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Recent flu vaccine and HIV trial holds promising news
HIV patients could quickly, safely enroll
A new study suggests that a clinical trial to test a new flu vaccine, such as a vaccine against the novel 2009 H1N1 influenza virus, could enroll HIV patients both quickly and safely.
"The study very rapidly recruited almost 300 HIV patients, and we had 80% of them in the first few weeks," says Curtis Cooper, MD, FRCPC, an associate professor of medicine at the University of Ottawa, and a physician in the division of infectious diseases at the Ottawa Hospital in Ottawa, Canada.
The Ottawa Hospital clinical trial site will be one of the Canadian sites that will evaluate the H1N1 influenza vaccine when it first becomes available for study, Cooper notes.
"Canadian researchers have established an influenza network funded by the Public Health Agency of Canada and the Canadian Institutes of Health Research," Cooper says. "Part of our mandate is to rapidly evaluate vaccine candidates in the event of a pandemic. I'm an investigator with that project."
The flu vaccine study was conducted last summer and evaluated the vaccine that was distributed for the 2008-2009 flu season.
"The reason we did the study is because people living with HIV are more susceptible to symptoms of influenza," Cooper says. "The recommendations are made on pretty tenuous data of studies conducted in the pre-HAART [highly active antiretroviral therapy] era."
So Cooper and co-investigators conducted a randomized clinical trial that looked at different vaccination strategies in HIV patients. They examined increasing the dose of vaccine for HIV patients and also at providing a booster dose of influenza vaccine.
The study's findings are still being analyzed, but one of the more positive outcomes was that a flu vaccine trial can enroll HIV patients very rapidly, which would be necessary under pandemic conditions.
Within a month, almost all HIV-infected participants were enrolled, Cooper says.
"We were able to recruit and vaccinate all our patients in a very rapid period of time while still doing it safely and capturing clinical and laboratory information necessary to evaluate a vaccine," he says.
Investigators are still collecting case report forms, but initial findings suggest there were no severe adverse events related to the dosing strategies they used, including when they increased the vaccine dose, Cooper says.
"In general the vaccines were well tolerated," he says. "It was a slow flu season last year, so we didn't have a lot of flu-like illness presenting to our research units."
With further analysis, researchers hope to answer the question of whether alternative types of vaccination strategy would produce higher levels of antibodies than the usual vaccination strategy, he adds.
Also, investigators studied HIV patients' receptivity to being vaccinated against the flu virus.
"For this study we had a questionnaire that we gave to each participant and the control population, asking about factors that would make them more or less likely to receive the flu vaccine and make them more or less likely to participate in a clinical trial," Cooper says. "This is all very important information to guide mass immunization against swine flu."