The United States will start human trials of an experimental vaccine for preventing the 2009 H1N1 influenza virus in August; the first study will involve 1,000 volunteer adults and children in 10 centres throughout the country.
The announcement was made yesterday by the University of Maryland School of Medicine’s Center for Vaccine Development, one of 8 of a nationwide network of Vaccine and Treatment Evaluation Units (VTEUs) that will start recruiting volunteers and testing the vaccine in August.
The VTEU network, which will evaluate the safety of the vaccine and measure its ability to stimulate immune responses to the H1N1 virus, is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
This step is the first toward the US government’s goal to have a safe and effective vaccine available to the public before the flu season starts in the fall.
The US government has declared the H1N1 flu outbreak a public health emergency, following the World Health Organization’s declaration last month that the virus spread was now a global pandemic.
Experts anticipate that the virus will cause significant illness during the US flu season this fall and winter, including hospitalizations and deaths.
Dr Karen L Kotloff, who is a lead investigator at the VTEU, and also professor of pediatrics, and a researcher in the Center for Vaccine Development at the University of Maryland School of Medicine, told the press that:
“Vaccines have always been a vital tool for controlling influenza. The results of these studies will help to guide the optimal use of the H1N1 vaccines in the US and elsewhere in the world.”
The idea of VTEUs is not new: the Center for Vaccine Development at the University of Maryland School of Medicine has been an NIAID centre for more than 30 years.
Dr E Albert Reece, dean of the School, who is also Vice President for Medical Affairs, University of Maryland, and the John Z and Akiko K Bowers Distinguished Professor at the School of Medicine, said they were very pleased to lead the effort to stop the H1N1 pandemic before the start of the 2009 flu season.
“Our VTEU is now one of just eight in the country, and it is the only one in the mid-Atlantic region,” said Reece.
The trial vaccine will first be tested on healthy adults and elderly volunteers. If they show good tolerance to the vaccine, it will then be tested on children. The researchers anticipate enrolling as many as 200 adults, 200 seniors and 600 children on the trial.
The trial will also test two strengths of the vaccine and evaluate which of them offers the best protection against the H1N1 swine flu.
All the volunteers will receive two doses of vaccine three weeks apart, and also give blood samples each time so the researchers can compare the response after one dose with the response after two doses. The volunteers will be asked to keep a log of how they feel and any symptoms they experience.
The researchers will continue to keep an eye on the volunteers for another two months, and check them after four and six months.
Kotloff told CNN:
“The purpose of these trials is always to make sure they are safe.”
“But even after six weeks, if things look good, we’re pretty sure the vaccine will work,” she added.
Kotloff said in a press statement that because young people have not experienced a flu virus like this one before, she and her colleagues expect that the response may be different in different age groups.
“Learning the responses of different age groups of people to the vaccine will not only tell us the best way to use the vaccine in an individual, but we also learn ways to use the vaccine supply most efficiently to protect the greatest number of people,” added Kotloff.
“Older adults might have some immunity to the new H1N1 virus as a result of being exposed to similar flu viruses in the past. As a result, older adults might need fewer doses or a lower strength of the vaccine than younger individuals,” she explained.
Further trials will look at how the vaccine works when combined with the seasonal flu vaccine, and whether adding an adjuvant to boost the immune response helps the vaccine remain effective at lower doses.
The other 7 VTEU sites are: Baylor College of Medicine, Cincinnati Children’s Hospital Medical Center, Emory University, Saint Louis University, Seattle Group Health Cooperative, the University of Iowa, and Vanderbilt University.
The Children’s Mercy Hospital in Kansas City and Duke University Medical Center are also expected to join the VTEU network.
Earlier this week, a spokesperson for CSL Ltd, a biopharmaceutical company based in Melbourne, Australia, told CNN that they were planning to start the first human trials of a swine flu vaccine on Wednesday, with 240 healthy volunteers aged 18 to 64, who will also receive two shots, three weeks apart, and give blood samples so researchers can evaulate their immune response.
Source: University of Maryland School of Medicine, CNN.
Written by: Catharine Paddock, PhD