We conduct clinical trials at a single research center to evaluate the safety, tolerability, efficacy, and immunogenicity of vaccines in healthy individuals.
During Phase I, we introduce the vaccine candidate to assess its safety in healthy subjects. Participants are randomly assigned to receive either the vaccine candidate or a placebo. Our primary objectives are to detect any adverse events and demonstrate evidence of an immune response. To minimize the likelihood of serious adverse effects, we employ an escalation study design with a small group of healthy volunteers. The initial subgroup receives the lowest expected dose necessary to elicit an immune response. Subsequent subgroups are administered increasing doses until the tolerability requirement is met. The vaccination schedule varies based on the specific characteristics of the vaccine. We believe that escalation trial designs are ideal for mitigating the risks of serious adverse events.
In Phase II, we have the capacity to include hundreds of healthy volunteers from the target population for the vaccine. This allows us to assess reactions in a more diverse set of individuals and explore different dosing schedules.
During Phase III, we continue to monitor toxicity, immunogenicity, and safety on a larger scale. We collaborate with our partners to investigate the safety and effectiveness of their vaccine products before they submit their documentation for regulatory authority approval.
Experience efficiency and cost-effectiveness with the expertise of Convex Research. We offer a comprehensive range of services for vaccine clinical trials, including:
If you have any inquiries regarding clinical trials on vaccines or if you would like to discuss your upcoming project and how Convex can contribute to its successful execution, please do not hesitate to contact us. You can reach us at firstname.lastname@example.org, and we would be delighted to respond to your inquiries and provide you with the necessary information.