IDCRC Launches Phase 1 Clinical Trial for Experimental Malaria Vaccine (LARC2 Study)

malaria

The Infectious Diseases Clinical Research Consortium (IDCRC) is excited to announce the launch of a Phase 1 clinical trial for an innovative malaria vaccine. This study aims to evaluate the safety, immunogenicity, and efficacy of the Sanaria® PfSPZ-LARC2 vaccine, which is a late-arresting, replication-competent, genetically attenuated form of Plasmodium falciparum, through controlled human malaria infection in malaria-naïve healthy adults. 

Malaria is caused by a parasite transmitted to humans through the bite of the Anopheles mosquito and continues to be a major public health issue. In 2023, there were an estimated 263 million cases worldwide, resulting in 597,000 reported deaths. Most cases reported in the United States are among travelers returning from sub-Saharan Africa and South Asia.

A highly effective vaccine is urgently needed to reduce the morbidity and mortality associated with this disease. Developing a successful vaccine could dramatically decrease the incidence of malaria and save countless lives. 

This clinical trial is a randomized, double-blind, placebo-controlled Phase 1 trial currently recruiting 22 healthy volunteers aged 18 to 45. Participants will be randomly assigned to receive either the experimental vaccine or a saline placebo injection. After receiving the vaccine or placebo, participants will be exposed to malaria in a controlled environment. Throughout the trial, participants will be closely monitored for any signs of malaria. If malaria is detected in their blood or if they exhibit symptoms, they will receive immediate treatment. This rigorous monitoring process ensures the safety and well-being of all participants.  

IDCRC leaders and study protocol chairs share the following on the launch of this study.

“The IDCRC Leadership Group is proud to support the investigative teams that are about to launch the LARC2 malaria vaccine and challenge study. This clinical trial represents a phenomenal team effort, and its results will provide crucial data on safety, immune responses, and protection from heterologous malaria challenge after receipt of the LARC2 vaccine. The world needs improved malaria vaccines, and we anticipate this trial will help us to move closer to that goal." —James Campbell, MD, MS; IDCRC Leadership Group vice chair;  professor, Department of Pediatrics, University of Maryland School of Medicine 

"More than 500,000 children die every year from malaria and therefore making a vaccine that is highly effective at preventing these infections is a major global goal. This vaccine study builds on decades of experience with early-arresting sporozoite vaccines and makes use of cutting-edge molecular technologies used to engineer this candidate product. Using the safe and effective human challenge model, we will be able to quickly evaluate the late-attenuated LARC2 sporozoite vaccine as we work to decipher the keys to anti-malarial immunity and to identify highly effective products that could change the way we fight malaria globally." —Sean Murphy, MD, PhD; co-protocol chair;  professor, Department of Laboratory Meedicine and Pathology, University of Washington 

“The University of Washington VTEU is thrilled to be preparing for the launch of the LARC2 malaria vaccine trial, contributing to the global fight against a disease that causes an estimated 250 million cases and 600,000 deaths each year. The LARC2 vaccine presents an opportunity to provide a high level of protection, representing a meaningful improvement over currently available vaccines.” — Scott McClelland, MD; co-protocol chair; professor of medicine (infectious disease), epidemiology, and global health, University of Washington 

The IDCRC is conducting the study in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. For details, visit ClinicalTrials.gov and search for the identifier NCT06735209.

Participating IDCRC study site:

  • University of Washington Vaccine and Treatment Evaluation Unit

About Infectious Disease Clinical Research Consortium (IDCRC)
This activity is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through the NIAID (UM1AI148684). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. For more information about the IDCRC, please visit www.IDCRC.org.