Recent developments in clinical trial designs for HIV vaccine research

Ending the Global HIV/AIDS Pandemic: The Critical Role of an HIV Vaccine

(2014) A. S. Fauci et al.   CLINICAL INFECTIOUS DISEASES

Dendritic cell-based therapeutic vaccine elicits polyfunctional HIV-specific T-cell immunity associated with control of viral load

(2014) Yves Lévy et al.   EUROPEAN JOURNAL OF IMMUNOLOGY

Analysis of HLA A*02 Association with Vaccine Efficacy in the RV144 HIV-1 Vaccine Trial

(2014) A. J. Gartland et al.   JOURNAL OF VIROLOGY

Potential Role for HIV-Specific CD38−/HLA-DR+ CD8+ T Cells in Viral Suppression and Cytotoxicity in HIV Controllers

(2014) Stéphane Hua et al.   PLoS One

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design

(2014) Laura Richert et al.   Trials

Quantifying and Predicting the Effect of Exogenous Interleukin-7 on CD4+T Cells in HIV-1 Infection

(2014) Rodolphe Thiébaut et al.   PLoS Computational Biology

Is the current use of ‘positivity’ thresholds meaningful for evaluating HIV-vaccine immunogenicity endpoints?

(2013) Laura Richert et al.   AIDS

In Pursuit of an HIV Vaccine: Designing Efficacy Trials in the Context of Partially Effective Nonvaccine Prevention Modalities

(2013) Holly Janes et al.   AIDS RESEARCH AND HUMAN RETROVIRUSES

Mixture models for single-cell assays with applications to vaccine studies

(2013) G. Finak et al.   BIOSTATISTICS

Defining ELISpot cut-offs from unreplicated test and control wells

(2013) Neal Alexander et al.   JOURNAL OF IMMUNOLOGICAL METHODS

Challenges in clinical trial design for HIV-1 cure research

(2013) Nir Eyal et al.   LANCET

Efficacy Trial of a DNA/rAd5 HIV-1 Preventive Vaccine

(2013) Scott M. Hammer et al.   NEW ENGLAND JOURNAL OF MEDICINE

Designing Tomorrow's Vaccines

(2013) Gary J. Nabel   NEW ENGLAND JOURNAL OF MEDICINE

New clinical trial designs for HIV vaccine evaluation

(2013) Zoe Moodie et al.   Current Opinion in HIV and AIDS

Vaccine and immunotherapeutic interventions

(2013) Giuseppe Pantaleo et al.   Current Opinion in HIV and AIDS

Human Immunodeficiency Virus Vaccine Trials

(2013) R. J. O'Connell et al.   Cold Spring Harbor Perspectives in Medicine

A Robust Bayesian Random Effects Model for Nonlinear Calibration Problems

(2012) Y. Fong et al.   BIOMETRICS

Nomenclature for Immune Correlates of Protection After Vaccination

(2012) S. A. Plotkin et al.   CLINICAL INFECTIOUS DISEASES

Adaptive Clinical Trials

(2012) William J. Meurer et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Adaptive Trials in Clinical Research

(2012) Rieke van der Graaf et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Risk behaviour and time as covariates for efficacy of the HIV vaccine regimen ALVAC-HIV (vCP1521) and AIDSVAX B/E: a post-hoc analysis of the Thai phase 3 efficacy trial RV 144

(2012) Merlin L Robb et al.   LANCET INFECTIOUS DISEASES

Vaccine protection against acquisition of neutralization-resistant SIV challenges in rhesus monkeys

(2012) Dan H. Barouch et al.   NATURE

Immune-Correlates Analysis of an HIV-1 Vaccine Efficacy Trial

(2012) Barton F. Haynes et al.   NEW ENGLAND JOURNAL OF MEDICINE

Can immunotherapy be useful as a “functional cure” for infection with Human Immunodeficiency Virus-1?

(2012) Guido Vanham et al.   Retrovirology

Adaptive trial designs: a review of barriers and opportunities

(2012) John A Kairalla et al.   Trials

Measurements of Immune Responses for Establishing Correlates of Vaccine Protection Against HIV

(2011) Wendy A. Burgers et al.   AIDS RESEARCH AND HUMAN RETROVIRUSES

Designing phase II trials in cancer: a systematic review and guidance

(2011) S R Brown et al.   BRITISH JOURNAL OF CANCER

Statistical Interpretation of the RV144 HIV Vaccine Efficacy Trial in Thailand: A Case Study for Statistical Issues in Efficacy Trials

(2011) P. B. Gilbert et al.   JOURNAL OF INFECTIOUS DISEASES

Results of a Multicentric In Silico Clinical Trial (ROCOCO): Comparing Radiotherapy with Photons and Protons for Non-small Cell Lung Cancer

(2011) Erik Roelofs et al.   Journal of Thoracic Oncology

Safety and efficacy of the HVTN 503/Phambili Study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study

(2011) Glenda E Gray et al.   LANCET INFECTIOUS DISEASES

Adaptive clinical trials in oncology

(2011) Donald A. Berry   Nature Reviews Clinical Oncology

HIV-1 Vaccines and Adaptive Trial Designs

(2011) L. Corey et al.   Science Translational Medicine

AIDS Vaccines and Preexposure Prophylaxis: Is Synergy Possible?

(2010) Jean-Louis Excler et al.   AIDS RESEARCH AND HUMAN RETROVIRUSES

Some design issues in phase 2B vs phase 3 prevention trials for testing efficacy of products or concepts

(2010) Peter B. Gilbert   STATISTICS IN MEDICINE

Effector memory T cell responses are associated with protection of rhesus monkeys from mucosal simian immunodeficiency virus challenge

(2009) Scott G Hansen et al.   NATURE MEDICINE

Vaccination with ALVAC and AIDSVAX to Prevent HIV-1 Infection in Thailand

(2009) Supachai Rerks-Ngarm et al.   NEW ENGLAND JOURNAL OF MEDICINE

Simultaneous Evaluation of the Magnitude and Breadth of a Left- and Right-Censored Multivariate Response, With Application to HIV Vaccine Development

(2009) Yunda Huang et al.   Statistics in Biopharmaceutical Research

Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial

(2008) Susan P Buchbinder et al.   LANCET

Efficient and robust method for comparing the immunogenicity of candidate vaccines in randomized clinical trials

(2008) Peter B. Gilbert et al.   VACCINE

Evaluating a surrogate endpoint at three levels, with application to vaccine development

(2007) Peter B. Gilbert et al.   STATISTICS IN MEDICINE