Clinical Trials News

Start Of U.S. H1N1 Vaccine Clinical Trials

2009-08-26T02:45:00.000-07:00

CSL Biotherapies has announced the initiation of the company's first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. The studies will determine the safety of CSL's candidate vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in adults and children. The pediatric study will evaluate CSL's candidate vaccine in a thimerosal-free (i.e., preservative-free) formulation.

The clinical studies are sponsored by CSL Biotherapies and are being funded in whole or in part with Federal funds from the U.S. Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority. They will take place at 24 study sites throughout the country. It is anticipated that findings from these trials will be used to determine the most appropriate dosing schedule of the Influenza A/H1N1 2009 vaccine for use in the general population. This clinical trial program is part of a larger, global effort by CSL Biotherapies, in partnership with government and regulatory bodies, to bring an Influenza A/H1N1 2009 vaccine to market in the United States, in Australia and in select regions of the southern hemisphere.

"The H1N1 pandemic has had a significant toll on the health and well-being of people worldwide, which makes the development of an effective vaccine against the virus an urgent public health need," said Kawsar Talaat, MD, principal investigator of the CSL vaccine adult trials and assistant scientist in the Johns Hopkins Bloomberg School's Department of International Health. "Through these trials, we hope to identify the most effective dose and dosing regimen to protect the public against this highly infectious new strain of influenza virus."

"Children are often at greater risk from influenza infection and its complications than adults, so it is extremely important to understand the efficacy of an H1N1 vaccine in this very vulnerable population," said Pedro Piedra, MD, principal investigator for the vaccine pediatric trials and professor in the department of molecular virology and microbiology, and pediatrics at Baylor College of Medicine. "The clinical trials of CSL's candidate vaccine will be the first to use a thimerosal-free formulation of the H1N1 vaccine antigen."

About CSL's H1N1 Clinical Trial Initiative

The goal of CSL's H1N1 clinical trial program is to evaluate the safety and efficacy of the Influenza A/H1N1 2009 vaccine in adults and children (http://www.clinicaltrials.gov). Approximately 1,300 adults (aged 18 years and older) and 450 children (aged ≥ 3 months to < 9 years) are expected to be enrolled in the randomized, placebo-controlled U.S. studies. In the adult trials, three doses of the vaccine - 7.5, 15 and 30 mcg - will be evaluated, administered as two vaccinations, three weeks apart.

In the pediatric trials, two doses - 7.5 and 15 mcg - will be evaluated, administered as two vaccinations, three weeks apart. The studies will also evaluate the incidence of adverse events up to six months after first injection. CSL's Influenza A/H1N1 2009 vaccine is manufactured by a process identical to the one used in manufacturing CSL's U.S. Food and Drug Administration-licensed trivalent seasonal influenza vaccine; only the single A/H1N1 flu strain differs between the two.

CSL Limited, the parent company of CSL Biotherapies, initiated Australian clinical trials of its Influenza A/H1N1 2009 vaccine candidate with a design and study objectives similar to its U.S. program. First administration in healthy adult volunteers began on July 22, 2009 and in healthy pediatric volunteers on August 3, 2009, making CSL the first vaccine manufacturer to initiate human studies of this vaccine. CSL expects to report interim post-dose 1 data from the adult trials in Australia by mid-September.

CSL Biotherapies recently signed an initial contract for $180 million to supply the U.S. Department of Health & Human Services with Novel influenza A (H1N1) antigen.

About Influenza and the Novel Influenza A/H1N1 Virus

Influenza (commonly referred to as the flu) is a serious illness that accounts for approximately 36,000 deaths annually in the U.S. While most healthy individuals recover from influenza within a few days to a week, some people, especially those with certain chronic illnesses, such as heart or lung disease, can develop complications. Seasonal influenza vaccination has been shown to reduce illness, hospitalization and death. The emergence of the novel H1N1 flu, which was first detected in humans in April 2009, has proven to be very contagious, spreading worldwide, and has led to the World Health Organization declaring a pandemic on June 11, 2009. The pandemic virus has caused more than a thousand deaths worldwide and created a significant burden on hospitals.

Vaccination against pandemic influenza is the most important step in bringing the pandemic under control and protecting those most at risk from infection. CSL Biotherapies is developing and producing candidate Influenza A/H1N1 2009 vaccine, drawing on four decades of experience with its proven vaccine production processes.

50 Percent Of Healthcare Workers In Hong Kong Refuse To Get The Swine Flu Vaccine

2009-08-26T02:18:00.000-07:00

Research just published on bmj.com reports that about half of healthcare workers surveyed in Hong Kong say they would not be vaccinated against swine flu because of fears of side effects and doubts about effectiveness.

Still, the authors underline that vaccination is one of the most effective ways to reduce illness and death linked with pandemic flu. They believe that the benefits highly compensate for any possible risks.

The results of the research are unexpected, according to the authors, given SARS had such a huge impact in Hong Kong. Also, the study was underway at the same time as the World Health Organization (WHO) escalated its alert for swine flu to phase 5.

The results are comparable to a recent UK poll of almost 1,500 Nursing Times readers. It revealed that 30 percent of nurses said they would not have the swine flu vaccine.

The study documents that practically all countries with a pandemic flu plan intend to vaccinate healthcare workers as a priority group in order to protect the essential health infrastructure of their countries. However, this policy will only be successful if there is a high uptake of the vaccine.

Given the results of this study, lead author Professor Paul Chan from the Chinese University of Hong Kong mentions that a campaign to promote vaccination among healthcare workers is required.

Over 8,500 doctors, nurses, and related health professionals were surveyed. All were working at 31 hospital departments of internal medicine, pediatrics, and emergency medicine in Hong Kong.

