Search

Your search keyword '"Chen, Wilbur"' showing total 442 results
Start Over Author "Chen, Wilbur"
442 results on '"Chen, Wilbur"'

101. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials

Author

Gaudinski, Martin R, primary, Houser, Katherine V, additional, Morabito, Kaitlyn M, additional, Hu, Zonghui, additional, Yamshchikov, Galina, additional, Rothwell, Ro Shauna, additional, Berkowitz, Nina, additional, Mendoza, Floreliz, additional, Saunders, Jamie G, additional, Novik, Laura, additional, Hendel, Cynthia S, additional, Holman, LaSonji A, additional, Gordon, Ingelise J, additional, Cox, Josephine H, additional, Edupuganti, Srilatha, additional, McArthur, Monica A, additional, Rouphael, Nadine G, additional, Lyke, Kirsten E, additional, Cummings, Ginny E, additional, Sitar, Sandra, additional, Bailer, Robert T, additional, Foreman, Bryant M, additional, Burgomaster, Katherine, additional, Pelc, Rebecca S, additional, Gordon, David N, additional, DeMaso, Christina R, additional, Dowd, Kimberly A, additional, Laurencot, Carolyn, additional, Schwartz, Richard M, additional, Mascola, John R, additional, Graham, Barney S, additional, Pierson, Theodore C, additional, Ledgerwood, Julie E, additional, Chen, Grace L, additional, Plummer, Sarah, additional, Costner, Pamela, additional, Zephir, Kathryn, additional, Casazza, Joseph, additional, Ola, Abidemi, additional, Victorino, Milalynn, additional, Levinson, Carol, additional, Whalen, William, additional, Wang, Xiaolin, additional, Cunningham, Jennifer, additional, Vasilenko, Olga, additional, Burgos Florez, Maria, additional, Hickman, Somia, additional, Pittman, Iris, additional, Le, Lam, additional, Larkin, Brenda, additional, Andrews, Charla, additional, Apte, Preeti, additional, Hicks, Renunda, additional, Trelles Cartagena, Cora, additional, Williams, Pernell, additional, Boyd, Catina R, additional, Conan-Cibotti, Michelle, additional, Stein, Judy, additional, Kaltovich, Florence, additional, DeCederfelt, Hope, additional, McAdams, Stacey, additional, Renehan, Phyllis, additional, Chen, Wilbur, additional, Greenberg, Nancy, additional, Wymer, Nancy, additional, Wadsworth, Linda, additional, Billington, Melissa, additional, Robinson, Toni, additional, Boyce, Colleen, additional, Pa'ahana Brown, Faith, additional, Chrisley, Lisa, additional, Kwon, Alyson, additional, Patel, Prashant, additional, Kominou, Panagoita, additional, Dorsey, Brenda, additional, Eddington, Staci, additional, Telscher, Shinyi, additional, Lee, Myoughee, additional, Mosely, Regina, additional, Ross, April, additional, Ford, Geoffrey, additional, Domjahn, Briyana, additional, Xu, Jianguo, additional, Beck, Allison, additional, Fineman, Rebecca, additional, Heeke, Shiela, additional, Winter, Jean, additional, Nagar, Shashi, additional, Kelley, Colleen, additional, and Mulligan, Mark, additional

Published
2018
Full Text
View/download PDF

103. Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator

Author

Sow, Samba O., primary, Tapia, Milagritos D., additional, Chen, Wilbur H., additional, Haidara, Fadima C., additional, Kotloff, Karen L., additional, Pasetti, Marcela F., additional, Blackwelder, William C., additional, Traoré, Awa, additional, Tamboura, Boubou, additional, Doumbia, Moussa, additional, Diallo, Fatoumata, additional, Coulibaly, Flanon, additional, Onwuchekwa, Uma, additional, Kodio, Mamoudou, additional, Tennant, Sharon M., additional, Reymann, Mardi, additional, Lam, Diana F., additional, Gurwith, Marc, additional, Lock, Michael, additional, Yonker, Thomas, additional, Smith, Jonathan, additional, Simon, Jakub K., additional, and Levine, Myron M., additional

Published
2017
Full Text
View/download PDF

108. The Live Attenuated Cholera Vaccine CVD 103-HgR Primes Responses to the Toxin-Coregulated Pilus Antigen TcpA in Subjects Challenged with Wild-Type Vibrio cholerae

Author

Mayo-Smith, Leslie M., primary, Simon, Jakub K., additional, Chen, Wilbur H., additional, Haney, Douglas, additional, Lock, Michael, additional, Lyon, Caroline E., additional, Calderwood, Stephen B., additional, Kirkpatrick, Beth D., additional, Cohen, Mitchell, additional, Levine, Myron M., additional, Gurwith, Marc, additional, and Harris, Jason B., additional

Published
2017
Full Text
View/download PDF

110. Safety and Immunogenicity of a Parenterally Administered, Structure-Based Rationally Modified Recombinant Staphylococcal Enterotoxin B Protein Vaccine, STEBVax

Author

Chen, Wilbur H., primary, Pasetti, Marcela F., additional, Adhikari, Rajan P., additional, Baughman, Holly, additional, Douglas, Robin, additional, El-Khorazaty, Jill, additional, Greenberg, Nancy, additional, Holtsberg, Frederick W., additional, Liao, Grant C., additional, Reymann, Mardi K., additional, Wang, Xiaolin, additional, Warfield, Kelly L., additional, and Aman, M. Javad, additional

Published
2016
Full Text
View/download PDF

113. Single-dose Live Oral Cholera Vaccine CVD 103-HgR Protects Against Human Experimental Infection WithVibrio choleraeO1 El Tor

Author

Chen, Wilbur H., primary, Cohen, Mitchell B., additional, Kirkpatrick, Beth D., additional, Brady, Rebecca C., additional, Galloway, David, additional, Gurwith, Marc, additional, Hall, Robert H., additional, Kessler, Robert A., additional, Lock, Michael, additional, Haney, Douglas, additional, Lyon, Caroline E., additional, Pasetti, Marcela F., additional, Simon, Jakub K., additional, Szabo, Flora, additional, Tennant, Sharon, additional, and Levine, Myron M., additional

Published
2016
Full Text
View/download PDF

117. A roadmap for enterotoxigenic Escherichia colivaccine development based on volunteer challenge studies

Author

Levine, Myron M., Barry, Eileen M., and Chen, Wilbur H.

Abstract

ABSTRACTEnterotoxigenic Escherichia coli(ETEC) is a major cause of travelers’ diarrhea and of diarrhea among young children in developing countries. Experimental challenge studies in adult volunteers have played a pivotal role in establishing ETEC as an enteric pathogen, elucidating its pathogenesis by identifying specific virulence attributes, characterizing the human immune response to clinical and sub-clinical ETEC infection and assessing preliminarily the clinical acceptability, immunogenicity and efficacy of prototype ETEC vaccines. This review provides a historical perspective of experimental challenge studies with ETEC. It summarizes pioneering early studies carried out by investigators at the University of Maryland School of Medicine to show how those studies provided key information that influenced the directions taken by many research groups to develop vaccines to prevent ETEC. In addition, key experimental challenge studies undertaken at other institutions will also be cited.

Published
2019
Full Text
View/download PDF

118. Serological Correlates of Protection against a GII.4 Norovirus

Author

Atmar, Robert L., primary, Bernstein, David I., additional, Lyon, G. Marshall, additional, Treanor, John J., additional, Al-Ibrahim, Mohamed S., additional, Graham, David Y., additional, Vinjé, Jan, additional, Jiang, Xi, additional, Gregoricus, Nicole, additional, Frenck, Robert W., additional, Moe, Christine L., additional, Chen, Wilbur H., additional, Ferreira, Jennifer, additional, Barrett, Jill, additional, Opekun, Antone R., additional, Estes, Mary K., additional, Borkowski, Astrid, additional, Baehner, Frank, additional, Goodwin, Robert, additional, Edmonds, Anthony, additional, and Mendelman, Paul M., additional

Published
2015
Full Text
View/download PDF

121. Vaccination in the elderly: an immunological perspective

Author

Grubeck-Loebenstein, Beatrix, Kozlovsky, Bernard F., Sztein, Marcelo B., Effros, Rita B., Edelman, Robert, and Chen, Wilbur H.

Subjects
Biological Sciences
Abstract

Successful vaccination of the elderly against important infectious pathogens that cause high morbidity and mortality represents a growing public health priority. Building on the theme of aging and immunosenescence, we review mechanisms of human immunosenescence and the immune response to currently licensed vaccines. We discuss the difficulties in identifying the risk factors that, in addition to aging, cause immunosenescence and address the relative paucity of vaccine studies in the elderly. We conclude that vaccine responses are blunted in the elderly compared with that of healthy young adults. However, it is also clear that our understanding of the mechanisms underlying immunosenescence is limited and much remains to be learned to improve the effectiveness of next generation vaccines.

Published
2009

125. Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers

Author

Islam, Kamrul, Hossain, Motaher, Kelly, Meagan, Mayo Smith, Leslie M., Charles, Richelle C., Bhuiyan, Taufiqur Rahman, Kováč, Pavol, Xu, Peng, LaRocque, Regina C., Calderwood, Stephen B., Simon, Jakub K., Chen, Wilbur H., Haney, Douglas, Lock, Michael, Lyon, Caroline E., Kirkpatrick, Beth D., Cohen, Mitchell, Levine, Myron M., Gurwith, Marc, Harris, Jason B., Qadri, Firdausi, and Ryan, Edward T.

Subjects
Medicine and Health Sciences, Infectious Diseases, Infectious Disease Control, Vaccines, Cholera Vaccines, Biology and Life Sciences, Immunology, Immune Response, Antibody Response, Microbiology, Medical Microbiology, Microbial Pathogens, Bacterial Pathogens, Vibrio Cholerae, Pathology and Laboratory Medicine, Pathogens, Organisms, Bacteria, Vibrio, Physiology, Immune Physiology, Antibodies, Immune System Proteins, Biochemistry, Proteins, Gastroenterology and Hepatology, Diarrhea, Diagnostic Medicine, Signs and Symptoms, Immunologic Techniques, Immunoassays, Enzyme-Linked Immunoassays, Bacterial Diseases, Cholera, Tropical Diseases, Neglected Tropical Diseases
Abstract

Background: Cholera is an acute voluminous dehydrating diarrheal disease caused by toxigenic strains of Vibrio cholerae O1 and occasionally O139. A growing body of evidence indicates that immune responses targeting the O-specific polysaccharide (OSP) of V. cholerae are involved in mediating protection against cholera. We therefore assessed whether antibody responses against OSP occur after vaccination with live attenuated oral cholera vaccine CVD 103-HgR, and whether such responses correlate with protection against cholera. Methodology We assessed adult North American volunteers (n = 46) who were vaccinated with 5 × 108 colony-forming units (CFU) of oral cholera vaccine CVD 103-HgR and then orally challenged with approximately 1 × 105 CFU of wild-type V. cholerae O1 El Tor Inaba strain N16961, either 10 or 90 days post-vaccination. Principal findings Vaccination was associated with induction of significant serum IgM and IgA anti-OSP and vibriocidal antibody responses within 10 days of vaccination. There was significant correlation between anti-OSP and vibriocidal antibody responses. IgM and IgA anti-OSP responses on day 10 following vaccination were associated with lower post-challenge stool volume (r = −0.44, P = 0.002; r = −0.36, P = 0.01; respectively), and none of 27 vaccinees who developed a ≥1.5 fold increase in any antibody isotype targeting OSP on day 10 following vaccination compared to baseline developed moderate or severe cholera following experimental challenge, while 5 of 19 who did not develop such anti-OSP responses did (P = 0.01). Conclusion: Oral vaccination with live attenuated cholera vaccine CVD 103-HgR induces antibodies that target V. cholerae OSP, and these anti-OSP responses correlate with protection against diarrhea following experimental challenge with V. cholerae O1. Trial registration ClinicalTrials.gov NCT01895855

Published
2018
Full Text
View/download PDF

129. Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study

Author

Beigel, John H, Tebas, Pablo, Elie-Turenne, Marie-Carmelle, Bajwa, Ednan, Bell, Todd E, Cairns, Charles B, Shoham, Shmuel, Deville, Jaime G, Feucht, Eric, Feinberg, Judith, Luke, Thomas, Raviprakash, Kanakatte, Danko, Janine, O'Neil, Dorothy, Metcalf, Julia A, King, Karen, Burgess, Timothy H, Aga, Evgenia, Lane, H Clifford, Hughes, Michael D, Davey, Richard T, Tebas, Pablo, Quinn, Joseph, Jiang, Yan, Elie-Turenne, Marie-Carmelle, Hoelle, Robyn, Iovine, Nicole, Wills, Robert Shawn, Pata, Socorro, Huggins, Monique, Manukian, Belinda, Bajwa, Ednan, Holland, Carrie, Brait, Kelsey, Hunt, Taylor, Stowell, Christopher, Slater, Amy, Bell, Todd E, Townsends, Mary, Cairns, Charles B, Quackenbush, Eugenia B, Park, Yara A, Jordan, Paul Gaither, Blanchet, Cherie, Chronowski, Kevin, Alvarez, Kathleen, Shoham, Shmuel, Ostrander, Darin, Woessner, Terry, Thoman, Sandra, Deville, Jaime G, Lin, James, Ziman, Alyssa, Shankar, Kavita, Feucht, Eric, Blok, Tom, Batts, Don, Beck, Bob, Massey, Gail, Bradley, Carol, Feinberg, Judith, Carey, Patricia, Baer, Jenifer, Whitehead, Eva Moore, Kohrs, Sharon, Giulitto, Robert, Schofield, Christina, Fairchok, Mary, Chambers, Susan, Baker, Cindy, RN, Parker, Michelle, Harshbarger, Marta, Nguyen, M Hong, Carey, Mary Ellen, Paronish, Julie, Cornell, Frank, Cramer, Jim, Pakstis, Diana Lynn, Ison, Michael G, Wunderink, Richard, Glesby, Marshall, Ham, Kirsis, Hughes, Valery, Cushing, Melissa, Goss, Cheryl, Grenade, Joanne, Park, Pauline K, Napolitano, Lena M, Raghavendran, Krishnan, Hyzy, Robert C, Davenport, Robertson, Brierley, Kristin, Downs, Theresa, Gong, Michelle Ng, Uehlinger, Joan, Lin, Michael, Fritsche, Janice, Green, Tondria, McLeod, Bruce, Patel, Deena, Bavaro, Mary F, Deiss, Robert, Brandt, Carolyn, Cammarata, Stephanie, Kremp, Allan, Hollis-Perry, Karine, Lalani, Tahaniyat, Banks, Susan, Johnson, Jacqueline, Maguire, Jason, McNiff, Janet, Rigg, Leslie E, Ganesan, Anuradha, Barahona, Irma, Danko, Janine, Spencer, Steven, Stagliano, David, Burgess, Timothy, Talmor, Daniel, Mohammed, Monique, Banner-Goodspeed, Valerie, Salata, Robert, Finberg, Robert, Wang, Jennifer, Longtine, Karen, Longtine, Jaclyn, O'Neil, Mellissa, Bauer, Philippe R, Gajic, Ognjen, Weist, Suanne M, Sevransky, Jonathan, Brown, Mona, Roback, John, Oropello, John, Twohig, Bridget, Jhang, Jeffrey, Seethala, Rahgu, Chen, Wilbur H, Fontaine, Magali, Saharia, Kapil, Husson, Jennifer, DeBiasi, Roberta, Wilson, Jurran L, Criss, Valli Ree, Voell, Jocelyn, Leitman, Susan, Atkins, James Wade, Patel, Hemaxi, Paige, Traci, Cantilena, Cathy, Siegel, Donald, DeMuth, Faye, Fletcher, Craig H, Pelletier, J Peter R, Alnuaimat, Hassan, and Pourde, Michelle

Abstract

Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza.

Published
2017
Full Text
View/download PDF

132. Intranasal norovirus vaccination shows efficacy in preventing acute gastroenteritis following a live GI.1 NoV challenge (106.5)

Author

Bargatze, Robert, primary, Bernstein, David, additional, Harro, Clayton, additional, Al-Ibrahim, Mohamed, additional, Chen, Wilbur, additional, Ferreira, Jennifer, additional, Estes, Mary, additional, Graham, David, additional, Richardson, Charles, additional, Mendelman, Paul, additional, and Atmar, Robert, additional

Published
2011
Full Text
View/download PDF

137. Safety and immunogenicity of a subvirion inactivated influenza A/H5N1 vaccine with or without aluminum hydroxide among healthy elderly adults

Author

Brady, Rebecca C., primary, Treanor, John J., additional, Atmar, Robert L., additional, Keitel, Wendy A., additional, Edelman, Robert, additional, Chen, Wilbur H., additional, Winokur, Patricia, additional, Belshe, Robert, additional, Graham, Irene L., additional, Noah, Diana Lee, additional, Guo, Kuo, additional, and Hill, Heather, additional

Published
2009
Full Text
View/download PDF

140. Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons #8805;18 Years Old.

Author

Winokur, Patricia L., Patel, Shital M., Brady, Rebecca, Chen, Wilbur H., El-Kamary, Samer S., Edwards, Kathryn, Creech, C. Buddy, Frey, Sharon, Keitel, Wendy A., Belshe, Robert, Walter, Emmanuel, Bellamy, Abbie, and Hill, Heather

Subjects
H5N1 Influenza, VIRUS diseases, VIRAL disease treatment, DRUG dosage, HEMAGGLUTINATION tests, PATIENTS, VACCINATION
Abstract

Background. Variant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed. Methods. Healthy adults received 2 doses of subvirion H3N2v vaccine (15 μg of hemagglutinin/dose) 21 days apart in this open-label trial. Serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody (Ab) titers were measured before and 8 and 21 days after each dose. Memory B-cell (MBC) responses were assessed. Results. Vaccine was well tolerated. A total of 40% of subjects had an HAI Ab titer of ≥40 before vaccination. Eight-seven percent (95% confidence interval [CI], 79%-93%) and 73% (95% CI, 63%-81%) of subjects 18-64 years old (98 subjects) and ≥65 years old (90 subjects), respectively, had an HAI titer of ≥40 21 days after dose 1 (P = .01); 51% (95% CI, 41%-61%) and 52% (95% CI, 41%-62%) of younger and older subjects, respectively, developed ≥4- fold rises in titer (P = not significant). Neut Ab response patterns were similar. Geometric mean titers were higher in younger subjects. Dose 2 provided no significant enhancement in responses. Cross-reactive MBCs were detected before vaccination and expanded after vaccination. Preexisting H3N2v-specific MBCs positively correlated with early increases in vaccine-induced Ab. Conclusions. In most healthy adults, one 15-μg dose of vaccine elicited levels of HAI Abs associated with protection. Studies in children and elderly individuals are indicated to define the immunization needs of these groups. [ABSTRACT FROM AUTHOR]

Published
2015
Full Text
View/download PDF

141. Norovirus Vaccine Against Experimental Human GII.4 Virus Illness: A Challenge Study in Healthy Adults.

Author

Bernstein, David I., Atmar, Robert L., Lyon, G. Marshall, Treanor, John J., Chen, Wilbur H., Jiang, Xi, Vinjé, Jan, Gregoricus, Nicole, Frenck, Robert W., Moe, Christine L., Al-Ibrahim, Mohamed S., Barrett, Jill, Ferreira, Jennifer, Estes, Mary K., Graham, David Y., Goodwin, Robert, Borkowski, Astrid, Clemens, Ralf, and Mendelman, Paul M.

Subjects
NOROVIRUSES, VIRAL vaccines, HEALTH of adults, GASTROENTERITIS, CLINICAL drug trials, REVERSE transcriptase polymerase chain reaction, PLACEBOS
Abstract

Background. Vaccines against norovirus, the leading cause of acute gastroenteritis, should protect against medically significant illness and reduce transmission.Methods. In this randomized, double-blind, placebo-controlled trial, 18- to 50-year-olds received 2 injections of placebo or norovirus GI.1/GII.4 bivalent vaccine-like particle (VLP) vaccine with 3-O-desacyl-4′-monophosphoryl lipid A (MPL) and alum. Participants were challenged as inpatients with GII.4 virus (4400 reverse transcription polymerase chain reaction [RT-PCR] units), and monitored for illness and infection.Results. Per protocol, 27 of 50 (54.0%) vaccinees and 30 of 48 (62.5%) controls were infected. Using predefined illness and infection definitions, vaccination did not meet the primary endpoint, but self-reported cases of severe (0% vaccinees vs 8.3% controls; P = .054), moderate or greater (6.0% vs 18.8%; P = .068), and mild or greater severity of vomiting and/or diarrhea (20.0% vs 37.5%; P = .074) were less frequent. Vaccination also reduced the modified Vesikari score from 7.3 to 4.5 (P = .002). Difficulties encountered were low norovirus disease rate, and inability to define illness by quantitative RT-PCR or further antibody rise in vaccinees due to high vaccine-induced titers. By day 10, 11 of 49 (22.4%) vaccinees were shedding virus compared with 17 of 47 (36.2%) placebo recipients (P = .179).Conclusions. Bivalent norovirus VLP vaccine reduced norovirus-related vomiting and/or diarrhea; field efficacy studies are planned.Clinical Trials Registration. NCT01609257. [ABSTRACT FROM AUTHOR]

Published
2015
Full Text
View/download PDF

142. A novel intramuscular bivalent norovirus virus-like particle vaccine candidate--reactogenicity, safety, and immunogenicity in a phase 1 trial in healthy adults.

Author

Treanor, John J, Atmar, Robert L, Frey, Sharon E, Gormley, Robert, Chen, Wilbur H, Ferreira, Jennifer, Goodwin, Robert, Borkowski, Astrid, Clemens, Ralf, and Mendelman, Paul M

Subjects
GASTROENTERITIS, VIRAL vaccines, IMMUNOGLOBULINS, INTRAMUSCULAR injections, RANDOMIZED controlled trials, NOROVIRUS diseases, BLIND experiment, RESEARCH funding, RNA viruses, VIRAL antibodies, LONGITUDINAL method
Abstract

