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Publication Metadata only Conducting human challenge studies in LMICs: A survey of researchers and ethics committee members in Thailand(2019-01-01) Jaranit Kaewkungwal; Pornpimon Adams; Jetsumon Sattabongkot; Reidar K. Lie; David Wendler; Universitetet i Bergen; NIH Clinical Center; Mahidol Universitythat have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers... domain dedication. Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries (LMICs). Most of these concerns are based on theoretical considerations and there exists little dataPublication Metadata only HIV-specific antibody-dependent phagocytosis matures during HIV infection(2014-01-01) Fernanda Ana-Sosa-Batiz; Angus P.R. Johnston; Haiyin Liu; Robert J. Center; Supachai Rerks-Ngarm; Punnee Pitisuttithum; Sorachai Nitayaphan; Jaranit Kaewkungwal; Jerome H. Kim; Nelson L. Michael; Anthony D. Kelleher; Ivan Stratov; Stephen J. Kent; Marit Kramski; University of Melbourne; Monash University; Burnet Institute; Thailand Ministry of Public Health; Mahidol University; Armed Forces Research Institute of Medical Sciences, Thailand; Walter Reed Army Institute of Research; University of New South Wales (UNSW) Australiaduring HIV infection, a significant increase in ADP responses in all 31 subjects studied was detected (P<0.001). However, when we tested 30 HIV-negative human subjects immunised with the Canarypox/gp120 vaccine regimen (subjects from the RV144 trial) we...© 2014 Australasian Society for Immunology Inc. All rights reserved. Antibody-dependent phagocytosis (ADP) is a potentially important immune mechanism to clear HIV. How HIV-specific ADP responses mature during HIV infection or in responsePublication Metadata only HLA class II genes modulate vaccine-induced antibody responses to affect HIV-1 acquisition(2015-07-15) Heather A. Prentice; Georgia D. Tomaras; Daniel E. Geraghty; Richard Apps; Youyi Fong; Philip K. Ehrenberg; Morgane Rolland; Gustavo H. Kijak; Shelly J. Krebs; Wyatt Nelson; Allan DeCamp; Xiaoying Shen; Nicole L. Yates; Susan Zolla-Pazner; Sorachai Nitayaphan; Supachai Rerks-Ngarm; Jaranit Kaewkungwal; Punnee Pitisuttithum; Guido Ferrari; M. Juliana McElrath; David C. Montefiori; Robert T. Bailer; Richard A. Koup; Robert J. O'Connell; Merlin L. Robb; Nelson L. Michael; Peter B. Gilbert; Jerome H. Kim; Rasmi Thomas; Walter Reed Army Institute of Research; HJF; Duke University School of Medicine; Fred Hutchinson Cancer Research Center; Leidos Inc.; NYU School of Medicine; Armed Forces Research Institute of Medical Sciences, Thailand; Thailand Ministry of Public Health; Mahidol University; National Institute of Allergy and Infectious Diseases; Inova Fairfax Medical Campus© 2015, American Association for the Advancement of Science. All rights reserved. In the RV144 vaccine trial, two antibody responses were found to correlate with HIV-1 acquisition. Because human leukocyte antigen (HLA) class II-restricted CD4...+T cells are involved in antibody production, we tested whether HLA class II genotypes affected HIV-1-specific antibody levels and HIV-1 acquisition in 760 individuals. Indeed, antibody responses correlated with acquisition only in the presence of singlePublication Metadata only COMPASS identifies T-cell subsets correlated with clinical outcomes(2015-06-11) Lin Lin; Greg Finak; Kevin Ushey; Chetan Seshadri; Thomas R. Hawn; Nicole Frahm; Thomas J. Scriba; Hassan Mahomed; Willem Hanekom; Pierre Alexandre Bart; Giuseppe Pantaleo; Georgia D. Tomaras; Supachai Rerks-Ngarm; Jaranit Kaewkungwal; Sorachai Nitayaphan; Punnee Pitisuttithum; Nelson L. Michael; Jerome H. Kim; Merlin L. Robb; Robert J. O'Connell; Nicos Karasavvas; Peter Gilbert; Stephen C. De Rosa; M. Juliana McElrath; Raphael Gottardo; Fred Hutchinson Cancer Research Center; University of Washington, Seattle; South African Tuberculosis Vaccine Initiative; Centre Hospitalier Universitaire Vaudois; Duke University Medical Center; Thailand Ministry of Public Health; Mahidol University; Armed Forces Research Institute of Medical Sciences, Thailand; Walter Reed Army Institute of Research; HJFsubsets (COMPASS). COMPASS uses a Bayesian hierarchical framework to model all observed cell subsets and select those most likely to have antigen-specific responses. Cell-subset responses are quantified by posterior probabilities, and human subject-level... responses are quantified by two summary statistics that describe the quality of an individual's polyfunctional response and can be correlated directly with clinical outcome. Using three clinical data sets of cytokine production, we demonstrate how COMPASSPublication Metadata only Polyfunctional Fc-effector profiles mediated by IgG subclass selection distinguish RV144 and VAX003 vaccines(2014-03-19) Amy W. Chung; Musie Ghebremichael; Hannah Robinson; Eric Brown; Ickwon Choi; Sophie Lane; Anne Sophie Dugast; Matthew K. Schoen; Morgane Rolland; Todd J. Suscovich; Alison E. Mahan; Larry Liao; Hendrik Streeck; Charla Andrews; Supachai Rerks-Ngarm; Sorachai Nitayaphan; Mark S. De Souza; Jaranit Kaewkungwal; Punnee Pitisuttithum; Donald Francis; Nelson L. Michael; Jerome H. Kim; Chris Bailey-Kellogg; Margaret E. Ackerman; Galit Alter; Massachusetts Institute of Technology; Thayer School of Engineering at Dartmouth; Dartmouth College; Walter Reed Army Institute of Research; Duke University; Thailand Ministry of Public Health; Armed Forces Research Institute of Medical Sciences, Thailand; Mahidol University; Global Solutions for Infectious DiseasesThe human phase 2B RV144 ALVAC-HIV vCP1521/AIDSVAX B/E vaccine trial, held in Thailand, resulted in an estimated 31.2% efficacy against HIV infection. By contrast, vaccination with VAX003 (consisting of only AIDSVAX B/E) was not protective. Because... protection within RV144 was observed in the absence of neutralizing antibody activity or cytotoxic T cell responses, we speculated that the specificity or qualitative differences in Fc-effector profiles of nonneutralizing antibodies may have accountedPublication Metadata only Magnitude and breadth of the neutralizing antibody response in the RV144 and Vax003 HIV-1 vaccine efficacy trials(2012-08-01) David C. Montefiori; Chitraporn Karnasuta; Ying Huang; Hasan Ahmed; Peter Gilbert; Mark S. De Souza; Robert McLinden; Sodsai Tovanabutra; Agnes Laurence-Chenine; Eric Sanders-Buell; M. Anthony Moody; Mattia Bonsignori; Christina Ochsenbauer; John Kappes; Haili Tang; Kelli Greene; Hongmei Gao; Celia C. Labranche; Charla Andrews; Victoria R. Polonis; Supachai Rerks-Ngarm; Punnee Pitisuttithum; Sorachai Nitayaphan; Jaranit Kaewkungwal; Steve G. Self; Phillip W. Berman; Donald Francis; Faruk Sinangil; Carter Lee; Jim Tartaglia; Merlin L. Robb; Barton F. Haynes; Nelson L. Michael; Jerome H. Kim; Duke University School of Medicine; Armed Forces Research Institute of Medical Sciences, San Francisco; Fred Hutchinson Cancer Research Center; Walter Reed Army Institute of Research; University of Alabama; Ministry of Public Health; Mahidol University; University of California, Santa Cruz; Global Solutions for Infectious Diseases; Sanofi PasteurBackground. A recombinant canarypox vector expressing human immunodeficiency virus type 1 (HIV-1) Gag, Pro, and membrane-linked gp120 (vCP1521), combined with a bivalent gp120 protein boost (AIDSVAX B/E), provided modest protection against HIV-1... infection in a community-based population in Thailand (RV144 trial). No protection was observed in Thai injection drug users who received AIDSVAX B/E alone (Vax003 trial). We compared the neutralizing antibody response in these 2 trials. MethodsPublication Metadata only Comparison of antibody responses induced by RV144, VAX003, and VAX004 vaccination regimens(2017-05-01) Chitraporn Karnasuta; Siriwat Akapirat; Sirinan Madnote; Hathairat Savadsuk; Jiraporn Puangkaew; Surawach Rittiroongrad; Supachai Rerks-Ngarm; Sorachai Nitayaphan; Punnee Pitisuttithum; Jaranit Kaewkungwal; James Tartaglia; Faruk Sinangil; Donald P. Francis; Merlin L. Robb; Mark S. De Souza; Nelson L. Michael; Jean Louis Excler; Jerome H. Kim; Robert J. O'connell; Nicos Karasavvas; Armed Forces Research Institute of Medical Sciences, Thailand; Thailand Ministry of Public Health; Mahidol University; Sanofi Pasteur; Global Solutions for Infectious Diseases; Walter Reed Army Institute of Research; HJF; Thai Red Cross AIDS Research Centre; International Vaccine Institute, Seoulresponses may have contributed to the differences observed in vaccine efficacy. We assessed HIV-specific IgG, both total and subclass, and IgA binding to HIV envelope (Env): gp120 proteins and Cyclic V2 (CycV2) and CycV3 peptides and gp70 V1 V2 scaffolds... in these 3 HIV vaccine trials. After two protein immunizations, IgG responses to 92TH023 gp120 (contained in ALVAC-HIV vaccine) were significantly higher in RV144 but responses to other Env were higher in the VAX trials lacking ALVAC-HIV. IgG responsesPublication Open Access Vaccine-induced IgG antibodies to V1V2 regions of multiple HIV- 1 subtypes correlate with decreased risk of HIV-1 infection.