In their new study, researchers from the Johns Hopkins Bloomberg School of Public Health, Imperial College London and the University of Florida re-analyzed data
from vaccine trials conducted in 10 countries with more than 30,000 participants as well as recently published data on the long - term follow - up of these participants.
Not exact matches
He says that in animal
trials, a
vaccine against dengue protected «a hundred percent of animals
from a pathogenic dengue challenge.»
We talk with two pioneering physicians — one of whom is overseeing the world's largest HIV
vaccine trial and the other led a groundbreaking successful pilot in the U.S. — to see how far we are
from getting to zero.
Drugs that are specific to hepatitis C will soon go
from trial to clinic, giving more patients hope, but a
vaccine is still elusive
Vaccine proponents also point to the lessons learned
from the failed Merck STEP
trial.
So say scientists at Merck, who learned
from trials in 2007 that their
vaccine, based on a live, weakened adenovirus carrying genes for HIV proteins, was ineffective.
In a clinical
trial, this
vaccine protected 45 percent of the adults who received the highest dose against infection
from H5N1.
A retrospective analysis of those who participated in phase III
trials in 2011 found that those who had never had a dengue infection at the time of vaccination were in rare cases at risk of enhanced disease, although the Dengvaxia
vaccine did reduce infections and cases of serious illness in those who had previously suffered
from dengue.
The so - called STEP
trial, sponsored by pharmaceutical giant Merck & Co. and the federally funded HIV
Vaccine Trials Network (HVTN), was the first to test the idea of stimulating the immune system's killer T cells to hunt for the virus more aggressively, in this case using a weakened form of the cold virus to carry three genes
from HIV.
In the coming months, scientists will have to evaluate the
trial's full data to determine why the
vaccine failed: Were the infecting viruses too different
from the
vaccine strain to offer resistance?
The first
vaccine to receive the green light for human
trials is a product
from Pennsylvania - based Inovio Pharmaceuticals.
That's because a
trial like this one is almost without precedent in modern medical research: It involves giving children a
vaccine that is almost certain not to benefit them, and that might harm them, all to protect other children
from an unlikely scenario — a large - scale anthrax attack.
With HIV, progress has been slow, but we have a glimmer of hope now
from the so - called RV144
trial in Thailand, in which an experimental HIV
vaccine turned out to be about 30 percent effective.
The
vaccine from the Mount Sinai researchers is entering the first human safety
trials with drugmaker GlaxoSmithKline.
The company is starting larger
trials to see if the
vaccine can actually protect people
from getting sick.
In 2011, Science's editors will be watching a smaller detector at the Large Hadron Collider called LHCb, which will study B mesons in great detail; new techniques that should lead to the discovery of many more genes contributing to adaptation; an ignited fusion burn at the National Ignition Facility; broadly neutralizing antibodies, which are capable of disabling a wide range of viral variants; the first plug - in hybrid electric cars whose batteries are charged
from a wall socket go on the market; and the results of the first phase III
trial of a malaria
vaccine.
China has not approached the WHO about the
trial but the WHO says it has been kept informed by United Biomedical, and has seen the results
from animal tests of the
vaccine.
CDC based its decision for children under 10 to receive two doses on preliminary data
from clinical
trials of the
vaccines being used in the United States, but he said more complete data should emerge soon.
«The findings reported are derived
from an artificial in vitro experimental system and do not appear to be consistent with the data obtained by two independent groups utilising samples
from the human clinical
trials of the actual Merck Ad5 HIV
vaccine.»
Granted, different
vaccines are in use in different locales, but the differences reflect that data
from clinical
trials of various
vaccines in a range of age brackets is still preliminary.
NicVAX, an antismoking
vaccine that recently received $ 10 million in funding
from NIDA, is in large clinical
trials under the auspices of its maker, Nabi Biopharmaceuticals.
«[T] he visit also comes as the White House awaits action
from Congress on a nearly $ 6.2 billion emergency appropriations request to continue fighting [Ebola] in West Africa and to move candidate
vaccines through clinical
trials.
[NIAID Director Anthony] Fauci says $ 56 million of the total would go toward a larger efficacy
trial in Liberia, which would include both the NIAID / GSK [GlaxoSmithKline]
vaccine and another made by NewLink Genetics of Ames, Iowa (pending more data
from ongoing safety
trials).»
This clinical
trial, which included 1,518 participants, was the basis for the recent approval
from the Food and Drug Administration of a 2 - dose series of the 9 - valent HPV
vaccine for adolescents,» writes Lauri E. Markowitz, M.D., of the U.S. Centers for Disease Control and Prevention, Atlanta, and colleagues in an accompanying editorial.
«With data
from the
trial reported in JAMA, evidence now supports a 2 - dose schedule in adolescents (aged 9 to 14 years) for all 3 licensed HPV
vaccines.»
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.
«The findings
from this
trial are very encouraging to those of us who have spent many years working on
vaccine candidates to protect against dengue, a disease that is a significant burden in much of the world and is now endemic in Puerto Rico,» said Stephen Whitehead, Ph.D., of NIH's National Institute of Allergy and Infectious Diseases (NIAID).
