Navigation Links
Smallpox Vaccine Clinical Study Now Enrolling at Avail Clinical Research near Orlando, Florida; Accepting Healthy M/F Age 18-40
Date:3/27/2013

Orlando, Florida (PRWEB) March 27, 2013

*Avail Clinical Research conducts Clinical Trials near Orlando, FL. For more information about participating in this Vaccine Clinical Trial, please visit our website or contact us directly at (386) 310-1334

BACKGROUND & SCIENTIFIC RATIONALE

Despite the fact that the World Health Organization (WHO) officially declared successful global eradication of smallpox in 1980, the existence of variola stockpiles and the threat of bioterrorism demands to maintain immunity to smallpox through vaccination.

After the events of September 11th, 2001, concern over the use of bioweapons as agents of terrorism increased. As mass vaccination programs halted more than 30 years ago, it is estimated that the majority of the world population has no existing immunity to smallpox, and as such, the release of this highly contagious virus would have devastating effects.

As a consequence, there is an urgent need for a safe and efficacious vaccine to protect the public against smallpox.

PRIMARY OBJECTIVE

-To assess the consistency of three consecutively produced IMVAMUNE® lots.

SECONDARY OBJECTIVE

-To assess uncommon adverse reactions, in particular any cardiac sign and symptom indicating a case of myo-/pericarditis, and to compare the frequency of those reactions against placebo.

-To collect vaccinia-specific humoral immune response data.

INCLUSION CRITERIA

1. Male and female subjects, 18 to 40 years of age

2. The subject has read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures

3. BMI greater than/equal to 18.5 and less than 35

4. Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products)

5. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination

6. White blood cells greater than/equal to 2,500/mm3 and less than ULN

7. Absolute neutrophil count (ANC) within normal limits

8. Hemoglobin within normal limits

9. Platelets within normal limits

10. Adequate renal function defined as a calculated Creatinine Clearance (CrCl) greater than 60 ml/min as estimated by the Cockcroft- Gault equation

11. Adequate hepatic function

12. Troponin I less than 2 x ULN

13. Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia)

For information about how to participate in a Vaccine Clinical Trial, visit Avail Clinical Research or contact us directly at (386) 310-1334

Read the full story at http://www.prweb.com/releases/trials/smallpox/prweb10567096.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Man Who Got Smallpox Vaccine Passes Milder Infection to Sex Partner: CDC
2. Study: Research reveals protective properties of influenza vaccines
3. TransactRx Pharmacy Vaccine Billing Provider Partners with R.J. Hedges & Associates
4. Study offers new way to discover HIV vaccine targets
5. Parents Worries About HPV Vaccine on the Rise: Study
6. Japanese P2 study shows potential of combined vaccine and steroid drug in castration-resistant PCa
7. Japanese P2 study shows potential of combined vaccine and steroid drug in castration resistant PCa
8. Chicken pox vaccine saving childrens lives
9. Prediction of seasonal flu strains improves chances of universal vaccine
10. New cancer vaccine shows future promise in treating and preventing metastatic cancers
11. H1N1 Swine Flu Vaccine Tied to Sleep Disorder in British Children
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes ... a mock evacuation of the facility as part of a disaster drill on October ... Hose EMS and Shelton City Emergency Manager, as well as the Connecticut Long ...
(Date:10/13/2017)... Texas (PRWEB) , ... October 13, 2017 , ... Yisrayl ... this week that explains one of the most popular and least understood books in ... like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance (FHC), an ... showcase a range of technology and learning solutions at the 68th Annual American ... to be held October 14–18, 2017 at the Mandalay Bay Resort in Las ...
(Date:10/12/2017)... ... ... The American College of Medical Informatics (ACMI) will present the 2017 Morris F. ... AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is taking place ... the field of medical informatics, this prestigious award is presented to an individual whose ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s National ... 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. ... for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... 2017 AVACEN Medical , Inc. (AVACEN) announced ... 2017 New Product Innovation Award for Its fibromyalgia pain ... secondary medical device market research by Frost & Sullivan,s industry ... drug-free pain relief product, the AVACEN 100, offers a safe ... widespread pain. ...
(Date:10/11/2017)... Texas , Oct. 11, 2017  Caris Life ... focused on fulfilling the promise of precision medicine, today ... has joined Caris, Precision Oncology Alliance™ (POA) as its ... cancer centers, the St. Jude Crosson Cancer Institute will ... advance the use of tumor profiling, making cancer treatment ...
(Date:10/10/2017)...   West Pharmaceutical Services, Inc. (NYSE: WST), ... administration, today shared the results of a study highlighting ... intradermal administration of polio vaccines. The study results were ... 2017 by Dr. Ondrej Mach , Clinical Trials ... (WHO), and recently published in the journal Vaccine. ...
Breaking Medicine Technology: