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Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial.

Open forum infectious diseases

Mulligan MJ, Bernstein DI, Frey S, Winokur P, Rouphael N, Dickey M, Edupuganti S, Spearman P, Anderson E, Graham I, Noah DL, Mangal B, Kim S, Hill H, Whitaker J, Emery W, Beck A, Stephens K, Hartwell B, Ogilvie M, Rimann N, Osinski E, Destefano E, Gajadhar T, Strudwick A, Pierce K, Lai L, Yue L, Wang D, Ying C, Cline A, Foltz T, Wagner N, Dull G, Pacatte T, Taggart B, Johnson V, Haller L, Looney C, Li S, May M, Myers B, May R, Parker L, Cochran N, Bowen D, Bell M, Scoggins J, Burns A, Stablein C, Wolff M, Jolles B, Leung B, Lambert L, Shorer S, Buchanan W, Murray S, Chang S, Gorman R.
PMID: 25734170
Open Forum Infect Dis. 2014 Nov 18;1(3):ofu102. doi: 10.1093/ofid/ofu102. eCollection 2014 Dec.

BACKGROUND: Avian influenza A/H5N1 has threatened human health for nearly 2 decades. Avian influenza A vaccine without adjuvant is poorly immunogenic. A flexible rapid tactic for mass vaccination will be needed if a pandemic occurs.METHODS: A multicenter, randomized, blinded...

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Mulligan MJ, Bernstein DI, Frey S, et al. Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial. Open Forum Infect Dis. 2014;1(3):ofu102doi: 10.1093/ofid/ofu102.
Mulligan, M. J., Bernstein, D. I., Frey, S., Winokur, P., Rouphael, N., Dickey, M., Edupuganti, S., Spearman, P., Anderson, E., Graham, I., Noah, D. L., Mangal, B., Kim, S., Hill, H., Whitaker, J., Emery, W., Beck, A., Stephens, K., Hartwell, B., Ogilvie, M., Rimann, N., Osinski, E., Destefano, E., Gajadhar, T., Strudwick, A., Pierce, K., Lai, L., Yue, L., Wang, D., Ying, C., Cline, A., Foltz, T., Wagner, N., Dull, G., Pacatte, T., Taggart, B., Johnson, V., Haller, L., Looney, C., Li, S., May, M., Myers, B., May, R., Parker, L., Cochran, N., Bowen, D., Bell, M., Scoggins, J., Burns, A., Stablein, C., Wolff, M., Jolles, B., Leung, B., Lambert, L., Shorer, S., Buchanan, W., Murray, S., Chang, S., & Gorman, R. (2014). Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial. Open forum infectious diseases, 1(3), ofu102. https://doi.org/10.1093/ofid/ofu102
Mulligan, Mark J, et al. "Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial." Open forum infectious diseases vol. 1,3 (2014): ofu102. doi: https://doi.org/10.1093/ofid/ofu102
Mulligan MJ, Bernstein DI, Frey S, Winokur P, Rouphael N, Dickey M, Edupuganti S, Spearman P, Anderson E, Graham I, Noah DL, Mangal B, Kim S, Hill H, Whitaker J, Emery W, Beck A, Stephens K, Hartwell B, Ogilvie M, Rimann N, Osinski E, Destefano E, Gajadhar T, Strudwick A, Pierce K, Lai L, Yue L, Wang D, Ying C, Cline A, Foltz T, Wagner N, Dull G, Pacatte T, Taggart B, Johnson V, Haller L, Looney C, Li S, May M, Myers B, May R, Parker L, Cochran N, Bowen D, Bell M, Scoggins J, Burns A, Stablein C, Wolff M, Jolles B, Leung B, Lambert L, Shorer S, Buchanan W, Murray S, Chang S, Gorman R. Point-of-Use Mixing of Influenza H5N1 Vaccine and MF59 Adjuvant for Pandemic Vaccination Preparedness: Antibody Responses and Safety. A Phase 1 Clinical Trial. Open Forum Infect Dis. 2014 Nov 18;1(3):ofu102. doi: 10.1093/ofid/ofu102. eCollection 2014 Dec. PMID: 25734170; PMCID: PMC4324215.
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Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant.

