HIV vaccine regimen demonstrates modest preventive effect in Thailand clinical study
EUREKALERT
Sep 24 2009, 9:40 AM EST
Contact: Kathy Stover
stoverk@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.
"These new findings represent an important step forward in HIV vaccine research," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, which provided major funding and other support for the study. "For the first time, an investigational HIV vaccine has demonstrated some ability to prevent HIV infection among vaccinated individuals. Additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection, but certainly this is an encouraging advance for the HIV vaccine field.
"We thank the trial staff in Thailand and the United States for their years of effort in successfully conducting this study and the study participants and the people of Thailand for their long-standing support of HIV vaccine research," Dr. Fauci adds.
The Thai Phase III HIV vaccine study, also known as RV144, opened in October 2003. The placebo-controlled trial tested the safety and effectiveness of a prime-boost regimen of two vaccines: ALVAC-HIV vaccine (the primer dose), a modified canarypox vaccine developed by Sanofi Pasteur, based in Lyon, France, and AIDSVAX B/E vaccine (the booster dose), a glycoprotein 120 vaccine developed by Vaxgen Inc., and now licensed to Global Solutions for Infectious Diseases (GSID), based in South San Francisco, Calif. The vaccines are based on the subtype B and E HIV strains that commonly circulate in Thailand. The subtype B HIV strain is the one most commonly found in the United States.
Led by principal investigator Supachai Rerks-Ngarm, M.D., of the Thai Ministry of Public Health's Department of Disease Control, the study was sponsored by the U.S. Army in collaboration with NIAID, Sanofi Pasteur and GSID. The trial, conducted in the Rayong and Chon Buri provinces of Thailand, enrolled 16,402 men and women ages 18 to 30 years old at various levels of risk for HIV infection. Study participants received the ALVAC HIV vaccine or placebo at enrollment and again after 1 month, 3 months, and 6 months. The AIDSVAX B/E vaccine or placebo was given to participants at 3 and 6 months. Participants were tested for HIV infection every 6 months for 3 years. During each clinic visit, they were counseled on how to avoid becoming infected with HIV.
In the final analysis, 74 of 8,198 placebo recipients became infected with HIV compared with 51 of 8,197 participants who received the vaccine regimen. This level of effectiveness in preventing HIV infection was found to be statistically significant. The vaccine regimen had no effect, however, on the amount of virus in the blood of volunteers who acquired HIV infection during the study.
"The Thai study demonstrates why the HIV vaccine field must take a balanced approach to conducting both the basic research needed to discover and design new HIV vaccines and, when appropriate, testing candidate vaccines in people," says Margaret I. Johnston, Ph.D., director of NIAID's Vaccine Research Program within the Division of AIDS. "Both avenues provide critical information that will continue to help us better understand what is needed to develop a fully protective HIV vaccine."
NIAID and the collaborating partners are working with other scientific experts to determine next steps, including additional research of the RV144 vaccine regimen and the need to consider the impact of these new findings on other HIV vaccine candidates.
Individuals who acquired HIV infection while participating in the Thai trial have been provided access to HIV care and treatment, including highly active antiretroviral therapy based on the guidelines of the Thai Ministry of Public Health.
###
For more information about the Thai Phase III HIV vaccine trial, please see: www.hivresearch.org.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
The National Institutes of Health (NIH)The Nation's Medical Research Agencyincludes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
Young children need 2 doses of H1N1 vaccine: U.S.
Mon Sep 21, 2009 11:43am EDT
WASHINGTON (Reuters) - Younger children will need two doses of the vaccine against the new pandemic of H1N1 influenza, U.S. officials said on Monday. They said tests of Sanofi-Pasteur's swine flu vaccine showed that children respond to it just as they do with seasonal flu vaccines, with children over 10 needing just a single dose.
Dr. Anthony Fauci, director of the U.S. Institute of Allergy and Infectious Diseases, said young children will likely need to have their doses 21 days apart, but he said they could receive seasonal flu shots and H1N1 shots on the same day -- something that could ease the logistics of vaccinating children multiple times.
"Immunologically this is acting like seasonal flu and we are very pleased with that," Fauci told reporters in a telephone briefing. "The response in younger children is less robust but that is not unexpected." The children up to age 17 all mounted an immune response that should protect them from H1N1 within 8 to 10 days, Fauci said. The U.S. Centers for Disease Control and Prevention said 46 U.S. children have died from swine flu.
