Kaiser Permanente Vaccine Study Center: Highlights of 2009–2012
2. Study Highlights
2.1. Clinical Trials
- Evaluated the safety and immunogenicity of the combination vaccine DTaP-IPV with MMR with and without varicella vaccine in 4–6 year olds .
- Evaluated the safety and immunogenicity of an investigational combination measles, mumps, rubella, varicella (MMRV) vaccine with hepatitis A and 7-valent pneumococcal conjugate vaccine in 1–2 year olds .
- Evaluated the safety and immunogenicity of inactivated hepatitis A vaccine concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) and Haemophilus influenzae type b (HiB) vaccines .
- Safety and immunogenicity of MenACWY—CRM in infants , toddlers (with and without MMRV vaccine) , children aged 2–10 years  and adolescents [9,10]. Novartis’ quadrivalent meningitis vaccine uses a mutant diphtheria toxoid as the conjugate. The product is now licensed for ages 2–55 years in the U.S.
- Long term follow up studies designed to evaluate the 5 year antibody titer persistence following receipt of MenACWY-CRM in adolescents (P13E1) and infants (P14E1).
2.2. Observational Post-Licensure Vaccine Safety Studies
- Human Papilloma Virus (HPV4, Gardasil) vaccine [22,23]: This study evaluated the general safety of HPV4 administered routinely to girls using a risk interval design. Rates for all emergency room and hospitalization events in females who received HPV4 (n = 189,629) were evaluated during the post-vaccination risk interval and compared with rates for the same events during the control period which was a post-vaccination interval distant in time from vaccination. This study found that HPV4 was associated with same-day syncope (OR, 6.0; 95% CI, 3.9–9.2) and skin infections in the 2 weeks after vaccination (OR, 1.8; 95% CI, 1.3–2.4). This study did not detect evidence of new safety concerns among females 9 to 26 years of age secondary to vaccination with HPV [22,23].
- Zoster vaccine safety : The zoster (shingles) vaccine was approved in 2006 for adults 60 years and older. This study was conducted to monitor the safety of this vaccine when routinely administered to adults and found the vaccine to be very safe. Similar to many post-licensure studies, this study assessed numerous post-vaccination many outcomes, each of which that found a statistical association required follow up and additional investigation. While the study did not identify any safety concerns, interestingly this study found that persons vaccinated with zoster vaccine appeared to be protected against multiple outcomes, including death. Additional analyses revealed that this observation was actually due individuals receiving the vaccine at times when their health was optimized, making it appear (falsely) that the vaccine was protective. In addition, people who were vaccinated appeared to be healthier than the general population of the same age .
- Varicella long term effectiveness and epidemiology after introduction of the vaccine—a 14 year study . Over the 14-year period, we found that Varicella vaccine was very protective (around 90%) against varicella disease without evidence of waning protection. No cases were seen after a second dose. There was no increase of chicken pox in children as they aged, and no increase in zoster (shingles), both of which had been worries prior to the vaccine.
- Tdap (Adacel), in adolescents and adults: The study evaluated the safety of Tdap by evaluating all medical events following immunization of more than 120,000 persons who received Tdap as part of routine clinical care. Final analysis is currently underway.
- Quadrivalent Neisseria meningitidis (ACW135Y) conjugate vaccine (MCV4, Menactra). This study evaluated the safety of this vaccine administered to more than 31,000 individuals ages 11–55 using both observational data in KPNC database (i.e., medical events) and active telephone calls to vaccine recipients. Preliminary analyses using the risk interval method have not detected any safety concerns .
- Menactra in 2–10 year old children. This study will be assessing the safety of this vaccine among a population of 2–10 year old children. Analyses are currently underway.
- Menactra in 9 and 12 month old children. This study will be assessing the safety of this vaccine among a population of infants and toddlers. Study accrual is underway.
- Tetanus, diphtheria and acellular pertussis vaccine (DTaP, Daptacel). The primary aim of the study was to assess the general safety of this vaccine in infants. A secondary specific aim focused on the risk of Hypotonic Hyporesponsive Episodes (HHE), a syndrome where infants become transiently less responsive and lose muscle tone. Final analyses are completed. This study identified no safety concerns and no increased risk of HHE related to vaccination.
- DTaP-inactivated polio-Hemophilus influenza type B vaccines (DTaP-IPV-Hib, Pentacel) safety study. This study is evaluating the general safety of this combination vaccine by evaluating all events in emergency department and inpatient setting and selected outpatient events following immunization of infants and toddlers. Subject accrual has been completed and analyses will begin shortly.
2.3. CDC-Sponsored Studies: VSD
- Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. This study demonstrated that in 1–2 year old children receiving a first dose, receipt of the measles, mumps, rubella and varicella (MMRV) combination vaccine is associated with a twofold increased risk of febrile seizures 7–10 days after immunization in when compared with separately administered same-day MMR and varicella vaccines .
