Not exact matches
In households where women between the ages of 15 and 40 were pregnant, volunteer
participants were administered either influenza
vaccine or placebo as part of a randomized, placebo - controlled Phase 4 clinical
trial.
The company plans in October to conduct a separate test specifically to study the seasonal flu
vaccine's effectiveness among 480 elderly
participants (a demographic often encouraged to get seasonal flu shots), and Phase III efficacy
trials across a larger set of demographics are scheduled to begin early next year.
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.
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.
Tomaras and colleagues found that
participants in the RV144
vaccine trial were more likely to have HIV - specific IgG3 antibodies, compared to individuals in the VAX003
trial.
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.
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.
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.
Trial participants who receive a
vaccine product may develop HIV antibodies and show a reaction on antibody tests.
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.
Importantly this new
vaccine has a better safety profile than traditional injection allergen immunotherapy, however the
trial participants experienced a high frequency of local side effects which were unexpected and warrants further investigation in larger numbers of patients.»
Seventy - five
participants will receive the
vaccine at WRAIR's Clinical
Trial Center in Silver Spring, Md..
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.
Many scientists believe that the Thai HIV
vaccine trial, which had recruited over 2,500 of its projected 16,000
participants by June 2004, has no chance of success.4 Yet the investigators overseeing the study (who include American scientists), the local Thai institutional review boards, and the Thai Ministry of Health have all remained silent — at least on the record.
Immune responses of patients could point way forward for future vaccines.In the latest study, researchers involved with the
trial at Mahidol University in Bangkok and the U.S. Military HIV Research Program in Washington DC assembled a team to scour the blood of
trial participants for immune indicators that differed between 41 people who received the
vaccine and contracted HIV and 205
participants who did not become infected.
The randomised controlled
trial has been described elsewhere.19 Eligible
participants for the
vaccine trial, and consequently for this study, were Indigenous women aged 17 — 39 years who: