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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Cytomegalovirus Disease01:27

Cytomegalovirus Disease

Cytomegalovirus (CMV) disease is caused by human cytomegalovirus, a double-stranded DNA virus of the Herpesviridae family. While primary CMV infection is often asymptomatic in immunocompetent individuals, the virus can cause severe disease in neonates and immunocompromised patients. CMV is the most common cause of congenital viral infection in the United States, and a major pathogen in solid organ and hematopoietic stem cell transplant recipients.CMV is transmitted via bodily fluids, sexual...
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

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Related Experiment Video

Updated: Jun 19, 2026

Simultaneous Quantification of Anti-vector and Anti-transgene-Specific CD8+ T Cells Via MHC I Tetramer Staining After Vaccination with a Viral Vector
08:10

Simultaneous Quantification of Anti-vector and Anti-transgene-Specific CD8+ T Cells Via MHC I Tetramer Staining After Vaccination with a Viral Vector

Published on: November 28, 2018

CMV vaccine trial endpoints.

P D Griffiths1

  • 1Centre for Virology, University College London Medical School, United Kingdom. p.griffiths@medsch.ucl.ac.uk

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
|November 3, 2009
PubMed
Summary
This summary is machine-generated.

Developing a cytomegalovirus (CMV) vaccine shows promise. Phase III trials should prioritize congenital CMV infection endpoints to demonstrate cost-effectiveness, particularly in teenage immunization programs.

Related Experiment Videos

Last Updated: Jun 19, 2026

Simultaneous Quantification of Anti-vector and Anti-transgene-Specific CD8+ T Cells Via MHC I Tetramer Staining After Vaccination with a Viral Vector
08:10

Simultaneous Quantification of Anti-vector and Anti-transgene-Specific CD8+ T Cells Via MHC I Tetramer Staining After Vaccination with a Viral Vector

Published on: November 28, 2018

Area of Science:

  • Vaccinology
  • Public Health
  • Infectious Diseases

Background:

  • Cytomegalovirus (CMV) infection presents significant challenges for vaccine development.
  • Optimism exists for developing effective CMV vaccines.
  • Vaccine cost-effectiveness is a key consideration for public health recommendations.

Purpose of the Study:

  • To anticipate the interpretation of positive CMV vaccine trial results by immunization policymakers.
  • To evaluate the cost-effectiveness of potential CMV vaccines.
  • To guide the design of Phase III clinical trials for CMV vaccines.

Main Methods:

  • Economic modeling based on quality-adjusted life years (QALYs) gained.
  • Analysis of cost-effectiveness across different age groups for immunization.
  • Consideration of primary endpoints for Phase III trials.

Main Results:

  • Immunizing teenagers is projected to be more cost-effective than immunizing toddlers due to future benefit discounting.
  • Protecting women of childbearing age is crucial but may require extrapolation for fetal transmission protection.
  • Congenital CMV infection is proposed as a preferred primary endpoint for Phase III studies.

Conclusions:

  • Phase III trials must be designed to directly capture data for cost-effectiveness assessments using QALYs.
  • Congenital CMV infection in infants born to immunized mothers should be the primary endpoint for trials targeting seronegative women.
  • Strategic trial design is essential to convince policymakers of CMV vaccine value and facilitate universal immunization recommendations.