- Risk of Febrile Seizures Following Measles-Containing Vaccine in 4–6 year old Children. This study evaluated risk of febrile seizures after measles-containing vaccine in 4–6 year old children and no evidence that either MMRV or separately administered MMR and varicella vaccines are associated with an increased risk of febrile seizures in children receiving a second dose of vaccine .
- Effect of age on risk of fever and seizures from measles vaccines: We found that the rate of seizures after measles-containing vaccines is modified by the age of the child receiving the vaccine. Children receiving vaccines on schedule, at one year of age, had a lower rate of seizure compared to those receiving the vaccines later in the second year of life .
- Risk of Rheumatoid Arthritis following vaccination with Tetanus, Influenza and Hepatitis B vaccines among persons 15–59 years of age. This VSD retrospective cohort study assessed for an association between rheumatoid arthritis and 3 different vaccines over a 13 year period. This study did not find any conclusive association between immunization and rheumatoid arthritis .
- Immunization and Bell’s Palsy in Children: A Case-Centered Analysis: Using the Case Centered method described above, this study assessed for an association between vaccinations and the occurrence of Bell’s palsy in children and found no association .
- Lack of association of Guillain Barré Syndrome (GBS) with vaccines : As with the Bell’s palsy study, this study also used the case centered method to examine the risk of GBS after vaccination with any type of vaccine. Evaluating data collected over 13 years which included more than 30 million person-years, we found no association between vaccination and GBS.
2.4. CDC-Sponsored Studies: CISA
- Immunization rates and safety of vaccines administered to children with inborn errors of metabolism (IEM): Using KPNC’s electronic medical record, we identified children with IEM from 1990 to 2007 and assessed immunization rates and AEFI in these children. This study found that children less than 2 years old with IEM in KPNC were not delayed in their receipt of recommended vaccines when compared with healthy infants. This study also did not detect an increased risk for serious adverse event following immunizations among all children 18 years and younger with IEM during 30 days after vaccination .
- Evidence-based approach to defining post-vaccination risk intervals: KPVSC led a CISA working group with the aims of examining how the choice of specific post-vaccination risk intervals (i.e., number of days in the interval, placement of the interval) affect the results of vaccine safety studies. The WG also developed a method by which the best available evidence would be used to determine the “best” risk interval for various adverse events and vaccines. The WG then applied this approach to assess the “best” risk intervals for (1) fever after influenza vaccines and (2) acute disseminated encephalomyelitis after various vaccines .
- Recurrent Guillain-Barré Syndrome Following Vaccination : This study examined all persons with a history of Guillain-Barré syndrome and determined whether receipt of vaccines after GBS diagnosis was associated with a relapse of GBS. This study was reassuring in that in over more than 30 million person-years, there no relapses of GBS after vaccination identified.
- Recurrent sterile abscesses after vaccination: In this case report, we described two cases of recurrent sterile abscesses which occurred following vaccines containing aluminum adjuvant and discussed a possible association between receipt of vaccines containing higher levels of aluminum adjuvant and development of sterile abscesses .
- Preterm infant responses to Polio vaccine: In this study, we prospectively enrolled 2 month old preterm and term infants and compared their T cell responses to inactivated poliovirus vaccine. The study found that preterm infants develop poliovirus-specific T cell responses that are comparable to those of term infants. However, preterm infants also demonstrated nonspecific and poliovirus-specific functional T cell limitations. Additional studies will be needed to assess whether these deficiencies have clinical implications .
- Risk of fever and sepsis evaluations after immunization in NICU: In this study, we evaluated whether immunization in the neonatal intensive care unit (NICU) were increased after immunizations due to potential post-immunization changes in clinical status. This study did find that there was an increase in fever and cardiorespiratory events after immunization in the NICU, but routine vaccination was not associated with increased risk of receiving sepsis evaluations .
- Vaccination rates at discharge from the NICU: This study determined immunization rates at discharge from the NICU among infants 2 months of age and found that significant proportion of infants discharged on or after 2 months of age in the NICU was unimmunized or underimmunized at discharge .
2.5. Effectiveness Studies
- Influenza vaccine and mortality in the elderly : Earlier observational studies had shown that influenza vaccine was more effective at preventing death in the elderly than was plausible. We determined that the differences in persons vaccinated with influenza vaccines compared to those not vaccinated were significant, and that many of these differences are not measured by the medical system, so it is not possible to account for their confounding in studies of Influenza vaccine effectiveness (VE). Therefore, in order to bypass this severe confounding, we used a “difference-in-differences” approach, subtracting out the “effects” of vaccination that seemed to occur outside of the influenza season, when no virus is circulating. Although we verified that previous studies had overestimated VE, we demonstrated that the vaccine can still prevent almost half of all deaths attributable to Influenza infection.
