H1N1 Influenza Vaccine Trial in Pregnant Women

Dec. 24, 2009 - PRLog -- The first H1N1 Influenza Vaccine trial testing a candidate 2009 H1N1 influenza vaccine in pregnant lady is launching this week, a report from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health told

"Women are usually at higher risk of developing harsh illness if they become infected with influenza virus while they pregnant, which is why they are strongly encouraged to receive the cyclic influenza vaccine every year.” Report indicates that pregnant women are at more risk for complications from the 2009 H1N1 influenza virus as well, so this trial will provide dangerous information for public health planning."

The H1N1 Influenza Vaccine trial is being conducted through the NIAID-funded national network of Vaccine and Treatment Evaluation Units (VTEUs).

The American public has revealed once again its remarkable willingness to step up and help during an emergency. The interest in this trial has been strange, and participating medical centers expect to fill all the available slots for volunteers shortly.

Up to 120 women 18 to 39 years of age who are in their second or third trimester (14 to 34 weeks) of pregnancy will be enrolled into this primary trial. Volunteers will receive 15 micrograms or 30 micrograms of a candidate 2009 H1N1 influenza vaccine manufactured. All women will receive a primary injection and a second injection 21 days later. Safety data will be collected and assessed continuously throughout the trial by the study investigators and by an independent safety monitoring team. Study investigators will take blood samples to conclude how the immune system responds to the vaccine at set time points before and following each vaccination. Cord blood also to be collected to calculate maternal antibodies transferred to the infants through the placenta.

Because the vaccine contains inactivated virus, it is not possible to become infected with the 2009 H1N1 influenza virus by taking this vaccine. This vaccine contains no thimerosal, a preservative, or adjuvant, a substance added to some vaccines to improve the body's response to vaccine.

The design of this H1N1 Influenza Vaccine trial in pregnant women is decorated after clinical trials that opened in August through NIAID's VTEU network. Those trials are testing the same vaccine in various groups of healthy individuals, including adults, the elderly and children. The candidate vaccine is being tested in a pregnant woman because they represent a population who public health officials have recommended to receive a licensed 2009 H1N1 influenza vaccine when it becomes available this fall.

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