Philimmune LLC

Vaccine and Biologics Research & Development


PUBLICATIONS




(EXCLUDING ABSTRACTS)


2021

21-1. HM El Sahly, LR Baden, B Essink, S Doblecki-Lewis, J. Martin, EJ Anderson, TB Campbell, J Clark, LA Jackson, CJ Fichtenbaum, M Zervos, B Rankin, F Eder, G Feldman, C Kennelly, L Han-Conrad, M Levin, KM Neuzil, L Corey, P Gilbert, H Janes, D Follmann, M Marovich, L Polakowski, JR Mascola, JE Ledgerwood, BS Graham, A August, H Clouting, W Deng, S Han, B Leav, D Manzo, R Pajon, F Schödel, JE Tomassini, H Zhou, J Miller, on behalf of the COVE Study Group. 2021. Phase 3 Trial of mRNA-1273 SARS-CoV-2 Vaccine: Completion of Blinded Phase. NEJM. DOI:
https://doi.org/10.1056/NEJMoa2113017

21-2. LR Baden, HM El Sahly, B Essink, D Follman, KM Neuzil, A August, H

Clouting, G Fortier, W Deng, S Han, X Zhao, B Leav, C Talarico, B Girard, YD Paila, JE Tomassini, F Schödel, R Pajon, H Zhou, R Das, and J Miller. 2021. Phase 3 Trial of mRNA-1273 During the Delta-variant Surge. NEJM doi: 101056/NEJMc2115597


21-3. R Pajon, YD Paila, B Girard, G Dixon, K Kacena, LR Baden, HM El Sahly, B
Essink, KM Mullane, I Frank, D Denhan, E Kerwin, X Zhao, B Ding, W Deng, JE Tomassini, H Zhou, B Leav, F Schödel. 2021. Initial Analysis of Viral Dynamics and Circulating Viral Variants During the mRNA-1273 Phase 3 COVE Trial. https://www.medrxiv.org/content/10.1101/2021.09.28.21264252v1

2019

19-1. M Petrecz, CJ Acosta, SO Klopfer, BJ Kuter. MG Goveia, JE Stek FP Schödel and AW Lee. 2019. Safety and immunogenicity of VAQTA® in children 12 to 23 months of age with and without administration of other US pediatric vaccines. Human Vaccines & Immunotherapeutics 15 (2) 426-432.

2018

18-1. JE Edwards, MM Schwarz, CS Schmidt, JD Sobol, P Nyirjesy, F Schödel, E.
Marchus, M Lizakowski, EA DeMontigny, J Hoeg, T Holmberg, MT Cooke, k Hoover, L Edwards, M Jacobs, S Sussman, M Augenbraun, M Drusano, MR Yeaman, AS
Ibrahim, SG Filler and JP Hennessey. 2018. A fungal immunotherapeutic vaccine (NDV3A) for treatment of recurrent vulvovaginal candidiasis – a phase 2 randomized, doubleblind, placebo-controlled trial. Clin Infect Dis
https://doi.org/10.1093/cid/ciy185

2017

17-1. F Schödel, NJ Moreland, JT Wittes, K Mulholland, I Frazer, AC Steer, JF Fraser, J Carapetis. 2017. Clinical development strategy for a candidate group A streptococcal vaccine. Vaccine 35 (16) 2007-2014.

2016

16-1. M Mellata, NM Mitchell, F Schödel, R Curtiss, GB Pier. 2016. Novel vaccine antigen combinations elicit protective immune responses against Escherichia coli sepsis. Vaccine 34 (5) 656-662.

16-2. AC Steer, JR Carapetis, JB Dale, JD Fraser, MF Good, L Guilhermen, NJ Moreland, EK Mulholland, F Schödel, and PR Smeesters. 2016. Status of research and development of vaccines for Streptococcus pyogenes. Vaccine 34: 2953-2958.

2015

15-1. R Wiedmann, KS Reisinger, J Hartzel, E Malacamari, SD Senders, KED Giacoletti, E Shaw, SO Klopfer, BJ Kuter, F Schödel and L Musey. 2015. M-M-R®II manufactured using recombinant human serum albumin (rHSA) and M-M-R®II manufactured using human serum albumin (HSA) exhibit similar safety and immunogenicity profiles when administered as a 2-dose regimen to healthy children. Vaccine 33 (18) 2132-2140.

15-2 M Petrecz, KP Ramsey, JE Stek, JC Martin, SO Klopfer, B Kuter. FP Schödel and AW Lee. 2015. Concomitant use of VAQTA® with PedvaxHIB® and Infanrix® in 12 to 17 month old children. Human Vaccines & Immunotherapeutics 12 (2) 503-511.

2014

14-1. SO Klopfer, JE Stek, M Petrecz, KS Reisinger, SB Black, MG Goveia, O Nicholson, JL Gardner, AD Grosso, ML Brown, BJ Kuter and F Schödel. 2014. Analysis of safety data in children after receiving two doses of ProQuad® (MMRV). Vaccine 32 (52) 7154-7160.

14-2 M Kirchmeier, A-C Fluckiger, C Soare, J Bozic, b Onsouka, T Ahmed, A Diress, L Pereira, F Schödel, S Plotkin, C Dalba, D Klatzmann and DE Anderson. 2014.
Enveloped virus-like particle expression of human cytomegalovirus glycoprotein B antigen induces antibodies with potent and broad neutralizing activity. Clinical and Vaccine Immunology 21 (2): 174-180.

14-3 GL Gilbert, JE Stek, G Villa, SO Klopfer, JC Martin, FP Schödel and PK Bhuyan. 2014. Safety and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in renal pre-dialysis and dialysis patients. Vaccine 32 (48) 6521-6526.

14-4 J Lawrence, S he, J Martin, F Schödel, M Ciarlet and AV Murray. 2014. Safety and immunogenicity of pentavalent rotavirus vaccine in a randomized, double-blind,
placebo-controlled study in healthy elderly subjects. Human Vaccines & Immunotherapeutics 10 (8) 2247-2254.


2013

13-1 JB Dale, VA Fischetti, JR Carapetis, AC Steer, S Sow, R Kumar, BM Mayosi, FA Rubin, K Mulholland, JM Hombach, F Schödel, AM Henao-Restrepo. 2013. Group A streptococcal vaccines: Paving a path for accelerated development. Vaccine 31S: B216 – B222.

13-2 S Iwata, S Nakata, S Ukae, Y Koizumi, Y Morita, H Kuroki, Y Tanaka, T Shizuya, F Schödel, ML Brown, J Lawrence. 2013. Efficacy and Safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Human Vaccines 9(8): 1626-1633.

13-3 RY Yetman, JS Shephard, A Duke, JE Stek, M Petrecz, SO Klopfer, BJ Kuter, FP Schödel, AW Lee. 2013. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23monthold children. Human Vaccines 9(8): 1691 – 1697.


2012

12-1 Vermeulen JN, JMA Lange, SK Tyring, PH Peters, M Nunez, G Poland, MJ
Levine, C Freeman, I Chalikonda, J Li, JG Smith, MJ Caulfield, JE Stek, ISF Chang, R Vessey, FP Schödel, PW Annunziato, K Schlienger, JS Silber. 2012. Safety, tolerability and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults
60 years of age. Vaccine. 30(5): 904-910.

12-2 G Minervini, BJ McCarson, KS Reisinger, JC Martin, JE Stek, BM Atkins , KB
Nadig, FP Schödel, PK Bhuyan. 2012. Safety and Immunogenicity of a Modified Process Hepatitis B Vaccine in Healthy Neonates. Vaccine doi:10.1016/j.vaccine.2011.12.095.

2011

11-1 T Vesikari, JC Mason, CL Liss, V Liska, F Schödel and PK Bhuyan. 2011. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Ped Infect. Dis. 30 (7): 109-113.

11-2 A W Lee, T Vesikari, CL Gilbert, SO Klopfer, FP Schödel and P K Bhuyan 2011. Immunogenicity and safety of a Haemophilus influenzae B (Hib) – hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine 29 (45): 7942-7948.

11-3 F Schödel 2011. Immunological correlates of vaccine-derived protection.
Fondation Mérieux Conference Center ‘Les Pensières’ Veyrier du Lac, France, Sept. 20-
22, 2010. Vaccine 29: 9575-9577. http://dx.doi.org/10.1016/j.vaccine.2011.10.046

11-4 Leonardi M, K Bromberg, R Baxter, JL Gardner, S Klopfer, O Nicholson, M Brockley, J Trammel, V Leamy, W Williams, B Kuter and F Schödel. 2011.
Immunogenicity and safety of MMRV and PCV-7 administered concomitantly in healthy children. Pediatrics. DOI: 10.1542/peds.2010-2132


2010

10-1 K Zaman, DD Anh, JC Victor, S Shin, MD Yunus, MJ Dallas, G Podder, VD
Thiem, LTP Mai, SP Luby, LH Tho, ML Coia, K Lewis, SB Rivers, DA Sack, F Schödel, AD Steele, KM Neuzil, M Ciarlet. 2010. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo controlled trial. The Lancet 376: 606-614.

10-2 GE Armah. SO Sow, RF Breiman, MJ Dallas, MD Tapia, DR Feikin, FN Binka,
AD Steele, KF Laserson, NA Ansah, MM Levine, K Lewis, ML Coia, M Attah-Poku, J
Ojwando, SB Rivers, JC Victor, G Nyambane, A Hodgson, F Schödel, M Ciarlet and KM Neuzil. 2010. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. The Lancet 376: 615-623.

10-3 J Diez-Domingo, SA Flores, JC Martin, SO Klopfer, FP Schödel an PK Bhuyan. A randomized, multi-center, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. 2010. The Pediatric Infectious Disease Journal 29 (10) 972-974.


2009

09-1 Ciarlet M, S He, S Lai, M Petrecz, G Yuan, GF Liu, E Mikviman, PM Heaton, F
Panzer, T Rose, DY Koller, P Van Damme and F Schödel 2009. Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-
Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. Pediatr Infect Dis J. 28: 177-181.

09-2 A Weinberg, JH Zhang, MN Oxman, GR Johnson, AR Hayward, MJ. Caulfield, MR Irwin, J Clair, JG Smith, H Stanley, RD Marchese, R Harbecke, HM Williams, ISF
Chan, RD Arbeit, AA Gershon, F Schödel, VA Morrison, CA Kauffman, SE Straus; KE
Schmader, Larry E. Davis and MJ Levin for the US Department of Veterans Affairs (VA) Cooperative Studies Program Shingles Prevention Study Investigators. 2009. Varicellazoster virus-specific immune responses to herpes zoster in elderly participants in a trial of a clinically effective zoster vaccine.
J Infect Dis 200(7): 1068-1077.

09-3 Ciarlet M and F Schödel. Development of a rotavirus vaccine: clinical safety, immunogenicity and efficacy of the pentavalent rotavirus vaccine RotTeq®. 2009. Vaccine 27 (Suppl 6): G72-G81.

2008

08-1 Gilderman, LI, JF Lawless, TM Nolen, T Sterling, RZ Rutledge, DA Fernsler, N Azrolan, SC Suhradhar, WW Wang, ISF Chan, K Schlienger, F Schödel and JL Silber for the Zostavax Protocol 010 Study Group. 2008. A double-blind, randomized, controlled, multicenter safety and immunogenicity study of a refrigerator-stable formulation of Zostavax. Clinical and Vaccine Immunology 15: 314-319.

08-2 Ciarlet M, R Sami-Grosso, G Yuan, GF Liu, PM Heaton, K Gottesdiener, JL Arredondo, and F Schödel. 2008. Concomitant use of the oral pentavalent human-bovine reassortant rotavirus vaccine and oral poliovirus vaccine Ped Infect Dis J, 27: 874-880.

2007

07-1 Kuter B and F Schödel. 2007. Second varicella vaccine dose (letter to the editor). Ped Infect Dis 26: 193-194.

07-2 Macalad N, T Marcano, M Guzman, J Moya, F Jurado, M Thompson, C Meechan, D Li, I Chan, J Sadoff, F Schödel and JL Silber. 2007 Safety and immunogenicity of a zoster vaccine in varicella-zoster virus seronegative and lowseropositive healthy adults. Vaccine 25: 2139-2144.

07-3 Bernstein HH, K Eves, K Campbell, SB Black, JD Twiggs, KS Reisinger, RM
Conti, CE Flodmark, L Rombo, S Klopfer, F Schödel, J Hartzel, BJ Kuter and the Refrigerator Stable Formulation Study Group for ProQuad. 2007. Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella and varicella virus vaccine live). Pediatrics 119: 1299-1305.

07-4 Kerzner B, VA Murray , E Cheng MD, R Ifle, PR Harvey, M Tomlinson, JL
Barben, K Rarrick, JE Stek M-O Chung, FP Schödel, WWB Wang, J Xu MS, ISF Chan,
JL Silber, K Schlienger 2007. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Amer Geriatrics Soc 55: 1499–1507.

07-5 Patterson-Bartlett J, MJ Levin, N Lang, FP Schödel, R Vessey, A Weinberg. 2007. Phenotypic and functional characterization of ex vivoT cell responses to the live attenuated herpes zoster vaccine. Vaccine 25: 7087-7093.

07-6 Stojanov S, JG Liese, BH Belohradsky, C Vandermeulen, K Hoppenbrouwers, M
Van der Wielen, P Van Damme, B Georges, M Dupuy, M Scemama, M Watson, A
Fiquet, JE Stek, GT Golm, FP Schödel, B Kuter , the HEXAVAC®/VAQTA® Study Group. 2007. Administration of hepatitis A vaccine at 6 and 12 months of age concomitantly with hexavalent (DTaP-IPV-PRP~T-HBs) combination vaccine. Vaccine 25: 7549-7558.


2006

06-1 Reisinger K, ML Hoffman Brown. BS Jin Xu, BJ Sullivan, GS Marshall, B
Nauert, DO Matson, PE Silas, Protocol 014 Group for ProQuad,, F Schödel, JO Gress, BJ Kuter 2006. A combination measles, mumps, rubella and varicella vaccine (ProQuad) given to 4-6-year-old children vaccinated previously with M-M-RII and Varivax. Pediatrics 117: 265-272.

06-2 Shinefield H, S Black, M Thear, D Coury, K Reisinger, E Rothstein, J Xu, J Hartzel, B Evans, L Digilio, F Schödel, ML Hoffman Brown, B Kuter and the 013 study group for ProQuad. 2006. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined haemophilus influenzae type B conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Ped Infect Dis 25: 287-292.

06-3 Vesikari T, HF Clark, PA Offit, MJ Dallas, DJ DiStefano, MG Goveia, RL Ward, F Schödel, A Karvonen, MJ DiNubile, PJ Heaton. 2006. Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine 24: 4821- 4829.

06-4 Lieberman JM, WR Williams, JM Miller, S Black, H Shinefield, F Henderson, CD Marchant, A Werzberger, S Halperin, J Hartzel, S Klopfer, F Schödel, BJ Kuter and the Consistency Lot Study Group for ProQuad. 2006. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Ped Infect Dis 25: 615-622.

06-5 Kuter BJ, ML Hoffman Brown, J Hartzel, WR Williams, KA Eves, S Black, H
Shinefield, KS Reisinger, CD Marchant, BJ Sullivan, M Thear, S Klopfer, J Xiu, JO Gress, F Schödel and the Study Group for ProQuad®. 2006. Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad®). Human Vaccines: 2: 205-214.

06-6 Jäger G, B Kuter, H Campe, H Lakkis, H Nitschko, M Watson, E Harzer and F Schödel. 2006. Large-scale serologic testing program to assess the immunogenicity of inactivated hepatitis A vaccine (VAQTA™) in prefilled syringes following product recall in Germany. Human Vaccines 2: 233-236.

06-7 Diaz C, P Dentico, R Gonzalez, RG Mendez, S Cinquetti, JL Barben, A Harmon,
I Chalikonda, JG Smith, JE Stek, A Robertson, MJ Caulfield, LR Biasio, JL Silber, CY Chan, R Vessey, J Sadoff, ISF Chan, H Matthews, W Wang, K Schlienger, FP Schödel and the Protocol 049 Study Group. 2006. Safety, tolerability, and immunogenicity of a two-dose regimen of high-titer varicella vaccine in subjects ≥ 13 years of age. Vaccine 24: 6875-6885.

2005

05-1. Lagos R., Hoffenbach A., Scemama M., Dupuy M., Schödel F., Hessel L., Levine M. 2005. Lot-to-lot consistency of a combined hexavalent diphtheria-tetanus-acellularpertussis, hepatitis B, inactivated polio and Haemophilus b conjugate vaccine, administered to healthy Chilean infants at 2, 4 and 6 months of age. Human Vaccines 1: 112-117.

05-2. Shinefield H, S Black, L Digilio, K Reisinger, M Blatter, JO Gress, ML Hoffman Brown, KA Eves, S Olsen Klopfer, F Schödel, and BJ Kuter. 2005. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Ped Infect Dis 24: 665-669.

05-3. Shinefield H, WR Williams, C Marchant, K Reisinger, T Stewart, HC Meissner, J
Guerrero, S Olsen Klopfer, F Schödel, BJ Kuter and the Dose Selection Study Group for Proquad. 2005. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Ped Infect Dis 24: 670-675.

05-4 Billaud J-N, D Peterson F Schödel, M Sallberg, A Chen, F Garduno, P Goldstein, W McDowell, J Hughes, J Jones and D Milich. 2005. Comparative Antigenicity and Immunogenicity of Hepadnavirus Core Proteins. J Virol, 79: 13641-13655.

2003

03-1 Clark, H.F., Burke, C.J., Volkin, D.B., Offit, P., Ward, R.L., Bresee, J.S.,
Dennehy, P., Gooch, W.M., Malacaman, E., Matson, D., Walter, E., Watson, B., Krah, D.L., Dallas, M.J., Schödel, F., Kaplan, K.M. , Heaton, P. 2003. Safety, immunogenicity, and efficacy in healthy infants of G1 and G2 human reassortant rotavirus vaccine in a new stabilizer/buffer liquid formulation. Ped. Infect. Dis. J. 22: 914-20.

03-2 Mallet E, BH Belohradsky, R Lagos, L Gothefors, P Camier, J-P Carrière, G
Kanra , A Hoffenbach, J Langue, F Undreiner, F Roussel, P Reinert, C-E Flodmark, S
Stojanov, J Liese, MM Levine, A Muñoz, F Schödel, Luc Hessel on behalf of the
Hexavalent Vaccine Trial Study Group. 2003. A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type B and hepatitis B: review of immunogenicity and safety. Vaccine 22: 1343-1357.

2002

02-1 Liese, J.G., Stojanov, S., Berut, F., Minimi, P., Harzer, E., Jow, S., Schödel, F.,
Boslego, J., Hoffenbach, A., Kronwitter, A., Behohradsky, B.H. 2002. Large Scale Safety Study of a Liquid Hexavalent Vacine (D-T-acP-IPV-PRP-T-HBs) administered at 2, 4, 6 and 12 to 14-months of age. Vaccine 20: 448-454.

2000

00-1 Mallet, E., P. Fabre, E. Pines, H. Salomon, T. Staub, F. Schödel, P. Mendelman,
L. Hessel, G. Chryssomalis, E. Vidor, A. Hoffenbach and the Hexavalent Vaccine Trial Study Group. 2000. Immunogenicity and safety of a new liquid hexavalent combined vacine compared with separate administration of reference licensed vaccines in infants. Ped. Infect. Dis. J. 19: 1119-1127.

1999

99-1 Schödel, F. 1999. Impfstoffe. In: Handbuch der molekularen Medizin, Band 4. Immunsystem und Infektiologie. D. Ganten/K. Ruckpaul (Hrsg.). Springer-Verlag Berlin, Heidelberg, p.p. 367- 385.

1998

98-1 Schödel, F. 1998. Hepatitis B virus vaccines. In: Hepatitis B Virus: Molecular Mechanisms in Disease and Novel Strategies for Therapy. R. Koshy and W. H. Caselmann (eds.). Imperial College Press, London, pp. 219-250

98-2 Schödel, F. & Minor P. 1998. Hepatitis and Polio Vaccines. In: P. Perlmann & H. Wigzell (eds.) Vaccines. Handbook of Experimental Pharmacology, Vol. 133; chapter 6, pp. 121-169, Springer Verlag, Heidelberg.

1997

97-1 Milich, D.R., F. Schödel, J.L. Hughes, J.E. Jones and D.L. Peterson. 1997. The hepatitis B virus core and e antigens elicit different Th cell subsets: Antigen structure can affect Th cell phenotype. J. Virol. 71: 2192-2201.

97-2 Collins, V. And F. Schödel. 1997. Live bacterial vectors. In: Veterinary vaccinology. Eds. Pastoret, P.P., J. Blancou, P. Vannier and C. Verschueren. Elsevier, Amsterdam, p. 293-308.

97-3 Schödel, F. 1997. Attenuated Salmonella spp. As live vectors for viral antigens. In: New Generation Vaccines. M. M. Levine, G. C. Woodrow, J. B. Kaper, G. S. Cobon (eds.). Marcel Dekker, Inc., New York, NY, pp. 343-349.

