The assay will be validated against clinical outcomes in
human vaccine studies (correlates of protection such as neutralising antibodies or vaccine - induced protection in human challenge models, or exploratory correlates such as multifunctional Th1 cells).
Thus, this study has implications for analysis of
human vaccine studies, as in addition to searching for defined lineages it is worthwhile to perform functional analysis of monoclonal antibodies that may have found new structural solutions to high affinity binding which can not be discerned from DNA sequence alone.
Not exact matches
«
Study offers new recommendations for TB
vaccine testing in
humans.»
Yet there is reason for optimism: the NIH has already developed a DNA
vaccine against the West Nile virus that appeared promising in early
human studies (although ultimately the NIH could not find a commercial partner to take that
vaccine forward).
«We have followed a less potent neutralizing lineage in this particular individual before, but now we have found a far more potent antibody and have been able to
study its development over six years,» said first author Mattia Bonsignori, M.D., of the Duke
Human Vaccine Institute.
For their research, Pekosz and his team, using
human nasal tract cells,
studied the weakened strain of the flu virus that is used in the nasal spray
vaccine and compared its behavior with that of the flu virus itself.
And scientists who conduct
human challenge
studies, which typically involve a few dozen participants, say they have critical benefits: In addition to saving time and money, they can reveal harm caused by a potential drug or
vaccine before it enters large - scale
human efficacy trials.
According to a
study published in
Human Vaccines & Immunotherapeutics, the Tdap
vaccine is safe for both mothers and infants.
Last year the National Institutes of Health announced plans to put some 180 ex-Coulston chimps currently housed at the Alamogordo Primate Facility back in service, to rejoin the roughly 800 other chimps that serve as subjects for
studies of
human diseases, therapies and
vaccines in the U.S., which is the only country apart from Gabon to maintain chimps for this purpose.
This
study strengthens the argument for focusing on the malaria side of the parasite -
human interaction in our search for new
vaccine candidates.»
Profectus BioSciences in Tarrytown, New York, which is developing a similar
vaccine, needs some $ 2 million to produce it under good manufacturing practice standards, a prerequisite for any
human study.
Ding's next goal is to raise $ 5 million so he can spend about five years
studying new
vaccines for
human pathogens such as dengue fever.
«Given the key similarities to
human infections, a marmoset model of Zika may be useful for testing of new drug and
vaccines,» said Texas Biomedical Research Institute virologist Jean Patterson, Ph.D. «Having an animal model of Zika infection to
study may help us identify places where we might be able to block transmission.»
The multi-author
study, by the Global Alliance for Rabies Control's Partners for Rabies Prevention Group, also shows that annual economic losses because of the disease are around 8.6 billion US dollars, mostly due to premature deaths, but also because of spending on
human vaccines, lost income for victims of animal bites and other costs.
«There are several
vaccines in
human trials right now, but to date, none of them has been shown to protect during pregnancy,» said Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine at Washington University School of Medicine in St. Louis, and the
study's co-senior author.
Guided by findings from
human and monkey
studies, researchers are working to improve upon the efficacy of the RV144
vaccine regimen.
The
study, published Aug. 13, 2014, in the journal Cell Host & Microbe, builds on previous work from researchers at the Duke
Human Vaccine Institute that outlined a perplexing quality about HIV: The antibodies that originally arise to fight the virus are ineffective.
A recent
study in the journal
Human Vaccines & Immunotherapeutics, showed that two doses of the HPV - 16 / 18 AS04 - adjuvanted
vaccine Cervarix (GlaxoSmithKline) are non-inferior to three - doses in the current schedule.
The Walter Reed Army Institute of Research (WRAIR) and collaborators at the Beth Israel Deaconess Medical Center and Harvard Medical School have completed a promising preclinical
study of two Zika
vaccine candidates that suggests that an effective
human vaccine will be achievable.
Due to major advances in their immune potency DNA
vaccines are being
studied in
human clinical trials for treating cancer and infectious diseases.
They have become a valuable resource for biologists, enabling momentous scientific breakthroughs including the development of the polio
vaccine the Nobel Prize winning
studies defining the role of telomerase in aging, and research on the causative role of
human papillomavirus (HPV) in some types of cervical cancer.
The Pilot Bioproduction Facility headed by Dr. Kenneth H. Eckels, produced small batches of
vaccine candidates that were used for the preclinical
studies and is currently manufacturing a
vaccine lot for use in initial
human clinical
studies.
A 2014
study used epidemiological data to show egg - based mutations are associated with low
vaccine effectiveness in
human populations.
The loss was bad for the
vaccine: In a series of experiments Hensley and his colleagues showed antibodies from
humans and ferrets (a good animal model for influenza A
studies) that had been exposed to the egg - grown
vaccine did not effectively kill the circulating sugar - adorned viruses.
