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Vaccine Study Information
Click here for information on Vaccine Studies in conjunction with University of Md.


 

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We're getting a lot of calls about Lyme Disease. Click here for more information.

 

Vaccine Information 


Who we are:

The Pediatric Center has partnered with The University of Maryland Center for Vaccine Development for over 25 years to evaluate new, improved and combination vaccines.  In fact, many of the best licensed vaccines for protecting children's health were tested right here. Our research nurse, Nancy Wymer RN, has worked at the Frederick site since 1992. She can be contacted at 301-662-2051 or at nwymer@thepedcenter.com.

 Nancy Wymer, R.N.

Suggested Websites:

http://www.chop.edu/consumer/jsp/microsite/microsite.jsp?id=75918

 
 

http://www.cdc.gov/flu/

Current CVD Studies:

Current Studies

Parent Informational Flyer

Age

Questions?

 

 

Evaluate the Safety and Effectiveness of GlaxoSmithKline Biologicals' MMR vaccine when given with routine childhood vaccinations

Flyer available in Recent News section of this website 

12-14 mo

Nwymer@thepedcenter.com

 

What we've done:

Over the past 25 years, The Pediatric Center of Frederick and the University of Maryland CVD            have helped to evaluate many vaccines, including:

Acellular Pertussis Vaccines:
Tdap Sanofi / Tdap GSK

 

Neisseria meningitidis Vaccines:
Conjugate ACWY Meningococcal Sanofi / Conjugate ACWY Meningococcal Novartis

 

Combination Vaccines:
Combined DTaP, IPV, Hib Sanofi
Combined Mumps, Measles, Rubella and Varicella GSK (To be licensed)
Combined Mumps, Measles and Rubella GSK (To be licensed)

Influenza Vaccines:
H5N1 Avian Influenza NIH - DMID / Cold-Adapted Nasal Influenza MedImmune / H1N1 Novel Pandemic Influenza NIH - DMID

 

Streptococcus pneumoniae Vaccines:
Conjugate Pneumococcal Wyeth

 

Hepatitis A Vaccines:
Hepatitis A GSK

Rotavirus Vaccines:
Rotavirus GSK  / Rotavirus Wyeth / Rotavirus Merck

Polio Vaccines:
Polio - oral and injectable

 

Why Immunize?

Benefits of Vaccines
Disease prevention is the key to public health. It is always better to prevent a disease than to treat it. Vaccines prevent disease in the people who receive them and protect those who come into contact with an unvaccinated individual. Once scientists have identified the microorganism or toxin that causes an illness, they pursue a number of approaches to develop a vaccine. All approaches to vaccine development focus on the immune system and the body's natural defenses against foreign invaders. The immune system is made up of highly specialized cells which work together to make antibodies and clear infection from the body. The purpose of a vaccine is to educate a person's immune system so that it is ready to fight disease. Vaccines are second only to hygiene in preventing infection, and new or improved vaccines should be made and studied.

How are Vaccines made and studied?
Vaccines are made in many ways, including weakening, killing, or producing a part of a germ such as a virus or bacteria. The Food and Drug Administration (FDA) is responsible for licensing vaccines in the United States, a process similar to that used for medicines. Vaccines are often more complex than medicines, however, and are called "biologics".
Before a vaccine can be tested in humans, a sponsor must submit an Investigational New Drug application (IND) to the FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release. Also included is information about the vaccine's safety and ability to elicit a protective immune response (immunogenicity) in animal testing, as well as the proposed clinical studies in humans.
Once an IND is obtained, pre-licensure vaccine clinical trials are typically done in three phases. Initial human studies, referred to as Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects. Phase 2 studies are dose-ranging studies and may enroll hundreds of subjects. Finally, Phase 3 trials typically enroll thousands of individuals and provide the critical documentation that the vaccine works. Safety data is critical and collected throughout the whole process. At any stage of the clinical or animal studies, if data raise significant concerns about either safety or lack of efficacy, the FDA may request additional information, or may halt ongoing clinical studies.
If successful, the completion of all three phases of clinical development can be followed by the submission of a Biologics License Application (BLA) to the FDA. Following FDA's review of a BLA, the sponsor and the FDA may present their findings to FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication. If children are to get the vaccines, the vaccines must be studied in children. This is only done after there is safety data from adults, and the potential benefits of the vaccine outweigh the risks.
Vaccine approval also requires the provision of adequate product labeling to allow health care providers to understand the vaccine's proper use, including its potential benefits and risks, to communicate with patients and parents, and to safely deliver the vaccine to the public.
The FDA continues to oversee the production of vaccines after the vaccine and the manufacturing processes are approved, in order to ensure continuing safety. After licensure, monitoring of the product and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the product.
Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market.


Immunization Updates

Vaccines are not just for young children. Adolescents and adults should keep up-to-date on certain immunizations. Unvaccinated adults who did not have certain childhood diseases should consider being immunized. And, people who travel overseas may receive vaccines depending on their destinations.

Since 2005, the following developments have occurred in the field of vaccinology:

  • Two infectious agents (human papillomavirus [HPV] and herpes zoster) were added to the list of vaccine-preventable diseases.
  • One infectious agent (rotavirus) returned, after a more than 5-year hiatus, to the list of vaccine-preventable diseases.
  • Two new formulations of vaccines for infectious agents (meningococcal disease and pertussis) now allow provision of broader coverage to more age groups.
  • A new vaccine combination (measles-mumps-rubella with varicella vaccine -- MMRV [ProQuad], Merck) was released.
  • A form of cancer (cervical) can now be largely prevented by a vaccine against 4 strains of HPV.
  • New emphasis has been placed on vaccination of males and females aged 11-12 years and older against meningococcal disease and pertussis, and for females against HPV, in turn potentially strengthening the role of the preadolescent healthcare visit.


When children return to school, it's a convenient time to remind parents that they may also need vaccines themselves.

Adults may need:

  • A booster dose of tetanus toxoid
  • A hepatitis B or hepatitis A vaccine
  • A pneumococcal vaccine
  • And with influenza season nearly upon us, many adults need a flu vaccine
  • Vaccines for travel (if applicable)


Vaccines of the Future
Vaccines remain among the most powerful tools we have for disease prevention, and advances in biotechnology have ushered in a new era in vaccine development that holds even more promise for improving public health. Currently scientists are pursuing many promising new strategies in vaccine development and exploring novel ways to administer vaccines that may provide safer, more effective ways to fight disease.

 

 

 


 

 

  1475 Taney Avenue | Frederick, MD 21702 | phone 301.662.0133 | fax 301.695.8604 | © 2007