Phyllis Zaia Alderman

Experienced Project Leader adept at completing projects with confidence and skill. History of performing well under pressure and accomplishing successive assignments with high accuracy. Experienced in fast-paced environments and adapts well to changing situations. Talented Project Lead with strengths in client management and problem-solving. Highly effective at managing multiple, concurrent projects. Instrumental Project Leader bringing 30+ years of experience achieving ambitious goals in challenging clinical research environment. Diligent, forward-thinking and adaptable to dynamic company, customer and project needs. Successful at motivating teams to meet demanding timelines.

Recipient of a NIAID Merit Award in 2015 in recognition of outstanding performance in response to the Ebola outbreak, expediting clinical development of a promising vaccine candidate, providing expert consultation to internal, external and international partners

International HIV Vaccine Trials through International AIDS Vaccine Initiative (IAVI)

The program’s mission is to conduct clinical trials of candidate HIV vaccines, primarily in developing countries. Emmes serves as the Data Coordinating Center (DCC) for these trials, providing electronic data capture, statistical consulting, analysis and reporting of safety and immunogenicity data, trial progress monitoring, immunology laboratory assay development and validation, site monitoring support, and administrative and operational support. For this project, I manage a portfolio of 6 Phase I vaccine studies conducted both domestically and internationally.

Role: Project Director Project duration: 2000–2026

PATH

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. Emmes, as the Coordinating Center, supports PATH’s Center for Vaccine Innovation and Access (CVIA); previously known as PATH’s Vaccine Development Global Program, by supporting select sponsored trials, providing data management, statistical, operational, monitoring, regulatory and administrative support services. For this project, I provide project management support for a Phase 3 HPV vaccine trial conducted in Bangladesh and Ghana

Role: Project Manager Project duration: 2011–2024

Vaccine Research Center (VRC) Data Management Support, NIH/NIAID/VRC

The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate research in vaccine development. The mission of the Vaccine Research Center (VRC) is to conduct research that facilitates the development of effective vaccines for human diseases. Emmes serves as the Data Management Support Center (DMSC) and supports VRC-sponsored trials by providing data management, operational and administrative support. The DCC’s responsibilities include designing and implementing electronic data capture systems, providing user training and study websites maintenance, quality review of data, general statistical support including data listings and summary reports, and submission of trial results to clinical trials.gov. Under this contract, the DMSC has also developed and maintains a data warehouse and associated reporting tool, which provides advanced analytics and visualizations. This project is supporting/has supported in excess of 50 Phase I and Phase 2 vaccine and monoclonal antibody trials across many infectious disease areas, including HIV, Influenza, Ebola, Zika, SARS, Marburg and Malaria as well as two sample collection protocols.

Role: Project Director Project duration: 2004–2027

General Clinical Research Support Services (GCRSS), NIH/NIAID/VRC

Emmes was one of three awardees of an IDIQ that supports both intramural and extramural efforts for the Vaccine Research Center not otherwise covered by the Data Management Support contract. Several task orders, ranging from full scope (including site selection and management) to those limited to eTMF creation and management, have been awarded to Emmes under this IDIQ.

Role: IDIQ Principal Investigator Project duration: 2018–2024

Universal Influenza and Clinical Trials Support (UNI), Vaccine Research Center

The Universal Influenza and Clinical Trials Support Project (UNI) supported various studies by the Vaccine Research Center (VRC) at NIH in developing novel vaccine candidates for influenza, malaria, Ebola and Zika based on recombinant DNA (rDNA) technologies. Most notably, Emmes provided data management, monitoring, regulatory, project management and statistical services in support of a phase 2B, randomized, placebo-controlled trial to evaluate the safety, immunogenicity and efficacy of a Zika virus DNA vaccine (VRC 705). 2,200 subjects were enrolled at 17 domestic and international clinical sites. Statistical support for the project included analysis of efficacy and immunogenicity endpoints, generation of the statistical analysis plan (SAP), DSMB report generation and general statistical expertise.

