Abstract
HPV infections are associated with human cancers. Although three prophylactic vaccines have been approved to protect against HPV infections, the vaccines require cold-chain storage and may not be suitable for third world countries with less developed refrigeration facilities. We previously developed a bacteriophage L2 virus-like particle (VLP)-based candidate vaccine, which elicited broadly protective antibodies against diverse HPV types. Spray-drying of MS2-16L2 VLPs into a dry powder enhanced the stability of these VLPs. Building on these studies, we assessed the long-term stability and immunogenicity of the spray-dried VLPs. Mice immunized with a single dose of spray-dried MS2-16L2 VLPs, which had been stored for 14 months at room temperature (RT), were partially protected from challenge with a high dose of HPV16, one year after immunization. However, immunization with two doses of MS2-16L2 VLPs stored at RT for 34 months elicited high titer anti-HPV antibodies. More importantly, this group of mice showed significant protection from HPV16, 4 months after immunization. These results suggest that spray-dried MS2-16L2 VLPs retain their effectiveness after long-term storage at RT, and may be suitable in third world countries with less developed refrigeration facilities.
Highlights
Infection with human papillomaviruses (HPVs) is associated with ~99.7% of cervical cancer, 46.9–71% of penile cancers/lesions, 71– 90% of anal cancers, and 10–70% of oral, oropharyngeal, and laryngeal cancers [1,2]
Spray-dried MS2-16L2 virus-like particle (VLP) are stable at room temperature for 34 months and they are protective against HPV16 infection
We assessed the longevity of immune protection, one year after immunization with the spray-dried VLPs that were stored at room temperature or 37 °C for 14 months
Summary
Infection with human papillomaviruses (HPVs) is associated with ~99.7% of cervical cancer, 46.9–71% of penile cancers/lesions, 71– 90% of anal cancers, and 10–70% of oral, oropharyngeal, and laryngeal cancers [1,2]. These vaccines are very effective in protecting against HPV infections, they all require continuous refrigeration to maintain their efficacy This requirement comes with an additional challenge – the expense associated with refrigeration and the concern that the vaccines may be accidentally exposed to either freezing or warm conditions during storage or transportation, which may affect their efficacy. Spray-dried MS2-16L2 VLPs stored at room temperature or at 37 °C for 7–14 months were still immunogenic following immunization of mice [11,12]. Assessed the immunogenicity and protection efficacy of the spray-dried MS2-16L2 VLPs following storage at room temperature for 34 months. We assessed the longevity of protection in mice: i) one year after immunization with spray-dried MS2-16L2 VLPs stored at room temperature or at 37 °C for 14 months; ii) two years after immunization with lipopolysaccharide (LPS)-free MS2-16L2 VLPs. 2.
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