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Frequently Asked Questions

Immunization studies

Vaccine Safety Bibliography

Vaccine Schedule, Multiple Vaccines, & Your Child’s Immune System

Vaccine Ingredients

  • Aluminum
  • Thimerosal

Vaccine Safety Testing

MMR Vaccine and Autism: Lack of Association

HPV Vaccine Safety Studies

  • HPV Vaccine Safety Reviews
  • HPV9 Vaccine Safety Studies
  • HPV4 Vaccine Safety Studies
  • HPV Vaccine for Males
  • HPV Vaccine and Autoimmune Disorders

Influenza Vaccine Studies

Pregnancy and Vaccine Safety

  • Pregnancy and Influenza Vaccine
  • Pregnancy and Pertussis Vaccine/Tdap                                

 

Vaccine Schedule, Multiple Vaccines, & Your Child’s Immune System

  • The Vaccine Schedule

The induction of breast milk pertussis specific antibodies following gestational tetanus-diphtheria-acellular pertussis vaccination.
Raya et al. Vaccine, 2014 (Abstract)

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Libster R et al. Pediatrics, 2016 (abstract)

Recommended immunization schedule: What you should know
Vaccine Education Center. Children’s Hospital of Philadelphia, 2012 (full article)

Childhood immunization schedule and safety: Stakeholder concerns, scientific evidence, and future studies
Hinshaw et al. Institute of Medicine of the National Academies, 2013 (full article)

On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes
Smith & Woods. Pediatrics, 2010 (abstract)

Timely versus delayed early childhood vaccination and seizures
Hambidge et al. Pediatrics, 2014 (full article)

Vaccinating my way – use of alternative vaccination schedules in New York State
Nadeau et al. The Journal of Pediatrics, 2015 (abstract)

Delaying vaccination is not a safer choice
Feemster & Offit. Journal of the American Medical Assn, 2013 (abstract)

The association between intentional delay of vaccine administration and timely childhood vaccination coverage
Smith et al. Public Health Report, 2010 (full article)

The problem with Dr. Bob’s alternative vaccine schedule
Offit & Moser. Pediatrics, 2009 (full article)

 

  • Multiple Vaccines & Your Child’s Immune System

MenACWY-TT is immunogenic when co-administered with Tdap and AS04-HPV16/18 in girls and young women: Results from a phase III randomized trial.
Rivera et al. Vaccine, 2018 (full article)

Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study.
Dbaibo et al. 
Vaccine. 2018 (full article)

Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non–Vaccine-Targeted Infections From 24 Through 47 Months of Age
Glanz et al.  JAMA, 2018 (abstract)

Long-term measles-induced immunomodulation increases overall childhood infectious disease mortality
Moro et al. Clinical Infectious Diseases, 2015 (abstract)

Too many vaccines? What you should know
Vaccine Education Center. Children’s Hospital of Philadelphia, 2015 (full article)

Safety of vaccines used for routine immunizations of US children: A systematic review
Maglione et al. Pediatrics, 2014 (full article)

Safety and immunogenicity of early vaccination with two doses of tetravalent measles-mumps-rubella-varicella (MMRV) vaccine in healthy children from 9 months of age
Goh et al. Infection, 2007 (abstract)

Addressing parents’ concerns: Do vaccines cause allergic or autoimmune diseases?
Offit & Hackett Pediatrics, 2003 (full article)

Addressing parents’ concerns: Do multiple vaccines overwhelm or weaken the infant’s immune system?
Offit et al. Pediatrics, 2002 (full article)

Loss maternally derived measles immunity in Argentinian infants
Nates et al. Pediatric Infectious Disease Journal, 1998 (abstract)

 

Vaccine Ingredients

Comparative Safety of Vaccine Adjuvants: A Summary of Current Evidence and Future Needs.
Petrovsky N. Drug Safety, 2015 (abstract)

Vaccine ingredients: What you should know

Vaccine Education Center. Children’s Hospital of Philadelphia, 2012 (full article)

Aluminum

Aluminum in vaccines: What you should know
Vaccine Education Center. Children’s Hospital of Philadelphia, 2014 (full article)

Safety and immunogenicity of a primary series of Sabin-IPV with and without aluminum hydroxide in infants
Verdijk et al. Vaccine, 2014 (abstract)

Mechanism of immunopotentiation and safety of aluminum adjuvants
Hogenesch. Front Immunology, 2013 (full article)

Updated aluminum pharmacokinetics following infant exposures through diet and vaccination
Mitkus et al. Vaccine, 2011 (abstract)  

Aluminum salts in vaccines — US perspective
Baylor et al. Vaccine, 2002 (abstract)       

Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine
Sobanjo-ter et al. Pediatric Infectious Disease Journal, 2015 (abstract)                      

Thimerosal

Pediatric vaccines and neurodevelopment: Primate study finds no adverse behavioral effects
Barrett. Environmental Health Perspectives, 2015 (full article)

Prenatal and infant exposure to thimerosal from vaccines and immunoglobulins and risk of autism
Price et al. Pediatrics, 2010 (full article)

Continuing increases in autism reported to California’s developmental services system
Schechter & Grether. Archives of General Psychiatry, 2008 (abstract)

Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years 
Thompson et al. New England Journal of Medicine, 2007 (full article)

Lack of association between Rh status, Rh immune globulin in pregnancy and autism    
Miles & Takahashi. American Journal of Medical Genetics, 2007 (full article)

Comparison of brain mercury levels in infant monkeys exposed to methylmercury or vaccines containing thimerosal
Burbacher et al. Environmental Health Perspectives, 2005 (full article)

Thimerosal exposure in infants and developmental disorders: A prospective cohort study in the United Kingdom does not support a causal association
Heron & Golding. Pediatrics, 2004 (abstract)

Neurotoxic effects of postnatal thimerosal are mouse strain dependent 
Hornig et al. Molecular Psychiatry, 2004 (full article)

Safety of thimerosal-containing vaccines: A two-phased study of computerized health maintenance organization databases    
Verstaeten et al. Pediatrics, 2004 (abstract)

Association between thimerosal-containing vaccine and autism
Hviid et al. Journal of the American Medical Association, 2003 (full article)

Thimerosal and the occurrence of autism: Negative ecological evidence from Danish population-based data 
Madsen et al. Pediatrics, 2003 (abstract)

Autism and thimerosal-containing vaccines: Lack of consistent evidence for an association 
Steer-Green et al. American Journal of Preventative Medicine, 2003 (abstract)

Thimerosal and autism?          
Nelson & Bauman. Pediatrics, 2003 (full article)

Mercury concentrations and metabolism in infants receiving vaccines containing thimerosal: A descriptive study     
Pichichero et al. The Lancet, 2002 (abstract)

Mercury levels in newborns and infants after receipt of thimerosal-containing vaccines   
Pichichero et al. Pediatrics, 2008 (abstract)

Addressing parents’ concerns: Do vaccines contain harmful preservatives, adjuvants, additive, or residuals?         
Offit & Jew. Pediatrics, 2003 (full article)           

 


Vaccine Safety Testing   

Vaccination and 30-Day Mortality Risk in Children , Adolescents, and Young Adults
McCarthy et al. 2016 Pediatrics (full article)

Risk of anaphylaxis after vaccination in children and adults
McNeil MM et al. J Allergy Clin Immunol, 2015 (abstract)

Deaths reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 1997-2013
Moro et al. Clinical Infectious Diseases, 2015 (abstract)

Clinical vaccine development
Seunghoon. Clinical and Experimental Vaccine Research, 2015 (full article)

Integrating safety and efficacy evaluation throughout vaccine research and development
Curlin et al. Pediatrics, 2011 (full article)

Food and Drug Administration regulation and evaluation of vaccines 
Marshall & Baylor. Pediatrics, 2010 (full article)

Ensuring the optimal safety of licensed vaccines: A perspective of the vaccine research, development, and manufacturing companies
Kanesa-Thasan et al. Pediatrics, 2010 (full article)

Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration 
Bell et al. Pediatrics, 2010 (full article)         

        

MMR Vaccine and Autism: Lack of Association

Autism occurrence by MMR vaccine status among US children with older siblings with and without autism         
Jain et al. The Journal of the American Medical Association, 2015 (abstract)

Patches of disorganization in the neocortex of children with autism
Stoner et al. New England Journal of Medicine, 2014 (full article)

Age-dependent brain gene expression and copy number anomalies in autism suggest distinct pathological processes at young versus mature ages
Chow et al. Public Library of Science Genetics, 2012 (full article)

Lack of association between measles-mumps-rubella vaccination and autism in children: A case-control study
Mrozek-Budzyn et al. The Pediatric Infectious Disease Journal, 2010 (abstract)

Lack of association between measles virus vaccine and autism with enteropathy: A case-control study
Hornig et al. Public Library of Science, 2008 (full article)

Measles vaccination and antibody response in autism spectrum disorders       
Baird et al. Archives of Disease in Childhood, 2008 (abstract)

Measles vaccination and antibody response in autism spectrum disorders 
Baird et al. Archives of Disease in Childhood, 2008 (abstract)