When the team injected the
vaccine into the skin of macaque monkeys, the reaction was similar to that in
humans, but when injected into the bloodstream, the
vaccine provided a strong and long - lasting CD8 + response in all three animals
studied.
«This is an important demonstration of the possibilities opened up for immunotherapy by DMAb technology to direct in vivo production of antibodies of major relevance to
human cancer,» said David B. Weiner, Ph.D., executive vice president of The Wistar Institute, director of The Wistar Institute
Vaccine & Immunotherapy Center, W.W. Smith Charitable Trust Professor in Cancer Research, and senior author of the
study.
«You certainly can't do a $ 100 million
study for every candidate
vaccine that appears safe and immunogenic,» says Mark Mulligan, a molecular virologist who heads the
vaccine center at Emory University in Atlanta and does
human challenges with norovirus and tuberculosis.
Forty years ago Levine was one of a tiny cadre of researchers doing so - called
human challenge
studies — intentionally infecting people with V. cholerae and other pathogens to test drugs and
vaccines.
Janssen, a division of Johnson & Johnson, described its plans to speed development of yet another Ebola
vaccine strategy that has yet to enter
human studies.
«In line with our company's commitment to address global health needs, we are committed to working with leading experts to develop a preventative HIV
vaccine and our team is excited to advance this program into
human clinical
studies.»
«Taken together, these two
studies suggest that the new scalable
vaccine formulation is likely to prove as effective as the original formulation — which would make it the first protective TB
vaccine in
humans since BCG, which was introduced almost a century ago,» said Professor Ajit Lalvani, Director of the Tuberculosis Research Centre, National Heart and Lung Institute, Imperial College London and a member of the DAR - 901 development team.
«Investigational
vaccine protects cattle from respiratory syncytial virus:
Study provides model for developing an effective
human RSV
vaccine.»
The version of RSV that naturally infects cattle is closely related to
human RSV, so the results suggest that a similar
human RSV
vaccine construct may provide protection in
humans, according to the
study authors.
The immunological benefits from the wild mice's gut bacteria may, in part, explain a persistent problem in disease research: Why disease experiments in lab mice, such as
vaccine studies, turn out very differently in
humans or other animals.
This new work suggests that anti-PD-1 antibodies might be equally effective in treating hepatitis C and other persistent
human viral infections, says Christopher Walker, PhD, a senior author on the
study and director of the Center for
Vaccines and Immunity at Nationwide Children's.
The agency approved the
vaccines with scant clinical data, relying instead on the same «strain change» rules that allow manufacturers to change the seasonal
vaccine without conducting
human studies.
After all the work of planning, funding and getting approval for a
vaccine trial in
humans, «you're talking at least about three years in a best - case scenario, if you have a very promising product,» said Matthew Laurens, an associate professor of pediatrics and medicine at the University of Maryland who was not associated with the
study.
Phase II trial - an intermediate clinical trial for
studying an experimental
vaccine in
humans.
Phase I trial - an early clinical trial designed to
study an experimental
vaccine in
humans.
A retracted
study linking the
vaccine for
human papillomavirus (HPV) to behavioral problems in mice has been republished by a different journal.
Recent
studies have identified genetic variants that account for variability in
human susceptibility and severity of infection and might be useful for
vaccine and treatment development in malaria [80][84] and dengue [85], [86], for example.
What if he designed a similar
vaccine for dogs, but with
human DNA instead — would it be easier to get approval for this
study?
Dr Peter Barlow says
study represents a promising step forward in the rapid development of a safe and robust
vaccine against Zika virus infection in
humans.
Subsequent
studies in animal models that are thought to mimic the
human experience indicate RSV inactivated
vaccine induces an increased CD4 + T lymphocyte response, primarily of Th2 cells and the occurrence of immune complex depositions in lung tissues [32], [42], [43].
First, this is a
study in mice; DNA
vaccines that work in mice have a sorry history of not working in
humans.
Specifically, we will test samples from aged and, as a control, younger
human subject before and after vaccination with the trivalent inactivated influenza
vaccine (TIV) in an exploratory / confirmatory
study design to assess age - related responsiveness to the
vaccine.
The
study relates to a particular type of
vaccine (killed) against a particular virus, influenza, though the findings might hold true for other killed
vaccines and for those
vaccines consisting only of proteins produced by GM in bacteria, yeast or insect cells, against diseases such as hepatitis B (HBV) and
human papilloma virus (HPV, the causative agent of cervical cancer).
Limitations of the present
studies include their performance in mice only and uncertainty of the relevance of rodent models to SARS - CoV
vaccines in
humans.
Phase I
studies in
humans have been conducted with a whole virus
vaccine and a DNA
vaccine [29]--[30].
A pilot
study of the
vaccine in
humans is scheduled to open soon at seven different sites.