The Army - led RV144 HIV
vaccine trial provided the first evidence in humans that a safe and effective preventive HIV vaccine is possible.
In 2009, the RV144 Thai
vaccine trial provided the first evidence in humans that a safe and effective preventive HIV vaccine is possible.
Not exact matches
Those
trials will test the safety and feasibility of giving children four doses of the
vaccine, which
provides only partial protection against the disease.
And a new analysis of the STEP
trial, published last November in Proceedings of the National Academy of Sciences USA,
provides a warning that the very vectors (adenoviruses, which are also employed in other
vaccine development work) used to distribute the inactive HIV strains can actually make the immune system more vulnerable to infection by recruiting susceptible T cells to mucous membranes, where they are more likely to be infected during sexual activity.
And a new analysis of the stopped STEP
trial, published online Monday in Proceedings in the National Academy of Sciences,
provides a warning that the very vectors (adenoviruses, which are also employed in other
vaccine development) used to distribute the inactive HIV strains can actually prime the immune system to be infected by recruiting susceptible T cells to mucous membranes, where they are more likely to be infected during sexual activity.
«Additionally, this
provides evidence needed to begin investigating a
vaccine in human cancer clinical
trials to determine whether genetically modified tumor cells producing IL - 15 and IL - 15Rα may induce anti-cancer responses.»
The researchers hope that understanding the level of virus needed for transmission of infection will
provide a useful reference point for the development of experimental drugs and
vaccines and could be used to inform the endpoints for clinical
trials evaluating such interventions.
The data obtained from this study
provide a basis for more rapid, cost - effective clinical
trials to evaluate new influenza drugs or to determine the efficacy of candidate
vaccines for both seasonal and pandemic influenza.
Results from the RV144
trial, reported in 2009,
provided the first signal of HIV
vaccine efficacy: a 31 percent reduction in HIV infection among vaccinees.
«This randomized controlled
trial provides valuable information for establishing best practices for influenza
vaccine text message reminders.
In October at the WHO in Geneva, scientists and activists from developing and industrialised countries agreed that, despite the American decision,
trials of the two
vaccines could be justified in countries hit hard by HIV,
provided that their governments approved (This Week, 22 October 1994).
The Jenner will
provide RNAseq and / or bioinformatics analysis of pre-existing transcriptomics data for up to 200 samples from
vaccine clinical
trials.
iBET's infrastructure comprises 16 laboratories fully equipped with state - of - the - art technology (70 m2 each), including a BSL2 laboratory for working with viruses; a GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs; a GMP Mass - Spectroscopy Unit that
provides state - of - the - art MS services to the scientific community and Industry; a 2600 m2 bio-pilot plant supporting production and purification of proteins ATMPs and
vaccines from bench top to 300 L scale and privileged access to GeniBET Biopharmaceuticals, an iBET spin - off producing ATMPs under cGMP certification for phase I / II / III clinical
trials.
While it is not possible to compare antibody levels measured in this
trial with those seen in
trials of other AMA1
vaccines, based on the relative fold - rise and duration of antibody responses this profile compares favorably with much lower and shorter - lived increases in antibody levels observed in Malian children immunized with AMA1 - C1, an AMA1
vaccine adjuvanted with aluminum hydroxide [19], which
provided no measurable protection in a recently reported Phase 2
trial at another site in Mali.
Those
trials will test the safety and feasibility of giving children four doses of the
vaccine, which
provides only partial... -LSB-...]
In this role, Ms. Roxland re-launched and chaired J&J's Ethics Committee, created an enterprise - wide consultation service for teams and individuals confronting complex research ethics issues, and
provided guidance on issues such as post-trial access for former research participants, conducting clinical
trials in war - torn regions, testing of a potential Ebola
vaccine during a public health crisis, commercialization of stem cell therapies, subject recruitment and withdrawal, and expanded access / compassionate use.
In the regulatory affairs arena, her group
provides the necessary documentation to the U.S. Food and Drug Administration for review and approval of IDRI's
vaccine and adjuvant candidates in human clinical
trials.
ECRIN will
provide consultancy services for human
vaccines clinical
trials development.