MMR-vaccine and regression in autism spectrum disorders: Negative results presented from Japan
Uchiyama et al. Journal of Autism and Developmental Disorders, 2007 (abstract)

Pervasive developmental disorders in Montreal, Quebec, Canada: Prevalence and links with immunizations 
Fombonne et al. Pediatrics, 2006 (abstract)

No evidence of persisting measles virus in peripheral blood mononuclear cells from children with autism spectrum disorder      
D’Souza et al. Pediatrics, 2006 (abstract)

No effect of MMR withdrawal on the incidence of autism: A total population study        
Honda et al. Journal of Child Psychology and Psychiatry, 2005 (full article)

Age at first measles-mumps-rubella vaccination in children with autism and school-matched control subjects: A population-based study in metropolitan Atlanta
DeStefano et al. Pediatrics, 2004 (abstract)

Relationship between MMR vaccine and autism
Klein & Diehl. The Annals of Pharmacology, 2004 (abstract)

MMR vaccination and pervasive developmental disorders: A case-control study
Smeeth et al. The Lancet, 2004 (abstract)

Association of autistic spectrum disorder and the measles, mumps, and rubella vaccine
Wilson et al. Archives of Pediatrics & Adolescent Medicine, 2003 (abstract)

Neurologic disorders after measles-mumps-rubella vaccination
Makela et al. Pediatrics, 2002 (abstract)

Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: Population study 
Taylor et al. BMJ, 2002 (full article)

Neurologic disorders after measles-mumps-rubella vaccination
Makela & Peltola. Pediatrics, 2002 (abstract)

A population-based study of measles, mumps, and rubella vaccination and autism    
Madsen et al. New England Journal of Medicine, 2002 (full article)

Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: A time trend analysis 
Kaye et al. The BMJ, 2001 (full article)

MMR and autism: Further evidence against a causal association
Farrington et al. Vaccine, 2001 (abstract)

Time trends in autism and in MMR immunization coverage in California 
Dales et al. The Journal of the American Medical Association, 2001 (full article)

No evidence for a new variant of measles-mumps-rubella-induced autism
Fombonne & Chakrabarti. Pediatrics, 2001 (full article)

Autism and measles, mumps, and rubella vaccine: No epidemiological evidence for causal association
Taylor et al. The Lancet, 1999 (abstract)

No evidence for measles, mumps, and rubella vaccine-associated inflammatory bowel disease or autism in a 14-year prospective study    
Peltola et al. The Lancet, 1998 (requires paid subscription to view)                       

 

HPV Vaccine Safety Studies

HPV Vaccine Safety Reviews

Ten years of human papillomavirus vaccination in the United States.
Markowitz et al.
Acad Pediatr. 2018. (full article)
 
Safety of Human Papillomavirus Vaccines: An Updated Review.
Phillips et al.
Drug Saf. 2018 (abstract)

Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine.
Sy et al.
Hum Vaccin Immunother. 2018. (abstract)

Safety of human papillomavirus vaccines in healthy young women: a meta-analysis of 24 controlled studies.
Ogawa et al.
J Pharm Health Care Sci. 2017. (full article) 

Quadrivalent HPV vaccine safety review and US safety monitoring plans for nine-valent HPV vaccine
Gee et al. Human Vaccine Immunotherapy, 2016 (abstract)

Vaccines against human papillomavirus in low and middle income countries: A review of safety, immunogenicity and efficacy
Nakalembe et al. Infectious Agents and Cancer, 2015 (full article)

Safety of human papillomavirus vaccines: A review
Stillo et al. Expert Opinion on Drug Safety, 2015 (full article)

Systematic review of human papillomavirus vaccine coadministration
Noronha et al. Vaccine, 2014 (abstract)

Safety, tolerability and side effects of human papillomavirus vaccines: A systematic quantitative review
Gonçalves et al. Brazilian Journal of Infectious Diseases, 2014 (full article)
 

HPV-9 Vaccine Studies

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine: Subgroup analysis of participants from asian countries.
Garland et al. 
J Infect Dis. 2018 (abstract)

Summary of the NACI Update on the recommended use of human papillomavirus (HPV) vaccine: Nine-valent HPV vaccine two-dose immunization schedule and the use of HPV vaccines in immunocompromised populations.
Deeks, Tunis, Ismail; National Advisory Committee on Immunization. 
Can Commun Dis Rep
. 2017.  (full article)

Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age.
Moreira et al. 
Hum Vaccin Immunother. 2018 (full article)

An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age
Kosalaraksa et al. Pediatric Infectious Disease Journal, 2015 (abstract)

