The race for a vaccine against Covid-19, which first officially emerged in December 2019 and has infected over 33.24 million people worldwide, continues. Several vaccines are currently being tested and developed under different stages of clinical trials. One of these efforts is driven by Johnson & Johnson, which have conductedd a multicenter phase 1/2a randomized, double-blinded, placebo-controlled clinical trial to evaluate the safety and immunogenicity of a non-replicating adenovirus-based vaccine (Ad26.COV2.S).
Findings show that the vaccine has proven to be mostly safe for human use, introducing robust immune responses, and was previously used for Ebola, Zika, and HIV vaccines. In preclinical studies, the vaccine had already shown a strong immune response in monkeys as well as in a Syrian golden hamster model of severe Covid-19.
The trial with 796 participants of all age groups (age 18 -55 = Groups 1a and 1b; age 65 and older =group 3) was divided into three groups, that received a single-dose vaccination regimen with 5x1010 or 1x1011 viral particles per vaccination, with its safety and effectiveness assessed after 4 weeks after the vaccination.
Researchers found that participants from groups 1 and 3 showed solicited local adverse events (58% and 27%), while solicited systemic adverse events were found in 64% and 36% of all participants. Side effects included pain at the site of injection, fatigue, headaches, and myalgia, and for 19% and 4% of the participants, a mild fever was detected, which resolved after 1-2 days.
Overall, the vaccine appears to be mostly safe for all participants of all age groups, with a higher vaccine dose being associated with higher reactogenicity. The vaccine seems to be capable of inducing strong neutralizing antibody responses and T cell-mediated immune responses among all participants. Therefore, a phase 3 clinical trial has been initiated to research and evaluate the efficacy and durability of the adaptive immunity of a two-dose regimen.
Research sites looking to increase patient recruitment and retention in clinical trials should look no further than Citrus. Our patient recruitment dashboard provides your study with fully integrated software to streamline your patient recruitment process. Recruit at scale with a human touch through automated, customized campaigns, and engage your patients in ways not possible with CTMS systems.
With over 200 research sites using the Citrus platform to screen thousands of patients every month, researchers across the globe are getting one step closer to finding new treatments for hundreds of different health conditions. Save valuable hours in your recruitment timeline. Increase on-site screenings, boost your enrollment targets, and retain more patients in your clinical trials.
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