(Reporting by Maggie Fox, Editing by Sandra Maler)
Mon Sep 21, 2009 11:43am EDT
WASHINGTON (Reuters) - Younger children will need two doses of the vaccine against the new pandemic of H1N1 influenza, U.S. officials said on Monday. They said tests of Sanofi-Pasteur's swine flu vaccine showed that children respond to it just as they do with seasonal flu vaccines, with children over 10 needing just a single dose.
Dr. Anthony Fauci, director of the U.S. Institute of Allergy and Infectious Diseases, said young children will likely need to have their doses 21 days apart, but he said they could receive seasonal flu shots and H1N1 shots on the same day -- something that could ease the logistics of vaccinating children multiple times.
"Immunologically this is acting like seasonal flu and we are very pleased with that," Fauci told reporters in a telephone briefing. "The response in younger children is less robust but that is not unexpected." The children up to age 17 all mounted an immune response that should protect them from H1N1 within 8 to 10 days, Fauci said. The U.S. Centers for Disease Control and Prevention said 46 U.S. children have died from swine flu.
(Reporting by Maggie Fox, Editing by Sandra Maler)
1 Swine Flu Shot Enough?
Single Swine Flu Shot Gives Immunity in Early Tests
By Daniel J. DeNoon
WebMD Health News Reviewed by Louise Chang, MDSept. 10, 2009 -
Adults are immune to swine flu after just one shot of vaccine, early test results suggest. It's a surprise finding. Most experts expected that two shots of the vaccine -- given three weeks apart -- would be needed.
Now vaccine supplies may go twice as far, and may start working twice as fast as expected, suggests University of Washington researcher Kathleen M. Neuzil, MD, MPH, chairwoman of the flu vaccine working group of the Advisory Committee on Immunization Practices (ACIP), the independent panel that recommends vaccine policy to the CDC.
"On the basis of these data, it would be appropriate to begin vaccination with the use of one dose," Neuzil writes in an editorial accompanying a report of the study rushed into online publication by The New England Journal of Medicine. Neuzil, a pediatrician, notes that children may still need two doses of the vaccine. But she says vaccine supplies "should not be held in reserve to be used for a second dose."
The finding comes from a clinical trial of the CSL H1N1 swine flu vaccine in Australia. Some 40% of the 195 million doses of swine flu vaccine purchased by the U.S. will be made by CSL, although other makers' swine flu vaccine is expected to be equally effective. In the Australian study, Michael E. Greenberg, MD, MPH, and colleagues gave the vaccine to two groups of adults, one group age 18 to 50 and the other age 50 to 64. Half of the subjects in each group got a 15-microgram doses of the vaccine -- the same dosage being prepared for U.S. vaccines. The other half got a double 30-microgram dose. Of the 120 volunteers who got the lower dose, 116 -- 96.7% -- developed at least the minimum level of anti-flu antibodies considered to be protective.
"The robust immune response to the H1N1 vaccine after a single dose was unanticipated," Greenberg and colleagues note. "Much of the current global pandemic planning is predicated on previous experience that two doses of vaccine are required to elicit a protective immune response in populations that are immunologically naive to a new influenza strain." U.S. trials of swine flu vaccine are underway. It remains to be seen whether these studies will support the Australian findings. Even then, larger studies will be needed to know exactly how different people, at different ages and with different health status, will react to the vaccine. But Neuzil says that in the face of an ongoing pandemic, it's urgent to deploy the vaccine as soon as possible. "The desire to see all the available data must be balanced with the needed to deploy vaccine quickly to reduce morbidity associated with the pandemic," Neuzil writes.
Single Swine Flu Shot Gives Immunity in Early Tests
By Daniel J. DeNoon
WebMD Health News Reviewed by Louise Chang, MDSept. 10, 2009 -
Adults are immune to swine flu after just one shot of vaccine, early test results suggest. It's a surprise finding. Most experts expected that two shots of the vaccine -- given three weeks apart -- would be needed.
Now vaccine supplies may go twice as far, and may start working twice as fast as expected, suggests University of Washington researcher Kathleen M. Neuzil, MD, MPH, chairwoman of the flu vaccine working group of the Advisory Committee on Immunization Practices (ACIP), the independent panel that recommends vaccine policy to the CDC.
"On the basis of these data, it would be appropriate to begin vaccination with the use of one dose," Neuzil writes in an editorial accompanying a report of the study rushed into online publication by The New England Journal of Medicine. Neuzil, a pediatrician, notes that children may still need two doses of the vaccine. But she says vaccine supplies "should not be held in reserve to be used for a second dose."
