Vaccine Studies

We conduct clinical trials at a single research center to evaluate the safety, tolerability, efficacy, and immunogenicity of vaccines in healthy individuals.

Phase I: 

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.

Phase II: 

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.

Phase III: 

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:

• Scientific advisory: Benefit from our expert guidance and consultation throughout your research journey.
• Medical writing: Our team provides professional writing services for essential documents such as the Clinical Study Report and Informed Consent forms.
• Regulatory meeting organization and conduct: We assist in organizing and facilitating regulatory meetings to ensure smooth interactions with authorities.
• Regulatory submission services and approvals: Rely on our support in preparing and submitting regulatory documents, facilitating the approval process.
• Study kick-off activities: We assist in initiating your study, ensuring a seamless start to the clinical trial.
• Fast study subject recruitment: With our strategies and resources, we optimize participant recruitment to accelerate the study timeline.
• Clinical study project management: Our skilled project managers oversee all aspects of the clinical trial, ensuring efficient execution.
• Clinical monitoring: We provide comprehensive monitoring services to ensure compliance and quality throughout the study.
• Pharmacovigilance: Our team monitors and assesses the safety of the investigational vaccine during the trial.
• Data management: We employ robust data management techniques to ensure accurate and secure handling of study data.
• Biostatistics: Our biostatisticians analyze and interpret study data, providing valuable insights for decision-making.
• Final clinical study report: We compile and deliver a comprehensive final report summarizing the findings and outcomes of the study.