Gates Foundation Bets $7M on srRNA Vaccines for HIV and Malaria

SAN DIEGO, CA – January 08, 2026 – The Bill & Melinda Gates Foundation has awarded approximately $7 million in grants to Replicate Bioscience, a clinical-stage company, to accelerate the development of novel vaccines for HIV and malaria. The funding signals a significant strategic investment in the company's pioneering self-replicating RNA (srRNA) technology, which holds the promise of overcoming long-standing hurdles in the fight against two of the world's most persistent infectious diseases.

The grants, split evenly at around $3.5 million for each disease, are aimed at creating low-dose, highly effective vaccines for use in low- and middle-income countries (LMICs), where HIV and malaria exact their heaviest toll. Crucially, the funding is subject to humanitarian licensing terms, a condition designed to ensure that any successful vaccines are made affordable and accessible to the global populations that need them most.

"We are thrilled to accelerate development of our HIV and malaria vaccine candidates with the support of the Gates Foundation," said Nathaniel Wang, PhD, Chief Executive Officer of Replicate. "We expect the clinically demonstrated high therapeutic index of our novel srRNA technology and platform will translate to these targets into potential new vaccines with improved durability, dose sparing, and safety for people in need."

A New Generation of RNA Technology

While mRNA vaccines became a household name during the COVID-19 pandemic, Replicate Bioscience is championing a next-generation evolution of the technology. Unlike conventional mRNA, which delivers a transient set of instructions for cells to produce antigens, srRNA includes genetic code that enables the RNA to make copies of itself once inside the cell. This self-amplification process is designed to produce a larger and more sustained amount of the target antigen from a much smaller initial dose.

This dose-sparing potential is a cornerstone of Replicate's platform. The company's lead candidate, a rabies vaccine named RBI-4000, has already provided compelling proof-of-concept. In a Phase 1 clinical trial, results of which were published in Nature Communications, RBI-4000 demonstrated the ability to elicit protective levels of immunity at doses as low as 0.1 micrograms—a fraction of what's required for current mRNA vaccines. The study also showed durable immune responses, with protective antibody levels maintained for at least six months, and a favorable safety profile with a therapeutic index exceeding 100-fold.

These characteristics—low dose, durability, and safety—are precisely what global health experts see as critical for vaccines targeting endemic diseases in resource-limited settings. A lower dose requirement can dramatically simplify manufacturing logistics and reduce costs, while greater durability could mean fewer required booster shots, easing the strain on local healthcare systems.

Targeting Two of Global Health's Greatest Foes

The challenges posed by HIV and malaria have stymied vaccine developers for decades. HIV's rapid mutation and ability to hide from the immune system have made it an elusive target. Despite numerous attempts, no licensed preventive HIV vaccine exists. Meanwhile, the world’s first WHO-recommended malaria vaccine, RTS,S/AS01E, offers only moderate and waning protection, highlighting the urgent need for more efficacious alternatives.

Replicate's srRNA technology offers a potential advantage by stimulating a more comprehensive immune attack. "Replicate's novel srRNA technology and platform offer key differentiators for vaccine development, including the ability to generate both antibody and T cell responses, high therapeutic index, and ease of manufacturing," said the company's Chief Scientific Officer, Parinaz Aliahmad, PhD.

The competitive landscape is active, with giants like Moderna and BioNTech also pursuing mRNA-based vaccines for HIV and malaria, respectively, some also with support from the Gates Foundation. However, Replicate's focus on a self-replicating platform positions it as a distinct and potentially disruptive player. The Gates Foundation's investment serves as a powerful validation of this approach, placing a strategic bet that srRNA could provide the breakthrough needed for these notoriously difficult pathogens.

The Humanitarian Imperative: Ensuring Global Access

Beyond the scientific innovation, the structure of the grants underscores a fundamental principle of the Gates Foundation's global health strategy: equity. The inclusion of "humanitarian licensing terms" is a critical component aimed at dismantling the barriers that often prevent life-saving medicines from reaching LMICs.

Typically, such terms involve non-exclusive voluntary licensing agreements, often facilitated by organizations like the Medicines Patent Pool. These agreements allow multiple generic manufacturers to produce and sell a patented drug or vaccine in designated developing countries, fostering competition that drives prices down dramatically. This model has been instrumental in expanding access to HIV antiretroviral therapies, saving millions of lives.

By building this requirement into the grant from the outset, the foundation is ensuring that if Replicate's research yields a successful vaccine, it will not become a product accessible only to the wealthy. This proactive approach aims to prevent a repeat of the inequities seen in past health crises and aligns with global efforts to end the AIDS epidemic and drastically reduce the burden of malaria by 2030.

From Lab to Last Mile: The Road Ahead

Developing a promising vaccine candidate is only the first step. The path from clinical trials to widespread immunization in LMICs is fraught with immense logistical challenges. Many regions lack the reliable cold-chain infrastructure required for RNA vaccines, and shortages of trained healthcare workers, limited funding, and difficult terrain can impede delivery to remote populations.

The potential advantages of srRNA could help mitigate some of these hurdles. A vaccine that is effective at a very low dose and requires fewer follow-up shots would be inherently easier and cheaper to distribute. This could make vaccination campaigns more feasible in areas with stretched healthcare resources.

Even so, the journey for these HIV and malaria candidates remains long. They must first progress through rigorous preclinical and clinical trials to prove their safety and efficacy. Should they succeed, overcoming the final-mile delivery challenges will require a coordinated effort involving governments, global health organizations like Gavi and the WHO, and local communities. The grants to Replicate Bioscience represent a crucial injection of hope and resources, fueling a technological approach that may finally turn the tide against two of humanity's most devastating diseases.