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Immune correlates analysis using vaccinees from test negative designs.

Dean A Follmann1, Lori Dodd1

  • 1Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda MD.

Biostatistics (Oxford, England)
|September 24, 2020
PubMed
Summary
This summary is machine-generated.

This study introduces a novel retrospective method using test-negative vaccinees to assess immune responses and vaccine efficacy, particularly useful in outbreak settings. The approach estimates immune response proxies to predict disease risk when prospective sampling is infeasible.

Keywords:
ImputationLikelihood, Logisitic regressionRegression calibration

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Area of Science:

  • Vaccinology
  • Epidemiology
  • Immunology

Background:

  • Assessing vaccine-induced immune responses is crucial for understanding disease risk.
  • Prospective immune correlates analyses are standard but challenging in outbreak or rare disease scenarios.
  • The test-negative design is a retrospective method for vaccine efficacy studies.

Purpose of the Study:

  • To propose a novel retrospective method for estimating immune response slopes using test-negative vaccinees.
  • To enable vaccine efficacy assessment when prospective immune sampling is not feasible.
  • To provide a proxy for immune response proximal to infection in retrospective studies.

Main Methods:

  • Utilizing a test-negative design where vaccinees are assessed for both relevant and irrelevant protein immune responses.
  • Employing logistic regression with imputed immune response as a covariate to estimate prospective immune response slopes.
  • Evaluating the method's performance through simulations under various immune response scenarios (constant and decaying).

Main Results:

  • Demonstrated that immune response to irrelevant proteins can serve as a proxy for relevant immune response.
  • Showcased the ability of logistic regression with imputed immune response to estimate prospective immune response slopes.
  • Validated the method's utility with a simulated dataset from an Ebola outbreak ring vaccination scenario.

Conclusions:

  • The proposed retrospective method offers a feasible approach to estimate vaccine-induced immune responses and efficacy in challenging settings.
  • This technique allows for unbiased inference under specified assumptions, expanding the application of immune correlates analyses.
  • The findings are particularly relevant for vaccine development and deployment during public health emergencies.