97-4 Tacket, C.O., Kelly-S.M., Schödel F., Losonsky G., Nataro J.P., Edelman R., Levine M.M. and Curtiss III R. 1997. Safey and immunogenicity in humans of an attenuated Salmonella typhi vaccine vector strain expressing plasmid-encoded hepatitis B antigens stabilized by the Asd-balanced lethal vector system. Infect. Immun, 1997 65:3381-3385.

97-4b Tacket, C.O., Kelly-S.M., Schödel F., Losonsky G., Nataro J.P., Edelman R., Levine M.M. and Curtiss III R. 1997. Erratum : Safey and immunogenicity in humans of an attenuated Salmonella typhi vaccine vector strain expressing plasmid-encoded hepatitis B antigens stabilized by the Asd-balanced lethal vector system. Infect. Immun, 1997 65:3981.

97-5 Milich, D.R., Chen, M., Schödel, F., Peterson, D. L., Jones, J. E., Hughes, J. L.
1997. Role of B cells in antigen presentation of the hepatitis B core. Proc. Natl. Acad. Sci. US, 94: 14648-14653.

97-6 Schödel, F., D. Peterson, D. R. Milich, Y. Charoenvit, J. Sadoff and R. Wirtz.
1997. Immunization with hybrid hepatitis B virus core particles carrying circumsporozoite antigen epitopes protects mice against Plasmodium yoelii challenge. Behring Institute Research Communications 98: 114-119.

1996

96-1 Schödel, F., D. Peterson, J. Hughes, R. Wirtz and D. Milich. 1996. Hybrid hepatitis B virus core antigen as a vaccine carrier moiety. I. Presentation of foreign epitopes. J. Biotech. 44:91-96.

96-2 Schödel, F., S. Kelly, S. Tinge, S. Hopkins, D. Peterson, D. Milich and R. Curtiss III. 1996. Hybrid hepatitis B virus core antigen as a vaccine carrier moiety. II. Expression in avirulent Salmonella spp. for mucosal immunization. In: Novel Strategies in Design and Production of Vaccines. S. Cohen and A. Shafferman (eds). Plenum, New York, pp. 15-21.

96-3 Shafferman, A, S. Lustig, Y. Inbar, M. Halevy, P. Schneider, T. Bino, M. Leitner, H. Grosfeld, B. Velan, Schödel, F., and S. Cohen. 1996. Alphavirus hybrid virion vaccines. In: Novel Strategies in Design and Production of Vaccines. S. Cohen and A. Shafferman (eds). Plenum, New York, pp. 41-47

96-4 Schödel, F., D. Peterson, D. Milich. 1996. Hepatitis B virus core and e antigen:
immune recognition and use as a vaccine carrier moiety. Intervirol. 39: 104-110.

96-5 Nardelli-Haefliger, D., J-P. Kraehenbuhl, R. Curtiss III, F. Schödel, A. Potts, S. Kelly and P. De Grandi. 1996. Oral and rectal immunization of adult female volunteers with a recombinant attenuated Salmonella typhi vaccine strain. Infect. Immun. 64: 52195224.

1995

95-1. Schödel, F. and R. Curtiss III. 1995. Avirulent Salmonella as vaccine carriers. Dev. Biol. Stand. 84: 245-253.

95-2 Bäckström, M., M. Lebens, F. Schödel and J. Holmgren. 1995. Characterization of the internal permissive site in the cholera toxin B-subunit and insertion of epitopes from human immunodeficiency virus-1, hepatitis B virus and enterotoxinogenic Escherichia coli. Gene 165: 163-171.

95-3 Milich, D.R., D. L. Peterson, F. Schödel, J. E. Jones and J. L. Hughes. 1995. Preferential recognition of hepatitis B nucleocapsid antigens by Th1 or Th2 cells is epitope and major histocompatibility complex dependent. J. Virol. 69: 2776-2785.

95-4 Milich, D.R., F. Schödel, D. L. Peterson, J. E. Jones and J. L. Hughes. 1995.
Characterization of self-reactive T-cells that evade tolerance in HBeAg transgenic mice. Eur. J. Immunol. 25: 1663-1672.

95-5 Hopkins, S., J.-P. Kraehenbuhl, F. Schödel, A. Potts, D. Peterson, P. De Grandi and D. Nardelli. 1995. A recombinant Salmonella typhimurium vaccine induces local immunity by four different routes of immunization. Infect. Immun. 63: 3279-3286.

95-6 Milich, D., D. L. Peterson, J. Zheng, J. L. Hughes, R. Wirtz, F. Schödel. 1995.
The hepatitis nucleocapsid as a vaccine carrier moiety. Annals New York Acad. Sciences, 754: 187-201.


1994

94-1 Schödel, F., S. M. Kelly, D. L. Peterson, D. R. Milich, R. Curtiss III. 1994. Hybrid hepatitis B virus core/pre-S proteins synthesized in avirulent Salmonella typhimurium and Salmonella typhi for oral vaccination. Infect. Immun. 62: 16691676.moiety. Annals New York Acad. Sciences, 754: 187-201.

94-2 Maruyama, T., F. Schödel, S. Iino, K. Koike, K. Yasuda, D. Peterson and D. R. Milich. 1994. Distinguishing between acute and symptomatic chronic hepatitis B virus infection. Gastroenterol. 106: 1006-1015.

94-3 Toth, A., F. Schödel, M. Duchêne, K. Massarat, B. Blum, A. Schmitt, H. Domdey, and B.-U. von Specht. 1994. Protection of immunosuppressed mice against translocation of Pseudomonas aeruginosa from the gut by oral immunization with recombinant, Pseudomonas aeruginosa outer membrane protein I expressing Salmonella dublin. Vaccine 12:1215-1221.

