Trusted Resource for Clinical Trials, Protocols & Progress
Comparing Humoral vs Cellular Immunity in Vaccines Humoral vs Cellular Immunity in Vaccine Trials: What to Measure, How to Compare, and When It Matters Humoral and Cellular Immunity—Different Jobs, Shared Goal Vaccine programs routinely track two arms of the adaptive immune system. Humoral immunity is quantified by binding antibody concentrations (e.g., ELISA IgG geometric mean…
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Correlates of Protection in Infectious Disease Trials Correlates of Protection in Infectious Disease Trials: From Concept to Cutoff What Is a Correlate of Protection—and Why It Matters to Your Trial “Correlates of protection” (CoP) are measurable immune markers that predict a vaccine’s ability to prevent infection, symptomatic disease, or severe outcomes. A mechanistic correlate causally…
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Dosing Schedules and Booster Strategies Designing Vaccine Dosing Schedules and Smart Booster Plans Why Schedules and Boosters Matter: Balancing Biology, Safety, and Public Health Vaccine schedules and boosters translate immunology into public health impact. The interval between doses modulates germinal center maturation and class switching, while the decision to boost later counters waning immunity and…
Bridging Studies Between Age Groups in Vaccines Designing Age-Group Immunobridging Studies for Vaccines What Immunobridging Aims to Show—and When Regulators Expect It Age-group immunobridging studies answer a practical question: if a vaccine’s dose and schedule are proven in one population (often adults), can we infer comparable protection in another (adolescents, children, older adults) without running…
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Phase III Vaccine Efficacy Trial Design and Execution How to Plan and Run Phase III Vaccine Efficacy Trials Purpose of Phase III: Confirming Efficacy, Safety, and Consistency at Scale Phase III vaccine trials provide the pivotal evidence needed for licensure: they confirm clinical efficacy, characterize safety across thousands of participants, and may assess consistency across…
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