Recently in Allergy Vaccine Category

COPENHAGEN (AFX) - Danish pharmaceutical group ALK Abello AS said its tablet-based grass pollen vaccine Grazax showed very positive results for the second treatment year in the ongoing GRAZAX GT-08 study.

In the second treatment year, Grazax reduces hay fever symptoms by 44 pct and reduces the need for symptom-relieving medication by 73 pct compared with placebo, ALK Abello said.

ALK Abello said it has recently entered strategic alliances for the Grazax programme with the Menarini Group for some European markets and with Schering-Plough (nyse: SGP - news - people ) for North America..

Copyright AFX News

ALLERGY sufferers could bid farewell to their sneezes with a new generation of vaccines that take effect within weeks.

Existing vaccines for allergies involve three to five years of regular injections with increasing amounts of allergen - the substance that triggers an allergy. All the while the immune response slowly changes from a predominance of T-helper 2 (TH2) cells, immune cells responsible for triggering allergic reactions, to T-helper 1 (TH1) cells, which stimulate the production of protective antibodies.

Because nothing is directing allergens to the right place in immune cells, it takes a lot of allergen to generate a response.

Allergen immunotherapy is a powerful and effective treatment option for patients with allergic rhinitis, allergic asthma, and allergy to stinging insects. Allergen immunotherapy (ie, "allergy shots") has been used for nearly 100 years, and has been shown to provide both short-term and often long-term relief from allergic symptoms. It may also help prevent the development of asthma, and may reduce the incidence of new allergic sensitivities. Creticos and colleagues evaluated an experimental alternative to the traditional approach to immunotherapy.

The study authors conducted a double-blind, randomized, placebo-controlled, phase 2 trial with a ragweed antigen (Amb a 1), conjugated to a phosphorothioate oligodeoxyribonucleotide immunostimulatory sequence of DNA (AIC) in 25 ragweed-allergic adults. Patients were given injections once weekly for 6 weeks. Their allergic rhinitis symptoms were then followed for 2 years.

Purpose of review: Plant pollens are the most common cause of seasonal allergic disease. The number of patients undergoing treatment for allergies to the pollen of Japanese cedar (major antigens: Cry j 1 and Cry j 2) has increased steadily each year. Integration of an effective, safe and inexpensive clinical program would be greatly improved by addressing deficiencies in systemically delivered immunotherapy.

Recent findings: We have demonstrated that feeding mice transgenic rice seeds accumulating the T-cell epitope peptides of Cry j 1 and Cry j 2 before systemic challenge with total protein of cedar pollen inhibits the development of allergen-specific IgE, IgG and CD4⁺ T-cell proliferative responses. The levels of allergen-specific CD4⁺ T-cell-derived allergy-associated T-helper 2 cytokine of IL-4, IL-5, and IL-13 and histamine release in serum were also significantly decreased. Moreover, clinical symptoms were inhibited in an experimental sneezing-mouse model.

LONDON, Dec 7 (Reuters) - Biotech group Allergy Therapeutics Plc <AGY.L> said on Thursday a Phase IIa study of its orally delivered hay fever vaccine showed it to be safe and effective.

The company said it was now confident that it can go ahead and develop the vaccine, which could be the first ever oral alternative to existing injectable treatments.

"These results provide the first indication that we have the technology to deliver a painless, injection-free potentially curative allergy treatment," Chief Executive Keith Carter said.

Analysts at Bridgewell -- which has a buy rating on the stock -- said that the statement was "good news that could uniquely position the drug against its competitors".

© Reuters 2006

The authors note that inactivated, trivalent, injectable influenza vaccine (injectable vaccine) is the only formulation approved for use in high-risk children, owing in part to concerns that live attenuated influenza vaccine (given nasally) might worsen asthma symptoms in asthmatics. This paper reports the results of an efficacy and safety trial of a reformulated live attenuated vaccine (live vaccine).

