Safety, tolerability, and immunogenicity of a single dose 4-antigen or 3-antigen Staphylococcus aureus vaccine in healthy older adults: Results of a randomised trial

Vaccine

Volumn 35, Issue 2, 2017, Pages 385-394

  Creech, C Buddy ^a   Frenck, Robert W ^b   Sheldon, Eric A ^c   Seiden, David J ^d   Kankam, Martin K ^e   Zito, Edward T ^f,g   Girgenti, Douglas ^f,g   Severs, Joseph M ^f   Immermann, Frederick W ^f   McNeil, Lisa K ^f   Cooper, David ^f   Jansen, Kathrin U ^f   Gruber, William ^f   Eiden, Joseph ^f   Anderson, Annaliesa S ^f   Baber, James ^f  

^a VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^b CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

^c MIAMI RESEARCH ASSOCIATES   (United States)

^d Broward Research Group   (United States)

^e Vince and Associates Clinical Research   (United States)

^f PFIZER INC   (United States)

^g Sydney ^*  (United States)

Author keywords

Capsular polysaccharides; Clumping factor A; Functional antibodies; Manganese transporter C; Staphylococcus aureus; Vaccine

Indexed keywords

BACTERIAL ANTIGEN; BILIRUBIN; DIPHTHERIA TOXOID CRM197; FIBRINOGEN; PLACEBO; POTASSIUM; STAPHYLOCOCCUS AUREUS 3 ANTIGEN; STAPHYLOCOCCUS AUREUS 4 ANTIGEN; STAPHYLOCOCCUS VACCINE; UNCLASSIFIED DRUG; BACTERIAL POLYSACCHARIDE; BACTERIAL PROTEIN; BACTERIUM ANTIBODY; CRM197 (NON-TOXIC VARIANT OF DIPHTHERIA TOXIN); CYTOKINE; IMMUNOLOGICAL ADJUVANT; OPSONIN; VACCINE;

ACUTE CHOLECYSTITIS; AGED; ANEMIA; ANTIBODY TITER; ARTHRALGIA; ARTICLE; BACTERIAL STRAIN; BILIRUBIN BLOOD LEVEL; BREAST CANCER; COLITIS; CONTROLLED STUDY; CYTOKINE RESPONSE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG FORMULATION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EDEMA; ENZYME ACTIVITY; ENZYME ASSAY; FATIGUE; FEMALE; FEMUR FRACTURE; FEVER; HEADACHE; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; IMMUNOASSAY; IMMUNOGENICITY; INJECTION SITE BLEEDING; INJECTION SITE PRURITUS; INTRACELLULAR CYTOKINE STAINING; KIDNEY FAILURE; LOW DRUG DOSE; LYMPHADENITIS; MALAISE; MALE; MULTICENTER STUDY; MYALGIA; NONCARDIAC CHEST PAIN; NORMAL HUMAN; OPSONOPHAGOCYTIC ACTIVITY; OSTEOARTHRITIS; PAIN; PAPULE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; SINGLE DRUG DOSE; STAINING; STAPHYLOCOCCUS AUREUS; SWELLING; T LYMPHOCYTE; TENDON RUPTURE; TESTIS DISEASE; TRANSIENT ISCHEMIC ATTACK; VACCINATION; VOMITING; ADVERSE DRUG REACTION; BLOOD; CLINICAL TRIAL; IMMUNOLOGY; METABOLISM; PHAGOCYTOSIS; TREATMENT OUTCOME; VERY ELDERLY;

ADJUVANTS, IMMUNOLOGIC; AGED; AGED, 80 AND OVER; ANTIBODIES, BACTERIAL; ANTIGENS, BACTERIAL; BACTERIAL PROTEINS; CYTOKINES; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; OPSONIN PROTEINS; PHAGOCYTOSIS; PLACEBOS; POLYSACCHARIDES, BACTERIAL; STAPHYLOCOCCAL VACCINES; STAPHYLOCOCCUS AUREUS; T-LYMPHOCYTES; TREATMENT OUTCOME; VACCINES, CONJUGATE;

EID: 85006580119     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2016.11.032     Document Type: Article

References (33)