Background: Noroviruses are the most important viral causes of gastroenteritis-related morbidity and mortality. A randomized, double-blind, placebo-controlled study evaluated an adjuvanted bivalent intramuscular norovirus virus-like particle (VLP) vaccine.Methods: Forty-eight adults aged 18-49 years received either 2 doses containing genotype GI.1 VLP and a consensus GII.4 VLP or 2 doses of placebo. Doses (5 µg, 15 µg, 50 µg, or 150 µg of each VLP) were administered 4 weeks apart in the first stage. Subsequently, 54 adults, aged 18-49 (n=16), 50-64 (n=19), and 65-85 (n=19) years, received 2 doses of vaccine containing 50 µg of each VLP. Total and class-specific antibody responses, as well as histoblood group antigen (HBGA) blocking antibody responses, were measured before and after each dose.Results: Local reactions were mainly injection site pain/tenderness, with no reported fever or vaccine-related serious adverse events. One dose of vaccine containing 50 µg of each VLP increased GI.1 geometric mean titers (GMTs) by 118-fold, 83-fold, and 24-fold and increased GII.4 GMTs by 49-fold, 25-fold, and 9-fold in subjects aged 18-49, 50-64, and 65-83 years, respectively. Serum antibody responses peaked at day 7 after the first dose, with no evidence of boosting following a second dose. Most subjects achieved HBGA-blocking antibody titers of ≥200.Conclusions: The vaccine was well tolerated and immunogenic. Rapid immune response to a single dose may be particularly useful in military personnel and travelers and in the control of outbreaks. Clinical Trials Registration. NCT01168401. [ABSTRACT FROM AUTHOR]

Published
2014
Full Text
View/download PDF

149. Persistence of Antibody to Influenza A/H5N1 Vaccine Virus: Impact of AS03 Adjuvant

Author

Chen, Wilbur H., Jackson, Lisa A., Edwards, Kathryn M., Keitel, Wendy A., Hill, Heather, Noah, Diana L., Creech, C. Buddy, Patel, Shital M., Mangal, Brian, and Kotloff, Karen L.

Abstract

ABSTRACTThe adjuvant AS03 is stockpiled for future formulations with new and existing vaccines for the control of pandemic influenza virus. We previously reported the immunogenicity of an A/H5N1 vaccine extemporaneously mixed with the AS03 adjuvant for 42 days following vaccination. This report extends those findings to 1 year after vaccination.

Published
2015
Full Text
View/download PDF

150. Safety and Immunogenicity of Escalating Dosages of a Single Oral Administration of Peru-15 pCTB, a Candidate Live, Attenuated Vaccine against Enterotoxigenic Escherichia coliand Vibrio cholerae

Author

Chen, Wilbur H., Garza, Jose, Choquette, Monique, Hawkins, Jennifer, Hoeper, Amy, Bernstein, David I., and Cohen, Mitchell B.

Abstract

ABSTRACTEnterotoxigenic Escherichia coli(ETEC) organisms are a leading cause of infectious diarrhea in developing countries. A live, attenuated cholera strain that expresses high levels of the nontoxic B subunit of cholera toxin, which might also serve as an ETEC protective antigen, was evaluated for safety, excretion, and immunogenicity in healthy volunteers. We enrolled four inpatient dose-escalation cohorts of 15 to 16 eligible subjects to randomly (3:1) receive a single oral dose of vaccine or placebo (buffer alone), evaluating 1 ×107, 1 ×108, 1 ×109, and 1 ×1010CFU of the vaccine. The vaccine was well tolerated, although some subjects experienced moderate diarrhea. The serum Inaba vibriocidal antibody response appeared to display a dose-response relationship with increasing dosages of vaccine, plateauing at the 109-CFU dosage. The serum antitoxin (cholera toxin and heat-labile enterotoxin) antibody seroconversion rate (4-fold increase over baseline) also appeared to display a dose-response relationship. The vaccine strain was excreted in stool cultures, displaying a dose-response relationship. A single oral dose of Peru-15 pCTB at dosages up to 1 ×1010CFU was safe and immunogenic in this first-in-human trial. These encouraging data support the ongoing clinical development of this candidate combined cholera and ETEC vaccine. (This study has been registered at ClinicalTrials.gov under registration no. NCT00654108.)

Published
2014
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results