Clinical Immunization Safety Assessment (CISA) Project Publications
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Schmader KE, Liu CK, Harrington T, Rountree W, Auebach H, Walter EB, Barnett ED, Schlaudecker EP, Todd CA, Poniewierski M, Staat M A, Wodi P, Broder KR. Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted versus Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults. A Randomized Clinical Trialexternal icon JAMA Network Open. 2021 Jan 4;4(1):e2031266.
Older adults are at higher risk of flu-related complications and are encouraged to get a flu vaccine. Previous studies have shown that Fluad trivalent (aIIV3) and Fluzone High-Dose trivalent (HD-IIV3) are more effective than standard trivalent doses in older adults, but aIIV3 and HD-IIV3 have not been compared directly. CISA Project conducted a randomized clinical trial to compare the two vaccines’ safety, effectiveness, and short-term health-related quality of life (HRQOL) effects in adults ≥65 years. During the 2017-18 and 2018-19 influenza seasons, 757 adults were randomized to receive aIIV3 (378) and HD-IIV3 (379) vaccines. Moderate-to-severe injection-site pain after aIIV3 was not higher than HD-IIV3. Report of injection-site tenderness, joint pain, and fatigue were higher after aIIV3, but no serious adverse events were reported and no significant differences in HRQOL were observed. Overall, safety findings support using aIIV3 or HD-IIV3 to prevent influenza in older adults.
Walter EB, Klein NP, Wodi AP, Roundtree W, Todd CA, Wiesner A, Duffy J, Marquez PL, Broder K. Fever after Influenza, Diphtheria-Tetanus-Acellular Pertussis, and Pneumococcal Vaccinations.external icon Pediatrics. 2020 Mar;145(3):e20191909.
A previous CDC study showed that children aged 6-23 months had an increased risk for febrile seizure after simultaneously receiving inactivated influenza vaccine (IIV), pneumococcal conjugate vaccine (PCV13) and diphtheria-tetanus-acellular pertussis vaccine (DTaP). Researchers wanted to see if administering the IIV at a separate visit reduced the risk of post-vaccination fever and potentially febrile seizure. In the 2017-2018 influenza season, 221 children aged 12-16 months were randomized at two CISA sites into 2 groups. Both groups had 2 visits, 2 weeks apart: group 1 (simultaneous) received the PCV13, DTaP, and quadrivalent IIV (IIV4) vaccines at visit 1; no vaccines at visit 2. Group 2 (sequential) received PCV13 and DTaP at visit 1 and IIV4 visit 2. Similar proportions of children in both groups had fever on days 1-2 after visits (simultaneous 8.1%; sequential 9.3%). Delaying IIV4 by 2 weeks in children receiving DTaP and PCV13 did not reduce fever occurrence after vaccination.
Christianson MS, Wodi P, Talaat K, Halsey N. Primary Ovarian Insufficiency and Human Papilloma Virus Vaccines: A Review of the Current Evidence.external icon Am J Obstet Gynecol. 2020 Mar;222(3):239-244. Epub 2019 Aug 31.
Human papillomavirus (HPV) is the primary cause of cervical cancer, and vaccination is the primary means of preventing cancers caused by HPV infection. Despite HPV vaccine being available for over a decade, coverage rates are lower than other vaccines. Public concerns regarding the vaccine’s safety, including that it may cause primary ovarian insufficiency (POI), have been identified as an important barrier to vaccination. POI-related concerns are driven in part by isolated reports of ovarian failure following the HPV vaccine. In this Clinical Immunization Safety Assessment Project review, researchers summarize published peer-reviewed literature on HPV vaccines and POI. In summary, the current evidence is insufficient to suggest or support a causal relationship between HPV vaccination and POI. Healthcare providers can help address concerns about POI and the HPV vaccine by sharing these findings during consultations with their patients.
Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, Liang J, Walter EB, Heine RP, Moody MA, Yoder S, Edwards KM. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant womenexternal icon. Vaccine. 2018 Oct 8;36(42):6354-6360. Epub 2018 Sep 13.
CDC recommends that pregnant women receive Tdap vaccine to protect young infants from pertussis (whooping cough). The CISA Project study enrolled 374 pregnant and 225 nonpregnant women to evaluate safety and immune responses after Tdap; 53% of the pregnant women had received Tdap in the past. Pregnancy and infant health outcomes were also assessed and will be described in a future report. Injection-site and systemic reactions (e.g., fever) were assessed for 7 days after Tdap. Blood was collected from the women before and after Tdap to evaluate immune responses. Researchers found that Tdap was well-tolerated in pregnant and nonpregnant women. Pregnant women were more likely to report moderate or severe injection-site pain (18%) compared with nonpregnant women (11%) but this did not lead to medical visits. Prior Tdap receipt did not increase occurrence of moderate or severe reactions in pregnant women. Immune responses to all Tdap vaccine antigens were robust in both groups.
Tamez RL, Tan WV, O’Malley JT, Broder KR, Garzon MC, LaRussa P, Lauren CT. Influenza B virus infection and Stevens-Johnson syndrome.external icon Pediatr Dermatol. 2018 Jan; 35(1):e45-e48. Epub 2017 Dec 28.
Kemper AR, Barnett ED, Walter EB, Hornik C, Pierre-Joseph N, Broder KR, Silverstein M, Harrington T. Drinking Water to Prevent Postvaccination Presyncope in Adolescents: A Randomized Trial.external icon Pediatrics 2017 Nov; 140(5).
Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging.external icon Vaccine. 2017 Dec 15; 35(50):6941-6948. Epub 2017 Oct 28.
Walter EB, Hornik CP, Grohskopf L, McGee CE, Todd CA, Museru OI, Harrington L, Broder KR. The effect of antipyretics on immune response and fever following receipt of inactivated influenza vaccine in young children.external icon Vaccine. 2017 Oct 19.
Stockwell MS, Broder KR, Lewis P, Jakob K, Iqbal S, Fernandez N, Sharma D, Barrett A, LaRussa P. Assessing Fever Frequency After Pediatric Live Attenuated Versus Inactivated Influenza Vaccination.external icon J Pediatric Infect Dis Soc. 2017 Sep 1; 6(3):e7-e14.
Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castaño PM, Lewis P, Barrett A, Museru OI, Castellanos O, LaRussa PS. Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy.external icon Am J Prev Med. 2017 Sep; 53(3):282-289.
Shaw J, Halsey NA, Weinberg A, Scott Schmid D, George KS, Weldon WC, Jordan M, Bryant PW, LaRussa P, Bradshaw DY, Harrington T, Gershon A. Arm Paralysis After Routine Childhood Vaccinations: Application of Advanced Molecular Methods to the Causality Assessment of an Adverse Event After Immunization.external icon J Pediatric Infect Dis Soc. 2017 Jan 25.
Lauren CT, Belsito DV, Morel KD, LaRussa P. Case Report of Subcutaneous Nodules and Sterile Abscesses Due to Delayed Type Hypersensitivity to Aluminum-Containing Vaccines.external icon Pediatrics. 2016 Oct; 138(4).
Baxter R, Lewis N, Bohrer P, Harrington T, Aukes L, Klein NP. Sudden-Onset Sensorineural Hearing Loss after Immunization: A Case-Centered Analysis.external icon Otolaryngol Head Neck Surg. 2016 Jul;155(1):81-6. Epub 2016 Mar 29.
Hofstetter AM, Jakob K, Klein NP, Dekker CL, Edwards KM, et al. Live vaccine use and safety in DiGeorge syndromeexternal icon. Pediatrics. 2014 Apr;133(4):e946-54. doi: 10.1542/peds.2013-0831. Epub 2014 Mar 31.
