How Sites Can Prepare for COVID-19 Genetically Engineered Vaccine Studies

The global pandemic caused by the coronavirus (SARS-CoV-2) and the disease it causes (COVID-19) has brought vaccine research to the forefront. Currently available genetic engineering techniques and the available SARS-CoV-2 genome sequence provide a wealth of opportunities for research and development of new vaccines. In fact, the most prominent vaccine candidates contain engineered genetic material.

Sources: LiveScience, BioSpace, BioPharma Dive, Pfizer, CureVac, Johnson & Johnson, EndPoint News (1), EndPoint News (2), Endpoint News (3), Reuters

In particular, these candidates work with the gene encoding the virus’ spike protein. This approach is comparable to a subunit vaccine in the sense that the vaccine only delivers the key target antigen for the immune system to attack without the added risk associated of utilizing an attenuated or killed coronavirus.

Clinical researchers are likely familiar with the regulatory requirements pertaining to the Food and Drug Administration (FDA) phases of research, as well as with institutional review board (IRB) review. But they may not be aware that research involving investigational products containing engineered genetic material may also require review by an institutional biosafety committee (IBC).

Why IBC Review?

National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) provide the standard for oversight of research involving genetic engineering and gene therapy. NIH Guidelines are promulgated by the NIH Office of Science Policy (OSP) and call for local oversight at the research site by an IBC that reports to the NIH OSP. IBCs are charged with protecting study personnel, the community, and the environment from exposure to engineered genetic material. An IBC may also advise the IRB to aid in assessing risks to the study participants. (For more information on IRB and IBC responsibilities, check out our blog IBC vs IRB: What’s the Difference?)

The requirement for IBC review applies to gene therapy research at sites that receive funding from the NIH or that have ever participated in NIH-funded research. Sponsors or sites that have received any NIH funding are obligated to comply with IBC review regardless of whether the funding is associated with the gene therapy study. In cases where the agency did not provide monetary support, IBC review can still be required if the NIH collaborated in the research of the study agent or provided materials for its development, as stated in NIH Guidelines Section I-C-1-a-(2).

Even if there are truly zero NIH funds or collaboration involved, IBC review is considered a best practice: “Individuals, corporations, and institutions not otherwise covered by the NIH Guidelines are encouraged to adhere to the standards and procedures set forth in Sections I through IV” (Section IV-D-1).

What Should Sites Do to Prepare?

The best way a site can prepare to participate in genetically engineered vaccine studies (or any gene therapy studies) is to register an IBC with the NIH and become familiar with the basic requirements for IBC review. Each site’s IBC must first register with the NIH OSP before convening a meeting or issuing an approval. The NIH OSP will review the qualifications of the proposed committee members to confirm the IBC meets the requirements set forth in NIH Guidelines. As NIH OSP review of a site’s IBC registration may take 4-6 weeks, sites can compress timelines by registering their IBCs well in advance of having a new study ready for IBC review. This way sites are ready to start the IBC review process immediately, staying one step ahead of their less proactive colleagues. Furthermore, sites with registered IBCs already in place may choose to position themselves as “gene therapy ready” to be more attractive to sponsors and contract research organizations (CROs) during the site selection process.

Keep in mind there is no cost to register an IBC with the NIH. Research sites that do not already have access to an IBC may consider relying on a commercial IBC (such as Advarra). Additionally, pharmaceutical companies and CROs conducting multisite clinical trials may benefit from efficiencies provided by centrally administered IBC reviews, utilizing a model similar to central IRB reviews.

Advarra is honored to provide IBC and IRB oversight for the majority of COVID-19 research being conducted in the US. Advarra offers centralized or externally administered IBC review services and can submit site IBC registrations to the NIH on the site’s behalf. If you’d like to know more about preparing for genetic vaccine and gene therapy studies, contact us.

Note: This article was updated on April 24, 2020, April 28, 2020, and April 30, 2020 to include additional vaccine trials and updated trial information.

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