A randomized, double-blind, Phase III study of the immunogenicity and safety of a 9-valent human papillomavirus L1 virus-like particle vaccine (V503) versus Gardasil®in 9-15-year-old girls
Vesikari et al. Pediatric Infectious Disease Journal, 2015 (abstract)
 

HPV-4 Vaccine Studies

An overview of quadrivalent human papillomavirus vaccine safety – 2006 to 2015
Vichnin et al. Pediatric Infectious Disease Journal, 2015 (abstract)

Evaluation of the long-term anti-HPV 6, 11, 16, and 18 immune responses generated by Gardasil
Nygård et al. Clinical and Vaccine Immunology, 2015 (abstract)

Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to two- and three-dose schedules in girls aged 9-14 years: results to month 12 from a randomized trial
Leung et al. Human Vaccines & Immunotherapies, 2015 (full article)

Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience
Angelo et al. Pharmacoepidemiology and Drug Safety, 2014 (full article)

Safety and immunogenicity of a quadrivalent human papillomavirus vaccine in HIV-infected and HIV-negative adolescents and young adults
Giacomet et al. Vaccine, 2014 (abstract)

FDA Sentinel study finds no association between venous thromboembolism and Gardasil vaccination
Food and Drug Administration, 2015 (abstract)

HPV Vaccine for Males

HPV related diseases in males: A heavy vaccine-preventable burden
Canepa et al. Journal of Preventative Medicine and Hygiene, 2013 (abstract)

HPV Vaccine and Autoimmune Disorders

Association between human papilloma virus (HPV) vaccination and risk of multiple sclerosis: A systematic review.
Meggiolaro A, Migliara G, La Torre G.
Hum Vaccin Immunother. 2018. (full article)

Human papillomavirus vaccine and demyelinating diseases-A systematic review and meta-analysis.
Mouchet et al. 
Pharmacol Res. 2018 (full article)

Absence of association between Guillain-Barré syndrome hospitalizations and HPV-vaccine.
Deceuninck et al.
Expert Rev Vaccines. 2018  (full article)

Risk of Guillain-Barré syndrome following quadrivalent human papillomavirus vaccine in the Vaccine Safety Datalink. (full article)
Gee J, Sukumaran L, Weintraub E; Vaccine Safety Datalink Team.
Vaccine. 2017 (full article)

Immunogenicity and safety of the human papillomavirus vaccine in patients with autoimmune diseases: A systematic review
Pellegrino et al. Vaccine, 2015 (abstract)

Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects
Grimaldi-Bensouda et al. Journal of Internal Medicine, 2014 (abstract)

Guillain–Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States
Rohit et al. Human Vaccines & Immunotherapies, 2014 (full article)                         


 

Influenza Vaccine Studies

Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasons
Li et al. Pharmacoepidemiol Drug Safety, 2016 (abstract)

Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial
Cadorna-Carlos et al. Vaccine, 2015 (full article)

The burden of influenza hospitalization in infants from 2003 to 2012, United States
Chaves et al.  Pediatric Infectious Disease Journal, 2014 (abstract)

Prevention and control of seasonal influenza with vaccines
Grohskopf et al.  CDC Morbidity and Mortality Weekly Report, 2013 (full article)

Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old   
Hambidge et al. The Journal of the American Medical Association, 2006 (full article)

Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma
Fleming et al. Pediatric Infectious Disease Journal, 2006 (abstract)

A randomized, double-blind study of the safety, transmissibility and phenotypic and genotypic stability of cold-adapted influenza virus vaccine
Vesikari et al. Pediatric Infectious Disease Journal, 2006 (abstract)


 

Pregnancy and Vaccine Safety

Maternal and infant outcomes among women vaccinated against pertussis during pregnancy
Berenson et al. Human Vaccine Immunotherapy, 2016 (abstract)

Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis and Influenza Vaccinations in Pregnancy
Sukumaran, L. Obstetrics & Gynecology, 2015 (full article)

Breastfeeding after maternal immunization during pregnancy: Providing immunological protection to the newborn: A review
Maertens et al.  Vaccine, 2014 (abstract)

Maternal immunization: an update for pediatricians
Munoz. Pediatric Annals, 2013 (abstract)

Safety of immunization during pregnancy: A review of the evidence of selected inactivated and live attenuated vaccines       
Keller-Stanislawski et al. Vaccine, 2014 (abstract)

Prenatal infection and schizophrenia: A review of epidemiological and translational studies
Brown & Derkits. American Journal of Psychiatry, 2009 (full article)

