Clinical studies at NYU Langone’s Vaccine Center lead to impactful results. Below we’ve compiled result summaries from a collection of our most important discoveries.

JYNNEOS Vaccine: A Study on Mpox Immunity

Mark J. Mulligan, MD and Angelica Cifuentes Kottkamp, MD, initiated the NYC Observational Study of Mpox Immunity (OSMI) at NYU Langone Vaccine Center in response to the 2022 mpox outbreak and JYNNEOS vaccine shortage. The study evaluates the immune response of JYNNEOS vaccinations in populations with diverse health backgrounds. Initial results indicate that antibody titers post-vaccination were similar, regardless of the administration route or HIV status, but booster shots might be needed for long-term immunity.

Read more about the results of this study in the The New England Journal of Medicine. Results of this study are also discussed in HealthDay, Business Insider, and Medpage Today.

Vaccine Equity: Lessons Learned Exploring Facilitators and Barriers to COVID‑19 Vaccination in Urban Black Communities

The Vaccine Center’s sites at NYU Langone Hospital—Brooklyn conducted a study to assess knowledge and attitudes toward COVID-19 vaccination focusing on trust or discrimination among Black individuals in Brooklyn, which, in the first few months of the pandemic, experienced more COVID-19-related deaths than any other urban location in the United States.

Read more about the results of this study in the Journal of Racial and Ethnic Health Disparities.

Bivalent Boosts: The COVID-19 Variant Immunologic Landscape Trial (COVAIL)

The Vaccine Center’s sites at NYU Langone Hospital—Long Island and 660 First Avenue participated in the NIAID–funded “COVAIL” trial. The trial evaluated various additional COVID-19 booster shots. The trial aimed to understand if different vaccine regimens—prototype and variant vaccines alone and in combinations—can broaden immune responses in adults who already have received a primary vaccination series and a first booster shot.

Read more about the results of this study in NPJ Vaccines, Clinical Infectious Diseases, and Research Square.

Heterologous Prime Boosts: The “Mix and Match” Study

The Vaccine Center’s sites at NYU Langone Hospital—Long Island and Bellevue participated in the National Institutes of Health–funded “Mix and Match” study—a SARS-CoV-2 vaccine booster trial—the results of which directly influenced Centers for Disease Control and Prevention (CDC) guidelines on COVID-19 booster vaccines.

Read more about the results of this study in The New England Journal of Medicine, Cell Report Medicine, and NPJ Vaccines.

SARS-CoV-2 Vaccines in Pregnancy and Postpartum: The MOMI-VAX Study

The Vaccine Center sites at 660 First Avenue and NYU Langone Hospital—Brooklyn participated in an observational study to evaluate the development and durability of COVID-19 antibodies in individuals who receive, or who already have received, a COVID-19 vaccine while pregnant or during the first two months postpartum. Additionally, the study assessed the transfer of antibodies to infants across the placenta and through breast milk. The results from this study showed that COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses as well as transplacental antibody transfer to the newborn.

Read more about the results of this study in Vaccine.

Prior History of COVID-19 Influences Adaptive Immune Responses to mRNA Vaccination

Teams working with Ramin Herati, MD , and Mark J. Mulligan, MD , compared the COVID-19 vaccine immune responses of participants who had experienced COVID-19 infection to those who did not. Their work stressed the relevance of immunological history for understanding COVID-19 vaccine immune responses and has important implications for personalizing mRNA vaccination regimens and the deployment of booster shots.

Read more about this study in Science Translational Medicine. Read more about Dr. Mulligan and Dr. Herati’s related work.

AZD1222 COVID-19 Vaccine Trial

Our five sites (660 First Avenue in Manhattan, NYU Langone Hospital—Brooklyn , NYU Langone Hospital—Long Island , NYC Health + Hospitals/Bellevue, and the VA NY Harbor Healthcare System ) participated in an international double-blind, randomized, placebo-controlled phase 3 clinical trial to investigate vaccine efficacy and immunogenicity of the two-dose AZD1222 COVID-19 vaccine.

Read more from our study in The New England Journal of Medicine on how the data from this trial demonstrated that AZD1222 was safe and efficacious in preventing COVID-19 in large, diverse, at-risk populations, as well as the most recent results published in the Journal of Clinical Investigation, that demonstrates the durability of its protection.

Pfizer–BioNTech mRNA Vaccine Trials

The Vaccine Center was the sentinel site of this trial, enrolling the first phase 1 study participant to receive experimental Pfizer–BioNTech messenger RNA (mRNA) to prevent SARS-CoV-2 infection. The Vaccine Center has since continued to participate in phase 2/3 trials with Pfizer and has been recruiting participants to study booster doses.

Read an interview with our first phase 1 Pfizer–BioNTech participant , who reflects on her experience two years later.

Read our paper in Nature describing the Pfizer–BioNTech vaccine trial .

VIDEO: Infectious diseases expert Dr. Mark J. Mulligan discusses the phase 2/3 clinical trial that tests the efficacy of a COVID-19 vaccine candidate.

The Neutralizing Antibody LY-CoV555 Treatment Against SARS-CoV-2 Infection

In Spring 2020, the labs of Dr. Mulligan and Meike Dittmann, PhD, helped support Eli Lilly in the search for new promising therapeutic options for individuals with COVID-19 by testing their monoclonal antibodies candidates against live virus in vitro. A few weeks later, the Vaccine Center enrolled the first participant in a phase 1 clinical trial to test LY-CoV555 , a monoclonal antibody designed to treat patients hospitalized due to infection with SARS-CoV-2.

Read more about this work in Science Translational Medicine.

REGEN-COV Antibody Trial to Prevent Covid-19

Our team at 660 First Avenue participated in a trial assessing the efficacy and safety of the combination of monoclonal antibodies casirivimab and imdevimab to prevent SARS-CoV-2 infection in people who had household contact with individuals with a positive SARS-CoV-2 RT-PCR. The study showed that the treatment prevented symptomatic COVID-19 and asymptomatic SARS-CoV-2 infection and reduced the duration of symptomatic disease among participants who became infected.

Read more about this study in JAMA Network and in The New England Journal of Medicine.