In A First, UK Launches Covid-19 Alternating Vaccine Study

Summary

• The UK has launched the world’s first alternating Covid-19 vaccine dose study.
• The trials will be supported by government funding to the tune of £7 million.
• Over 800 patients are likely to volunteer in the study at eight sites across England.

The United Kingdom launched the world’s first alternating Covid-19 vaccine dose study on Thursday under which the feasibility of different vaccine shots will be examined. Under the schema of study, individuals will be administered with AstraZeneca/Oxford University vaccine at the first instance followed by the Pfizer/BioNTech jab for the second dose.

Alternative vaccine study

The ongoing immunisation programme in the UK involves two vaccine doses from the same vaccine maker over the stretch of 12 weeks and will be unaltered. Separately the study will experiment with vaccines used one by one. The alternative Covid vaccine trials are supported by government funding to the tune of £7 million.

The alternative vaccine trials will be carried by the National Immunisation Schedule Evaluation Consortium (NISEC) across eight supported sites by the National Institute for Health Research (NIHR). The primary focus of the alternative Covid-19 vaccine study is to gauge the effects of administering different vaccines in the first and second dose to the same patient.

The patients and volunteers participating in the alternative vaccine study at a clinical stage are poised to receive different vaccines in either of the doses. The immunological evidence between the patients of mixed-vaccine regimen and the patients undergoing the same vaccine will be recorded at different intervals.

No changes in the ongoing drive

The healthcare officials have no plans to change the ongoing Covid-19 inoculation programme, which is following the same-dose regimen at the national level.

Any vulnerable patient, frontline worker, caregiver, or individuals of more than 70 years of age who have received the first jab will not be affected by the alternative vaccine study. Therefore, people will be receiving the second dose from the same vaccine maker of which they were given the first shot.

The alternative Covid vaccine study has received an approval from the drug regulator Medicines and Healthcare products Regulatory Agency (MHRA) and the ethics approval from the Research Ethics Committee. The impact of different dosing regimens on the immune responses of the patients will be monitored closely during the 13-month long alternative vaccine trials.

The NISEC is expected to share the initial findings of the clinical study in the summer. The government may consider the mixed-vaccine regimen structure for the upcoming vaccination programme if the study is proven to be safe according to the standards of the Joint Committee on Vaccination and Immunisation (JCVI).                                                  

Copyright © 2021 Kalkine Media Pty Ltd.

Study details

According to the prescribed framework, the study will only include eight arms testing eight different combinations at the initial level, however, more products are likely to be added at a later stage.

More than 800 patients are likely to volunteer in the study at eight different sites across England, including St George’s, and UCL in London, Oxford, Liverpool, Birmingham, Nottingham, Southampton, and Bristol.  The eight arms of the study, referred as Covid-19 Heterologous Prime Boost study or Com-Cov, includes two doses of AstraZeneca/Oxford vaccine at an interval of 28 days and, separately at 12 weeks apart and two doses of Pfizer/BioNTech vaccine at an interval of 28 days and, independently at 12 weeks apart.

• Other four arms comprise of different vaccines in either of the doses, administered individually at different intervals of 28 days and 12 weeks.
• For instance, patients would receive Oxford/AstraZeneca vaccine for the first dose and Pfizer/BioNTech vaccine for the second dose, separately at an interval of 28 days and 12 weeks.
• The combination will be interchanged in the rest two arms.
• The recruitment of patients and different volunteers in the study will be done over the course of February via the NHS COVID-19 Vaccine Research Registry.
• Volunteers willing to participate in the study can sign up on the NHS website.
• The inoculation process within the study is likely to begin towards the middle of the month.