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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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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...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

627
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
627
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

407
Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
407
Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

419
Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
419
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

430
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...
430

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Updated: May 1, 2026

Protocol for Recombinant RBD-based SARS Vaccines: Protein Preparation, Animal Vaccination and Neutralization Detection
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Development of Next-Generation COVID-19 Vaccines: Biomedical Advanced Research and Development Authority

Daniel N Wolfe1, Elizabeth Arangies2, Gloria L David2

  • 1Biomedical Advanced Research and Development Authority, Administration for Strategic Preparedness and Response, Department of Health and Human Services, Washington, DC, USA.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|May 28, 2024
PubMed
Summary

Next-generation COVID-19 vaccines aim for improved efficacy and safety. Clinical trials will assess mucosal vaccines and broader antigen targets to reduce transmission and combat variants.

Keywords:
COVID-19SARS-CoV-2clinical trialpandemicvaccine

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Area of Science:

  • Immunology
  • Vaccinology
  • Infectious Diseases

Background:

  • The COVID-19 pandemic spurred rapid development of first-generation SARS-CoV-2 vaccines, significantly reducing mortality.
  • While effective, these vaccines can be improved for enhanced efficacy, safety, and broader protection against variants.
  • Next-generation vaccines offer potential advancements in these areas.

Purpose of the Study:

  • To outline the planned clinical trial endpoints for next-generation COVID-19 vaccines.
  • To discuss the potential challenges in evaluating these advanced vaccine candidates.
  • To inform stakeholders about upcoming Phase 2b trials supported by BARDA.

Main Methods:

  • Focus on Phase 2b clinical trials for next-generation vaccine candidates.
  • Primary endpoint: improved efficacy against symptomatic disease compared to existing vaccines.
  • Exploration of mucosal vaccine delivery and inclusion of diverse viral antigens.

Main Results:

  • The abstract does not contain results, as it discusses planned trials and endpoints.

Conclusions:

  • Next-generation vaccines, including mucosal and multi-antigenic approaches, hold promise for improved COVID-19 control.
  • Rigorous clinical trials are necessary to validate the efficacy and safety of these novel platforms.
  • Strategic planning of trial endpoints is crucial for regulatory approval and public health impact.