Participants were initially surveyed from January to March 2009. This was when the WHO influenza pandemic alert was at phase 3. Then they were surveyed again in May 2009. At that point, the WHO raised its pandemic alert to phase 5 and it was the first time participants were specifically asked if they were willing to be vaccinated against swine flu. There was a response rate of 46.6 percent for the first survey and 48 percent for the second.

About 28 percent of respondents in the initial survey said they would be willing to be vaccinated against avian flu (H5N1).Interestingly, the authors explain, "no significant changes in the level of intention to accept pre-pandemic H5N1 vaccine were observed, despite the escalation to phase 5 because of the wide spread of H1N1 virus (swine flu)."

When the WHO alert level was at phase 5, 47.9 percent of respondents said they would be willing to be vaccinated against swine flu (H1N1).

The most frequent reasons for an intention to accept were:
• "wish to be protected"
• "following health authority's advice"

The most common reasons for refusal were:
• "worry about side effects"
• "query on the efficacy of the vaccine"
• "simply did not want the vaccine"
People who said they would accept the swine flu vaccination tended to be younger. They usually had received the seasonal flu vaccine in 2008-9 and feared they were more likely to get swine flu.

The authors write in conclusion: "To our knowledge, this is the largest study conducted to assess the willingness of healthcare workers to accept pre-pandemic influenza vaccination, and it provides important information on barriers to vaccination. Campaigns to promote vaccination should consider addressing the knowledge gap of staff and the specific target groups for intervention."

In an associated editorial, Rachel Jordan from the University of Birmingham and Andrew Hayward from the UCL Centre for Infectious Disease Epidemiology, emphasize that vaccination for healthcare workers is vital for their own protection and the safety of their patients. It could be of assistance to keep the NHS functioning at full capacity during the swine flu pandemic.

They claim that education and promotional campaigns alone have not been sufficient to convince healthcare workers to get vaccinated, "but the additional use of convenient mobile systems, monitoring and feedback systems, and the use of "opt-out" systems (where healthcare workers need to indicate their reasons for not accepting the vaccine) show promise."

30% of nurses 'don't want' flu jab

Total confirmed human cases of Swine Flu A(H1N1) infection, and total deaths, 3rd July, 2009 (Source CDC) by state

2009-07-09T16:21:00.000-07:00

# Alabama - 330 cases, 0 deaths
# Alaska - 60 cases - 0 deaths
# Arkansas - 42 cases - 0 deaths
# Arizona - 761 cases - 10 deaths
# California - 1985 cases - 21 deaths
# Colorado - 136 cases - 0 deaths
# Connecticut - 1247 cases - 6 deaths
# Delaware - 316 cases - 0 deaths
# Florida - 1302 cases - 5 deaths
# Georgia - 118 cases - 0 deaths
# Hawaii - 616 cases - 0 deaths
# Idaho - 92 cases - 0 deaths
# Illinois - 3166 cases - 13 deaths
# Indiana - 267 cases - 0 deaths
# Iowa - 92 cases - 0 deaths
# Kansas - 117 cases - 0 deaths

# Kentucky - 130 cases - 0 deaths
# Louisiana - 183 cases - 0 deaths
# Maine - 82 cases - 0 deaths
# Maryland - 591 cases - 1 death
# Massachusetts - 1308 cases - 3 deaths
# Michigan - 484 cases - 7 deaths
# Minnesota - 576 - 1 death
# Mississippi - 161 cases - 0 deaths
# Missouri - 65 cases - 1 death
# Montana - 67 cases - 0 deaths
# Nebraska - 111 cases - 0 deaths
# Nevada - 301 cases - 0 deaths
# New Hampshire - 224 cases - 0 deaths
# New Jersey - 1159 cases - 9 deaths
# New Mexico - 232 cases - 0 deaths
# New York - 2499 cases - 44 deaths
# North Carolina - 255 cases - 2 deaths
# North Dakota - 57 cases - 0 deaths
# Ohio - 120 cases - 1 death
# Oklahoma - 128 cases - 1 death
# Oregon - 366 cases - 4 deaths
# Pennsylvania - 1748 cases - 4 deaths
# Rhode Island - 158 cases - 1 death
# South Carolina - 160 cases - 0 deaths
# South Dakota - 29 cases - 0 deaths
# Tennessee - 174 cases - 0 deaths
# Texas - 3991 cases - 17 deaths
# Utah - 920 cases - 10 deaths
# Vermont - 49 cases - 0 deaths
# Virginia - 191 cases - 1 death
# Washington - 588 cases - 4 deaths
# Washington, D.C. - 33 cases - 0 deaths
# West Virginia - 154 cases - 0 deaths
# Wisconsin - 5861 cases - 4 death
# Wyoming - 81 cases - 0 deaths
Territories
# Puerto Rico - 18 cases - 0 deaths
# Virgin Islands - 1 case - 0 deaths

TOTAL - 33,902 cases - 170 deaths

33,902 Swine Flu A(H1N1) Cases Including 170 Deaths In USA

2009-07-09T16:18:00.000-07:00

The Centers for Disease Control and Prevention (CDC) informed in its weekly update on Friday evening, 3rd July, 2009, that the total number of confirmed human cases of swine flu A(H1N1) infection stands at 33,902, including 170 deaths

In a Swine Flu conference held today in Cancun, Mexico, the World Health Organization (WHO) warned that the virus' spread is now "unstoppable". The WHO added that swine flu infection cases are mostly mild, with the vast majority of people recovering unaided.

Health authorities in the UK predict that British infection numbers should exceed 100,000 by the end of this summer