1. [1] Kang, C.I., Song, J.H., Ko, K.S., Chung, D.R., Peck, K.R., Clinical features and outcome of Staphylococcus aureus infection in elderly versus younger adult patients. Int J Infect Dis 15:1 (2011), e58–e62, 10.1016/j.ijid.2010.09.012.
2. [2] Tacconelli, E., Pop-Vicas, A.E., D'Agata, E.M., Increased mortality among elderly patients with meticillin-resistant Staphylococcus aureus bacteraemia. J Hosp Infect 64:3 (2006), 251–256, 10.1016/j.jhin.2006.07.001.
3. [3] van Hal, S.J., Jensen, S.O., Vaska, V.L., Espedido, B.A., Paterson, D.L., Gosbell, I.B., Predictors of mortality in Staphylococcus aureus Bacteremia. Clin Microbiol Rev 25:2 (2012), 362–386, 10.1128/CMR.05022-11.
4. [4] Anderson, D.J., Surgical site infections. Infect Dis Clin North Am 25:1 (2011), 135–153, 10.1016/j.idc.2010.11.004.
5. [5] Aga, E., Keinan-Boker, L., Eithan, A., Mais, T., Rabinovich, A., Nassar, F., Surgical site infections after abdominal surgery: incidence and risk factors. A prospective cohort study. Infect Dis (Lond) 47:11 (2015), 761–767, 10.3109/23744235.2015.1055587.
6. [6] Harrington, G., Russo, P., Spelman, D., et al. Surgical-site infection rates and risk factor analysis in coronary artery bypass graft surgery. Infect Control Hosp Epidemiol 25:6 (2004), 472–476, 10.1086/502424.
7. [7] Schuster, J.M., Rechtine, G., Norvell, D.C., Dettori, J.R., The influence of perioperative risk factors and therapeutic interventions on infection rates after spine surgery: a systematic review. Spine (Phila Pa 1976) 35:Suppl 9 (2010), S125–S137, 10.1097/BRS.0b013e3181d8342c.
8. [8] Yokoe, D.S., Anderson, D.J., Berenholtz, S.M., et al. A compendium of strategies to prevent healthcare-associated infections in acute care hospitals: 2014 updates. Infect Control Hosp Epidemiol 35:8 (2014), 967–977, 10.1086/677216.
9. [9] Kumar, R., Burns, E.A., Age-related decline in immunity: implications for vaccine responsiveness. Expert Rev Vaccines 7:4 (2008), 467–479, 10.1586/14760584.7.4.467.
10. [10] Pawelec, G., Immunosenescence and vaccination. Immun Ageing, 2, 2005, 16, 10.1186/1742-4933-2-16.
11. [11] Nissen, M., Marshall, H., Richmond, P., et al. A randomized phase I study of the safety and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults. Vaccine 33:15 (2015), 1846–1854, 10.1016/j.vaccine.2015.02.024.
12. [12] Anderson, A.S., Scully, I.L., Timofeyeva, Y., et al. Staphylococcus aureus manganese transport protein C is a highly conserved cell surface protein that elicits protective immunity against S. aureus and Staphylococcus epidermidis. J Infect Dis 205:11 (2012), 1688–1696, 10.1093/infdis/jis272.
13. [13] Frenck Jr R, Creech CB, Sheldon EA, et al. Safety, tolerability, and immunogenicity of a 4-antigen Staphylococcus aureus vaccine (SA4Ag): results from a first-in-human randomised, placebo-controlled phase 1/2 study. Vaccine 2016;35(2):375–84.
14. [14] Nanra, J.S., Buitrago, S.M., Crawford, S., et al. Capsular polysaccharides are an important immune evasion mechanism for Staphylococcus aureus. Hum Vaccin Immunother 9:3 (2013), 480–487, 10.4161/hv.23223.
15. [15] Rozemeijer, W., Fink, P., Rojas, E., et al. Evaluation of approaches to monitor Staphylococcus aureus virulence factor expression during human disease. PLoS One, 10(2), 2015, e0116945, 10.1371/journal.pone.0116945.
16. [16] Hawkins, J., Kodali, S., Matsuka, Y.V., et al. A recombinant clumping factor A-containing vaccine induces functional antibodies to Staphylococcus aureus that are not observed after natural exposure. Clin Vaccine Immunol 19:10 (2012), 1641–1650, 10.1128/CVI.00354-12.
17. [17] US Department of Health and Human Services, Food and Drug Administration. Guidance for industry. Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, http://www.fda.gov/downloads/BiologicsBloodVaccines/ucm091977; 2007 [accessed 19.08.15].