Grohskopf LA, Olsen SJ, Sokolow LZ, Bresee JS, Cox NJ, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) — United States, 2014–15 Influenza Season. MMWR. 2014 Aug 15;63(32):691-697.
Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, et al. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccineexternal icon. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469.
Halsey NA, Griffioen M, Dreskin SC, Dekker CL, Wood R, et al. Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: Reports to VAERSexternal icon. Vaccine. 2013 Dec 9;31(51):6107-12. doi: 10.1016/j.vaccine.2013.09.066. Epub 2013 Oct 8.
Pahud BA, Williams SE, Dekker CL, Halsey N, LaRussa P, et al. Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccinationexternal icon. Pediatr Infect Dis J. 2013 Feb;32(2):163-168.
Williams SE, Edwards KM, Baxter RP, Larussa PS, Halsey NA, et al. Comprehensive assessment of serious adverse events following immunization by health care providersexternal icon. J Pediatr. 2013 Jun;162(6):1276-81, 1281.e1. doi: 10.1016/j.jpeds.2013.01.028. Epub 2013 Feb 26.
Technical Report: The Clinical Immunization Safety Assessment (CISA) Working Group. Review of a published report of cerebral vasculitis after vaccination with the Human Papillomavirus (HPV) Vaccine. November 2012.
Baxter R, Lewis N, Bakshi N, Vellozzi C, Klein NP; CISA Network. Recurrent Guillain-Barre syndrome following vaccinationexternal icon. Clin Infect Dis. 2012 Mar;54(6):800-4. doi: 10.1093/cid/cir960. Epub 2012 Jan 19.
Halsey NA, Edwards KM, Dekker CL, Klein NP, Baxter R, et al. Algorithm to assess causality after individual adverse events following immunizationsexternal icon. Vaccine. 2012 Aug 24;30(39):5791-8. Epub 2012 Apr 14.
Loughlin AM, Marchant CD, Adams W, Barnett E, Baxter R, et al. Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)external icon. Vaccine. 2012 Nov 26;30(50):7253-9. Epub 2012 Oct 9.
Pahud BA, Rowhani-Rahbar A, Glaser C, Gavali S, Salibay CJ, et al. Lack of association between childhood immunizations and encephalitis in California, 1998-2008external icon. Vaccine. 2012 Jan 5;30(2):247-53.
Rowhani-Rahbar A, Klein NP, Dekker CL, Edwards KM, Marchant CD, et al. Biologically plausible and evidence-based risk intervals in immunization safety researchexternal icon. Vaccine. 2012 Dec 17;31(1):271-7. Epub 2012 Jul 24.
Rowhani-Rahbar A, Baxter R, Rasgon B, Ray P, Black S, Klein JO, Klein NP. Epidemiologic and clinical features of Bell’s palsy among children in Northern Californiaexternal icon. Neuroepidemiology. 2012;38(4):252-8. doi: 10.1159/000338303. Epub 2012 Jun 5.
Rowhani-Rahbar A, Klein NP, Lewis N, Fireman B, Ray P, Rasgon B, Black S, Klein JO, Baxter R. Immunization and Bell’s palsy in children: A case-centered Analysisexternal icon. Am J Epidemiol 2012 May 1;175(9):878-85. doi: 10.1093/aje/kws011. Epub 2012 Mar 12.
Klein NP, Gidudu J, Qiang Y, Pahud B, Rowhani-Rahbar A, et al. Developing the next generation of vaccinologistsexternal icon. Vaccine. 2011 Nov 21;29(50):9296-7. Epub 2011 Apr 19.
LaRussa P, Edwards K, Dekker C, Klein N, Halsey NA, et al. Understanding the role of human variation in vaccine adverse events: The Clinical Immunization Safety Assessment (CISA) Networkexternal icon. Pediatrics. 2011 May;127(5):e1147-53.
