ReCAP is a series of interviews with the members of the RBDCOV Community Advisory Panel that will explore the world of community engagement, EU projects and the importance of including people living with immunocompromising conditions in clinical trials.
Today, we bring you the third and last part of this interesting conversation with Siegfried Schwarze, EATG member and member of the Community Advisory Panel for the RBDCOV project.
What type of vaccine is the RBDCOV project developing in their clinical trials and what could the benefits be for people with immunocompromising conditions?
The aim of the RBDCOV project is to develop a recombinant protein vaccine against the SARS-CoV-2-virus. Some benefits of these types of vaccines for people with immunocompromising conditions are:
- Protection: Individuals with weakened immune systems may not face infections as effectively as those with robust immune responses. A vaccine can provide an additional layer of defense, even if the response may be less robust than in individuals without prior health conditions.
- Reduced Severity: Even if a person living with immunocompromising conditions gets infected with a virus after vaccination, the severity of the consequences may be reduced.
- Herd Immunity: By vaccinating a broader population, we create a protective barrier around those who might be more vulnerable to infections, including people living with immunocompromising conditions. The more people we vaccinate, the more challenging it becomes for a virus to spread.
- Special Formulations: Some vaccines are specifically developed for people living with immunocompromising conditions. These formulations often avoid live attenuated versions (which can sometimes pose a risk to those with weakened immune systems) in favor of inactivated or recombinant versions.
How does research for new vaccines contribute to improving the effectiveness and accessibility of vaccines for individuals living with HIV?
Research for new vaccines, even if not directly targeted at HIV, can have positive implications for individuals living with HIV in several ways:
- Better Adjuvants and Formulations: As vaccine research advances, it leads to the development of better adjuvants (ingredients that enhance the body’s immune response to a vaccine) and formulations. These advancements can be particularly beneficial for people living with immunocompromising conditions, including those living with HIV, who might need stronger or more targeted immune responses.
- Tailored Vaccines for people living with immunocompromising conditions: Through research, vaccines can be designed specifically for populations with weaker immune responses, ensuring they are both effective and safe for people living with HIV.
- Reduction in Co-Infections: Individuals living with HIV are at higher risk for other infections, such as tuberculosis or certain types of pneumonia. The development of effective vaccines to tackle these diseases can significantly reduce the morbidity and mortality in the HIV-positive population.
- Improved Vaccine Accessibility: As research leads to the production of vaccines that are more heat-stable, or that require fewer doses, or no cold chain, it enhances the accessibility of these vaccines in regions where HIV prevalence is high, and resources may be limited.
- Innovative Delivery Mechanisms: Research might lead to vaccines that can be administered through routes other than injections, such as nasal sprays or oral doses. These methods can be beneficial in areas with limited medical infrastructure and can also improve vaccination rates.
- Cross-Protective Immunity: Sometimes, the immune response triggered by a vaccine for one pathogen can offer some level of protection against another, even if not directly targeted. Such cross-reactive immunity could be of potential benefit to people living with HIV, reducing their vulnerability to certain diseases.
- Direct HIV Vaccine Research: Of course, direct research towards an HIV vaccine has been ongoing for decades. Even if a fully effective vaccine for HIV is nowhere in sight, the knowledge gained from such research efforts informs vaccine strategies for other diseases and advances the broader field of immunology.
- Cost Reduction: As vaccine research advances, newer manufacturing techniques and economies of scale might reduce the cost of vaccine production, making them more affordable in areas hit hardest by HIV.
- Strengthened Healthcare Infrastructure: The infrastructure built for vaccine research, such as clinical trial networks, laboratories, and trained personnel, can be leveraged for the benefit of HIV care and treatment.
- Community Engagement: Vaccine research often involves community education and engagement, which can help debunk myths about both vaccines and HIV, leading to better health outcomes and reduced stigma.
In essence, advancements in vaccine research not only provide direct benefits in terms of protection from diseases but also indirectly support the well-being of individuals living with HIV.
How does the inclusion of people living with immunocompromising conditions in clinical trials for new vaccines help ensure their safety and efficacy in this specific population?
Including people living with immunocompromising conditions in clinical trials for new vaccines is crucial for several reasons:
- Specific Efficacy Data: The primary goal of clinical trials is to assess the efficacy of a vaccine. People living with immunocompromising conditions may not respond to vaccines in the same way as the general population. Including them in trials ensures that the vaccine’s efficacy is directly tested in this group, allowing for a clearer understanding of its protective benefits.
- Safety Assessment: While vaccines undergo rigorous testing for safety in the general population, specific side effects or reactions may be more prevalent or unique in people living with immunocompromising conditions. By including them in trials, researchers can identify and address any safety concerns that might arise.
- Dosage and Scheduling: People living with immunocompromising conditions might require different dosages or vaccine schedules to achieve optimal immunity. Clinical trials can help determine the best regimen for this specific population group.
- Potential Interactions: People living with immunocompromising conditions often take medications, such as immunosuppressants. Clinical trials can detect any potential interactions between the vaccine and these medications, ensuring that the vaccine remains both effective and safe.
- Strengthening Public Trust: Knowing that a vaccine has been tested specifically in people living with immunocompromising conditions can improve trust among this group and their healthcare providers. This can lead to higher vaccination rates and better overall protection.
- Ethical Considerations: Excluding people living with immunocompromising conditions from clinical trials could deny them the potential benefits of participation, such as early access to a working vaccine. Ethically, all groups should have an opportunity to participate in research.
- Guidance for Healthcare Providers: Detailed data from clinical trials that include participants living with immunocompromising conditions can guide physicians and healthcare providers in making informed decisions about vaccination for their patients.
- Tailored Recommendations: Based on the results from these clinical trials, health organisations can make specific recommendations or guidelines for vaccinating people living with immunocompromising conditions, ensuring optimal outcomes.
- Broader Understanding of Immune Responses: Studying vaccine responses in people living with immunocompromising conditions can provide valuable insights about the human immune system, potentially leading to advancements in other areas of medicine.
Including people living with immunocompromising conditions in clinical trials ensures that vaccines are not only generalised for the broader population but also tailored to the specific needs and challenges faced by those with weakened immune systems. This approach is a cornerstone of personalised medicine, ensuring that all individuals, regardless of their health status, receive optimal care and protection.
Disclaimer: This activity was developed under the RBDCOV Project, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101046118.