(2014-02-04) Zolla-Pazner, Susan; deCamp, Allan; Gilbert, Peter B.; Williams, Constance; Yates, Nicole L.; Williams, William T.; Howington, Robert; Fong, Youyi; Morris, Daryl E.; Soderberg, Kelly A.; Irene, Carmela; Reichman, Charles; Pinter, Abraham; Parks, Robert; Punnee Pitisuttithum; พรรณี ปิติสุทธิธรรม; Jaranit Kaewkungwal; จรณิต แก้วกังวาล; Supachai Rerks-Ngarm; ศุภชัย ฤกษ์งาม; Sorachai Nitayaphan; สรชัย นิตยพันธ; Andrews, Charla; O’Connell, Robert J.; Yang, Zhi-yong; Nabel, Gary J.; Kim, Jerome H.; Michael, Nelson L.; Montefiori, David C.; Liao, Hua-Xin; Haynes, Barton F.; Tomaras, Georgia D.; Zolla-Pazner, Susan; Mahidol University. Faculty of Tropical Medicine.In the RV144 HIV-1 vaccine efficacy trial, IgG antibody (Ab) binding levels to variable regions 1 and 2 (V1V2) of the HIV-1 envelope glycoprotein gp120 were an inverse correlate of risk of HIV-1 infection. To determine if V1V2-specific Abs cross-react with V1V2 from different HIV-1 subtypes, if the nature of the V1V2 antigen used to asses cross-reactivity influenced infection risk, and to identify immune assays for upcoming HIV-1 vaccine efficacy trials, new V1V2-scaffold antigens were designed and tested. Protein scaffold antigens carrying the V1V2 regions from HIV-1 subtypes A, B, C, D or CRF01_AE were assayed in pilot studies, and six were selected to assess cross-reactive Abs in the plasma from the original RV144 case-control cohort (41 infected vaccinees, 205 frequency-matched uninfected vaccinees, and 40 placebo recipients) using ELISA and a binding Ab multiplex assay. IgG levels to these antigens were assessed as correlates of risk in vaccine recipients using weighted logistic regression models. Levels of Abs reactive with subtype A, B, C and CRF01_AE V1V2-scaffold antigens were all significant inverse correlates of risk (p-values of 0.0008-0.05; estimated odds ratios of 0.53-0.68 per 1 standard deviation increase). Thus, levels of vaccine-induced IgG Abs recognizing V1V2 regions from multiple HIV-1 subtypes, and presented on different scaffolds, constitute inverse correlates of risk for HIV-1 infection in the RV144 vaccine trial. The V1V2 antigens provide a link between RV144 and upcoming HIV-1 vaccine trials, and identify reagents and methods for evaluating V1V2 Abs as possible correlates of protection against HIV-1 infection.TRIAL REGISTRATION: ClinicalTrials.gov NCT00223080.Publication Metadata only Vaccine-induced human antibodies specific for the third variable region of HIV-1 gp120 impose immune pressure on infecting viruses(2014-01-01) Susan Zolla-Pazner; Paul T. Edlefsen; Morgane Rolland; Xiang Peng Kong; Allan deCamp; Raphael Gottardo; Constance Williams; Sodsai Tovanabutra; Sandra Sharpe-Cohen; James I. Mullins; Mark S. deSouza; Nicos Karasavvas; Sorachai Nitayaphan; Supachai Rerks-Ngarm; Punnee Pitisuttihumi; Jaranit Kaewkungwal; Robert J. O'Connell; Merlin L. Robb; Nelson L. Michael; Jerome H. Kim; Peter Gilbert; New York Veterans Affairs Harbor Healthcare System; NYU School of Medicine; Fred Hutchinson Cancer Research Center; Walter Reed Army Institute of Research; University of Washington, Seattle; Thai Red Cross AIDS Research Centre; Armed Forces Research Institute of Medical Sciences, Thailand; Thailand Ministry of Public Health; Mahidol University; US Military HIV Research Program© 2014 The Authors. To evaluate the role of V3-specific IgG+antibodies (Abs) in the RV144 clinical HIV vaccine trial, which reducedHIV-1 infection by 31.2%, the anti-V3 Ab response was assessed. Vaccinees' V3 Abs were highly cross-reactivewithPublication Open Access Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand(2015) Pornpimon Adams; Sukanya Prakobtham; Chanthima Limphattharacharoen; Pitchapa Vutikes; Srisin Khusmith; Krisana Pengsaa; Polrat Wilairatana; Jaranit Kaewkungwal; Mahidol University. Faculty of Tropical Medicine. Department of Tropical Hygieneof study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research
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