University of Birmingham in clinical trial of COVID-19 booster vaccines

Six COVID-19 vaccines are safe and boost the immunity of people who have received two doses of Pfizer / BioNTech or Oxford / AstraZeneca, results from a UK-wide trial conducted in collaboration with the ‘University of Birmingham.

The latest results of the first global COV-BOOST study are Posted in The Lancet and played a key role in shaping the UK booster program, providing vital evidence to the global immunization efforts. The trial examined the safety, side effects and immune response of seven vaccines when used as a third booster injection.

Trial participants received one of these boosters 10 to 12 weeks after their initial two-dose vaccination with the Oxford / AstraZeneca or Pfizer / BioNTech vaccines. A control group received a meningitis vaccine to account for non-specific reactions to COVID-19 jabs. [1]

The seven vaccines tested were:

  1. Oxford / AstraZeneca
  2. Pfizer / BioNTech
  3. Modern
  4. Novavax
  5. Valneva
  6. Janssen
  7. CureVac

Of these, only the Oxford / AstraZeneca, Pfizer / BioNTech, Moderna and Janssen vaccines are currently authorized for use in the UK. Half doses of Pfizer / BioNtech, Novavax and Valneva have also been tested.

Led by the University Hospital Southampton NHS Foundation Trust (UHS), the trial recruited more than 2,800 participants aged 30 or older through sites supported by the National Institute for Health Research (NIHR), including one co-hosted by the University of Birmingham and Birmingham University Hospitals NHS Trust Foundation.

Professor Saul Faust, director of the trial and director of the NIHR Clinical Research Center at UHS, said: “Our side effect data shows that all seven vaccines can be used safely as a third dose, with acceptable levels. of “reactogenicity” – inflammatory side effects such as pain at the injection site, muscle soreness, fatigue. The seven peak anti-protein antibody levels increased significantly after two doses of the Oxford / AstraZeneca vaccine. However, only six also did so after two doses of Pfizer / BioNTech (Oxford / AstraZeneca, Pfizer / BioNTech, Moderna, Novavax, Janssen and CureVac). There was also great variation in the response with different boosters. It is really encouraging that a wide variety of vaccines, using different technologies, have advantages as a booster dose for either of these vaccines. This gives confidence and flexibility in developing recall programs here and around the world, with other factors like supply chain and logistics also at play. ”

Dr Christopher Green, Senior Clinical Lecturer at the University of Birmingham and Consultant Infectious Disease Physician at Birmingham University Hospitals NHS Foundation Trust, said: ‘We are extremely pleased to have played our part in how the vaccine research can respond quickly to public needs during this pandemic. The Wes Midlands public members of the public who participated in this trial, as well as the many other vaccine trials we have conducted, deserve special thanks for joining and supporting our team of researchers, and these trials are so important that we hope to stay one step ahead of the virus.

The study found that there were large differences in peak protein antibody levels after 28 days between vaccines. In people who received two initial doses of the Oxford / AstraZeneca vaccine, these ranged from 1.8 times to 32.3 times more with different booster vaccines. For those who had initially received the Pfizer / BioNTech vaccine, the range was 1.3 times higher to 11.5 times higher. The results of the booster were similar for people aged 30 to 69 and those aged 70 or older.

The study also looked at immune responses of T cells. T cells are likely to play an important role in controlling disease severity, although their impact on the overall protection or longevity of immunity is not. not yet known. COV-BOOST reported T cell responses in several combinations of initial and booster vaccines, but these were not predictable based on peak anti-protein antibody levels.

Reactions to the seven vaccines were similar, with fatigue, headache, and pain at the injection site most commonly reported. These were more frequently reported by people aged 30 to 69. 912 of the 2,878 participants experienced a total of 1036 adverse events, of which only 24 were serious.

Professor Faust added: “It is important to note two things about these results. First, they only relate to these vaccines as a booster to the two primary vaccinations, and not to their effectiveness as the first and second doses. Second, the data describes the immune response at 28 days, not the effectiveness of the vaccine. The relationship between this response and long-term protection is still poorly understood. We will look at longer-term immune responses in COV-BOOST, performing further testing three months and one year after receiving boosters. We are also investigating whether a longer period between the second and third dose improves the response to the two booster vaccines. Several studies have shown this effect between the first and second dose. We did this by giving some of our original control participants the recall at a later stage, and we expect those results to be available in the new year. “

Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Program, said: “As winter approaches, and due to the emergence of Omicron, the results of COV-BOOST are extremely timely and valuable. national and international importance. Since the start of the pandemic, the NIHR and NHS have been supported by the efforts and altruism of study participants – helping us identify the most effective vaccines and how they can be flexibly used to further protect of people. We welcome the latest study results and continue to support the COV-BOOST team with further analysis of the data that will help us understand the use of these vaccines as long-term boosters. “
COV-BOOST was designed so that stored samples could be used to assess the effectiveness of these vaccines in neutralizing any new variant of concern, and COV-BOOST samples were made available to UKHSA for testing against omicron .

Notes to Editors:

  • [1] The MenACWY vaccine was used because it can cause minor side effects similar to ChAd and BNT, such as arm pain, headache, and fever. A saline solution – which is often used as a control – does not cause any side effects.
  • For interviews with Dr Chris Green, please contact Emma McKinney (Media Relations Officer, University of Birmingham).
  • Media inquiries regarding immunization policies as a result of the study results should be directed to the press office of the Ministry of Health and Social Affairs by calling 0207 972 3272.
  • Munro et al (December 2021). “Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) after two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a phase 2, multicenter, randomized, controlled and blindly “. The Lancet. DOI: 10.1016 / S0140-6736 (21) 02717-3
  • This study was funded by the UK Vaccine Taskforce and the National Institute for Health Research.
  • The University of Birmingham is ranked among the top 100 institutions in the world and its work brings people from all over the world to Birmingham, including researchers and teachers and over 6,500 international students from almost 150 countries.
  • The mission of National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
  1. Fund high quality and timely research that benefits the NHS, public health and social services;
  2. Invest in world-class expertise, facilities and a skilled workforce to translate findings into improved treatments and services;
  3. Collaborate with patients, service users, caregivers and communities, improving the relevance, quality and impact of our research;
  4. Attract, train and support the best researchers to tackle complex challenges in health and social care;
  5. Collaborate with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
  6. Funding for applied global health research and training to meet the needs of the poorest people in low- and middle-income countries.
  7. NIHR is funded by the Department of Health and Social Affairs. Its work in low and middle income countries is primarily funded by UK Aid from the UK government.
  • The Vaccines Taskforce (VTF) is a joint unit of the Directorate of Economic, Energy and Industrial Strategy (BEIS) and the Directorate of Health and Social Action (DHSC). The VTF was created to ensure the UK population has access to clinically effective and safe vaccines as soon as possible, while working with partners to support international access to effective vaccines. The Vaccine Task Force includes a dedicated team of industry professionals from the private sector and officials from across government who are working quickly to build a portfolio of promising vaccine candidates that can end the global pandemic. The approach of the working group on vaccines to secure access to vaccines involves:
  1. obtain the rights to a diverse range of promising vaccine candidates to spread the risks and optimize the chances of success
  2. provide funding for clinical studies, diagnostic oversight and regulatory support to rapidly assess the safety and efficacy of vaccines
  3. providing funding and support for large scale manufacturing, filling and finishing at risk so that the UK has vaccines produced on a large scale and ready for administration if any of them prove to be effective

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