccines tested included different mixtures of components designed to protect against all four dengue viruses.

The Phase I study was conducted in Baltimore; Burlington, Vt.; and Washington, D.C. The final study analysis included 112 healthy men and women ages 18 to 50 years who had not previously been exposed to dengue or related viruses such as West Nile virus and yellow fever virus.

Participants were randomized into four groups. In each group, 20 volunteers received a single 0.5-milliliter subcutaneous (under the skin) injection of one of the tetravalent candidate vaccine combinations, and eight others received placebo.

All were monitored for immediate adverse reactions for at least 30 minutes after vaccination, and subsequently took their body temperatures three times daily for 16 days to check for possible adverse reactions.

Participants also received a physical exam every other day up to Study Day 16, and then again on study days 21, 28, 42 and 180, when blood tests were also performed.

The researchers found that all four candidate vaccine combinations induced antibody responses against each of the dengue viruses. However, one vaccine combination, TV003, appeared to induce the most balanced antibody response against the dengue viruses.

A single dose of TV003 resulted in an antibody response to all four dengue viruses in 45 percent of participants and against three of the four viruses in an additional 45 percent. Overall, an immune response to at least three viruses was seen in 90 percent of vaccinees given TV003.

"What is promising about TV003 is that it elicited solid antibody responses after just one dose," explained Stephen Whitehead, Ph.D., of NIAID's Laboratory of Infectious Diseases, who led the development of the vaccine candidates. "Other vaccines in development require two or three injections at higher doses to achieve similar results."

All four candidate tetravalent vaccines were found to be safe, and no participants experienced fever or dengue-like illness after vaccination. The most common side effect was a faint rash (in 64 percent of vaccinees and none of the placebo recipients) consisting of small, non-painful bumps on the arms and torso that resolved within five to seven days.

The presence of the rash appeared to correlate with being white and having a stronger immune response to vaccination, according to the researchers. Ninety percent of white vaccinees experienced a vaccine-related rash while only 35 percent of African-American vaccinees developed a rash.

Further, 97 percent of white vaccine recipients (42 of 43) developed antibodies to at least three of the dengue viruses, compared with 60 percent of African-American vaccine recipients (22 of 37). It is unclear what caused this difference, but previous studies of severe dengue outbreaks in Brazil, Cuba and Haiti suggest that black people may have some inherent protection from dengue infection.

Alternatively, unknown factors may have resulted in a weaker antibody response to the vaccine among African-American participants. Additional research to evaluate racial differences in dengue infection and antibody response rates to dengue vaccines is needed, the authors wrote.

"The results of this Phase I dengue vaccine study look very promising, and NIAID scientists and their partners are pursuing further development of TV003," said Kathryn Zoon, Ph.D., director of NIAID's Division of Intramural Research.

The researchers are conducting studies to further evaluate the vaccine's safety and ability to stimulate an immune response in healthy volunteers (http://www.clinicaltrials.gov/ct2/show/NCT01436422) and in people who have been infected previously (http://www.clinicaltrials.gov/ct2/show/NCT01506570) by dengue or related viruses.

TV003's inexpensive production cost - less than $1 per dose - is critical to its potential use in developing countries, noted Dr. Whitehead. Manufacturers in Brazil, India and Vietnam - countries where dengue is prevalent - have licensed the vaccine technology for production and further evaluation. Phase II trials to evaluate the safety of TV003 (http://www.clinicaltrials.gov/ct2/show/NCT01696422) and its capacity to create an immune response will begin soon in Brazil and Thailand.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More Than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Natural Protein Points to New Inflammation Treatment
Findings may offer insight to effective treatments for inflammatory diseases, such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
Friday, February 05, 2016
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Thursday, February 04, 2016
Genome-Wide Study Yields Markers of Lithium Response
An international consortium of scientists has identified a stretch of chromosome that is associated with responsiveness to the mood-stabilizing medication lithium among patients with bipolar disorder.
Monday, February 01, 2016
Schizophrenia’s Strongest Known Genetic Risk Deconstructed
Suspect gene may trigger runaway synaptic pruning during adolescence – NIH-funded study.
Thursday, January 28, 2016
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
Monday, January 25, 2016
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Friday, January 15, 2016
NIH Genome Sequencing Program Targets the Genomic Bases of Common, Rare Disease
The National Institutes of Health will fund a set of genome sequencing and analysis centers whose research will focus on understanding the genomic bases of common and rare human diseases.
Friday, January 15, 2016
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
Wednesday, January 13, 2016
Three Glaucoma-Related Genes Discovered
NIH-funded genetics analysis of glaucoma is largest to date.
Tuesday, January 12, 2016
NIH-funded Memory Drug Moves into Phase 1 Clinical Study
Collaboration between NIH and Tetra Discovery Partners leads to development of treatment that may affect cognition.
Monday, January 04, 2016
International Study Reveals New Genetic Clues to AMD
NIH-funded research provides framework for future studies of AMD biology, therapy.
Tuesday, December 22, 2015
NIH Unveils FY2016–2020 Strategic Plan
Detailed plan sets course for advancing scientific discoveries and human health.
Thursday, December 17, 2015
Biomarkers Outperform Symptoms in Parsing Psychosis Subgroups
Multiple biological pathways lead to similar symptoms - NIH-funded study.
Thursday, December 10, 2015
Researchers Investigate How a Developing Brain is Assembled
NIH 3-D software tracks worm embryo's brain development.
Tuesday, December 08, 2015
NIH Supports New Studies to Find Alzheimer’s Biomarkers in Down Syndrome
Initiative will track dementia onset, progress in Down syndrome volunteers.
Tuesday, December 01, 2015
Scientific News
Natural Protein Points to New Inflammation Treatment
Findings may offer insight to effective treatments for inflammatory diseases, such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
Genetic Cause of Rare Allergy
Institute has identified a genetic mutation responsible for a rare form of inherited hives induced by vibratory urticaria.
Battery Component Found to Harm Key Soil Microorganism
The material at the heart of the lithium ion batteries that power electric vehicles, laptop computers and smartphones has been shown to impair a key soil bacterium, according to new research.
Keeping Tumor Growth at Bay
Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Natural Protein Points to New Inflammation Treatment
Findings may offer insight to effective treatments for inflammatory diseases, such as rheumatoid arthritis, psoriasis, and multiple sclerosis.
Mitochondria Shown to Trigger Cell Ageing
An international team of scientists has for the first time shown that mitochondria, the batteries of the cells, are essential for ageing.
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Validating the Accuracy of CRISPR-Cas9
IBS Researchers create multiplex Digenome-seq to find errors in CRISPR-Cas9 processes.
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Genetic Mechanism Behind Cancer-Causing Mutations
Researchers at Indiana University has identified a genetic mechanism that is likely to drive mutations that can lead to cancer.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!