Human papillomavirus vaccine(Bioleaders Corp.)

Human parvovirus infections are common, provoke aplastic crises in patients with congenital haemolytic anaemia and cause fifth disease. An unknown proportion of the infections are subclinical. Parvoviraemia occurs in the early acute stage of infection and specific IgM can be detected during recovery. Most patients commencing an aplastic crisis are viraemic, but fifth disease arises after the viraemia. Serological tests for HPV, available at a small but increasing number of laboratories, will soon be complemented by tests for HPV DNA sequences present in blood, marrow and at other sites. Human parvovirus infection is occasionally fatal in patients with severe forms of congenital haemolytic anaemias and further study may reveal other unusual serious consequences of this ubiquitous infection. Short-term protection of vulnerable patients may be achievable with normal immunoglobulin, but there are still considerable obstacles to the preparation and use of a human parvovirus vaccine.

Cervical intraepithelial neoplasia (CIN), a precursor lesion to cervical cancer, is caused by high-risk human papillomavirus (HPV); high-grade CIN lesions (CIN2-3) are precancerous and require treatment. No globally approved therapy is available for CIN2-3 treatment. This study is a placebo-controlled randomized clinical trial of GLBL101c treatment for CIN2 in 40 patients with HPV16-positive CIN2 who were 1:1 randomized to receive GLBL101c (1 g/daily) or placebo for 5 days at 1, 2, 4, and 8 weeks. No differences were noted between the GLBL101c and placebo groups for patient background and adverse events. Moreover, no statistically significant difference was noted between the two groups at the primary endpoint, pathological regression after 16 weeks of the first oral dose; however, only in the GLBL101c group, two patients had complete regression (CR; regression to normal within 16 weeks). IFNγ production was significantly correlated with the number of spots identified by the interferon gamma enzyme-linked immunospot (IFNγ-ELISPOT) assay using cervical lymphocytes (CxLs) or peripheral blood mononuclear cells. In the two cases of CR, E7-specific Th1 immune responses were observed at week 16. Therefore, we concluded as a novel Lactobacillus-based vaccine with stronger immunogenicity than GLBL101c should be developed.