Role: IDIQ Principal Investigator Project duration: 2010–2022

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD), NIH/NINDS

The overall goal of this study was to establish the relationship between antiepileptic drug (AED) exposure and outcomes in a mother and child, as well as describe and explain the variability in AED exposure and response. Outcomes of interest for the mother include seizure frequency, OB complications, and depression rates. Child outcomes of interest include neurocognition and behavior outcomes, along with effects of breastfeeding and birth outcomes. Emmes’ primary responsibilities in this study include data management and statistical design and analysis.

Role: Project Manager Project duration: 2012–2023

Encephalitis Vaccine Study

This Vaccine Research Center-sponsored project supports one Phase I Encephalitis vaccine study conducted at the Vaccine Center at Emory University (VRC 313). Emmes provided data management, regulatory, statistical and CDISC support for this study.

Role: Project Director Project duration: 2019–2020

Chikungunya Vaccine Study

This Vaccine Research Center-sponsored project supported one Phase II Chikungunya vaccine study conducted at six clinical sites in the Caribbean. Emmes provided data management, clinical monitoring, regulatory and statistical support for this study.

Role: Project Director Project duration: 2015–2019

Ebola Vaccine Studies in Mali

The Center for Vaccine Development Ebola Vaccine project supported two Phase 1B Ebola vaccine studies sponsored by the University of Maryland Center for Vaccine Development (CVD01 and CVD02). The primary focus of research was the development of a vaccine for prevention of Ebola infection. Emmes provided data management and statistical support for these studies.

Role: Project Manager Project duration: 2014–2019

Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases (CRID), NIH/NIAID/DMID

Emmes has supported more than 100 clinical trials in vaccines and treatment strategies for infectious diseases for pathogens, including influenza, malaria, biodefense, emerging infectious diseases, and other infectious diseases with potential public health impact. In this role, Emmes provided AdvantageEDC, our proprietary internet-based data management system, and a full set of statistical, data coordinating and reporting activities for the Institute’s extramural vaccine research program.

Role: Project Manager Project duration: 2004–2015

1. DNA Priming for Seasonal Influenza Vaccine: a Phase 1b Double-Blind Randomized Clinical Trial. Ledgerwood, J., Bellamy, A., Belshe, R., Bernstein, D., Edupuganti, S., Patel, S., Renehan, P., Zajdowicz, T., Schwartz, R., Koup, R., Bailer, R., Yamshchikov, G., Enama, M., Sarwar, U., Larkin, B., Graham, B. and VRC 701 Study Team. PLoS One 10(5): e0125914. PMCID: PMC4423975. 2015

2. Phase 1 study of pandemic H1 DNA vaccine in healthy adults. Crank MC, Gordon IJ, Yamshchikov GV, Sitar S, Hu Z, Enama ME, Holman LA, Bailer RT, Pearce MB, Koup RA, Mascola JR, Nabel GJ, Tumpey TM, Schwartz RM, Graham BS, Ledgerwood JE; VRC 308 Study Team. PLoS One. 2015 Apr 17;10(4):e0123969. doi: 10.1371/journal.pone.0123969. eCollection 2015.

3. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.

4. Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary Report. Ledgerwood JE, DeZure AD, Stanley DA, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. N Engl J Med. 2014 Nov 26. [Epub ahead of print]

5. Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial. Sarwar UN, Novik L, Enama ME, Plummer SA, Koup RA, Nason MC, Bailer RT, McDermott AB, Roederer M, Mascola JR, Ledgerwood JE, Graham BS; VRC 015 Study Team. PLoS One. 2014 Sep 29;9(9):e106240. doi: 10.1371/journal.pone.0106240. eCollection 2014.

6. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.

7. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.

8. Phase I randomized clinical trial of VRC DNA and rAd5 HIV-1 vaccine delivery by intramuscular (i.m.), subcutaneous (s.c.) and intradermal (i.d.) administration (VRC 011). Enama ME, Ledgerwood JE, Novik L, Nason MC, Gordon IJ, Holman L, Bailer RT, Roederer M, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 011 Study Team. PLoS One. 2014 Mar 12;9(3):e91366. doi: 10.1371/journal.pone.0091366. eCollection 2014.

9. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL; VRC 312 Study Team. Science. 2013 Sep 20;341(6152):1359-65. doi: 10.1126/science.1241800. Epub 2013 Aug 8.

10. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team. J Infect Dis. 2013 Aug 1;208(3):418-22. doi: 10.1093/infdis/jit180. Epub 2013 Apr 30.

11. DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial. Graham BS, Enama ME, Nason MC, Gordon IJ, Peel SA, Ledgerwood JE, Plummer SA, Mascola JR, Bailer RT, Roederer M, Koup RA, Nabel GJ; VRC 008 Study Team. PLoS One. 2013;8(4):e59340. doi: 10.1371/journal.pone.0059340. Epub 2013 Apr 8.

12. Therapeutic vaccination expands and improves the function of the HIV-specific memory T-cell repertoire. Casazza JP, Bowman KA, Adzaku S, Smith EC, Enama ME, Bailer RT, Price DA, Gostick E, Gordon IJ, Ambrozak DR, Nason MC, Roederer M, Andrews CA, Maldarelli FM, Wiegand A, Kearney MF, Persaud D, Ziemniak C, Gottardo R, Ledgerwood JE, Graham BS, Koup RA; VRC 101 Study Team. J Infect Dis. 2013 Jun 15;207(12):1829-40. doi: 10.1093/infdis/jit098. Epub 2013 Mar 12.

13. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team. Lancet Infect Dis. 2011 Dec;11(12):916-24. doi: 10.1016/S1473-3099(11)70240-7. Epub 2011 Oct 3.

14. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.

15. A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults. Ledgerwood JE, Costner P, Desai N, Holman L, Enama ME, Yamshchikov G, Mulangu S, Hu Z, Andrews CA, Sheets RA, Koup RA, Roederer M, Bailer R, Mascola JR, Pau MG, Sullivan NJ, Goudsmit J, Nabel GJ, Graham BS; VRC 205 Study Team. Vaccine. 2010 Dec 16;29(2):304-13. doi: 10.1016/j.vaccine.2010.10.037. Epub 2010 Oct 27.

16. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team. PLoS One. 2010 Feb 2;5(2):e9015. doi: 10.1371/journal.pone.0009015.

17. A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial. Martin JE, Louder MK, Holman LA, Gordon IJ, Enama ME, Larkin BD, Andrews CA, Vogel L, Koup RA, Roederer M, Bailer RT, Gomez PL, Nason M, Mascola JR, Nabel GJ, Graham BS; VRC 301 Study Team. Vaccine. 2008 Nov 25;26(50):6338-43. doi: 10.1016/j.vaccine.2008.09.026. Epub 2008 Sep 26.

18. Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine. Catanzaro AT, Roederer M, Koup RA, Bailer RT, Enama ME, Nason MC, Martin JE, Rucker S, Andrews CA, Gomez PL, Mascola JR, Nabel GJ, Graham BS; VRC 007 Study Team. Vaccine. 2007 May 16;25(20):4085-92. Epub 2007 Mar 7.

19. Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax challenge in vaccinia-naïve and vaccinia-immune individuals. Parrino J, McCurdy LH, Larkin BD, Gordon IJ, Rucker SE, Enama ME, Koup RA, Roederer M, Bailer RT, Moodie Z, Gu L, Yan L, Graham BS; VRC 201/203 Study Team. Vaccine. 2007 Feb 9;25(8):1513-25. Epub 2006 Nov 7.

20. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ; VRC 004 Study Team. J Infect Dis. 2006 Dec 15;194(12):1650-60. Epub 2006 Nov 8.

21. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; VRC 006 Study Team. J Infect Dis. 2006 Dec 15;194(12):1638-49. Epub 2006 Nov 8. Erratum in: J Infect Dis. 2009 Oct 15;200(8):1352-3.

