Chickenpox is a highly contagious disease caused by the varicella-zoster virus. The most effective way to prevent chickenpox is through vaccination. Currently, there is a vaccine called vOka that is used to prevent chickenpox. However, there have been concerns about the safety of this vaccine.
To address these concerns, researchers have developed a vaccine candidate called v7D. They conducted a clinical trial to test the safety and effectiveness of this vaccine candidate. The trial involved 224 healthy participants aged 1–49 years who had not previously been vaccinated for chickenpox or had the disease.
Clinical Trial
The trial was randomized, double-blind, and placebo-controlled. This means that the participants were randomly assigned to receive one of three doses of v7D, the existing vOka vaccine, or a placebo. Neither the participants nor the researchers knew who received which treatment, and some participants received a placebo which means they did not receive any vaccine. This helped to ensure that the results were unbiased.
The primary goal of the trial was to determine the safety of the vaccine, while the secondary goal was to assess its effectiveness. The researchers monitored the participants for any adverse reactions for 42 days after vaccination. Adverse reactions can include things like fever, rash, or pain at the injection site. They also monitored the participants for any serious adverse events for six months after vaccination. Serious adverse events are things like hospitalization or death that are potentially related to the vaccine.
Results
The researchers found that the incidence of adverse reactions within 42 days post-vaccination was similar among the v7D groups, vOka group, and placebo group. In other words, the people who received the v7D vaccine did not experience more adverse reactions than those who received the vOka vaccine or the placebo. No serious adverse events were found to be related to the vaccine.