A clinical
trial in which volunteers were infected with dengue virus six months after receiving either an experimental dengue
vaccine developed by scientists
from the National Institutes of Health (NIH) or a placebo injection yielded starkly contrasting results.
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.
Using a novel synthetic platform for creating
vaccines originally developed in the laboratory of David Weiner, PhD, a professor of Pathology and Laboratory Medicine
from the Perelman School of Medicine at the University of Pennsylvania, a team led by his colleagues at the Johns Hopkins University School of Medicine, has successfully eradicated precancerous cervical lesions in nearly half of the women who received the investigational
vaccine in a clinical
trial.
Vaccine developers are trying to improve vaccines for transplant recipients and other people with a weak immune system, and the samples used in this study came from a clinical trial of different versions of a flu vaccine in patients on immune - suppressive
Vaccine developers are trying to improve
vaccines for transplant recipients and other people with a weak immune system, and the samples used in this study came
from a clinical
trial of different versions of a flu
vaccine in patients on immune - suppressive
vaccine in patients on immune - suppressive drugs.
The
vaccine that has been tested in the United States was made
from a cold - causing chimpanzee adenovirus that had been engineered to express proteins
from two species of the Ebola virus, known as Zaire and Sudan (after their origins), and that was already available when the
trial began in early September.
They examined 936 HIV sequences collected
from 44
trial participants who received the
vaccine and became infected, and 66 people who got the placebo.
In WRAIR's first
vaccine trial, all the participants were «my friends in the laboratory or
from down the hall,» says Ballou, and they went home after being infected.
In a few weeks, meeting participants learned, enough data may be available
from small phase I
trials of a
vaccine jointly made by the U.S. National Institute of Allergy and Infectious Diseases and GlaxoSmithKline (GSK) that began in September to launch efficacy studies.
Up until now, efforts in generating a
vaccine against TB have been mainly focused on T cells (cells
from the adaptive arm of our immune response with memory capacity), with very disappointing outcomes in both pre-clinical as well as clinical
trials.
The U.K. government also noted that «affected African countries will have the primary role of authorising or allowing use of investigational
vaccines» and said «buy in»
from those communities about the clinical
trials must be obtained as soon as possible.
Merck began a second
trial of its
vaccine in February in South Africa, where the circulating virus differs
from the one the
vaccine is based on.
Patients with recurrent glioblastoma multiforme (GBM) treated with an experimental
vaccine made
from the patient's own resected tumor tissue showed an improved survival compared with historical patients who received the standard of care alone, according to an analysis of a phase 2
trial of this
vaccine that was recently published in the journal Neuro - Oncology and accompanied by an editorial highlighting the importance of the
trial.
In clinical
trials, several candidate H7N9 pandemic influenza
vaccines made
from inactivated viruses have been shown to be safe and to generate an immune response.
Those who oppose the
trial think the approach with the greatest chance of success would be to test a
vaccine based on one subtype in a population at risk
from the same subtype.
The eagerly awaited results
from the world's first large - scale
trial of a malaria
vaccine are in, and they confirm what other, smaller studies had shown: The
vaccine, called RTS, S, offers partial protection, cutting episodes of malaria in babies and toddlers in half.
The latest data
from a large clinical
trial of Merck's cervical cancer
vaccine, Gardasil, found it offered 100 % protection against cervical, vulval and vaginal diseases, caused by HPV (types 6, 11, 16 and 18) and 98 % protection against advanced pre-cancers caused by HPV types 16 and 18 (New England Journal of Medicine: vol 356, p1915).
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 army landed $ 20 million for a
trial of an AIDS
vaccine after heavy lobbying, in part
from the company that makes the
vaccine.
The
trial would carefully evaluate safety, but this time there will be no control group because withholding the
vaccine from some participants is no longer seen as ethical.
White MT, Verity R, Griffin JT, et al.White MT, Verity R, Griffin JT, Asante KP, Owusu - Agyei S, Greenwood B, Drakeley C, Gesase S, Lusingu J, Ansong D, Adjei S, Agbenyega T, Ogutu B, Otieno L, Otieno W, Agnandji ST, Lell B, Kremsner P, Hoffman I, Martinson F, Kamthunzu P, Tinto H, Valea I, Sorgho H, Oneko M, Otieno K, Hamel MJ, Salim N, Mtoro A, Abdulla S, Aide P, Sacarlal J, Aponte JJ, Njuguna P, Marsh K, Bejon P, Riley EM, Ghani AC close, 2015, Immunogenicity of the RTS, S / AS01 malaria
vaccine and implications for duration of
vaccine efficacy: secondary analysis of data
from a phase 3 randomised controlled
trial, Lancet Infectious Diseases, Vol: 15, ISSN: 1473 - 3099, Pages: 1450 - 1458
Secondly, the Jenner will develop its transcriptomics core facility to carry out RNAseq analysis of clinical samples (both blood and bronchoalveolar lavage fluid)
from trials with novel TB, malaria and Ebola
vaccines.
The Jenner will provide RNAseq and / or bioinformatics analysis of pre-existing transcriptomics data for up to 200 samples
from vaccine clinical
trials.
Phase III
trials involve thousands of participants and occur only after the experimental
vaccine has successfully moved
from a Phase I and Phase II
trial.