Open forum infectious diseases

Chen WH, Jackson LA, Edwards KM, Keitel WA, Hill H, Noah DL, Creech CB, Patel SM, Mangal B, Kotloff KL.
PMID: 25734159
Open Forum Infect Dis. 2014 Oct 08;1(3):ofu091. doi: 10.1093/ofid/ofu091. eCollection 2014 Dec.

BACKGROUND: The national stockpile for influenza pandemic preparedness includes vaccines against an array of strains and adjuvants that could be utilized to induce immunologic priming as a pandemic wave emerges. We assessed the feasibility of a strategy that allows...

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Chen WH, Jackson LA, Edwards KM, et al. Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant. Open Forum Infect Dis. 2014;1(3):ofu091doi: 10.1093/ofid/ofu091.
Chen, W. H., Jackson, L. A., Edwards, K. M., Keitel, W. A., Hill, H., Noah, D. L., Creech, C. B., Patel, S. M., Mangal, B., & Kotloff, K. L. (2014). Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant. Open forum infectious diseases, 1(3), ofu091. https://doi.org/10.1093/ofid/ofu091
Chen, Wilbur H, et al. "Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant." Open forum infectious diseases vol. 1,3 (2014): ofu091. doi: https://doi.org/10.1093/ofid/ofu091
Chen WH, Jackson LA, Edwards KM, Keitel WA, Hill H, Noah DL, Creech CB, Patel SM, Mangal B, Kotloff KL. Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant. Open Forum Infect Dis. 2014 Oct 08;1(3):ofu091. doi: 10.1093/ofid/ofu091. eCollection 2014 Dec. PMID: 25734159; PMCID: PMC4324222.
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A structure-function approach to optimizing TLR4 ligands for human vaccines.

Clinical & translational immunology

Carter D, Fox CB, Day TA, Guderian JA, Liang H, Rolf T, Vergara J, Sagawa ZK, Ireton G, Orr MT, Desbien A, Duthie MS, Coler RN, Reed SG.
PMID: 27990284
Clin Transl Immunology. 2016 Nov 02;5(11):e108. doi: 10.1038/cti.2016.63. eCollection 2016 Nov.

Adjuvants are combined with vaccine antigens to enhance and modify immune responses, and have historically been primarily crude, undefined entities. Introducing toll-like receptor (TLR) ligands has led to a new generation of adjuvants, with TLR4 ligands being the most...

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Carter D, Fox CB, Day TA, et al. A structure-function approach to optimizing TLR4 ligands for human vaccines. Clin Transl Immunology. 2016;5(11):e108doi: 10.1038/cti.2016.63.
Carter, D., Fox, C. B., Day, T. A., Guderian, J. A., Liang, H., Rolf, T., Vergara, J., Sagawa, Z. K., Ireton, G., Orr, M. T., Desbien, A., Duthie, M. S., Coler, R. N., & Reed, S. G. (2016). A structure-function approach to optimizing TLR4 ligands for human vaccines. Clinical & translational immunology, 5(11), e108. https://doi.org/10.1038/cti.2016.63
Carter, Darrick, et al. "A structure-function approach to optimizing TLR4 ligands for human vaccines." Clinical & translational immunology vol. 5,11 (2016): e108. doi: https://doi.org/10.1038/cti.2016.63
Carter D, Fox CB, Day TA, Guderian JA, Liang H, Rolf T, Vergara J, Sagawa ZK, Ireton G, Orr MT, Desbien A, Duthie MS, Coler RN, Reed SG. A structure-function approach to optimizing TLR4 ligands for human vaccines. Clin Transl Immunology. 2016 Nov 02;5(11):e108. doi: 10.1038/cti.2016.63. eCollection 2016 Nov. PMID: 27990284; PMCID: PMC5133366.
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Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate.

NPJ vaccines

Roozendaal R, Hendriks J, van Effelterre T, Spiessens B, Dekking L, Solforosi L, Czapska-Casey D, Bockstal V, Stoop J, Splinter D, Janssen S, Baelen BV, Verbruggen N, Serroyen J, Dekeyster E, Volkmann A, Wollmann Y, Carrion R, Giavedoni LD, Robinson C, Leyssen M, Douoguih M, Luhn K, Pau MG, Sadoff J, Vandebosch A, Schuitemaker H, Zahn R, Callendret B.
PMID: 33335092
NPJ Vaccines. 2020 Dec 17;5(1):112. doi: 10.1038/s41541-020-00261-9.