18. [18] Fattom, A., Matalon, A., Buerkert, J., Taylor, K., Damaso, S., Boutriau, D., Efficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study. Hum Vaccin Immunother 11:3 (2015), 632–641, 10.4161/hv.34414.
19. [19] Jansen, K.U., Girgenti, D.Q., Scully, I.L., Anderson, A.S., Vaccine review: “Staphyloccocus aureus vaccines: problems and prospects”. Vaccine 31:25 (2013), 2723–2730, 10.1016/j.vaccine.2013.04.002.
20. [20] Boyle-Vavra, S., Li, X., Alam, M.T., et al. USA300 and USA500 clonal lineages of Staphylococcus aureus do not produce a capsular polysaccharide due to conserved mutations in the cap5 locus. MBio, 6(2), 2015, 10.1128/mBio.02585-14.
21. [21] Nanra, J.S., Timofeyeva, Y., Buitrago, S.M., et al. Heterogeneous in vivo expression of clumping factor A and capsular polysaccharide by Staphylococcus aureus: implications for vaccine design. Vaccine 27:25–26 (2009), 3276–3280, 10.1016/j.vaccine.2009.01.062.
22. [22] Li, X., Wang, X., Thompson, C.D., Park, S., Park, W.B., Lee, J.C., Preclinical efficacy of clumping factor A in prevention of Staphylococcus aureus infection. MBio, 7(1), 2016, e02232-15, 10.1128/mBio.02232-15.
23. [23] Anderson, A.S., Scully, I.L., Buurman, E.T., Eiden, J., Jansen, K.U., Staphylococcus aureus clumping factor A remains a viable vaccine target for prevention of S. aureus infection. MBio, 7(2), 2016, 10.1128/mBio.00225-16.
24. [24] Brown, A.F., Murphy, A.G., Lalor, S.J., et al. Memory Th1 cells are protective in invasive Staphylococcus aureus infection. PLoS Pathog, 11(11), 2015, e1005226, 10.1371/journal.ppat.1005226.
25. [25] Cho, J.S., Pietras, E.M., Garcia, N.C., et al. IL-17 is essential for host defense against cutaneous Staphylococcus aureus infection in mice. J Clin Invest 120:5 (2010), 1762–1773, 10.1172/JCI40891.
26. [26] Lin, L., Ibrahim, A.S., Xu, X., et al. Th1-Th17 cells mediate protective adaptive immunity against Staphylococcus aureus and Candida albicans infection in mice. PLoS Pathog, 5(12), 2009, e1000703, 10.1371/journal.ppat.1000703.
27. [27] Fowler, V.G. Jr., Proctor, R.A., Where does a Staphylococcus aureus vaccine stand?. Clin Microbiol Infect 20:Suppl 5 (2014), 66–75, 10.1111/1469-0691.12570.
28. [28] Joshi, A., Pancari, G., Cope, L., et al. Immunization with Staphylococcus aureus iron regulated surface determinant B (IsdB) confers protection via Th17/IL17 pathway in a murine sepsis model. Hum Vaccin Immunother 8:3 (2012), 336–346, 10.4161/hv.18946.
29. [29] Gorwitz, R.J., Kruszon-Moran, D., McAllister, S.K., et al. Changes in the prevalence of nasal colonization with Staphylococcus aureus in the United States, 2001–2004. J Infect Dis 197:9 (2008), 1226–1234, 10.1086/533494.
30. [30] McNeil, S.A., Andrew, M.K., Ye, L., et al. Interim estimates of 2014/15 influenza vaccine effectiveness in preventing laboratory-confirmed influenza-related hospitalisation from the Serious Outcomes Surveillance Network of the Canadian Immunization Research Network, January 2015. Euro Surveill, 20(5), 2015, 21024 doi: n/a.
31. [31] Simpson, C.R., Lone, N.I., Kavanagh, K., et al. Trivalent inactivated seasonal influenza vaccine effectiveness for the prevention of laboratory-confirmed influenza in a Scottish population 2000 to 2009. Euro Surveill, 20(8), 2015 pii 21043. doi: n/a.
32. [32] Izurieta, H.S., Thadani, N., Shay, D.K., et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using Medicare data: a retrospective cohort analysis. Lancet Infect Dis 15:3 (2015), 293–300, 10.1016/S1473-3099(14)71087-4.
33. [33] Lal, H., Cunningham, A.L., Godeaux, O., et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 372:22 (2015), 2087–2096, 10.1056/NEJMoa1501184.