Medicine and Health Sciences Commons^™

Randomized Controlled Trials: Who Fails Run-In?, Judy R. Rees, Leila A. Mott, Elizabeth L. Barry, John A. Baron, Jane C. Figueiredo, Douglas J. Robertson, Robert S. Bresalier, Janet L. Peacock

Dartmouth Scholarship

Background: Early identification of participants at risk of run-in failure (RIF) may present opportunities to improve trial efficiency and generalizability. Methods: We conducted a partial factorial-design, randomized, controlled trial of calcium and vitamin D to prevent colorectal adenoma recurrence at 11 centers in the United States. At baseline, participants completed two self-administered questionnaires (SAQs) and a questionnaire administered by staff. Participants in the full factorial randomization (calcium, vitamin D, both, or neither) received a placebo during a 3-month single-blinded run-in; women electing to take calcium enrolled in a two-group randomization (calcium with vitamin D, or calcium alone) and received calcium …

Integration Of Comprehensive Women’S Health Programmes Into Health Systems: Cervical Cancer Prevention, Care And Control In Rwanda, Agnes Binagwaho, Fidele Ngabo, Claire M. Wagner, Cathy Mugeni, Maurice Gatera, Cameron T. Nutt, Sabin Nsanzimana

Dartmouth Scholarship

PROBLEM: Although it is highly preventable and treatable, cervical cancer is the most common and most deadly cancer among women in Rwanda.

APPROACH: By mobilizing a diverse coalition of partnerships, Rwanda became the first country in Africa to develop and implement a national strategic plan for cervical cancer prevention, screening and treatment.

LOCAL SETTING: Rwanda - a small, landlocked nation in East Africa with a population of 10.4 million - is well positioned to tackle a number of "high-burden" noncommunicable diseases. The country's integrated response to infectious diseases has resulted in steep declines in premature mortality over the past decade. …

Achieving High Coverage In Rwanda's National Human Papillomavirus Vaccination Programme, Agnes Binagwaho, Claire Wagner, Maurice Gatera, Corine Karema, Cameron T. Nutt, Fidele Ngabo

Dartmouth Scholarship

Problem: Virtually all women who have cervical cancer are infected with the human papillomavirus (HPV). Of the 275000 women who die from cervical cancer every year, 88% live in developing countries. Two vaccines against the HPV have been approved. However, vaccine implementation in low-income countries tends to lag behind implementation in high-income countries by 15 to 20 years.

Approach: In 2011, Rwanda’s Ministry of Health partnered with Merck to offer the Gardasil HPV vaccine to all girls of appropriate age. The Ministry formed a “public–private community partnership” to ensure effective and equitable delivery.

Local setting: Thanks to a strong national …

Prophylaxis And Therapy Of Inhalational Anthrax By A Novel Monoclonal Antibody To Protective Antigen That Mimics Vaccine-Induced Immunity, Laura Vitale, Diann Blanset, Israel Lowy, Thomas O'Neill, Joel Goldstein, Stephen F. Little, Gerard P. Andrews, Gary Dorough, Ronald K. Taylor, Tibor Keler

Dartmouth Scholarship

The neutralizing antibody response to the protective antigen (PA) component of anthrax toxin elicited by approved anthrax vaccines is an accepted correlate for vaccine-mediated protection against anthrax. We reasoned that a human anti-PA monoclonal antibody (MAb) selected on the basis of superior toxin neutralization activity might provide potent protection against anthrax. The fully human MAb (also referred to as MDX-1303 or Valortim) was chosen from a large panel of anti-PA human MAbs generated using transgenic mice immunized with recombinant PA solely on the basis of in vitro anthrax toxin neutralization. This MAb was effective in prophylactic and postsymptomatic treatment of …

T-Cell Responses To The M3 Immune Evasion Protein Of Murid Gammaherpesvirus 68 Are Partially Protective And Induced With Lytic Antigen Kinetics, Joshua J. Obar, Douglas C. Donovan, Sarah G. Crist, Ondine Silvia, James P. Stewart, Edward J. Usherwood

Dartmouth Scholarship

DNA vaccination with the M3 gene, encoding an immune evasion molecule expressed during both the acute lytic and persistent phases of murid gammaherpesvirus 68 infection, yielded a significantly lower titer of virus in the lung than controls. The protection seen was dependent on T cells, and we mapped an epitope recognized by CD8 T cells. The immune response to this epitope follows the same kinetics as lytic cycle antigens, despite the fact that this gene is expressed in both lytic and persistent stages of infection. This has important implications for our understanding of T-cell responses to putative latency-associated gammaherpesvirus proteins …