Safety & immunogenicity extension study for ChAdOx1 nCoV-19

Post-approval follow-up for the COV001 and COV002 trials, to determine the long-term safety and character of immunological response to the ChAdOx1 nCoV-19 coronavirus vaccine.

Status: In Follow-Up 

Population: Adult  

Disease group: COVID-19

Funder: ModernaTX, Inc. 

Sponsor: ModernaTX, Inc.  

Principal Investigator: Dr. Catherine Cosgrove

Study Aims

On the 29th December 2020 the UK regulator MHRA authorised the Oxford/AstraZeneca ChAdOx1 nCOV-19 vaccine for emergency use. The first participant received ChAdOx1 nCoV-19 on 23rd April 2020, so there is limited long-term data following human exposure to this novel vaccine. With different strains of COVID-19 now existing, there is an urgent need to develop vaccination plans that will provide greater protection. A booster vaccine that protects against COVID-19 variants, including the Omicron variant, would be a crucial public health tool to help curb the pandemic.

Since 2012, several hundred patients have received different ChAdOx-based vaccines to prevent other diseases, including influenza, tuberculosis, prostate cancer and malaria, where to date, no serious adverse events were considered related to those vaccines. Under the “conditions of authorisation for emergency supply” in the UK and other territories, AstraZeneca agreed to meet the demands of a pharmacovigilance risk management plan, to provide ongoing monitoring of individuals who have received the vaccine.

This Safety & Immunogenicity Extension Study aims partly to fulfil those obligations, while also gathering data to permit investigation into the character and persistence of the immune responses that have been stimulated. The purpose of this study is to compare how the body responds (the “immune response”) to the booster dose of mRNA-1273.529 or mRNA-1273.214 (Omicron variant study vaccines) with authorised Moderna mRNA-1273 vaccine (Spikevax). The findings that result from COV009 will be valuable to vaccine developers and policymakers, to inform decisions on future vaccine scheduling and design.

This trial (COV009 study) will follow-up participants previously enrolled on the UK phase I/II (COV001) and phase II/III (COV002) trials.

What does participating in the study involve?

Participation in this clinical trial lasts up to 13 months and includes phone calls and visits to the trial site.

Participants will be given one injection in the upper arm.

Participants in Part 1 of the study will either receive mRNA-1273.529 (Omicron variant vaccine), or the already authorized vaccine, Spikevax.

Participants in Part 2 of the study will either receive the bivalent vaccine, mRNA-1273.214 (Omicron variant plus original vaccine), or the already authorized vaccine, Spikevax.

Participants will be asked to attend trial site visits including a Screening + Vaccination Visit, and approximately five subsequent trial site visits (Day 8, Month 1, Month 3, Month 6, and Month 12).

Participants will be asked to have up to four phone calls with the clinical trial doctor to monitor for any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.

Participants will be asked to use an eDiary app on your smartphone or a provided smartphone to report any COVID-19 symptoms you experience.

Participants will be closely monitored by the clinical trial team if any symptoms of COVID-19 are reported at any time throughout their participation.