94-4 Schödel, F. Emerging viral mutants in hepatitis B. (Letter) Lancet 343: 355.

94-5 Schödel, F., S. M. Kelly, D. Peterson, D. Milich, J. Hughes, S. Tinge, R. Wirtz, R.
Curtiss. 1994. Development of recombinant Salmonellae expressing hybrid hepatitis B virus core particles as candidate oral vaccines. In: F. Brown (ed.). Recombinant Vectors in Vaccine Development. Dev. Biol. Stand. 82: 151-158.

94-6 Schödel, F., D. Peterson, J. Hughes, D. Milich. Hepatitis B virus core particles as a vaccine carrier moiety. Int. Rev. Immunol. 11: 153-165.

94-7 Schödel, F., R. Wirtz, D. Peterson, J. Hughes, R. Warren, J. Sadoff, D. Milich. 1994. Immunity to malaria elicited by HBcAg-CS hybrid particles. J. Exp. Med. 180: 1037-1046.

94-8 Bäckström, M., M. Lebens, F. Schödel and J. Holmgren. 1994. Insertion of a HIV-1 neutralizing epitope in a surface-exposed internal region of the cholera toxin Bsubunit. Gene 149: 211-217.

v. Specht B.-U., H. Domdey, F. Schödel, B. Blum, Ch. Lücking, B. Knapp, G. Muth, K.D. Hungerer and M. Bröker. 1994. Outer membrane proteins of Pseudomonas aeruginosa as vaccine candidates.Behring Inst. Res. Commun. 95: 85-96.

Schödel, F., M.-T. Aguado and P.-H. Lambert. 1994. Introduction: Nucleic Acid Vaccines, WHO, Geneva, 17-18 May 1994. Editorial. Vaccine 12: 1491-1492.

1993

93-1 Schödel. F., G. Neckermann, D. Peterson, K. Fuchs, S. Fuller, H. Will, M. Roggendorf. Immunization with recombinant woodchuck hepatitis virus nucleocapsid antigen or hepatitis B virus nucleocapsid antigen protects woodchucks from woodchuck hepatitis virus infection. Vaccine, 11 (6) 624-628

93-2 Schödel. F., D. Peterson, J. Zheng, J. E. Jones, J. L. Hughes, D. R. Milich. 1993. Structure of hepatitis B virus core and e-antigen: a single precore amino acid prevents nucleocapsid assembly. J. Biol. Chem., 268,1332-1337.

93-3 Schödel. F., D. Peterson, J. Hughes, D. R. Milich. 1993. Avirulent Salmonellae expressing hybrid HBc/pre-S particles for oral vaccination. Vaccine, 11, 143-148.

93-4. Schödel F., D. Peterson, J. Hughes, D. R. Milich. Hybrid hepatitis B virus core/pre-S particles: position effects on immunogenicity of heterologous epitopes and expression in avirulent salmonellae for oral vaccination. In: NATO ASI: Series A: Life Sciences Vol. 245: The Biology of Salmonella, F. Cabello, C. Hormaeche, P. Mastroeni, L. Bonina (eds.). Plenum Publishing Corp., New York, NY pp. 347-353.

93-5 von Brunn, A., M. Brand, C. Reichhuber, C. Morys-Wortmann, F. Deinhardt, F. Schödel. The principal neutralizing domain of HIV-1 is highly immunogenic when expressed on the surface of hepatitis B core particles. Vaccine, 11(8) 817-824.

93-6 von Brunn, A., F. Schödel, C. Reichhuber, M. Brand, B. Bechowsky, A.
Kleinschmidt, V. Erfle, L. Gürtler and J. Eberle. The principal neutralizing domain (V3) of HIV-1 induces HIV-1-neutralizing antibodies upon expression on HBcAg particles. In:
Vaccines 93, Edts. Fred Brown, Robert M. Chanock, Harold S. Ginsberg, Richard A. Lerner. Cold Spring Harbor Laboratories, pp.159-165.

93-7 Bichko, V., F. Schödel, M. Nassal, E. Grene, I. Berzinsh, G. Borisova, S. Miska, D. L. Peterson, E. Gren, P. Pushko, H. Will. 1993. Epitopes recognized by antibodies to denatured core protein of hepatitis B virus. Mol. Immunol., 30:221-231.

93-8 Curtiss, R., III, J.O. Hassan, J. Herr, S. M. Kelly, M. Levine, G. G. Mahairas, D. Milich, D. Peterson, F. Schödel, J. Srinivasan, C. Tacket, S. A. Tinge and R. Wright. Nonrecombinant and recombinant avirulent Salmonella vaccines. Proc. Symposium "Recombinant and synthetic vaccines", New Delhi, India, December 1992. in press.

93-9 Cote, P. J., C. Roneker, K. Cass, F. Schödel, B. Tennant, F. De Noronha, J. Gerin. 1993. New immuno-assays for the serologic detection of woodchuck hepatitis virus infection. Viral Immunol. 6: 161-169.

1992

92-1 Schödel, F.. Prospects for oral vaccination using recombinant bacteria expressing viral epitopes. Adv. Virus Res., 41:409-446.

