P.B. Gilbert
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View article: Prediction of serum HIV-1 neutralization titers of VRC01 in HIV-uninfected Antibody Mediated Prevention (AMP) trial participants
Prediction of serum HIV-1 neutralization titers of VRC01 in HIV-uninfected Antibody Mediated Prevention (AMP) trial participants Open
VRC01 is being evaluated in the AMP efficacy trials, the first assessment of a passively administered broadly neutralizing monoclonal antibody (bnAb) for HIV-1 prevention. A key analysis will assess serum VRC01-mediated neutralization as a…
View article: Neutralization titer biomarker for antibody-mediated prevention of HIV-1 acquisition
Neutralization titer biomarker for antibody-mediated prevention of HIV-1 acquisition Open
The Antibody Mediated Prevention trials showed that the broadly neutralizing antibody (bnAb) VRC01 prevented acquisition of human immunodeficiency virus-1 (HIV-1) sensitive to VRC01. Using AMP trial data, here we show that the predicted se…
View article: A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated
A Deferred-Vaccination Design to Assess Durability of COVID-19 Vaccine Effect After the Placebo Group Is Vaccinated Open
Multiple candidate vaccines to prevent COVID-19 have entered large-scale phase 3 placebo-controlled randomized clinical trials, and several have demonstrated substantial short-term efficacy. At some point after demonstration of substantial…
View article: Mathematical Modeling of Vaccines That Prevent SARS-CoV-2 Transmission
Mathematical Modeling of Vaccines That Prevent SARS-CoV-2 Transmission Open
SARS-CoV-2 vaccine clinical trials assess efficacy against disease (VEDIS), the ability to block symptomatic COVID-19. They only partially discriminate whether VEDIS is mediated by preventing infection completely, which is defined as detec…
View article: Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa
Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa Open
As oral tenofovir-based regimens for preexposure prophylaxis (PrEP) are adopted as standard of care for HIV prevention, their utilization in clinical trials among women in southern Africa will require an accurate estimate of oral PrEP effi…
View article: Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials
Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials Open
Several vaccine candidates to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) have entered or will soon enter large-scale, phase 3, placebo-controlled randomized…
View article: COVID-19 vaccine trials should seek worthwhile efficacy
COVID-19 vaccine trials should seek worthwhile efficacy Open
View article: Super LeArner Prediction of NAb Panels (SLAPNAP): A Containerized Tool for Predicting Combination Monoclonal Broadly Neutralizing Antibody Sensitivity
Super LeArner Prediction of NAb Panels (SLAPNAP): A Containerized Tool for Predicting Combination Monoclonal Broadly Neutralizing Antibody Sensitivity Open
Summary Single broadly neutralizing antibody (bnAb) regimens are currently being evaluated in randomized trials for prevention efficacy against HIV-1 infection. Subsequent trials will evaluate combination bnAb regimens (e.g., cocktails, mu…
View article: A study of vaccine-induced immune pressure on breakthrough infections in the Phambili phase 2b HIV-1 vaccine efficacy trial
A study of vaccine-induced immune pressure on breakthrough infections in the Phambili phase 2b HIV-1 vaccine efficacy trial Open