Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB080-00-AB (VRC01LS), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to Healthy Adults

NCT02599896 on ClinicalTrials.gov Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) (government) Started 2015-11-16 Completed

Riskier than 7% of active trials

Model scores of the 29,894 trials active now.

Model score 6% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (106 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-07-25, after 2015-11-16 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-07-25. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Phase: 1 (lowers risk) · Design
Primary purpose: prevention (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
Sponsor's past trials: 1061 (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 8 (lowers risk) · Design
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: smalltypecancerthe safetychronic
Phrases that lowered it: participantshealthydayspharmacokinetics ofhiv

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 8 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: prevention (typical: treatment)
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 5 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 50 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: government (typical: academic or other)
Sponsor's past trials: 1061 (typical: 32)
Sponsor's past termination rate: 5.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 100 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: none matched

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults NCT01993706 · started 2013 · scored riskier than 6% of active trials completed
VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults NCT03015181 · started 2017 · scored riskier than 13% of active trials completed
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults NCT05627258 · started 2023 · scored riskier than 9% of active trials completed
Phase I Study to Evaluate a Human Monoclonal Antibody (MAb) 10E8VLS Administered Alone or Concurrently With MAb VRC07-523LS Via Subcutaneous Injection in Healthy Adults NCT03565315 · started 2018 · scored riskier than 5% of active trials terminated
A Phase 1 Trial to Evaluate CAP256V2LS in Healthy Adults NCT04408963 · started 2022 · scored riskier than 6% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.