(Press-News.org) Safety Monitoring Committee Clears Clinical Trial to Advance to Younger Age Groups
Physician-scientists at Groupe de Recherche Action en Santé (GRAS) in Burkina Faso have successfully completed initial safety evaluations in 30 adult Burkinabés as the first phase of a clinical trial of Sanaria® PfSPZ-LARC2 Vaccine, which is designed to prevent infection with Plasmodium falciparum malaria. The clinical trial is being conducted in collaboration with Sanaria Inc., Seattle Children’s Research Institute (SCRI) and the University of Maryland School of Medicine. Following its review, the independent Safety Monitoring Committee has endorsed proceeding to the next phase of the trial, which will test PfSPZ-LARC2 Vaccine in younger individuals who are 11–19 and 6–10 years old. Crucially, the initial data in adults confirmed the vaccine was safe, fully attenuated, and caused no malaria infections.
Why PfSPZ-LARC2 Vaccine Matters
Malaria remains a devastating disease, responsible for approximately 600,000 deaths and 263 million cases annually, disproportionately affecting Sub-Saharan Africa. PfSPZ-LARC2 Vaccine represents an exciting advance because it uses genetically engineered parasites incapable of causing disease but potent enough to stimulate strong protective immunity. Genetically engineered LARC parasite strains were invented at SCRI, and PfSPZ-LARC2 Vaccine was developed and manufactured at Sanaria in collaboration with SCRI. PfSPZ-LARC2 Vaccine is weakened by deletions of two critical parasite genes, Mei2 and LINUP, causing the parasites to disintegrate after initial replication in the liver without progression to disease-causing blood-stage malaria infection.
Preclinical data indicate that LARC vaccines offer unprecedented potency, achieving higher efficacy at lower doses than any existing vaccines. This is supported by recent clinical trial results published in Nature Medicine (January 2025) demonstrating 90% protection from malaria infection after just a single mosquito-bite administration of a single gene deletion LARC (LARC1, aka GA2). Unlike its predecessor, however, PfSPZ-LARC2 Vaccine has been manufactured by Sanaria for administration by injection, conforming with global distribution requirements.
Existing WHO-recommended malaria vaccines have shown moderate short-term efficacy in reducing disease burden. In contrast, PfSPZ-LARC2 Vaccine is designed to achieve the higher efficacy and durability necessary to interrupt transmission, aligning with WHO’s goals for malaria elimination.
Global Implications and Upcoming Steps
Consistent with prior Sanaria vaccine trials, this clinical trial in Burkina Faso is rigorously placebo-controlled, underscoring the robust clinical standards used to assess efficacy and safety. Additional PfSPZ-LARC2 Vaccine trials planned for 2025 in the United States (Seattle) and Germany (Tübingen) will further assess safety and efficacy. Results from these trials will shape the global rollout strategy, targeted for within three years, positioning PfSPZ-LARC2 Vaccine as a potential cornerstone in malaria control and targeted elimination.
Experts Share Enthusiasm and Optimism
Professor Rose Leke (University of Yaoundé I in Cameroon, 2023 Virchow Prize Winner and Chair of Gavi, the Vaccine Alliance’s review committee) noted,
“This clinical trial excites me deeply. A single-dose, highly effective vaccine like PfSPZ-LARC2 Vaccine could dramatically transform malaria elimination strategies in Africa. It’s inspiring and historic to see African scientists in Africa lead the first clinical trial of this vaccine.”
Professor Sodiomon Bienvenu Sirima (Director General of GRAS, and trial Principal Investigator) stated,
“PfSPZ-LARC2 Vaccine is uniquely positioned to meet WHO’s ambitious goal of achieving over 90% protection against malaria infection, a milestone no current vaccine has ever matched. This will be unprecedented”
Dr. Stephen L. Hoffman (Sanaria CEO) remarked,
“For two decades, our team has focused on creating highly protective, cost-effective malaria vaccines. Collaboration with SCRI has made possible our PfSPZ-LARC2 third-generation product—promising to set a new standard in malaria prevention worldwide.”
A Turning Point in the Global Fight Against Malaria
Despite billions spent annually, progress in reducing malaria’s global burden has stagnated. With resistance to current treatments rising, climate change increasing mosquito ranges, and political uncertainties jeopardizing global health commitments, the innovative PfSPZ-LARC2 Vaccine offers timely hope for millions. Its deployment could profoundly change the lives of communities suffering from malaria’s devastating impact. If the vaccine proves to be protective after a single dose, it will ease the burden on health systems that currently struggle with implementing multi-dose vaccination programs requiring multiple immunization contacts.
The possibility of a one-dose, high-efficacy vaccine is exciting not just for residents of malaria-endemic areas but also for travelers who face Plasmodium falciparum malaria as a significant risk. Until now, travelers relied on antimalarial drugs—taken daily or weekly before, during, and after travel—which can be costly, inconvenient, and carry side effects. A single-dose vaccine like PfSPZ-LARC2 could dramatically simplify malaria prevention for travelers and military personnel alike, significantly reducing the risk of imported malaria.
About Sanaria Inc.
Founded in 2003, Sanaria is committed to developing groundbreaking malaria vaccines, offering sustained protection against Plasmodium falciparum. Headquartered in Rockville, Maryland, we are a leader in malaria vaccine innovation. Our name—drawn from the Italian mal’aria (“bad air”)—symbolizes our mission to bring a breath of healthy air to the fight against malaria, with vaccines designed not only to prevent disease, but also to interrupt transmission and enable targeted elimination. With over $420M invested to date, Sanaria has secured 79 worldwide patents with 14 applications pending. The company is actively seeking partners to further advance its vaccine technologies. Learn more at https://sanaria.com/.
About GRAS Inc
The Groupe de Recherche Action en Santé santé (GRAS) is a research institute established in 2008 in Burkina Faso, West Africa. Its mission is to contribute through innovative health research to harnessing policymakers with the most needed critical knowledge, for an evidence-based decision-making. Learn more at https://gras.bf/
Forward-Looking Statements
This news release contains certain forward-looking statements that involve known and unknown risks and uncertainties, which may cause actual results to differ materially from anticipated results or achievements expressed or implied by the statements made. Such statements include the availability of an effective vaccine, the expectations for eliminating malaria, and beliefs concerning the suitability of a successful vaccine. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the Company’s ability to raise sufficient funds, the regulatory approval process, clinical trials results, the Company’s patent portfolio, dependence on key personnel and other risks associated with vaccine development. For further information email sanaria@sanaria.com or call 301-770-3222.
END
Sanaria reports positive initial safety results for groundbreaking PfSPZ-LARC2 malaria vaccine
2025-06-03
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