Antivirals and Vaccines Research

The mission of the Yale Antivirals and Vaccines Research Program (formerly the Yale HIV Clinical Trials Program), directed by Dr Onyema Ogbuagu, is to advance novel and innovative therapeutics and therapeutic strategies for HIV treatment and prevention as well as vaccines for infectious diseases. Established in 1993, and formerly known as the Yale HIV Clinical Trials Program, the Yale Antivirals and Vaccines Research Program is an independently functioning unit that is comprised of highly experienced physician investigators drawn primarily from Infectious diseases faculty at the Yale School of Medicine (YSM), research nurses and coordinators, regulatory and other research staff from YSM, who are passionate about novel breakthrough therapies and prophylactics for people affected by infectious diseases, including HIV. Innovation, participant safety and diversity, compassionate care and strict adherence to human subjects’ protection and good clinical practice tenets comprise the core values of our team. Our clinical trials and research have helped lead to regulatory approvals of many novel therapeutics and vaccines.

The Yale Antivirals and Vaccines Research Program aims to:

1. Evaluate and advance novel therapeutics or therapeutic strategies and prophylactics to people living with HIV or those with (or at risk for) other infectious diseases.
2. Foster and facilitate participation and collaboration by Yale investigators with international and national clinical research and clinical trial networks as well as external industry partners, to advance phase 1-4 clinical trials for therapeutics and vaccines, or related translational and clinical research that may be investigator –initiated or industry-supported.
3. Provide hands-on training, mentorship and research opportunities to a variety of trainees (ranging from post-baccalaureate, medical students and residents to Infectious Diseases fellows) who are interested in learning about conducting clinical trials, clinical pharmacology including pharmacokinetics, novel antivirals, vaccines, and other therapeutics for infectious diseases.

Faculty investigators within the Yale Antivirals and Vaccines Research Program provide clinical care at the outpatient Yale-New Haven hospital Nathan Smith HIV Clinic and/or the inpatient Donaldson Firm of the Yale-New Haven Hospital. Clinical trials are conducted in and research participants are recruited from these sites.

Historically, the program primarily focused on HIV prevention and treatment, which is our niche area, but, recent emerging infections and pandemics along with novel vaccine technologies (including mRNA platforms) have inspired the expansion to vaccine trials which now include vaccines to prevent SARS CoV-2, RSV, Influenza and bacterial vaccines (E coli). Ongoing clinical trials and research activity by our faculty and investigators showcase their varied interests and expertise, and include numerous global and national grant-funded and industry-sponsored projects as described below:

International/Domestic:

• Global Health capacity building projects and research training (Liberia, Rwanda)
• NIAID funded study on HIV PrEP for adolescent girls and young women in Liberia
• Novel therapies for HIV PrEP for high-risk sexual minority populations
• Patient reported outcomes and health care utilization assessment for people with HIV on various antiviral or monoclonal antibody treatments
• Immunologic studies including vaccine responses among PWH
• HIV and cancer studies

Clinical Trials:

• Trials of long-acting injectables for HIV prevention and treatment
• Growing repertoire of vaccine trials for infectious diseases (including mRNA and protein-based vaccine platforms) for multiple infectious diseases such as prevalent bacterial infections (E. coli) and viral infections (e.g. SARS-CoV-2, RSV and Influenza).
• Novel antiviral studies for hospitalized and non-hospitalized patients with COVID-19

The Yale Antivirals and Vaccine Research Program provides specialized and hands-on training in clinical investigation as well as research mentorship for undergraduates, medical students, residents, fellows and other trainees, including post-baccalaureate pre-medical students who are interested in learning about, participating and acquiring expertise in clinical research for novel therapeutics including trials for investigational agents. Some trainees have gone on to successful careers in pharmaceutical industry or integrate clinical investigation into their academic careers.