Even without healthcare education, common Internet users frequently access updated information on common diseases’ distribution patterns and some promising prevention methods. COVID-19 and vaccine-testing RCTs have become popular topics in online literature. This paper will explore diverse aspects of the RCT design with reference to a review article by Sandoiu (2020) from Medical News Today – a news website targeted at both professional and lay audiences.
Purpose and Study Population
Sandoiu (2020) reviews an RCT conducted by Folegatti et al. (2020) in more than a thousand human participants in the United Kingdom to test the Oxford vaccine’s (ChAdOx1 nCoV-19) safety and effectiveness. The RCT’s main purpose is to measure the new vaccine’s safety profile and the degree to which it induces both humoral and cellular immune reactions in healthy adults (Folegatti et al., 2020; Sandoiu, 2020). Regarding the population, as a two-phase RCT to be continued in larger samples, the reviewed trial explores the immune reactions of 1077 healthy men and women aged between 18 and 55 (Sandoiu, 2020). Other inclusion criteria are the absence of laboratory-confirmed COVID-19 infection in health history or flu-like symptoms right before the trial (Sandoiu, 2020). Therefore, participant selection practices allowed isolating unwanted factors that could influence the outcomes and the purpose.
Length of the Trial
In the RCT that Sandoiu (2020) discusses, all research efforts took more than fifty days due to the need for follow-up visits. Those randomly assigned to the Oxford vaccine (543 participants) or MenACWY control vaccine (534 participants) had five visits between day 3 and 56 after immunization (Folegatti et al., 2020; Sandoiu, 2020). One non-randomized subgroup of 10 individuals received two doses of the Oxford vaccine and had a similar follow-up schedule (Sandoiu, 2020). In the group with a two-dose regimen, the second dose was administered one month after the first one. Finally, the manuscript was first published in July 2020, three months after the beginning of the participant recruitment phase.
Data Collection Methods
Data collection involved administrating vaccines depending on the subgroup’s assigned regimen and measuring humoral/cellular immune responses and adverse events. Due to the target audience’s needs, Sandoiu (2020) does not report the details of data collection. In the primary source, Folegatti et al. (2020) specify that humoral responses were assessed using a standard Human SARS-CoV-2 Spike (Trimer) IgG ELISA kit and four more investigative assays, whereas cellular response data was captured using the ELISpot assay. Blood samples were taken on the day of immunization and 28 days later (Folegatti et al., 2020). As for adverse events, this information was collected from patients’ electronic diaries and included anticipated reactions at the site of injection and general flu-like symptoms (Folegatti et al., 2020). Notably, patient-reported information involves the risks of recall bias and poor adherence in terms of data entry recommendations (Friis & Sellers, 2021). Thus, the selected methods may vary in terms of data accuracy.
Outcome Measures
Among the outcome measures were COVID-19 incidence statistics, antibody responses, and adverse effects. The percentage of participants developing antibody levels sufficient to promote immunity against the infection was measured along with adverse event statistics (Sandoiu, 2020). Outcome data analysis and interpretation procedures were focused on summarizing the new vaccine’s safety and immunogenicity profiles, thus providing the rationale for implementing the next phases of the research program.
Results/Conclusions
The results indicate the Oxford vaccine’s safety for use in human research subjects and the ability to elicit antibody responses without substantial risks of adverse events. Almost all (91%) patients in the Oxford vaccine group developed COVID-19-neutralizing antibodies within a 14-day timeframe (Sandoiu, 2020). In the group receiving two doses, antibodies appeared in all participants. COVID-19 cases and serious adverse effects were not reported, but mild effects, including muscle ache, headache, and chills, were more widespread in the intervention group compared to controls (Sandoiu, 2020). However, most of the effects could be effectively reduced by taking paracetamol (Sandoiu, 2020). RCTs’ high costs in terms of time and financial expenditures require large projects to have strong rationales (Hariton & Locascio, 2018). The findings above supported the conclusion regarding the candidate vaccine’s safety and the feasibility of further evaluations with larger samples.
Ethical Issues
As standard choices for researching treatments’ effectiveness, RCTs might involve ethical issues. Sandoiu (2020) does not mention specific ethics-related concerns in her review. There have been previous trials of the candidate vaccine in non-human animals to make sure that the vaccine will not produce long-term harmful outcomes (Folegatti et al., 2020). The discussed trial used the MenACWY vaccine as an active placebo to improve participant masking, but the participants’ intake of paracetamol to prevent side effects might have concealed the true picture of adverse events (Oliveira & Paumgartten, 2021). Paracetamol use can be problematic from diverse points of view. On the one hand, the research group’s refusal to administer it would result in human subjects’ greater physical suffering, which runs counter to the principle of beneficence. On the other hand, pain relief medications could have distorted the information by painting the post-vaccination period in the best light. Potentially, such issues might result in the dissemination of incomplete information about new treatments’ side effects.
Conclusion
Finally, the RCT reports evidence in favor of the Oxford vaccine’s effectiveness, thus justifying the need for further studies. To consider the audience’s knowledge levels, the chosen article summarizes the RCT very briefly, without close attention to the details of data collection or ethical considerations. However, the dilemma of adverse effect data accuracy versus relieving any negative effects affecting the participants could be relevant to the case.
References
Folegatti, P. M., Ewer, K. J., Aley, P. K., Angus, B., Becker, S., Belij-Rammerstorfer, S., Bellamy, D., Bibi, S., Bittaye, M., Clutterbuck, E. A., Dold, C., Faust, S. N., Finn, A., Flaxman, A. L., Hallis, B., Heath, P., Jenkin, D., Lazarus, R., Makinson, R.,… Hamlyn, J. (2020). Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: A preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet, 396(10249), 467-478.
Friis, R. H., & Sellers, T. (2021). Epidemiology for public health practice (6th ed.). Jones & Bartlett Learning.
Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials: The gold standard for effectiveness research. BJOG: An International Journal of Obstetrics and Gynaecology, 125(13), 1-4.
Oliveira, A. C. A. X. D., & Paumgartten, F. J. R. (2021). Ethical issues in placebo-controlled trials of COVID-19 vaccines. Cadernos de Saúde Pública, 37, 1-4.
Sandoiu, A. (2020). Hopeful COVID-19 research: Not one but two vaccines show promise. Medical News Today.