Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Endpoints in vaccine trials.

Michael G Hudgens1, Peter B Gilbert, Steven G Self

  • 1Statistical Center For HIV/AIDS Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. mhudgens@bios.unc.edu

Statistical Methods in Medical Research
|April 8, 2004
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Comparing Care Coordination and Food Assistance Referrals to Improve Diabetes Outcomes: A Cohort Study.

Journal of general internal medicine·2026
Same author

Combining Observational Studies to Reduce Multiple Biases.

Epidemiology (Cambridge, Mass.)·2026
Same author

MVA.HIVconsvX vaccination-evoked T cell expansion inversely associates with age in people with HIV-1 on antiretroviral therapy.

The Journal of clinical investigation·2026
Same author

A Primer on Large-Sample Statistical Inference for Epidemiologists.

Epidemiologic methods·2026
Same author

Racial Differences in Expected Versus Actual Costs of Cervical Cancer Screening among Low-Income, Underscreened Women in North Carolina.

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology·2026
Same author

Comparative Effectiveness of Levonorgestrel Implant and Depot Medroxyprogesterone Acetate Injectable for Women Living With HIV on Dolutegravir-Based Antiretroviral Therapy.

Pharmacoepidemiology and drug safety·2026
Same journal

Asymptotic online FWER control for dependent test statistics.

Statistical methods in medical research·2026
Same journal

Regression analysis of misclassified current status data with potentially unknown test accuracy.

Statistical methods in medical research·2026
Same journal

Bayesian multivariate linear mixed-effects models with varied association structures.

Statistical methods in medical research·2026
Same journal

Inference about the ratio of age-standardized rates between two overlapping populations.

Statistical methods in medical research·2026
Same journal

A robust neural network with random effects for subject-specific prediction of clustered count data.

Statistical methods in medical research·2026
Same journal

A comparison of methods for designing hybrid type 2 cluster-randomized trials with continuous effectiveness and implementation endpoints.

Statistical methods in medical research·2026
See all related articles

This paper reviews statistical endpoints for vaccine trials, focusing on Phase III efficacy. It covers traditional measures, waning immunity, and advanced trial designs for robust vaccine evaluation.

Area of Science:

  • Vaccinology
  • Biostatistics
  • Clinical Trials

Background:

  • Endpoint selection is critical for evaluating vaccine efficacy and safety.
  • Early phase trials (preclinical, I, II) inform later-stage decisions.
  • Phase III trials require rigorous statistical planning for definitive efficacy assessment.

Purpose of the Study:

  • To discuss statistical considerations for endpoints in preventive vaccine trials.
  • To emphasize endpoint choice and analysis in Phase III efficacy trials.
  • To explore advanced endpoint concepts beyond traditional efficacy measures.

Main Methods:

  • Review of statistical methodologies for vaccine trial endpoints.
  • Focus on Phase III trial endpoint selection and analysis.

Related Experiment Videos

  • Inclusion of considerations for waning immunity, strain specificity, and correlates of protection.

    • Main Results:

    • Discussion of traditional efficacy endpoints.
    • Exploration of non-traditional endpoints like waning immunity and strain-specific effects.
    • Consideration of correlates of protective immunity and post-infection outcomes.

    Conclusions:

    • Appropriate endpoint selection is paramount for accurate vaccine efficacy assessment.
    • Advanced statistical approaches are necessary to address complex vaccine trial scenarios.
    • The paper provides a framework for optimizing endpoint strategies in vaccine development.