H1N1 flu vaccine trial questions and answers

Graciela Gutierrez
713-798-4710
ggutierr@bcm.edu

HOUSTON -- (August 11, 2009) -- Dr. Wendy Keitel, Director of the BCM Vaccine Research Center, and Dr. Flor Munoz-Rivas, assistant professor of Pediatrics - Infectious Diseases, answer questions about the H1N1 vaccine trial.

The H1N1 flu vaccine study begins this week; what are the goals?

In English

En español: El estudio de la vacuna para la influenza H1N1 ha comenzado. ¿Que son los objetivos de este estudio?

As everybody knows we are in a pandemic of influenza now and one of the most important things we can do to control a pandemic both for individuals as well as populations is to develop a safe and effective vaccine.

The NIH is sponsoring a number of clinical trials of vaccines for prevention of the type of flu that is causing the pandemic. Clinical trials for the vaccine have just begun this week.

The studies that we are doing have some very simple goals. They are to determine the safety of the vaccine, to study how well tolerated they are and to evaluate how people respond in terms of making antibodies against the vaccine and the viruses that cause the infections and illnesses.

Antibodies are proteins that circulate in your blood that can help prevent an infection. Each year when we develop the inactivated vaccine for the prevention of influenza, we typically include three strains in the vaccine. And one of the strains is the H1N1 virus. But these viruses are so different that most of the population is considered susceptible. So a major goal is to determine how many doses of the vaccine are needed and what strength the vaccine needs to be to stimulate affective antibody responses against the virus.

To start we are looking at two inactivated or killed influenza vaccines made by different manufacturers and we'll be looking at the different strengths and how many doses are necessary. We will be evaluating the vaccine in people basically of all ages, starting with 6-month-old infants and going up into the elderly population.

Here at Baylor we will be doing studies in both adults and children. The design of our studies includes a single strength of swine flu or 2009 H1N1 vaccine given in two doses and at the same time people receive the seasonal flu vaccine before, during and after the time that they are getting the swine flu vaccine shots.

In English

What are some symptoms participants can expect and will they get H1N1 flu from the vaccine?

The most common side effects, adverse reactions people experience after receiving that kind of vaccine are possibly some discomfort at the site of the injection and sometimes some redness and swelling.

Occasionally an individual will say that flu shot gave me the flu. And in fact they may feel like they have the flu because some people may develop a fever and feel a little under the weather after they receive a killed vaccine. It is not influenza. It is a reaction to the vaccine.

So those are the most common and that latter one is not that common. Any vaccine, food, drug can rarely causes an allergic reaction. For this kind of vaccine, because they are made in eggs, we would choose not to enroll someone who has known allergy to eggs.

In English

En español: ¿Cuando esperan que una vacuna será disponible al público?

When will the vaccine be available to the public?

It's not completely clear right now whether some of the vaccine will be available to the population before information from the clinical trials comes in. So for example the live attenuated vaccine which is not being tested in these studies may be available somewhat earlier.

The question is whether the policy makers or the FDA would permit its use as just a strain change as the seasonal influenza virus. I don't know the answer to that.

I think everyone would like to see some information certainly about safety for all of these vaccines and definitely about how much and how many doses will be required before final decisions are made about how to give the vaccine best.

So it's theoretically possible that vaccines could start before we have all of this information and that the recommendations could be altered as time goes by to reflect the needs of a particular population. So by September or October we would hope to have information that would guide the appropriate use of the vaccines.

In English

En español: ¿Debería todavía yo conseguir la vacuna de gripe estacional por mientras que estoy esperando que la vacuna H1N1 sea disponible al público?

Should I still get the seasonal flu vaccine while waiting for the H1N1 vaccine to become available to the public?

We are facing a very important influenza year. We have the H1N1 virus circulation during the summer and it is expected that it will continue during the winter time. However, we can not forget that we still have seasonal influenza.

The regular seasonal influenza viruses will be circulating sometime during the fall and in the winter this year so it is very important that everyone receives that vaccine, because in addition to the studies we are doing, there will be an opportunity to receive the seasonal influenza vaccine at any time starting in the next few weeks through your community doctor or pharmacy or any other physician or other source in the community.

So regardless of whether individuals want to participate in the study or not, they need to try to go ahead and get the seasonal influenza vaccine as well.

If the study vaccine becomes available to the community at large, then having received the flu vaccine, the seasonal vaccine, is not a reason why they could not receive the new vaccine as well. They can go ahead and get both as they become available in the community.

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