H7N9 Influenza Vaccine and MF59 Study

What is the H7N9 influenza virus?

The H7N9 influenza virus is an avian influenza (bird flu) strain that has caused outbreaks of human infections in China since 2013. Many of the people infected with H7N9 reported contact with live poultry, and it seems that the human infections occurred after exposure to infected birds or their surroundings. Since then, avian influenza H7N9 viruses have continued to circulate in China. As of September 5, 2018, H7N9 viruses have caused over 1500 laboratory confirmed infections and over 600 deaths in humans, according to the World Health Organization.

The H7N9 virus does not typically spread from one person to another, but influenza viruses constantly change, and it's possible that this virus could become able to spread among people. If this occurs, there could be a global outbreak of disease (pandemic). To prepare for this possibility, we need vaccines to prevent H7N9 infection. This type of influenza virus is not included in the regular influenza vaccines (flu shots) given each year.

What is the purpose of this study?

The main purpose of this study is to find out more about ways to improve immune responses to H7N9 influenza vaccines. Previous studies have found that H7 influenza strains generally do not lead to strong immune responses in people. One way to improve responses to vaccines is to include a substance called an adjuvant that can boost the immune system to produce more antibodies (proteins that fight infection). In this study, we will compare the immune response to H7N9 vaccines with an adjuvant to the immune response to H7N9 vaccines without an adjuvant. The study will also look at the safety of the vaccines and adjuvants. H7N9 vaccine (with or without adjuvants) is investigational, which means it is not licensed for sale in the United States by the U.S. Food and Drug Administration (FDA). Be aware that this sheet refers to the H7N9 vaccine with and without adjuvants as "study vaccine."

This study is funded by the National Institutes of Health (NIH).

Who can be in the study?

Adults 18-64 years of age who are in good general health can be in the study. People who have medical conditions that affect the immune system or are taking medications that affect the immune system may not be in the study. There are also other conditions and circumstances that may make you ineligible for this study.

Can I get the flu infection from the study vaccines?

No. Like the regular, yearly flu shot, the H7N9 vaccine includes only small pieces of killed influenza virus that are not able to cause influenza infection. You cannot get the H7N9 influenza infection from the study vaccine, just as you cannot get regular flu from the yearly flu shot.

Will the study vaccine prevent the regular flu?

No. The H7N9 study vaccine does not contain the type of flu strains that are included in the regular, licensed flu shot available each year. It is being developed specifically to protect against the H7N9 avian influenza infection.

Which adjuvant is being used in this study?

In this study, we will be using an adjuvant called MF59. It is only licensed by the FDA for use in the United States in one flu vaccine for adults aged 65 and older. This adjuvant is licensed by regulatory authorities in some other countries. The use of MF59 has helped people to form more antibodies when given with lower doses of flu shots.

What is involved if I take part in the study?

The study involves 6 or 7 study clinic visits and 5 telephone calls over about a year. The first 5 or 6 study clinic visits and 2 telephone visits happen in the first 6-8 weeks of the study. All study clinic visits include a blood draw, and 2 of the visits include injections of study vaccine.

You may be asked to come in for a screening clinic visit before the first vaccination visit. If the evaluations done at the screening visit confirm that you are eligible, the first study vaccination visit will be within 4 weeks. If you do not come in for a screening visit, evaluations will be done at your first vaccination visit to confirm that you are eligible for the study. At that visit, you will be assigned randomly (by chance) to 1 of 4 study groups. The group will determine which dose of the H7N9 study vaccine you receive and whether it includes the MF59 adjuvant or no adjuvant. Women who are able to have children will have a urine pregnancy test before each study vaccination. Pregnant women cannot be in the study.

After the first study vaccination, you will come back to the clinic 7 days later for a follow-up visit, 21 days later for the second study vaccination visit, and 7 and 21 days after the second study vaccination for follow-up visits. The final study clinic visit will be about 6 months after the second study vaccination. After each of the 2 study vaccination visits we will ask you to fill out a form daily for 8 days to record information on reactions or any other medical problems. You will have telephone visits about 3 days after each study vaccination visit and about 2, 4, and 12 months after the second study vaccination.

Can I get the regular seasonal influenza vaccine (flu shot)?

Yes, but there are timing restrictions. To be in the study, you must have the regular flu shot at least 3 weeks before the first study vaccination, or at least 3 weeks after the second study vaccination.

Where are the study visits?

All visits will be held at the Kaiser Permanente Washington Health Research Institute's clinic in downtown Seattle. The Research Clinic is located in the Metropolitan Park East Building, next to I-5.

Do I need to be a current Kaiser Permanente member to be in the study?

No. Both Kaiser Permanente members and non-members can be in this study. You may refer family and friends for possible study participation regardless of whether they received this letter or are Kaiser Permanente members.

Will there be any out-of-pocket study expenses?

No. All materials necessary for the study will be given to you. There will be no co-pay and no charge for the vaccination if you are in the study. Parking and bus tickets are provided at no cost.

Will I receive payment if I am in the study?

Yes. For your time and effort, you will receive $85 for each study clinic visit you attend. You will receive these payments by mailed check.

Can I be in this study if I'm in another research study?

If you are currently participating in another research study that involves a drug, supplement, device or vaccine, you cannot participate in this study at the same time. This is true even if you are currently only being followed by phone calls for the other study.

Can I donate blood if I take part in this study?

For a definite answer, you should ask your blood bank. Generally, blood banks will not want you to donate blood for one year after receiving any investigational drug or vaccine. We do not have restrictions against blood donation during participation in this study.

How do I join this study?

Email KPWA.vaccine@kp.org with your full name and the best phone number and time to reach you. You may also call us at 206-287-2061.