Phase 2 Trial of Oxford COVID-19 Vaccine in Older Adults Finds It Is Safe
Robust antibody and T-cell response seen in older adults is encouraging
The UK's vaccine against SARS-CoV-2 shows similar safety and immunogenicity results in healthy older adults (aged 56 years and over) to those seen in adults aged 18-55 years. The promising early stage results are published in The Lancet.
The phase 2 trial finds that the vaccine causes few side effects, and induces immune responses in both parts of the immune system in all age groups and at low and standard dose—provoking a T cell response within 14 days of the first dose of vaccination (i.e., a cellular immune response, it could find and attack cells infected with the virus), and an antibody response within 28 days of the booster dose of vaccination (i.e., humoral immune response, it could find and attack the virus when it was circulating in the blood or lymphatic system).
Phase 3 trials are ongoing to confirm these results—as well as how effective the vaccine is in protecting against infection with SARS-CoV-2 in a broader range of people, including older adults with underlying health conditions.
Study lead author professor Andrew Pollard, University of Oxford, UK, says: "Immune responses from vaccines are often lessened in older adults because the immune system gradually deteriorates with age, which also leaves older adults more susceptible to infections. As a result, it is crucial that COVID-19 vaccines are tested in this group who are also a priority group for immunization."
Co-author Dr. Maheshi Ramasamy, University of Oxford, UK, adds: "The robust antibody and T-cell responses seen in older people in our study are encouraging. The populations at greatest risk of serious COVID-19 disease include people with existing health conditions and older adults. We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure."
Related Article: Early Analysis Finds Moderna's COVID-19 Vaccine Is 94.5 Percent Effective
The new study is the fifth published clinical trial of a vaccine against SARS-CoV-2 tested in an older adult population. Other COVID-19 vaccines have also been shown to generate immune responses in older adults, but it can be difficult to compare results between different studies. One study has shown similar immune responses in young and old adults (Moderna mRNA vaccine), while other trials have suggested lower measured responses in older adults, compared to younger adults receiving the same vaccine (CanSino single dose adenovirus-vector vaccine, Pfizer/BioNTech mRNA vaccine, and SinoPharm/Beijing Institute of Biological Products inactivated viral vaccine).
In the phase 2 trial published today, 560 participants (160 aged 18-55 years, 160 aged 56-69 years, and 240 aged 70 or over) were split into 10 groups where they received either the ChAdOx1 nCoV-19 vaccine at a low or standard dose, or a control vaccine (the meningococcal conjugate vaccine). Participants aged over 55 years were also split into groups and either given a single dose of vaccine, or two doses 28 days apart.
Adverse reactions to the ChAdOx1 nCoV-19 vaccine were mild (the most common effects were injection-site pain and tenderness, fatigue, headache, feverishness, and muscle pain), but more common than seen with the control vaccine. Thirteen serious adverse events occurred in the six months since the first dose was given, none of which were related to either study vaccine.
The COVID-19 vaccine had similar immunogenicity across all age groups after a boost dose.
The ChAdOx1 nCoV-19 vaccine induced antibodies against the SARS-CoV-2 spike protein and receptor binding domain 28 days after a single low or standard dose across all age groups. Following the booster dose of the vaccine, antibody levels increased at day 56 of the trial, irrespective of dose or participant age. The same was seen with levels of neutralizing antibodies at day 42, two weeks after the booster vaccine dose. By 14 days after the boost dose, 208 of 209 (more than 99%) participants (selected from participants of all ages and doses) had neutralizing antibody responses.
T cell responses against the SARS-CoV-2 spike protein peaked 14 days after first vaccination, regardless of age and low or standard vaccine dose.
The authors note some limitations to their study, including that the participants in the oldest age group had an average age of 73-74 years and few underlying health conditions, so may not be representative of the general older population, including those living in residential care settings or over 80 years of age. Larger studies are now underway to evaluate immunogenicity, safety, and efficacy in older adults with a wider range of comorbidities. Lastly, the authors note that almost all participants of all ages were white and non-smokers, and may not be representative of the general population, but people from a range of backgrounds, countries, and ethnicities are being included in the phase 3 trial of this vaccine.
- This press release was provided by The Lancet