International HIV Vaccine Trials through International AIDS Vaccine Initiative (IAVI)

The program’s mission is to conduct clinical trials of candidate HIV vaccines, primarily in developing countries. Emmes served as the Data Coordinating Center (DCC) for these trials, providing electronic data capture, statistical consulting, analysis and reporting of safety and immunogenicity data, trial progress monitoring, immunology laboratory assay development and validation, site monitoring support, and administrative and operational support.

Role: Project Director Project duration: 2000–2023

PATH

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. Emmes, as the Coordinating Center, supports PATH’s Center for Vaccine Innovation and Access (CVIA); previously known as PATH’s Vaccine Development Global Program, by supporting select sponsored trials, providing data management, statistical, operational, monitoring, regulatory and administrative support services.

Role: Project Manager Project duration: 2011–2024

Vaccine Research Center (VRC) Data Management Support, NIH/NIAID/VRC

The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate research in vaccine development. The mission of the Vaccine Research Center (VRC) is to conduct research that facilitates the development of effective vaccines for human diseases. Emmes serves as the Data Management Support Center (DMSC) and supports VRC-sponsored trials by providing data management, operational and administrative support. The DCC’s responsibilities include designing and implementing electronic data capture systems, providing user training and study websites maintenance, quality review of data, general statistical support including data listings and summary reports, and submission of trial results to clinical trials.gov. Under this contract, the DMSC has also developed and maintains a data warehouse and associated reporting tool, which provides advanced analytics and visualizations. 

Role: Project Director Project duration: 2004–2027

General Clinical Research Support Services (GCRSS), NIH/NIAID/VRC

The mission of the Vaccine Research Center (VRC) is to conduct research that facilitates the development of effective vaccines for human diseases. The primary focus of research is the development of vaccines for prevention of HIV infection, Biodefense concerns, and emerging infectious diseases. Emmes supports VRC-sponsored trials by providing site selection and management, protocol development, regulatory, and safety monitoring support. Emmes won the first task order (TO) award under this IDIQ contract, where we will support a Phase I HIV monoclonal antibody study conducted at ten domestic clinical sites (VRC 607). Emmes began work on this TO in 2018 and provides data management, regulatory and statistical support for this study.

Role: IDIQ Principal Investigator Project duration: 2018–2024

Universal Influenza and Clinical Trials Support (UNI), Vaccine Research Center

The Universal Influenza and Clinical Trials Support Project (UNI) supports various studies by the Vaccine Research Center (VRC) at NIH in developing novel vaccine candidates for influenza, malaria, Ebola and Zika based on recombinant DNA (rDNA) technologies. Such vaccines have the potential to improve the response time for vaccine development and deployment in epidemics and pandemics, as well as inducing immune responses that are potentially more cross-protective in the swiftly moving world of antigenically distinct emerging viruses. Emmes currently provides data management, monitoring, regulatory, project management and statistical services in support of a phase 2B, randomized, placebo-controlled trial to evaluate the safety, immunogenicity and efficacy of a Zika virus DNA vaccine (VRC 705). 2,200 subjects were enrolled at 17 domestic and international clinical sites. Statistical support for the project includes analysis of efficacy and immunogenicity endpoints, generation of the statistical analysis plan (SAP), DSMB report generation and general statistical expertise.

Role: IDIQ Principal Investigator Project duration: 2010–2022

Clinical Research Previously Supported

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD), NIH/NINDS

The overall goal of this study is to establish the relationship between antiepileptic drug (AED) exposure and outcomes in a mother and child, as well as describe and explain the variability in AED exposure and response. Outcomes of interest for the mother include seizure frequency, OB complications, and depression rates. Child outcomes of interest include neurocognition and behavior outcomes, along with effects of breastfeeding and birth outcomes. Emmes’ primary responsibilities in this study include data management and statistical design and analysis.

Role: Project Manager  Project duration: 2012–2023

Encephalitis Vaccine Study

This Vaccine Research Center-sponsored project supports one Phase I Encephalitis vaccine study conducted at the Vaccine Center at Emory University (VRC 313). Emmes provides data management, regulatory, statistical and CDISC support for this study.

