По отношение на комбинираната ваксина Twinrix, тук пускам линка към 2 новини, които потвърждават след проведени изследвания, че ваксината гарантира имунитет най-малко за 6 години, като най-вероятно периода е по-голям.
New Study Confirms Length of Immunity Conferred by Twinrix, Combination Hepatitis A and B Vaccine
(Innsbruck, Austria) - Results of an international, follow-up study of GlaxoSmithKline Biologicals' Twinrix confirm earlier findings and further demonstrate the length of immunity provided by the vaccine.
Twinrix is the first and only combination hepatitis A and B vaccine. The study, presented at the 7th Conference of the International Society of Travel Medicine (ISTM), evaluated the combined vaccine in adults ages 17 - 60 years old over a six-year period. Twinrix adult vaccine is licensed in 70 countries and was recently approved by the US Food and Drug Administration (FDA) for the prevention of hepatitis A and B in adults age 18 and over.
Product and Full Prescribing Information for Twinrix (PDF File)
"We saw sustained levels of immunity several years after vaccination and, based on experiences with the monovalent vaccines, we expect the levels of immunity seen in this study to be maintained for a considerable amount of time," said Pierre Van Damme, MD, PhD, professor within the Department of Epidemiology and Social Medicine at the University of Antwerp, Belgium.
Hepatitis A and B, two highly infectious liver diseases, are the most common vaccine-preventable diseases in travelers. The Centers for Disease Control (CDC) recommends hepatitis A and B vaccination for those traveling to areas with intermediate or high endemicity, including Africa, Asia (except Japan), the Caribbean, South America, Central America, the Middle East and eastern and southern Europe. According to a study published in the Journal of Travel Medicine, international travelers are not adequately informed about the risks of hepatitis B and a significant proportion unknowingly expose themselves to infection.
Long-Term Data
The safety and immunogenicity of Twinrix has been demonstrated in numerous clinical trials conducted worldwide. The study presented at the ISTM meeting, however, is the first to look at the length of immunity conferred by the vaccine over a six-year period. Investigators followed two groups of adults (ages 17- 60) who received three doses of Twinrix adult formulation, which contains 720 EL.U inactivated hepatitis A virus and 20 mg HBs antigen, on a 0-,1-, 6- month schedule. After six years, 100 percent of adults in both groups showed an antibody response to the hepatitis A component of Twinrix; and, 89 and 95 percent showed a response to the hepatitis B component.
"Twinrix is an important advance in the fight against these two infectious diseases and part of our ongoing efforts to provide the highest quality and most innovative vaccines for the prevention of disease," said John Jabara, vice president and director, GlaxoSmithKline's U.S. Vaccine Business Unit.
In clinical trials, the most common adverse events associated with Twinrix included soreness at the injection site, headache and fatigue. They were mild and self-limiting and did not last more than 48 hours.
Preventing Hepatitis A and B in Travelers and Other At-risk Groups
Despite the availability of safe and effective vaccines, hepatitis A and B are still a significant public health concern. Many people are not aware they are at risk for these diseases and up to 50 percent of persons with hepatitis A and approximately 25 percent of persons with hepatitis B have no known risk factors.
In unprotected travelers, hepatitis A occurs 10 to 100 times more than typhoid fever and 1,000 times more than cholera. It is spread through the fecal-oral route, through close person-to-person contact or by ingesting contaminated food or water.
Hepatitis B is a serious disease that can cause permanent liver damage, liver cancer and even death. It can be spread through infected blood or body fluids, sexual contact, intravenous drug use, contact sports (via cuts and scrapes), body piercing and tattooing. In some settings, hepatitis B is up to 100 times more contagious than HIV. A clear link has been demonstrated between chronic hepatitis B infection and the occurrence of hepatocellular carcinoma (primary liver cancer). In a study of adult males, vaccination against the hepatitis B virus has been shown to decrease the incidence of, and risk of, developing hepatocellular carcinoma.
For more information on hepatitis A and B prevention visit www.travelsafely.com
6/01/01
Source
GlaxoSmithKline at www.gsk.com
След периода на наблюдение от 6 години,
100% от ваксинираните са имали антитела срещу
хепатит A, а
процента за хепатит B, бил съответно
89% и 95% за всяка една от наблюдаваните две групи от пациенти.
Ето още една информация за същото изследваня:
Length of immunity provided by Twinrix proved
Results of an international, follow-up study of GlaxoSmithKline Biologicals' Twinrix, the world's only combination hepatitis A and B vaccine, confirm earlier findings and further demonstrate the length of immunity provided by the vaccine.