- Flu and hospitalization : Utilizing our same methodology as in the previous study on Flu vaccine and mortality, we determined the effectiveness of influenza vaccination at preventing hospitalization in persons 50 years and older.
- Pertussis vaccine effectiveness (DTaP waning, Tdap effectiveness, DTaP vs. whole cell): In 2010–2011, California experienced the largest outbreak of pertussis (whooping cough) in over 50 years. During the epidemic, pertussis rates markedly increased beginning at age 8 years, peaking at ages 10–11 years, decreasing to age 15 year and were low in adults. We hypothesized that the pattern derived from waning immunity to diphtheria tetanus, acellular pertussis (DTaP) vaccines and undertook several case-control studies in KPNC in which we identified person who tested positive for pertussis and compared them with two different controls: one control group consisted PCR test negative individuals and the other controls were matched individuals identified from the entire KPNC population. Using this approach, we found that (1) the 5th DTaP dose wanes by more than 40% each year after vaccination ; (2) Tdap is only about 60% effective at preventing pertussis ; (3) the risk of pertussis among teenagers who received 4 doses of whole cell pertussis vaccines during the first 2 years of life was much lower than among teenager who received 4 doses of DTaP .
2.6. Studies on Epidemiology of Infectious Diseases, Vaccine-Preventable Diseases, and Diseases Related to Vaccine Adverse Events
- Invasive Pneumococcal disease following introduction of Prevnar 7 and Prevnar 13 into the KPNC population: We have been collecting specimens from patients with invasive pneumococcal infections since 2000 and serotyping them to see whether the serotypes are those that are included in either the 7- or 13-valent conjugate pneumococcal vaccines. Multiple studies are ongoing. Our system allows us to capture data on the entire underlying population, so that incidence rates of disease can be calculated.
- Bias and flu shots : Studies of influenza vaccine effectiveness are often confounded by unmeasured variables. We showed this in a study looking at multiple years of influenza vaccines. If a person had been vaccinated for all of the preceding 5 years, and then did not get a vaccination in the current year, mortality rose dramatically. However, if another person did NOT get the vaccine for 5 years, and then got vaccinated in the current year, mortality also rose significantly, making it appear that the vaccine both prevents and causes death. This clearly illustrated the problems inherent in retrospective flu studies, and highlighted differences between vaccinated and unvaccinated individuals.
- Lopsided Windows: Early on in the course of one of our studies noted above , we noted that shorter risk time intervals (compared to comparison intervals) and rare rates of events resulted statistically significant differences weighted against the shorter interval. We showed that this phenomenon is predictable, and can happen in any type of study with comparison intervals that vary in size. This finding has been helpful in assessing and interpreting study results .
- Rates of autoimmune disease : This study assessed baseline rates of various autoimmune diseases in KPNC, which is extremely valuable information in both the design and interpretation of vaccine safety studies.
- Genetics of Staph epidemiology : This study showed that for KPNC, the USA300 clone of MRSA is found both in outpatients and in hospital- and healthcare-acquired settings.
- Microbiology and epidemiology of skin and soft tissue infections (SSTIs) [50,51,52]: Within our health plan population, we examined the epidemiology of SSTIs, focusing on trends of staphylococcal and methicillin-resistant staphylococcal (MRSA) infections over time. In our health plan, MRSA rates are decreasing over time, though they are still a very important cause of SST
- Epidemiology of Bell’s palsy : This paper provides a descriptive analysis of the largest population of children with Bell’s palsy to date.
- Incidence of genital warts among adolescents and young adults prior to HPV vaccination .
- Flu surveillance : We have been monitoring Influenza and Respiratory Syncytial Virus (RSV) infections over many years. We provide a service to the KPNC medical providers and administrators, with weekly updates showing trends and predictions, and including guidelines on testing and treatment. Our publication was on how the H1N1 pandemic threw confusion into the surveillance, because the media releases were very early, before disease really hit our area. We found that fear drove utilization for medical services, even more than real disease. Another study analyzed patterns of flu seasons, and found a recurring pattern of latter seasons each year over 9 seasons . We think that peaks of influenza season are more susceptible to the immunity of the underlying population than to weather, humidity, or other fluctuations in natural conditions.
Conflicts of Interest
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© 2013 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/3.0/).
Baxter, R.; Klein, N.P. Kaiser Permanente Vaccine Study Center: Highlights of 2009–2012. Vaccines 2013, 1, 139-153. https://doi.org/10.3390/vaccines1020139
Baxter R, Klein NP. Kaiser Permanente Vaccine Study Center: Highlights of 2009–2012. Vaccines. 2013; 1(2):139-153. https://doi.org/10.3390/vaccines1020139Chicago/Turabian Style
Baxter, Roger, and Nicola P. Klein. 2013. "Kaiser Permanente Vaccine Study Center: Highlights of 2009–2012" Vaccines 1, no. 2: 139-153. https://doi.org/10.3390/vaccines1020139