Trials - Swine Flu vaccine in pregnant women

[Guest guest]

Some questions have popped up in recent weeks about pregnant women receiving the

H1N1 vaccine.  Here's info about a study being done... and I can think of

nothing scarier than to use pregnant women and their fetuses as lab rats... er,

test subjects...

 

Andrea Beth

 

Traditional Oriental Medicine

Happy Hours in the CALM Center

635 S. 10th St.

Cottonwood, AZ  86326

(928) 274-1373

 

 

U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH NIH News

National Institute of Allergy and Infectious Diseases (NIAID)

<http://www.niaid.nih.gov/>

For Immediate Release: Wednesday, September 9, 2009

 

CONTACT:

NIAID Office of Communications, 301-402-1663, <e-mail: niaidnews

 

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.

 

Detailed information about this study can be found on the ClinicalTrials.gov Web

site.

 

H1N1Vaccine in Pregnant Women NCT0093430

(http://www.clinicaltrials.gov/ct2/show/NCT00963430?term=NCT00963430 & rank=1)

 

NIAID is planning to conduct additional trials in pregnant women testing

candidate 2009 H1N1 influenza vaccines made by other manufacturers.

 

For

more information about NIAID-sponsored clinical trials in pregnant

women, see Questions and Answers: Trial of Candidate 2009 H1N1

Influenza Vaccine in Pregnant Women

(http://www3.niaid.nih.gov/news/QA/H1N1pregnanttrials.htm).

 

Additional information about

NIAID-sponsored clinical trials of candidate H1N1 vaccines: Clinical

Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported

Vaccine and Treatment Evaluation Units

(http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm) and Pediatric Trials of

Candidate 2009 H1N1 Vaccine at NIAID Vaccine and Treatment Evaluation Units

(VTEUs) (http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm).

 

Visit www.flu.gov for one-stop access to U.S. government information on avian

and pandemic influenza. A www.flu.gov Webcast on H1N1 and pregnant women

featuring NIAID Director Dr. Fauci is available at

<http://www.flu.gov/news/knowwhattodo.html#082709>.

 

Also, visit NIAID's flu Web portal (http://www3.niaid.nih.gov/topics/Flu/).

 

NIAID conducts and supports research-at NIH,

throughout the United States, and worldwide-to 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

Agency -- includes 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 <www.nih.gov>.

------------------------------

REFERENCE: DJ Jamieson et al. H1N1 2009 influenza virus infection during

pregnancy in the USA. The Lancet DOI: 10.1016/S014-6736(09)61304-0 (2009).

 

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This NIH News Release is available online at:

<http://www.nih.gov/news/health/sep2009/niaid-09.htm>.

 

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