Navigation Links
NIAID launches 2009 H1N1 influenza vaccine trial in pregnant women

The first trial testing a candidate 2009 H1N1 influenza vaccine in pregnant women is launching this week, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced today.

"Women are at higher risk of developing severe illness if they become infected with influenza virus while pregnant, which is why they are strongly encouraged to receive the seasonal influenza vaccine every year," says NIAID Director Anthony S. Fauci, M.D. "Data indicate that pregnant women are at higher risk for complications from the 2009 H1N1 influenza virus as well, so this trial will provide critical information for public health planning."

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

"The American public has shown once again its remarkable willingness to step up and help during an emergency. The interest in this trial has been extraordinary, and participating medical centers expect to fill all the available slots for volunteers soon," Dr. Fauci adds.

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 initial trial. Volunteers will receive 15 micrograms or 30 micrograms of a candidate 2009 H1N1 influenza vaccine manufactured by Sanofi Pasteur. All women will receive an initial 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 committee. Study investigators will take blood samples to determine how the immune system responds to the vaccine (for example, by producing antibodies) at set time points before and following each injection. Cord blood will also be collected to measure maternal antibodies transferred to the infants through the placenta.

Because the vaccine contains inactivated virus, it is impossible to become infected with the 2009 H1N1 influenza virus by receiving this vaccine. The 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 trial in pregnant women is patterned 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 also being tested in pregnant women 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.

The trial is taking place at the following six medical centers: Baylor College of Medicine VTEU in Houston; Group Health Cooperative Center for Health Studies VTEU in Seattle; Saint Louis University VTEU; Vanderbilt University VTEU in Nashville; Duke University in Durham, N.C.; and Scott and White Memorial Hospital and Clinic in Temple, Tex.

In a paper published Aug. 8 in The Lancet, researchers from the Centers for Disease Control and Prevention reported that six of 45 people (13 percent) who died from 2009 H1N1 influenza between mid-April and mid-June were pregnant women. In addition, during the first month of the H1N1 outbreak, the estimated rate of hospitalization for H1N1 infection in pregnant women was approximately four times higher than it was in the general population. U.S. public health officials, following the recommendation of CDC's Advisory Committee on Immunization Practices, have designated pregnant women among the top priority groups to receive the 2009 H1N1 influenza vaccine when it becomes available.


Contact: NIAID Office of Communications
NIH/National Institute of Allergy and Infectious Diseases

Related medicine news :

1. NIAID funds clinical trials that address the problem of antimicrobial resistance
2. NIAID Awards New Grant to Expand Studies of Peregrines Anti-PS Antibodies to Treat Viral Hemorrhagic Fevers
3. NIAID to fund new human immune profiling research centers
4. NIAID media availability: Still searching for predictors of asthma attacks
5. NIAID set to launch clinical trials to test 2009 H1N1 influenza vaccine candidates
6. NIAID media availability: New strategy proposed for designing antibody-based HIV vaccine
7. J. Craig Venter Institute Awarded $43 Million, Five Year Contract From NIAID to Continue to Develop and Provide Sequencing, Genotyping, and Bioinformatics Expertise and Services in Infectious Diseases
8. NIAID and Chinese officials sign agreement to foster TB research in Chinas Henan province
9. NIAID honors AIDS activist Martin Delaney
10. NIAID media availability: Seizures following parasitic infection associated with brain swelling
11. NIAID awards contracts to search for protein markers of disease
Post Your Comments:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Conventional wisdom preaches ... success. In terms of the latter, setting the bar too high can result in ... than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Scientific Sessions in Dallas that it will receive two significant new grants to ... came as PHA marked its 25th anniversary by recognizing patients, medical professionals and ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their ... Award, an essay contest in which patients and their families pay tribute to a ... the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm Slone Partners is ... sequencing and genomics experience, as Vice President of North American Capital Sales at ... for leading the sales team in the commercialization of the HTG EdgeSeq system and ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... Improvements Act of 1976, as amended ("HSR"), with respect ... Nasdaq: CPXX ) expired effective June 24, ... As previously announced on May 31, 2016, Jazz Pharmaceuticals ... which Jazz Pharmaceuticals has commenced a tender offer for ...
(Date:6/26/2016)... , June 26, 2016 ... value-based care operating models within the health care industry ... greater financial efficiency , Deloitte offers a suite ... key business issues impacting efficient cost optimization: labor resource ... , These services facilitate better outcomes and better economics ...
(Date:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
Breaking Medicine Technology: