As the coronavirus pandemic threatened the health and lives of people around the world, ICAP marshalled the resources of its two renowned research centers in New York City to fast-track critical research into the treatment and prevention of COVID-19.

Vaccine development was urgent, so ICAP teamed up with government and private partners to launch phase III clinical trials. In rapidly gearing up, ICAP’s Bronx Prevention Center and Harlem Prevention Center built on their long history of conducting world-class HIV and tuberculosis clinical trials, and ICAP’s deep community roots provided a ready pathway to volunteers for the testing. Located in multi-ethnic communities of New York City, these research centers also ensured a population diversity in the clinical trials that is essential for global distribution of a vaccine. “Different groups of people may have different responses to the same vaccine. It’s important that communities of color, who have historically been under represented in clinical trials, have the opportunity to participate in COVID-19 vaccine trials,” said Jessica Justman, MD, senior technical director at ICAP.

At the Bronx Prevention Center, under Justman’s leadership, ICAP participated in AstraZeneca’s Phase III double-blind, placebo-controlled study to assess the safety, efficacy and immunogenicity of the vaccine compared to a placebo. The vaccine is a recombinant form of an adenovirus which is unable to replicate. To bring the trial to adults throughout the community, ICAP connected with the Fred Hutchinson Cancer Research Center, a long-time partner, and collaborated with their outreach service vendor Metrix Medical Network to use mobile health clinics, increasing access to the investigational vaccines.

At its Harlem Prevention Center, ICAP participated in the massive ENSEMBLE study underway at over 200 clinical research sites in the United States and internationally. The trial involved more than 50,000 volunteers over age 18, with significant representation of people over the age of 60. Testing a single-dose vaccine in development by Janssen, a Johnson & Johnson company, this phase III trial offered the potential to significantly streamline future vaccination efforts. It was the only single-dose vaccine in development in the United States at the time.

Both the Bronx and Harlem Research Centers also participated in a study for Regeneron Pharmaceuticals to assess the safety and efficacy of a one-time subcutaneous infusion of monoclonal antibodies in preventing COVID-19 in household contacts of individuals infected with SARS-CoV-2. Dr. Ellen Morrison, the principal investigator of the Regeneron Study at ICAP, explained that household transmission fuels the COVID-19 epidemic. “This is particularly problematic for the multigenerational households living in the Bronx and Harlem,” she said. “Children attend school and the younger adults are the essential workers in our communities; unfortunately, this increases risk, especially for older members of the household.”

Testing proves what works and what doesn’t. Both research outcomes are critically important to ultimately reaching a solution. ICAP’s clinical trials contributed to findings that the AstroZeneca and Janssen vaccines were less promising than other vaccines in development by Moderna and Pfizer. Both of those vaccines, however, are mRNA vaccines – a relatively new technology that, until COVID-19, has never been widely deployed, licensed, or authorized for use. While countries around the world have moved forward with the Moderna and Pfizer vaccines to inoculate their people, currently planned production is only enough to vaccinate 11.5% of the world’s population in 2021. ICAP Global Director Wafaa El-Sadr has been an advocate for global health equity for over two decades, and she joined with two colleagues in a recent New York Times Op-Ed, to point out that unless vaccines still in the testing pipeline prove to have equal efficacy and can be quickly manufactured, then there may be critical shortages.

El-Sadr is calling for aggressive government action in the United States to increase manufacturing capacity of the high-quality vaccines that are already proven and to provide support for global distribution.  Reminding government leaders of the success of the President’s Emergency Plan for AIDS Relief (PEPFAR), which is estimated to have saved 19 million lives, El-Sadr and her colleagues are suggesting to President Biden that he can once again demonstrate what can be accomplished with generosity and partnership that builds on global health expertise.

With its network of partnerships with ministries of health in more than 30 countries, ICAP is at the ready to help drive the global distribution of COVID-19 vaccine to people who need this potentially lifesaving inoculation around the world.