Talks about volunteers needed H1N1 vaccine trials

Above about H1N1 vaccine trials.

Healthy volunteers may help the rest of us stay that way if the H1N1 virus makes a comeback in the fall.

In August, Rochester Clinical Research in Irondequoit will begin testing vaccines against the so-called swine flu, and the company needs about 300 volunteers of all ages.

Six vaccines are being tested among more than a dozen sites across the country, and RCR will be testing four, according to Patricia Larrabee, president and chief executive officer. Should any or all of the vaccines prove effective against H1N1, they could be used during the upcoming flu season.

RCR is the only Monroe County site involved in testing vaccines.

The University of Rochester is not involved in clinical trials to test the effectiveness of H1N1 vaccines being developed. But if the vaccines are used during the flu season, UR researchers would track how well they do the job.

H1N1 has stayed in the news since emerging this spring and there is concern that it could re-emerge in the fall with a vengeance. Research to be published in the journal Nature reported that swine flu multiplies in the respiratory system with more severity than seasonal flu. The current H1N1 has been compared to the 1918 Spanish flu pandemic.

Questions remain about how an H1N1 vaccine would be administered and which age groups would get priority. Traditionally, the elderly have been given precedence with vaccines against seasonal flu. But H1N1 has tended to be more troublesome for younger people. “Under 20 is where we’ve seen the bulk of the disease,” said Dr. Andrew Doniger, director of the Monroe County Health Department.

Public health officials also have to determine whether an H1N1 vaccine would be given at the same time as a seasonal flu vaccine. Other logistical issues, such as how the vaccine would be distributed, still need to be worked out.

But, as Doniger points out, fall — when flu vaccines start to be given — is coming. Usually it takes months for researchers to get to the stage of a clinical trial. For example, researchers have been working for two years on a vaccine for avian flu, Larrabee said.

But the quick start to this trial has researchers running a drill. RCR received word in June that it would run a clinical trial. Its first trial begins the first week of August. Another will start two weeks later and a third is scheduled for September.

Depending on the age group, Larrabee said that RCR needs as few as 10 people and as many as 160 for the trials. Worldwide, several thousand people will be needed.

RCR’s job is to make sure volunteers are eligible to participate, then administer the vaccine and prepare the volunteers’ blood to be analyzed.

In order to protect the integrity of the study, neither the researchers nor the volunteers will know who gets a placebo and who gets the vaccine.