Role: Project Director Project duration: 2019–2020

Chikungunya Vaccine Study

This Vaccine Research Center-sponsored project supported one Phase II Chikungunya vaccine study conducted at six clinical sites in the Caribbean. Emmes provided data management, clinical monitoring, regulatory and statistical support for this study.

Role: Project Director Project duration: 2015–2019

Ebola Vaccine Study in Mali

The Center for Vaccine Development Ebola Vaccine project supported two Phase 1B Ebola vaccine studies sponsored by the University of Maryland Center for Vaccine Development (CVD01 and CVD02). The primary focus of research was the development of a vaccine for prevention of Ebola infection. Emmes provided data management and statistical support for these studies.

Role: Project Manager Project duration: 2014–2019

Statistical and Data Coordinating Center for Clinical Research in Infectious Diseases (CRID), NIH/NIAID/DMID

Emmes supported more than 100 clinical trials in vaccines and treatment strategies for infectious diseases for pathogens, including influenza, malaria, biodefense, emerging infectious diseases, and other infectious diseases with potential public health impact. In this role, Emmes provided AdvantageEDC, our proprietary internet-based data management system, and a full set of statistical, data coordinating and reporting activities for the Institute’s extramural vaccine research program.

Role: Project Manager  Project duration: 2004–2015

1. DNA Priming for Seasonal Influenza Vaccine: a Phase 1b Double-Blind Randomized Clinical Trial. Ledgerwood, J., Bellamy, A., Belshe, R., Bernstein, D., Edupuganti, S., Patel, S., Renehan, P., Zajdowicz, T., Schwartz, R., Koup, R., Bailer, R., Yamshchikov, G., Enama, M., Sarwar, U., Larkin, B., Graham, B. and VRC 701 Study Team. PLoS One 10(5): e0125914. PMCID: PMC4423975. 2015

2. Phase 1 study of pandemic H1 DNA vaccine in healthy adults. Crank MC, Gordon IJ, Yamshchikov GV, Sitar S, Hu Z, Enama ME, Holman LA, Bailer RT, Pearce MB, Koup RA, Mascola JR, Nabel GJ, Tumpey TM, Schwartz RM, Graham BS, Ledgerwood JE; VRC 308 Study Team. PLoS One. 2015 Apr 17;10(4):e0123969. doi: 10.1371/journal.pone.0123969. eCollection 2015.

3. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23.

4. Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary Report. Ledgerwood JE, DeZure AD, Stanley DA, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; VRC 207 Study Team. N Engl J Med. 2014 Nov 26. [Epub ahead of print]

5. Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial. Sarwar UN, Novik L, Enama ME, Plummer SA, Koup RA, Nason MC, Bailer RT, McDermott AB, Roederer M, Mascola JR, Ledgerwood JE, Graham BS; VRC 015 Study Team. PLoS One. 2014 Sep 29;9(9):e106240. doi: 10.1371/journal.pone.0106240. eCollection 2014.

6. Safety and immunogenicity of DNA vaccines encoding Ebolavirus and Marburgvirus wild-type glycoproteins in a phase I clinical trial. Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. J Infect Dis. 2015 Feb 15;211(4):549-57. doi: 10.1093/infdis/jiu511. Epub 2014 Sep 14.

7. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14.

8. Phase I randomized clinical trial of VRC DNA and rAd5 HIV-1 vaccine delivery by intramuscular (i.m.), subcutaneous (s.c.) and intradermal (i.d.) administration (VRC 011). Enama ME, Ledgerwood JE, Novik L, Nason MC, Gordon IJ, Holman L, Bailer RT, Roederer M, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 011 Study Team. PLoS One. 2014 Mar 12;9(3):e91366. doi: 10.1371/journal.pone.0091366. eCollection 2014.

9. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL; VRC 312 Study Team. Science. 2013 Sep 20;341(6152):1359-65. doi: 10.1126/science.1241800. Epub 2013 Aug 8.

10. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 310 Study Team. J Infect Dis. 2013 Aug 1;208(3):418-22. doi: 10.1093/infdis/jit180. Epub 2013 Apr 30.

11. DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial. Graham BS, Enama ME, Nason MC, Gordon IJ, Peel SA, Ledgerwood JE, Plummer SA, Mascola JR, Bailer RT, Roederer M, Koup RA, Nabel GJ; VRC 008 Study Team. PLoS One. 2013;8(4):e59340. doi: 10.1371/journal.pone.0059340. Epub 2013 Apr 8.

12. Therapeutic vaccination expands and improves the function of the HIV-specific memory T-cell repertoire. Casazza JP, Bowman KA, Adzaku S, Smith EC, Enama ME, Bailer RT, Price DA, Gostick E, Gordon IJ, Ambrozak DR, Nason MC, Roederer M, Andrews CA, Maldarelli FM, Wiegand A, Kearney MF, Persaud D, Ziemniak C, Gottardo R, Ledgerwood JE, Graham BS, Koup RA; VRC 101 Study Team. J Infect Dis. 2013 Jun 15;207(12):1829-40. doi: 10.1093/infdis/jit098. Epub 2013 Mar 12.

13. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS; VRC 306 Study Team. Lancet Infect Dis. 2011 Dec;11(12):916-24. doi: 10.1016/S1473-3099(11)70240-7. Epub 2011 Oct 3.

14. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11.

15. A replication defective recombinant Ad5 vaccine expressing Ebola virus GP is safe and immunogenic in healthy adults. Ledgerwood JE, Costner P, Desai N, Holman L, Enama ME, Yamshchikov G, Mulangu S, Hu Z, Andrews CA, Sheets RA, Koup RA, Roederer M, Bailer R, Mascola JR, Pau MG, Sullivan NJ, Goudsmit J, Nabel GJ, Graham BS; VRC 205 Study Team. Vaccine. 2010 Dec 16;29(2):304-13. doi: 10.1016/j.vaccine.2010.10.037. Epub 2010 Oct 27.

16. Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, Nason MC, Larkin BD, Enama ME, Ledgerwood JE, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 009 Study Team; VRC 010 Study Team. PLoS One. 2010 Feb 2;5(2):e9015. doi: 10.1371/journal.pone.0009015.

17. A SARS DNA vaccine induces neutralizing antibody and cellular immune responses in healthy adults in a Phase I clinical trial. Martin JE, Louder MK, Holman LA, Gordon IJ, Enama ME, Larkin BD, Andrews CA, Vogel L, Koup RA, Roederer M, Bailer RT, Gomez PL, Nason M, Mascola JR, Nabel GJ, Graham BS; VRC 301 Study Team. Vaccine. 2008 Nov 25;26(50):6338-43. doi: 10.1016/j.vaccine.2008.09.026. Epub 2008 Sep 26.

18. Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine. Catanzaro AT, Roederer M, Koup RA, Bailer RT, Enama ME, Nason MC, Martin JE, Rucker S, Andrews CA, Gomez PL, Mascola JR, Nabel GJ, Graham BS; VRC 007 Study Team. Vaccine. 2007 May 16;25(20):4085-92. Epub 2007 Mar 7.

19. Safety, immunogenicity and efficacy of modified vaccinia Ankara (MVA) against Dryvax challenge in vaccinia-naïve and vaccinia-immune individuals. Parrino J, McCurdy LH, Larkin BD, Gordon IJ, Rucker SE, Enama ME, Koup RA, Roederer M, Bailer RT, Moodie Z, Gu L, Yan L, Graham BS; VRC 201/203 Study Team. Vaccine. 2007 Feb 9;25(8):1513-25. Epub 2006 Nov 7.

20. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ; VRC 004 Study Team. J Infect Dis. 2006 Dec 15;194(12):1650-60. Epub 2006 Nov 8.

21. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; VRC 006 Study Team. J Infect Dis. 2006 Dec 15;194(12):1638-49. Epub 2006 Nov 8. Erratum in: J Infect Dis. 2009 Oct 15;200(8):1352-3.