92-2 Schödel, F. Recombinant avirulent salmonella as oral vaccine carriers. Infection, 1, 1-12, 1992

92-3 Schödel, F., A. M. Moriarty, D. L. Peterson, J. Zheng, J. L. Hughes, H. Will, D. J. Leturcq, J. S. McGee, D. R. Milich. The position of heterologous epitopes inserted in hepatitis B virus core particles determines their immunogenicity. J. Virol. 66, 106-114. 92-4 Zheng, J., F. Schödel, D.L. Peterson. The structure of hepadnaviral core antigens: identification of free thiols and determination of the disulfide bonding pattern. J. Biol. Chem., 267, 9422-9429.

1991

91-1 Schödel, F., D. R. Milich, H. Will. Hybrid hepatitis B virus core/pre-S particles expressed in attenuated salmonellae for oral immunisation. In: Vaccines 91, Edts. Fred Brown, Robert M. Chanock, Harold S. Ginsberg, Richard A. Lerner. Cold Spring Harbor Laboratories, 319-325.

91-2 Schödel, F., H. Will, S. Johansson, J. Sanchez, J. Holmgren. Synthesis in Vibrio cholerae and secretion of hepatitis B virus antigens fused to E.coli heat labile enterotoxin subunit B. Gene, 99:255-259.

91-3 Schödel, F., R. Sprengel, T. Weimer, D. Fernholz, R. Schneider, G. Wildner, H.
Will. The biology of avian hepatitis B viruses. In: Molecular Biology of the Hepatitis B Virus. Chapter 3, pp. 53-80, Edt.: A. McLachlan. CRC Press, Boca Raton, 1991

91-4 Schödel, F., G. Enders, H. Will . Oral immunisation of mice with hepatitis B virus
B-cell and T-cell epitopes expressed in salmonella vaccine strains. In: Viral Hepatitis and
Liver Disease. Proceedings of the 1990 International Symposium on Viral Hepatitis and Liver Disease, Eds. F. B. Hollinger, S.M. Lemon, H. Margolis, Houston, 1991, pp. 784787.

91-5 Schödel F. Expression viraler Antigene in attenuierten Salmonellen zur Entwicklung von Schluckimpfstoffen gegen Hepatitis B Virus Infektion.
Habilitationsschrift zur Erlangung des Grades eines habilitierten Doktors der Medizin an der Ludwig-Maximilians-Universität München


91-6 Joys, T. M., F. Schödel. Epitope mapping of the d flagellar antigen of salmonella. Infect. Immun., 59:3330-3333.

91-7 Raimondo, G., R. Schneider, M., Stemler, S., Vincenzo, G. Wildner, G. Rodino, F. Schödel, G. Squadrito, H. Will. Reactivation and latency of hepatitis B viruses in chronically infected patients. In: Viral Hepatitis and Liver Disease. Proceedings of the 1990 International Symposium on Viral Hepatitis and Liver Disease, Eds. F. B. Hollinger, S.M. Lemon, H. Margolis, Houston, 1991, pp. 210-211.

91-8 Fuchs, K., F. Schödel, K. Manneck, G. Neckermann, H. Will, M. Roggendorf. Protection from infection with woodchuck hepatitis virus (WHV) by immunization with recombinant core protein of WHV and HBV. In: Viral Hepatitis and Liver Disease. Proceedings of the 1990 International Symposium on Viral Hepatitis and Liver Disease, Eds. F. B. Hollinger, S.M. Lemon, H. Margolis, Houston, 1991, pp. 267-270

1990

90-1 Schödel, F. Oral vaccination using recombinant bacteria. Seminars in Immunology, 2 (6) 341-349

90-2 Schödel, F., D.R. Milich, H. Will. Hepatitis B virus nucleocapsid/pre-S2 fusion proteins expressed in attenuated salmonellae for oral vaccination. J. Immunol., 145 (12) 4317-4321

90-3 Schödel, F., M. Hofnung. Oral Immunization Using Recombinant Bacteria:
Introduction. Res. Microbiol., 141 (7-8) 745-746 (1990)

90-4 Schödel, F., H. Will. Expression of hepatitis B virus antigens in attenuated salmonellae for oral immunisation. Res. Microbiol., 141 (7-8) 831-837 (1990)

90-5 Schödel, F., G. Enders, M.-C. Jung, H. Will. Recognition of a hepatitis B virus nucleocapsid T-cell epitope expressed as a fusion protein with the subunit B of E.coli heat-labile enterotoxin. Vaccine, 8 (6) 569 - 572 (1990)

90-6 Schödel, F., G. Enders, H. Will. Expression of hepatitis B virus core T-cell epitopes and pre-S2 B-cell epitope as fusion protein with LT-B in salmonella for oral vaccination. In: Progress in Hepatitis B Immunisation, Edts. P.Coursaget, M.J. Tong, Colloque INSERM/John Libbey Eurotext Ltd., pp. 43-50 (1990)

90-7 Schödel, F., T. Weimer, H. Will, D. R. Milich. 1990. Recombinant hepatitis B virus (HBV) core particles carrying immunodominant B-cell epitopes of the HBV preS(2) region. In: Vaccines 90, Edts. Fred Brown, Robert M. Chanock, Harold S. Ginsberg, Richard A. Lerner. Cold Spring Harbor Laboratories, pp. 193-198

90-8 Schödel, F., T. Weimer, H. Will. HBV: Molecular Biology and Immunology. Biotest Bull., 4: 63-83

90-9 Kachel, V., O. Kempski, J. Peters, F. Schödel. A method for calibration of flow cytometric wavelength shift fluorescence measurements. Cytometry, 11:913-915, 1990

