Faculty
Michelle Lally
Associate Professor of Medicine:
Bio Med Medicine
Phone: +1 401 793 4773
Michelle_Lally_MD@brown.edu
Read Michelle Lally's full Faculty Research Profile.
Michelle Lally serves as the Director of the HIV Vaccine Clinical Trials Unit for Brown University/The Miriam Hospital; her primary research interests include HIV prevention, testing, and vaccine development. Her attention also focuses on health care disparity, access to HIV and other STD education, testing, and treatment, and the representation of women and minorities in clinical trials. She has also worked extensively in the area of rapid HIV testing and its potential community applications.
Biography
Following her graduation from Boston College magna cum laude with a degree in Biochemistry and Philosophy in 1989, Dr. Michelle Lally pursued her education in medicine at the University of Virginia School of Medicine. She graduated in 1993, and continued her post-graduate training with an Internship in Internal Medicine and Residency in Internal Medicine at the New England Deaconess Hospital, affiliated with Harvard Medical School, where from 1996-1997 she served as a clinical fellow in Infectious Diseases. She then completed her Research Fellowship in Infectious Diseases at Beth Israel Deaconess Medical Center and remained at the Harvard School of Public Health to earn her M.Sc. in Epidemiology in 1999. She accepted an Assistant Professorship at Brown University Medical School that same year.
Interests
Michelle Lally serves as the Director of the HIV Vaccine Clinical Trials Unit at Brown, and her research is related to the development and eventual delivery of an HIV vaccine. Phase I, II, and III clinical trials are conducted at the Brown/Miriam Hospital Vaccine Clinical Trials Unit with sponsors including the National Institutes of Health (NIH) as well as private industry. The goal of the trials is to evaluate the safety, immunogenicity, and efficacy of multiple separate HIV vaccine candidates. Most trials are conducted through our involvement with the international, NIH-funded HIV Vaccine Trials Network (HVTN, www.hvtn.org).
Trials we have participated in include the following:
VAX004: A Phase III Trial to Determine the Efficacy of Bivalent Aidsvax™ B/B Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America and Europe (VAX004) (The only Phase III HIV vaccine trial in the U.S. to date).
Merck 007: A Probe Study of the Safety, Tolerability and Immunogenicity of a 3-Dose Regimen of theAd5 Human Immunogenicity Virus (HIV-1) gag Vaccine (adenovirus Serotype 5 HIV-1 gag Vector) in Health Adults (2001 - 2006)
A Phase I safety and immunogenicity trial of a combination vaccine (NefTat and gp120w61D) formulated with AS02A (GlaxoSmithKline Biologicals) given intramuscularly in HIV-1 uninfected adult participants (NIH: HVTN 041)
A Phase II clinical trial to evaluate the immunogenicity and safety of a combined regimen using ALVAC vCP1452 and AIDSVAX B/B (NIH: HVTN 203)
A Phase I/II clinical trial to evaluate the safety and Immunogenicity of LIPO-5 Alone, ALVAC-HIV (vCP1452) Alone, and ALVAC HIV Prime / LIPO-5 Boost in Healthy, HIV-1 uninfected adult participants (NIH: HVTN 042)
A Phase I clinical trial to evaluate the safety and immunogenicity of the HIV-1 DNA vaccine VRC-HIVDNA009-00-VP (GAG-POL-NEF-MULTICLADE ENV) with the plasmid cytokine adjuvant VRC-ADJDNA004-IL2-VP (IL-2/IG) (NIH: HVTN 044)
A Phase I dose escalation clinical trial to evaluate the safety and immunogenicity of the EP HIV-1090 DNA vaccine in healthy, HIV-1 uninfected adult participants (NIH: HVTN 048)
A Phase I clinical trial to evaluate the safety and immunogenicity of a Clade B GAG DNA/PLG and ENV DNA/PLG microparticles prime with a CLADE B recombinant, oligomeric GP140/MF59 adjuvant boost in healthy, HIV-1 uninfected adult participants (NIH: HVTN 049)
A Phase IB clinical trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine, VRC-HIVDNA009-00-VP, administered at 2 different dosing schedules, in HIV-1 uninfected adult participants (NIH: HVTN 052)
A Phase I clinical trial to evaluate the safety of a multiclade recombinant adenoviral vector HIV-1 vaccine administered to healthy, HIV-1 uninfected, adult participants who received DNA plasmid vaccine or placebo in the HVTN 052 clinical trial (NIH: HVTN 057)