Klein N, Aukes L, Lee J,Fireman B, Shapira S, et al. Evaluation of immunization rates and safety among children with inborn errors of metabolismexternal icon. Pediatrics. 2011 May;127(5):e1139-46. doi: 10.1542/peds.2010-3706. Epub 2011 Apr 11.
Miller EK, Dumitrescu L, Cupp C, Dorris S, Taylor S, et al. Atopy history and the genomics of wheezing after influenza vaccination in children 6-59 months of ageexternal icon. Vaccine. 2011 Apr 18;29(18):3431-7.
Morgan TM, Schlegel C, Edwards KM, Welch-Burke T, Zhu Y, et al. Vaccines are not associated with metabolic events in children with urea cycle disordersexternal icon. Pediatrics 2011 May;127(5):e1147-53. Epub 2011 Apr 11.
Navar-Boggan AM, Halsey NA, Escobar GJ, Golden WC, Klein NP. Underimmunization in the neonatal intensive care unitexternal icon. J Perinatol. 2012 May;32(5):363-7. doi: 10.1038/jp.2011.111. Epub 2011 Aug 11.
Pahud BA, Glaser CA, Dekker CL, Arvin AM, Schmid DS. Varicella zoster disease of the central nervous system: Epidemiological, clinical, and laboratory features 10 years after the introduction of the varicella vaccineexternal icon. J Infect Dis. 2011 Feb 1;203(3):316-23.
Williams SE, Pahud BA, Vellozzi C, Donofrio PD, Dekker CL, et al. Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccinationexternal icon. Vaccine. 2011 Oct 26;29(46):8302-8.
Williams SE, Klein NP, Halsey N, Dekker CL, Baxter RP, et al. Overview of the clinical consult case review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) Network 2004-2009external icon. Vaccine. 2011 Sep 16;29(40):6920.
Yen C, Jakob K, Hittier X, Gentsch J, LaRussa P, for the Clinical Immunization Safety Assessment (CISA) Network. Detection of fecal shedding of rotavirus vaccine in infants following their first dose of pentavalent rotavirus vaccineexternal icon. Vaccine. 2011May 31;29(24):4151-5.
Klein N, Gans H, Sung P, Yasukawa LL, Johnson J, et al. Preterm infants T cell responses to inactivated poliovirus vaccineexternal icon. J Infect Dis. 2010 Jan 15;201(2):214-22. doi: 10.1086/649590.
Navar-Boggan AM, Halsey NA, Golden WC, Escobar GJ, Massolo M, and Klein NP. Risk of fever and sepsis evaluations following routine immunizations in the neonatal intensive care unitexternal icon. J Perinatol. 2010 Sep;30(9):604-9. doi: 10.1038/jp.2010.8. Epub 2010 Feb 25.
Durbin A, Setse R, Omer S, Palmer J, Spaeder J, et al. Monitoring adverse events following yellow fever vaccination using an integrated telephone and internet-based systemexternal icon. Vaccine. 2009 Oct 19; 27(44):6143-47.
Klein NP, Edwards KM, Sparks R and Dekker CL; on behalf of the Clinical Immunization Safety Assessment (CISA) Network. Recurrent sterile abscesses following immunization: A possible association with aluminum adjuvantexternal icon. BMJ Case Rep. 2009. pii: bcr09.2008.0951. doi: 10.1136/bcr.09.2008.0951. Epub 2009 Mar 17.
Klein N, Kissner J, Aguirre A, Sparks R, Campbell S, et al. Differential maternal responses to a newly developed vaccine information pamphletexternal icon. Vaccine.2009 Dec 11;28(2):323-8. doi: 10.1016/j.vaccine.2009.10.046. Epub 2009 Oct 30.
Rosenberg M, Sparks R, McMahon A, Iskander J, Campbell JD, et al. Serious adverse events rarely reported after trivalent inactivated influenza vaccine (TIV) in children 6–23 months of ageexternal icon. Vaccine. 2009 Jul 9;27(32):4278-83. doi: 10.1016/j.vaccine.2009.05.023. Epub 2009 May 28.