The finding comes from a clinical trial of the CSL H1N1 swine flu vaccine in Australia. Some 40% of the 195 million doses of swine flu vaccine purchased by the U.S. will be made by CSL, although other makers' swine flu vaccine is expected to be equally effective. In the Australian study, Michael E. Greenberg, MD, MPH, and colleagues gave the vaccine to two groups of adults, one group age 18 to 50 and the other age 50 to 64. Half of the subjects in each group got a 15-microgram doses of the vaccine -- the same dosage being prepared for U.S. vaccines. The other half got a double 30-microgram dose. Of the 120 volunteers who got the lower dose, 116 -- 96.7% -- developed at least the minimum level of anti-flu antibodies considered to be protective.
"The robust immune response to the H1N1 vaccine after a single dose was unanticipated," Greenberg and colleagues note. "Much of the current global pandemic planning is predicated on previous experience that two doses of vaccine are required to elicit a protective immune response in populations that are immunologically naive to a new influenza strain." U.S. trials of swine flu vaccine are underway. It remains to be seen whether these studies will support the Australian findings. Even then, larger studies will be needed to know exactly how different people, at different ages and with different health status, will react to the vaccine. But Neuzil says that in the face of an ongoing pandemic, it's urgent to deploy the vaccine as soon as possible. "The desire to see all the available data must be balanced with the needed to deploy vaccine quickly to reduce morbidity associated with the pandemic," Neuzil writes.
Report Finds Swine Flu Has Killed 36 Children
Published: September 3, 2009
Federal health officials reported Thursday that at least 36 children in the United States had died of swine flu as of Aug. 8, including many who had underlying disorders of the nervous system. Some also had chronic lung disease, and one had leukemia.
Swine Flu (AH1N1 Virus)But some of the children had been perfectly healthy, and died of bacterial infections with staph or strep that set in after the flu. A report on the deaths was published online Thursday by the Centers for Disease Control and Prevention and discussed at a news conference by Dr. Thomas R. Frieden, the centers’ director. The report said the confirmed death count among people of all ages was 477 as of Aug. 8, but it focused on the toll on children. The 36 who died ranged in age from 2 months to 17 years, with a median age of 9 years. Nearly two-thirds had nervous system disorders like cerebral palsy, muscular dystrophy or developmental delays. Children with nerve and muscle problems may be at especially high risk for complications from the flu because they cannot cough hard enough to clear their airways.
It is too soon to tell whether the H1N1 swine flu will turn out to be more deadly in children than other types of influenza, Dr. Frieden said, adding that in most years 50 to 100 children die of seasonal flu. But so far the swine flu seems to be taking a heavier toll among chronically ill children than the seasonal flu usually does. The deaths mean that children with neurological conditions need to be seen quickly by a doctor if they run a fever, Dr. Frieden said. “Treatment in the first 48 hours can make a big difference in hastening your recovery,” he said. In children without chronic health problems, it is a warning sign if they seem to recover from the flu but then relapse with a high fever, Dr. Frieden said. The relapse may be bacterial pneumonia, which must be treated with antibiotics.
Dr. Frieden urged that children be vaccinated as soon as swine flu vaccine becomes available, probably next month. Health officials have recommended that children be among those given first priority for the vaccine, because they seem more vulnerable than adults to the H1N1 virus and to complications from it. Pregnant women will also receive top priority for the vaccine, because they have a high risk of infection and complications from the flu. Glen Nowak, a spokesman for the disease centers, said health officials worried that pregnant women who were vaccinated and then had miscarriages would blame the vaccine. But he said there was no evidence that flu vaccine increased the risk of miscarriages, which generally occur in 15 percent of pregnancies. Even so, Dr. Frieden said the disease centers would carefully monitor miscarriage rates to determine whether the new vaccine had any such effect.
Another report issued Thursday, by the Institute of Medicine, recommended that health care workers treating people with swine flu protect themselves from infection by wearing a type of specially fitted mask called an N95 respirator, which is tighter and better able to seal out viruses than the more common types of surgical masks. Dr. Frieden said the disease centers had not yet had time to evaluate the new report about masks. A spokesman for the centers said the nation had 79.7 million N95s in the “strategic national stockpile” controlled by the government. To put the H1N1 flu in perspective, Dr. Frieden emphasized that so far, most stricken people had had a relatively mild illness and that the virus had not become any more virulent over time in the United States or any other country.
Health » A version of this article appeared in print on September 4, 2009, on page A13 of th
Subscribe to:
Posts (Atom)