The study, presented today at the 7th Conference of the International Society of Travel Medicine (ISTM), evaluated the combined vaccine in adults ages 17 - 60 years old over a six-year period. Twinrix adult is licensed in 70 countries and was recently approved by the FDA for the prevention of hepatitis A and B in adults age 18 and over.
"We saw sustained levels of immunity several years after vaccination and, based on experiences with the monovalent vaccines, we expect the levels of immunity seen in this study to be maintained for a considerable amount of time," said Dr Pierre Van Damme, professor within the Department of Epidemiology and Social Medicine at the University of Antwerp, Belgium.
Hepatitis A and B, two highly infectious liver diseases, are the most common vaccine-preventable diseases in travelers. The Centers for Disease Control recommends hepatitis A and B vaccination for those traveling to areas with intermediate or high endemicity, including Africa, Asia (except Japan), the Caribbean, South America, Central America, the Middle East and eastern and southern Europe. According to a study published in the Journal of Travel Medicine, international travelers are not adequately informed about the risks of hepatitis B and a significant proportion unknowingly expose themselves to infection.
The safety and immunogenicity of Twinrix [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine, has been demonstrated in numerous clinical trials conducted worldwide. The study presented at the IS(TM) meeting, however, is the first to look at the length of immunity conferred by the vaccine over a six-year period. Investigators followed two groups of adults who received three doses of Twinrix adult formulation, which contains 720 EL.U inactivated hepatitis A virus and 20 micrograms HBs antigen, on a 0, one , six month schedule. After six years, 100% of adults in both groups showed an antibody response to the hepatitis A component of Twinrix; and, 89 and 95% showed a response to the hepatitis B component.
"Twinrix is an important advance in the fight against these two infectious diseases and part of our ongoing efforts to provide the highest quality and most innovative vaccines for the prevention of disease," said John Jabara, vice president and director of GlaxoSmithKline's US Vaccine Business Unit in a media release.
In clinical trials, the most common adverse events associated with Twinrix included soreness at the injection site, headache and fatigue. They were mild and self-limiting and did not last more than 48 hours.
Source: Datamonitor
Още една информация за Twinrix от
Американската Агенция по Храните и Лекарствата /U.S. Food and Drug Administration/:
TWINRIX [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine]
...
Two clinical trials involving a total of 129 subjects demonstrated that antibodies to both HAV and HBV persisted for at least 4 years after the first vaccine dose in a 3-dose series of TWINRIX, given on a 0-, 1-, and 6-month schedule. For comparison, after the recommended immunization regimens for HAVRIX and ENGERIX-B, respectively, similar studies involving a total of 114 subjects have shown that seropositivity to HAV and HBV also persists for at least 4 years.
The effect of age on immune response to TWINRIX was studied in 2 trials comparing subjects over 40 years of age (n = 183, mean age = 48 in one trial and n = 72, mean age = 50 in the other) with those ≤40 (n = 191; mean age 32.5). The response to the hepatitis A component of TWINRIX declined slightly with age, but >99% of subjects achieved protective antibody levels in both age groups, and antibody titers were comparable to 2 doses of hepatitis A vaccine alone in age matched controls.
The response to hepatitis B immunization is known to decline in vaccinees over 40 years of age. TWINRIX elicited a seroprotective response to hepatitis B in 97% of younger subjects and 93% to 94% of the older subjects, as compared to 92% of older subjects given hepatitis B vaccine alone. Geometric mean titers elicited by TWINRIX were 2,285 in the younger subjects and 1,890 or 1,038 for the older subjects in the 2 trials. Hepatitis B vaccine alone gave titers of 2,896 in younger subjects and 1,157 in those over 40 years of age.
It has been shown in open randomized clinical trials that combining the hepatitis A antigen with the hepatitis B surface antigen in TWINRIX resulted in comparable anti-HAV or anti-HBsAg titers, relative to vaccination with the individual monovalent vaccines or the concomitant administration of each vaccine in opposite arms.
...
Според тази информация ваксината, независимо дали е комбинираната Twinrix, или само тази за хепатит B - Engerix-B,
гарантират имунитет поне за 4 години. Разбира се, това са доказаните периоди, вероятно е ваксината да ви гарантира имунитет за доста повече време, но трябва редовно да си правите изследвания.
Препоръчвам на всички, които се интересуват да прегледат целия документ, защото има много полезна информация.
Ето и информацията за продукта, на страницата на производителя на ваксината:
Twinrix.
