Oct. 28, 2011

Variable Effects of Two Influenza A (H1N1) Vaccinations in People with Lupus

Factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) non-adjuvant vaccine in systemic lupus erythematosus
Mathian A, Devilliers H, Krivine A, Costedoat-Chalumeau N, Haroche J, Boutin-Le Thi Huong D, Wechsler B, Hervier B, Miyara M, Morel N, Le Corre N, Arnaud L, Piette JC, Musset L, Autran B, Rozenberg F, and Amoura Z. (2011).  Arthritis & Rheumatism. 2011 August 2. [Epub ahead of print]

What is the topic?

April 2009 marked the beginning of the world’s first influenza (commonly called “the flu”) pandemic (a worldwide outbreak) in 41 years. Most of the world’s population had little or no immunological protection from this new strain of influenza. At this time, people with lupus were considered at high risk of severe influenza A (H1N1) and were recommended to receive the vaccination for this influenza strain.

Little is known about the effects of vaccination in people with autoimmune diseases, including lupus. The 2009 influenza outbreak provided a unique opportunity to learn more. 

What did the researchers hope to learn?

The researchers hoped to learn about the safety and efficacy of two influenza A (H1N1) vaccinations given to people with lupus. 

Who was studied?

One hundred eleven people with active lupus (and variable disease activity) were given two vaccinations against influenza A (H1N1) between November 30, 2009 and January 28, 2010 in Paris, France. 

Patients were excluded from the study if they had known severe allergic reactions to ovalbumin or other vaccine components, acute infection with fever over 38 degrees Celsius (100.4 degrees Fahrenheit) or a history of Guillain-Barré syndrome (an autoimmune condition of the nervous system). Patients were not excluded based on lupus disease activity or medications being taken. 

How was the study conducted?

People with lupus received injections of Paneza® (Sanofi Pasteur, Lyon, France), an inactivated influenza vaccine against the virus A/California/7/2009 (H1N1)v-like strain. At Day 0, people with lupus received an injection of Paneza® (Sanofi Pasteur, Lyon, France) and also received a second injection on Day 21. Blood was collected from patients on Days 0, 21, and 42 in order to measure markers of active lupus. Patients were asked about their history of influenza vaccinations and illnesses. 

At each visit, lupus disease activity was assessed by use of various validated methods. At Day 21, patients filled out questionnaires to report on adverse events. Patients were also seen at various time points for a year to identify possible acute respiratory or systemic symptoms. 

Three weeks after receipt of each of the two influenza vaccinations, people with lupus were tested for the presence of antibodies to the 2009 influenza A (H1N1) virus in the blood in order to quantify the efficacy of the vaccinations. 

What did the researchers find?

The patients included in the study were mostly women with an average age of 35 and an average disease duration of 10 years. Most of the patients were taking hydroxychloroquine and did not have existing protection against influenza A (H1N1) in the blood. Many of them were taking prednisone while some were taking immune-suppressing drugs (including mycophenolate mofetil, azathioprine, cyclophosphamide, or methotrexate). 

The two vaccine injections (intramuscular) were generally well-tolerated by people with lupus. The pattern and frequency of adverse events were similar to those observed in healthy subjects, and included the following: itching, pain, redness, tenderness, chills, fever, headache, and nausea. Importantly, the vaccine did not increase lupus disease activity (even in patients with active disease at the time of vaccination). 

The effectiveness of the two vaccinations depended on whether or not people with lupus were taking immune-suppressing drugs (such as prednisone), as well as on their white blood cell count at the time of the vaccinations. In patients having their white blood cell counts attain a specific criterion (1.0 x 109/L) and not taking immune-suppressing drugs, the vaccination was fully effective after a single injection – just as in healthy people without lupus (and, in this case, a second vaccination made no difference). However, in patients having their white blood cell counts below the specified criterion (see above) or taking immune-suppressing drugs, a single vaccination was not fully effective and a second vaccination rendered some additional benefits. However, these additional benefits did not confer full protection. Thus, people with lupus having a well-established history of influenza vaccinations may benefit more from a second injection than those who do not. 

What were the limitations of the study?

In the context of the 2009 influenza A (H1N1) pandemic, it would not have been ethical to withhold the vaccination from people with lupus for experimental purposes. For this reason, this study did not include a group of people with lupus not receiving the vaccine (or just one vaccination). In addition, a group of healthy people without lupus, but who received the vaccination, were not included in this study. 

What do the results means for you?

The results suggest that new vaccination strategies should be developed for some people with lupus in order to improve vaccine efficacy (in the context of an influenza A (H1N1) pandemic). The results presented here may help to define these new strategies. However, it should be noted that certain types of vaccines (such as attenuated vaccines or those containing MF59 or AS03) may be more effective, but have not yet been tested for safety in people with lupus. Importantly, different routes of vaccine administration (such as vaccination in the skin by a needle or patch), or perhaps different vaccination protocols (such as stronger vaccinations, in terms of concentration) may be more effective and well-tolerated in people with lupus.

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