Subjects were European children aged 6-17 years with asthma enrolled during the 2002-2003 influenza season. The study excluded children with many other chronic diseases and children who were immune compromised. For 15 days after vaccination (1:1 randomization to live or injectable vaccine), parents recorded daily asthma symptom scores and peak expiratory flow measurements. In addition, the parents recorded nocturnal symptoms and asthma medication use. After the 15 days of parental log completion, investigators contacted subjects weekly to determine if they required revisit for symptoms. Any subject who developed fever or upper or lower respiratory illness was seen for office visit and nasal swab for influenza culture. The subjects were also monitored for side effects and other unscheduled medical visits. The study enrolled 2229 subjects, with 1114 receiving live vaccine.

HORSHOLM, Denmark, Nov. 20 (UPI) -- ALK-Abello said Monday it launched its tablet-based vaccine against grass pollen allergy, Grazax, in Germany.

"The launch of Grazax is the culmination of years of research and development at ALK-Abello," said Jens Bager, ALK-Abello's chief executive officer. "With this convenient tablet for home treatment, many more patients throughout Europe can be offered a treatment that targets the cause of their allergy, cuts the symptoms and improves their quality of life."

The company said it plans to introduce the vaccine in other, unspecified European markets.

A novel vaccine designed to treat ragweed allergy significantly improved nasal symptoms for at least 2 years, according to a study presented here at the 52nd annual scientific meeting of the American College of Allergy, Asthma and Immunology. In addition, patients given the vaccine showed similar trends in symptom relief, regardless of how severely allergic they were to ragweed at baseline.

"We're very excited about this," said Eduardo Martins, MD, vice-president for clinical development at Dynavax Technologies, the San Francisco-based company developing the Tolamba ragweed allergy vaccine. "There have been 14 research trials to date with different dosages, and although they've been small, trial after trial, we've had consistently good results like this for patients across the board."

This randomized placebo-controlled study — the largest to date on this ragweed vaccine — included 462 people aged 18 to 55 years with confirmed ragweed allergy. One group received 6 weekly injections of the vaccine in incremental doses; the other group received injected placebo. Patients were then followed for 2 allergy seasons and asked to electronically report their daily hayfever symptoms, medication use, and related factors.

NEW YORK (Reuters Health) - In children with asthma and recurrent respiratory tract infections, nasal spray flu vaccine (sometimes called live attenuated influenza virus vaccine) is well tolerated and more effective than inactivated influenza virus vaccine given as a shot, according to the results of two studies.

In the first study, Dr. William C. Gruber, from Wyeth Research in Pearl River, New York, and colleagues assessed the outcomes of 2220 children with asthma, who were between 6 and 17 years old. They were randomized to receive the live attenuated nasal spray flu vaccine or the inactivated flu vaccine shot during the 2002-2003 influenza season.

The influenza rate in the nasal spray flu vaccine group was 4.1 percent, significantly lower than the 6.2 percent rate noted in the group that got the flu shot. Thus, the nasal spray had a greater relative efficacy of 34.7 percent. The occurrence of asthma flare-ups and other asthma-related episodes did not differ significantly between the two vaccine groups.

Also, an Effective but Expensive Treatment for Macular Degeneration<

by Joanna Schaffhausen, ABCNews, 5 Oct 2006

A POTENTIAL RAGWEED VACCINE
A small study of 25 people, only 15 of whom completed the full study, finds that injections that lower the body's immune system reaction to ragweed may help alleviate people's symptoms during ragweed season. In the study, adults with ragweed allergy received either six once-a-week injections of the ragweed vaccine or injections with a placebo vaccine.

The vaccine was not a home run, as it failed to meet its major target for success, which was reducing nasal reaction when volunteers were tested with ragweed in the lab. However, the vaccine did show some potential. It improved volunteers' symptoms as self-rated in diaries they kept during the experiment and improved their quality of life during hay fever season. Moreover, the effects of the vaccine appeared to carry over into a second year, relieving symptoms for a second straight season. This study was published in the New England Journal of Medicine by researchers from Johns Hopkins University.