It has been proven challenging to conduct traditional efficacy trials for Ebola virus (EBOV) vaccines. In the absence of efficacy data, immunobridging is an approach to infer the likelihood of a vaccine protective effect, by translating vaccine immunogenicity in...

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Roozendaal R, Hendriks J, van Effelterre T, et al. Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate. NPJ Vaccines. 2020;5(1):112doi: 10.1038/s41541-020-00261-9.
Roozendaal, R., Hendriks, J., van Effelterre, T., Spiessens, B., Dekking, L., Solforosi, L., Czapska-Casey, D., Bockstal, V., Stoop, J., Splinter, D., Janssen, S., Baelen, B. V., Verbruggen, N., Serroyen, J., Dekeyster, E., Volkmann, A., Wollmann, Y., Carrion, R., Giavedoni, L. D., Robinson, C., Leyssen, M., Douoguih, M., Luhn, K., Pau, M. G., Sadoff, J., Vandebosch, A., Schuitemaker, H., Zahn, R., & Callendret, B. (2020). Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate. NPJ vaccines, 5(1), 112. https://doi.org/10.1038/s41541-020-00261-9
Roozendaal, Ramon, et al. "Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate." NPJ vaccines vol. 5,1 (2020): 112. doi: https://doi.org/10.1038/s41541-020-00261-9
Roozendaal R, Hendriks J, van Effelterre T, Spiessens B, Dekking L, Solforosi L, Czapska-Casey D, Bockstal V, Stoop J, Splinter D, Janssen S, Baelen BV, Verbruggen N, Serroyen J, Dekeyster E, Volkmann A, Wollmann Y, Carrion R, Giavedoni LD, Robinson C, Leyssen M, Douoguih M, Luhn K, Pau MG, Sadoff J, Vandebosch A, Schuitemaker H, Zahn R, Callendret B. Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidate. NPJ Vaccines. 2020 Dec 17;5(1):112. doi: 10.1038/s41541-020-00261-9. PMID: 33335092; PMCID: PMC7747701.
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Single dose of DPX-rPA, an enhanced-delivery anthrax vaccine formulation, protects against a lethal .

NPJ vaccines

Weir GM, MacDonald LD, Rajagopalan R, Sivko GS, Valderas MW, Rayner J, Berger BJ, Sammatur L, Stanford MM.
PMID: 30774997
NPJ Vaccines. 2019 Feb 08;4:6. doi: 10.1038/s41541-019-0102-z. eCollection 2019.

Anthrax is a serious biological threat caused by pulmonary exposure to aerosolized spores of

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Weir GM, MacDonald LD, Rajagopalan R, et al. Single dose of DPX-rPA, an enhanced-delivery anthrax vaccine formulation, protects against a lethal . NPJ Vaccines. 2019;4:6doi: 10.1038/s41541-019-0102-z.
Weir, G. M., MacDonald, L. D., Rajagopalan, R., Sivko, G. S., Valderas, M. W., Rayner, J., Berger, B. J., Sammatur, L., & Stanford, M. M. (2019). Single dose of DPX-rPA, an enhanced-delivery anthrax vaccine formulation, protects against a lethal . NPJ vaccines, 46. https://doi.org/10.1038/s41541-019-0102-z
Weir, Genevieve M, et al. "Single dose of DPX-rPA, an enhanced-delivery anthrax vaccine formulation, protects against a lethal ." NPJ vaccines vol. 4 (2019): 6. doi: https://doi.org/10.1038/s41541-019-0102-z
Weir GM, MacDonald LD, Rajagopalan R, Sivko GS, Valderas MW, Rayner J, Berger BJ, Sammatur L, Stanford MM. Single dose of DPX-rPA, an enhanced-delivery anthrax vaccine formulation, protects against a lethal . NPJ Vaccines. 2019 Feb 08;4:6. doi: 10.1038/s41541-019-0102-z. eCollection 2019. PMID: 30774997; PMCID: PMC6368554.
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Showing 1 to 5 of 5 entries