И една много интересна и полезна информация, за която съм убеден, че повечето лични лекари все още не знаят:
FDA approves accelerated dosing schedule for GlaxoSmithKline's Twinrix®FDA approves accelerated dosing schedule for GlaxoSmithKline's Twinrix®
Philadelphia, PA — April 2, 2007 — GlaxoSmithKline [NYSE:GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved Twinrix® [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine], for an accelerated dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months. The approval means Twinrix, the only hepatitis A and hepatitis B combination vaccine available in the United States, is now available on a dosing schedule at 0, 7, 21-30 days, followed by a booster dose at 12 months. The vaccine was first approved for adults over age 18 years by the FDA in May 2001 on a 0, 1, 6-month dosing schedule.
“Hepatitis A and hepatitis B are serious liver diseases which can be prevented through vaccination,” stated travel medicine specialist Bradley A. Connor, M.D., Past President, International Society of Travel Medicine and a principal study investigator. “Twinrix’s new accelerated dosing schedule offers an option that could benefit individuals such as those preparing to travel internationally to high-risk areas. It may also benefit emergency first care responders, especially those deploying to disaster areas overseas, as well as others at risk for hepatitis, such as people with sexually transmitted diseases and those who are HIV positive.”
Many regions throughout the world are endemic for hepatitis A and hepatitis B, such as Africa, Asia, South Americaand parts of the Caribbean. Worldwide, approximately 1.5 million cases of hepatitis A are reported annually. In addition, hepatitis B has infected 2 billion people — one-third of the world’s population. Millions of Americans travel each year to countries where hepatitis A and hepatitis B are endemic. An overwhelming majority of these international travelers are not vaccinated before the trip. Therefore, international travelers may be at risk for contracting both hepatitis A and hepatitis B. They should consult their health care provider prior to traveling abroad.
The FDA approved the new dosing schedule after reviewing the safety and immune response of Twinrix given to 250 healthy adults (aged ≥18 years) at 0-, 7-, and 21- to 30-day schedule, followed by a booster dose at 12 months, compared to separate vaccinations with monovalent hepatitis A vaccine (HAVRIX at 0 and 12 months) and hepatitis B vaccine (ENGERIX-B at 0, 1, 2, and 12 months) given to 246 healthy adults as a control group. The study demonstrated that the individuals who completed the series of Twinrix on the accelerated dosing schedule had an immune response comparable to those individuals who received complete vaccination with separately administered hepatitis A and hepatitis B vaccines.
About Vaccine-Preventable Hepatitis (VPH)
Vaccine-Preventable Hepatitis includes hepatitis A and hepatitis B. Hepatitis C is not vaccine preventable. Hepatitis A is a serious liver disease caused by the hepatitis A virus. This virus is found in the stool of persons with hepatitis A and is spread by close personal contact and by eating food or drinking water contaminated with the hepatitis A virus. Hepatitis A can be easily passed between people within the same household. About one in five people with the disease has to be hospitalized. Hepatitis A can be fatal. Symptoms of the disease can include fever, fatigue, loss of appetite, nausea, abdominal discomfort, jaundice (yellow skin and eyes) and dark urine.
Hepatitis B is a serious liver disease caused by the hepatitis B virus. The virus is passed through infected blood or body fluids. Approximately 50 percent of people with hepatitis B do not notice signs or symptoms. Those who do may experience diarrhea and vomiting, nausea, fatigue, loss of appetite, muscle and joint pain, and jaundice. Hepatitis B can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. An estimated 1.25 million Americans are chronically infected with Hepatitis B. Estimates show that tens of thousands of people (mostly young adults) are infected each year.
About Twinrix®
As with all prescription medications, please talk with your healthcare provider to see if Twinrix is right for you.
In clinical trials with Twinrix, the most common side effects included pain and redness at the injection site, headache, and tiredness. These effects were mild and did not last more than 48 hours. (See Adverse Reactions section of the Prescribing Information for Twinrix for other potential side effects.) As with any vaccine, there is a small risk of allergic reactions. If you notice any problems following vaccination, or if you are allergic to any component of the vaccine such as neomycin, yeast, or latex, please inform your healthcare provider.
For more information on Twinrix visit www.gskvaccines.com.
GlaxoSmithKline — A Leader in Vaccines
GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.
Това значи, че ваксината може да бъде слагана по-различен начин от сегашния, който е: първа доза, втора на 1-вия месец и 3-та на 6-ия месец.
Новият вариант е: първа доза, втора доза на 7-ия ден, трета доза между 21-30-ия ден, и четвърта доза на 12-ия месец.
Поздрави,
Радо