Halsey NA. The human papillomavirus vaccine and risk of anaphylaxisexternal icon. [Commentary]. CMAJ. 2008 Sep 9;179(6):509-10. doi: 10.1503/cmaj.081133. Epub 2008 Sep 1. Erratum in: CMAJ. 2008 Sep 23; 179(7):678.
Kohl K, Magnus M, Ball R, Halsey N, Shadomy S, et al. Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunizationexternal icon. Vaccine. 2008 Nov 25; 26(50):6349–60.
Lindsey N, Schroeder B, Miller E, Braun M, Hinckley A, et al. Adverse event reports following yellow fever vaccinationexternal icon. Vaccine. 2008 Nov 11; 26(48): 6077-82.
Rennels M, Black S, Woo E, Campbell S, Edwards KM. Safety of a fifth dose of diphtheria and tetanus toxoid and acellular pertussis vaccine in children experiencing extensive, local reactions to the fourth doseexternal icon. Pediatr Infect Dis J. 2008 May;27(5):464-5. doi: 10.1097/INF.0b013e31816591f7.
Wood R, Berger M, Dreskin S, Setse R, Engler R, et al. Algorithm for treatment of patients with hypersensitivity reactions after vaccinesexternal icon. Pediatrics. 2008 September; 122(3): e771-7.
Klein N, Fireman B, Enright A, Ray P, Black S, and Dekker CL for the Clinical Immunization Safety Assessment (CISA) Network. Role for genetics in the immune response to the varicella vaccineexternal icon. Pediatr Inf Dis J. 2007 Apr; 26(4):300-5.
Wood RA, Setse R, Halsey N, and the Hypersensitivity Working Group of the Clinical Immunization Safety Assessment (CISA) Network. Irritant skin test reactions to common vaccinesexternal icon. J Allergy Clin Immunol. 2007 Aug;120(2):478-81. Epub 2007 Jun 4.
Muralles AA, Ray P, Black S, and Shinefield H. Active telephone surveillance to evaluate adverse events among civilian smallpox vaccine recipientsexternal icon. Vaccine. 2006 Jan 23; 24(4):476-84.
Sekaran N, Edwards, K. Extensive swelling reaction associated with diphtheria and tetanus toxoids and acellular pertussis vaccineexternal icon. Pediatr Infect Dis J. 2006 Apr; 25(4):374-5.
Vellozzi C, Mitchell T, Miller E, Casey CG, Eidex RB, et al. Yellow fever vaccine-associated viscerotropic disease (YEL-AVD) and corticosteroid therapy: Eleven United States cases, 1996-2004external icon. Am J Trop Med Hyg. 2006 August; 75(2):333-6.
Rollison D, Helzlsouer K, Halsey N, Shah K, and Viscidi R. Markers of past infection with simian virus 40 (SV40) and risk of incident non-Hodgkin lymphoma in a Maryland cohortexternal icon. Cancer Epidemiol Biomarkers Prev. 2005 June; 14(6) 1448-1452.
Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, et al. Generalized convulsive seizure as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentationexternal icon. Vaccine. 2004 Jan 26; 22(5-6):557-62.
Rothstein E, Kohl K, Ball L, Halperin S, Halsey N, et al. Nodule at injection site as an adverse event following immunization case definition & guidelines for data collection, analysis, and presentationexternal icon. Vaccine. 2004 Jan 26; 22(5-6):575-85.
Halsey NA. The science of evaluation of adverse effects associated with vaccinationexternal icon. Semin Pediatr Infect Dis. 2002 Jul;13(3):205-14.
Halsey NA. Anthrax vaccine and causality assessment from individual case reportsexternal icon. Pharmacoepidemiol Drug Saf. 2002 Apr-May;11(3):185-7; discussion 203-4.