# Thermostable RG-1 VLPs, A Candidate Broadly Protective HPV Vaccine for the Prevention of Cervical Cancer Globally > **NIH NIH P50** · JOHNS HOPKINS UNIVERSITY · 2024 · $228,702 ## Abstract Project Summary/Abstract HPV is a necessary cause of 10% of all cancers of women globally, including 99% of cervical cancers. Rates of cervical cancer vary markedly by geographic region and level of economic development, with >85% occurring in developing countries. Global estimates of HPV vaccination delivery and cervical screening by region and income level show virtually none in many poorer populations. There are 13 mucosal high-risk (hr) HPV types plus 11 possibly carcinogenic types. Licensed HPV vaccines all target HPV16 and HPV18, and one (Gardasil®9) also targets the next five most common types in cervical cancer. Since none target all cancer-associated HPVs, screening is maintained even in vaccinated women, adding to medical costs. Further, the stringent cold-chain and ≥two dose requirements for HPV vaccines are a serious impediment to delivery in developing countries. Our overall goal is to develop an affordable HPV vaccine that durably extends the breadth of protection to all cancer- associated HPV types, needs only to be administered once, and is stable at ambient temperature. Here we address this goal with two innovations: 1) displaying an L2-based protective epitope (RG1, that is conserved for HPVs) in a unique position on the surface of HPV16 L1 virus-like particles (VLPs), producing a single antigen, broadly protective HPV vaccine technology, RG1-VLP, and 2) the RG1-VLP vaccine is formulated by freeze drying in a glassy organic matrix surrounded by single atomic layer deposits of Al2O3. This atomic layer deposition (ALD) technology confers heat stability, protects against degradation during delivery, and provides slow waves antigen release that potentially allows for a single dose regimen. HYPOTHESIS 1: Repeat dosing with alum-formulated RG1-VLP vaccine is safe and immunogenic. Specific Aim 1: To perform a dose escalation phase I trial of the safety and immunogenicity of RG1-VLP absorbed to alum in healthy female volunteers. HYPOTHESIS 2: RG1-VLP vaccination of healthy women induces cross-reactive serum antibody that broadly protects via neutralizing antibodies and Fc-mediated phagocytosis. Specific Aim 2: To analyze the levels of protection against intravaginal HPV challenge conferred by passive transfer of serum of patients vaccinated with either RG1-VLP or Gardasil®9 in mice with fully humanized Fc receptors or none. This clinical study employs RG1-VLP antigen mixed with alum adjuvant, a conventional approach that requires refrigeration during delivery and storage and a repeat dose vaccination regimen. HYPOTHESIS 3: Cold chain, continued Pap screening and multidosing needs are significant barriers to global HPV vaccine programs, and the development of a thermostable atomic-layered deposition (ALD) coated RG1- VLP vaccine will address these issues. Specific Aim 3: Develop an ALD coated RG1-VLP vaccine, study its in vitro temperature stability, and in murine models test its one dose immunogenicity and protective efficacy and breadt... ## Key facts - **NIH application ID:** 10935439 - **Project number:** 2P50CA098252-21 - **Recipient organization:** JOHNS HOPKINS UNIVERSITY - **Principal Investigator:** Richard Bruce Roden - **Activity code:** P50 (R01, R21, SBIR, etc.) - **Funding institute:** NIH - **Fiscal year:** 2024 - **Award amount:** $228,702 - **Award type:** 2 - **Project period:** 2003-09-30 → 2029-08-31 ## Primary source NIH RePORTER: https://reporter.nih.gov/project-details/10935439 ## Citation > US National Institutes of Health, RePORTER application 10935439, Thermostable RG-1 VLPs, A Candidate Broadly Protective HPV Vaccine for the Prevention of Cervical Cancer Globally (2P50CA098252-21). Retrieved via AI Analytics 2026-08-23 from https://api.ai-analytics.org/grant/nih/10935439. Licensed CC0. --- *[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*