Gestational influenza and bipolar disorder in adult offspring
Parboosing et al. JAMA Psychiatry, 2013 (full article)

Chorioamnionitis following vaccination in the Vaccine Adverse Event Reporting System
Datwani et al. Vaccine, 2015 (abstract)

Management of hepatitis B in pregnancy: Weighing the options          
Tran. Cleveland Clinic Journal of Medicine, 2009 (full article)

Pregnancy and Influenza Vaccine

Perinatal survival and health after maternal influenza A(H1N1)pdm09 vaccination: A cohort study of pregnancies stratified by trimester of vaccination
Baum et al. Vaccine, 2015 (abstract)

Influenza vaccination during pregnancy: A systematic review of fetal death, spontaneous abortion, and congenital malformation safety outcomes      
McMillan et al. Vaccine, 2015 (abstract)

Effectiveness of seasonal trivalent influenza vaccine for preventing influenza virus illness among pregnant women: A population-based case-control study during the 2010-2011 and 2011-2012 influenza seasons
Thompson et al. Clinical Infectious Diseases, 2014 (full article)

Maternal influenza vaccine and risks for preterm or small for gestational age birth
Nordin et al. The Journal of Pediatrics, 2014 (full article)

Safety of influenza vaccination during pregnancy: A review of subsequent maternal obstetric events and findings from two recent cohorts
Naleway et al. Vaccine, 2014 (abstract)

Influenza vaccination during pregnancy
Committee on Obstetric Practice and Immunization Expert Work Group.  American College of Obstetrics and Gynecologists, 2014 (full article)

Maternal and neonatal outcomes among pregnant women with 2009 pandemic Influenza A (H1N1) illness in Florida, 2009-2010: A population-based cohort study
Doyle et al. PLoS One, 2013 (full article)

Effects of influenza on pregnant women and infants
Rasmussen et al. American Journal of Obstetrics and Gynecology, 2012 (full article)

Severity of 2009 pandemic Influenza A (H1N1) virus infection in pregnant women
Creanga et al. Obstetrics and Gynecology, 2010 (full article)

Influenza vaccine given to pregnant women reduces hospitalization due to influenza in their infants
Benowitz et al. Clinical Infectious Diseases, 2010 (full article)

Safety of influenza immunization during pregnancy for the fetus and the neonate         
Bednarczyk et al. American Journal of Obstetrics and Gynecology, 2012 (abstract)

Risk of fetal death after pandemic influenza virus infection or vaccination          
Haberg et al. New England Journal of Medicine, 2013 (full article)

Benefits of influenza vaccination during pregnancy for pregnant women          
Jamieson et al. American Journal of Obstetrics and Gynecology, 2012 (abstract)

Pregnancy and Pertussis Vaccine/Tdap

Prenatal tetanus, diphtheria, acellular pertussis vaccination and autism spectrum disorder
Becerra-Culqui et al. Pediatrics, 2018 (full article)

Strategies to decrease pertussis transmission to infants
Forsyth et al. Pediatrics, 2015 (full article)

First pertussis vaccine dose and prevention of infant mortality
Tiwari et al. Pediatrics, 2015 (abstract)

Safety of pertussis vaccination in pregnant women in UK: Observational study
Donegan et al. The BMJ, 2014 (full article)

Association of childhood pertussis with receipt of 5 dises of pertussis vaccine by time since last vaccine dose, California, 2010
Misegades et al.  Journal of the American Medical Association, 2014 (full article)

Effectiveness of maternal pertussis vaccination in England: An observational study
Amirthalingam et al. The Lancet, 2014 (full article)

Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: A randomized clinical trial
Munoz et al. The Journal of the American Medical Association, 2014 (full article)

Update on immunization and pregnancy: Tetanus, diphtheria, and pertussis vaccination
Committee on Obstetric Practice and Immunization Expert Work Group.  American College of Obstetrics and Gynecologists, 2013 (full article)

Protecting pregnant women, newborns, and families from pertussis
Lloyd. Journal of Midwifery & Women’s Health, 2013 (full article)

Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: Pregnancy and infant health outcomes 
Shakib et al. The Journal of Pediatrics, 2013 (full article)

Pregnancy dose Tdap and postpartum cocooning to prevent infant pertussis: A decision analysis
Terranella et al. Pediatrics, 2013 (full article)

Updated recommendation for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) in pregnant women and persons who have or anticipate having close contact with an infant aged <12 months
Advisory Committee on Immunization Practices. CDC Morbidity and Mortality Weekly Report, 2011 (full article)

Infant pertussis: Who was the source?
Bisgard et al.  Pediatric Infectious Disease Journal, 2004 (full article)