90-10 Brunetto, M.R., M. Stemler, F. Bonino, F. Schödel, F. Oliveri, M. Rizzetto, G. Verme, H. Will. A new hepatitis B virus strain in patients with severe anti-HBe positive chronic hepatitis. J. Hepatol., 10: 258-261, 1990

90-11 Weimer, T., F. Schödel, M.-C. Jung, G.R. Pape, A. Alberti, G. Fattovich, H.
Beljaars, P.M.C.A. van Eerd, and H. Will. Antibodies to the RNaseH domain of hepatitis B virus P-protein are associated with ongoing viral replication. J.Virol. 64: 5665-5668

1989

89-1 Schödel, F., H. Will. Construction of a plasmid for the expression of foreign epitopes as fusion proteins with the subunit B of Escherichia coli heat-labile enterotoxin. Infect. Immun., 56:1347-1350 (1989)

89-2 Schödel F., R. Sprengel, T. Weimer, D. Fernholz, R. Schneider, H. Will. Animal Hepatitis B Viruses. Adv. Viral Oncol., 8:73-102, (1989),. edt. by George Klein, Raven Press, N.Y.

89-3 Brunetto, M.R., M. Stemler, F. Schödel, H. Will, A. Ottobrelli, M. Rizzetto, G.
Verme, F. Bonino. Identification of HBV variants which cannot produce precore derived
HBeAg and may be responsible for severe hepatitis. Ital. J. Gastroenterol., 21:151-154, 1989

1988

88-1 Schödel, F., T. Weimer, H. Will, R. Sprengel. Sequence similarity between retroviral and E.coli Rnase H and hepadnaviral gene products. AIDS Res. Human Retroviruses, 4:9-11, (1988)

88-2 Kempski O., F. Staub, M. Jansen, F. Schödel, A. Baethmann. Glial swelling during extracellular acidosis in-vitro. Stroke 3:385-392, (1988)

88-3 Sprengel R., D. Fernholz, R. Schneider, Z. Tu, F. Schödel, T. Weimer, E.F.
Kaleta, H. Will. Hepatitis B Viren bei Enten, Gänsen und Graureihern: Epidemiologie, Diagnostik und Pathogenese . In: VI. Tagung über Vogelkrankheiten, pp. 176-187, Ed.: Deutsche Veterinärmedizinische Gesellschaft e.V., Munich, 1988.

1987

87-1 Schödel F., F. Krombach, G. Höbel, C. Hammer, W. Brendel. 1987. Influence of acute kidney graft rejection on the chemiluminescence of fine needle aspirate and peripheral blood cells. In: Proc. 4th Intern. Symposium on Bioluminescence and Chemiluminescence. ed. Gerok, Schölmerich et al., John Wiley & Sons pp.57-60.

1986

86-1 Schödel F., F. Krombach, C. Hammer, W. Brendel. Peripheral blood and intrarenal phagocytic chemiluminescence during acute kidney graft rejection.
Inflammation 10 (3):271-280 (1986)

86-2 Schödel F., B. Hahn, R. Hübner, V. Hochstein-Mintzel. Transmission of bovine leukemia virus (BLV) to immunocompromised monkeys: evidence for persistent infection. Microbiologica 9 (2):163-172 (1986)

86-3 Schödel F., F. Krombach, C. Hammer, W. Brendel. Effects of acute kidney graft rejection on the chemiluminescence reactivity of peripheral blood and intragraft phagocytes. Transplantation Proc. XVIII (5):1368-1369 (1986)

86-4 Schödel F., F. Krombach, C. Hammer, W. Brendel. PhagozytenChemilumineszenz während Nierentransplantatabstoflung im Hundemodell.
Z.exp.Chir.künstl.Organe 19 (6):354-356 (1986)

86-5 Krombach F., F. Schödel, M. Rath, M. Gokel, J. Lissner, W. Brendel. 1986. Renal transplant rejection in core biopsy, fine needle aspiration cytology and magnetic resonance imaging: a comparative study. Transplantation Proc. XVIII (5):1099-1101.

1985

85-1 Schödel, F. Phagozytose-assoziierte Chemilumineszenz bei unbehandelter
Nierentransplantatabstoβung. Eine experimentelle Untersuchung. Dissertation, LudwigMaximilians-Universität München, (1985)

85-2 Schödel F., F. Krombach, C. Lersch, C. Hammer, W. Brendel.
Chemoluminescence of polymorphonuclear leukocytes during renal allograft rejection. In: Transplant. Proc. XVII (6):2534-2535 (1985)

85-3 Krombach F., F. Schödel, Ch. Lersch, C. Hammer, W. Brendel.
Granulozytenaktivierung bei Nierentransplantatabstoβung. Langenbecks Archiv Chir. Suppl.:95-98 (1985)

85-4 W. Land, M. Heim, S. Scholz, W. Mempel, W.D. Illner, L.A. Castro, F. Schödel. Preliminary experience with cadaveric donor-specific platelet transfusion (CDSPT) prior to kidney transplantation. Neth. J. Med. 28:262-264 (1985)

85-5 Thiel M., C. Lersch, C. Hammer, F. Krombach, F. Schödel, P. Lenz., W. Brendel.
Chemilumineszenz (CL) und Morphologie von Milzzellen in Mäusen unter
Tumorwachstum. Langenbecks Archiv Chir. Suppl.:85-88 (1985)


VIII. PATENTS

US-Patent number: 5726011. Method for diagnosing chronic hepatitis B virus infection.
Filing date: Mar 31, 1994. Issue date: Mar 10, 1998. Inventors: DR Milich, T Maruyama, F Schödel, D Peterson