A Phase I clinical trial to evaluate the safety and immunogenicity of HIV-1 gag DNA vaccine alone or with IL-15 DNA, boosted with HIV-1 gag DNA + IL-15 DNA, HIV CTL multiepitope peptide vaccine, or HIV-1 gag DNA + IL-12 DNA, in healthy, HIV-1 uninfected adult participants (NIH: HVTN 063)
A Phase II clinical trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine, VRC-HIVDNA016-00-VP, followed by a multiclade recombinant adenoviral vector HIV-1 vaccine boost, VRC-HIVADV014-00-VP, in HIV-1 uninfected adult participants(NIH: HVTN 204)
A multi-site evaluation of virologic, immunologic and clinical natural history of participants enrolled in Phase I and Phase II HIV-1 vaccine protocols or a vaccine preparedness cohort who develop HIV-1 infection subsequent to trial enrollment (NIH: HVTN 403)
A worldwide, Phase I, dose-escalating study of a 3-dose regimen of MRKAd5 HIV-1 gag vaccine in healthy adults (NIH: HVTN 050)
Merck 016-Trivalent: A Phase I dose-ranging study of the safety, tolerability, and immunogenicity of the Merck trivalent adenovirus serotype 5 HIV1 gag/pol/nef vaccine (MRKAd5 HIV-1 gag/pol/nef) in a prime-boost regimen in healthy adults (2003 - 2009)
Merck 019: A probe study of the safety, tolerability, and immunogenicity of a 1-dose Regimen of the MRKAd5 HIV-1 Gag Vaccine versus the ALVAC-HIV (vCP205) Vaccine in Healthy Adults Who Previously Received a 3-Dose Regimen of MRKAd5, Ad5 or Placebo in Merck V520 Protocols 007 (2003-2009)
We may have a licensed HIV vaccine in the next 10 years. Once a vaccine is available, HIV vaccine delivery will face many challenges. HIV testing may need to be done before an HIV vaccine is given, and ideally this will be quick and easy to do. As an effective HIV vaccine may lead to the development of antibodies against HIV, novel HIV testing methods may also be necessary. Dr. Lally has conducted specific research in rapid HIV testing among at risk populations, including those in drug treatment and those who are incarcerated. She is continuing to explore the use of rapid HIV testing in different settings.
Dr. Lally is the Co-Principal Investigator for Protocol RV 180: Nucleic Acid Assays for Diagnosis of HIV Infection in Anticipation of an HIV Vaccine. This study is being sponsored by the US Military HIV Research Program and will serve to evaluate multiple various nucleic acid assays. HIV nucleic acid tests theoretically afford the technological means to rule out or confirm true HIV infection in individuals where traditional serological methodology is no longer a reliable index of HIV infection, as is anticipated to be the case in HIV-vacinees.
In June, 2006, a vaccine was licensed to prevent infection with four strains of Human Pappilomavirus (HPV). HPV infection is required before the development of cervical cancer, and this vaccine may serve to markedly decrease the rate of abnormal PAP smears as well as cases of cervical cancer both in the United States and throughout the world, if the vaccine can be effectively delivered. Dr. Lally is also researching effective methods for HPV vaccine delivery among young women.
Degrees
MD, University of Virginia, 1993
Teaching
1998 to present: Infectious Disease Attending, The Miriam Hospital, Providence, RI
1998 to present: Immunology Center/HIV Clinic Inpatient Service, The Miriam Hospital, Providence, RI
1998-2000: HIV Medical Clinic for Incarcerated Women, Adult Correctional Institute, Cranston, RI
1998-2001: Stanley Street Treatment and Resources (SSTAR), Short Term Drug Treatment Center, Providence, RI
1998-2002: Immunology Center/HIV Clinic Attending, The Miriam Hospital, Providence, RI
2000-2003: BI0282 Pathophysiology, Infectious Diseases, Brown University, Providence, RI (Small Group Sessions Facilitator)
2005 to present: Fellows Lecture Series, Rhode Island Hospital, Providence, RI
2005 to present: Resident Lecture Series, The Miriam Hospital, Providence, RI
2006 to present: The Miriam Hospital Travel Clinic Attending, Providence, RI
2007-2008: BIO365 Pathophysiology, Infectious Diseases, Brown University, Providence, RI (Small Group Sessions Facilitator)
