[Clinical pilot study of HPV6b L1 virus-like particles as immune therapy for juvenile larynx papillomatosis].
OBJECTIVE
To study the safety and the immunogenicity of HPV6b virus-like particles (VLP) in children with juvenile laryngeal papilloma (JLP). The result of therapy is observed.


METHODS
HPV6b VLP were expressed with HPV6b L1 recombinant baculovirus in sf-9 insect cells. Ten case of recurrent JLP were immunized with HPV6b VLP in 5, 10, 25 microg doses progressively and any local or systemic adverse events were recorded. By ELISA was used to detect the serum HPV6b VLP antibody (Ab) of JLPs samples in therapy different stage. Seven cases of JLP were used DTH test. To understand the effects of VLP on disease prognosis subjects will be examined by fibrolaryngoscope.


RESULTS
All subjects did not experience local or systemic adverse events and specific serum antibody against HPV6b L1VLP was produced in JLP immunized. The A value of sera antibody in the first dose group have completed (0.310 +/- 0.012) were higher than that of pro-immune (0.110 +/- 0.035) (t = 4.673, P < 0.01). There was a significant difference of serum mean HPV6b Ab A value between JLP's patients immunized (0.772 +/- 0.013) and the control group (0.153 +/- 0.014) (t = 15.45, P < 0.01), 7 samples have male response of DTH test. All patients didn't recurrent papilloma after receiving treatment.


CONCLUSIONS
HPV6b VLP have immunogenicity and safety as therapy for JLP patients, and HPV6b VLP may be used in prophylactic and therapeutic vaccine for JLP.
Chen
Bobei
B
Department of Otolaryngology, the Second Affiliated Hospital of Wenzhou Medical College, Wenzhou, 325027, China.
Zhao
Kongnan
K
Liu
Xiaosong
X
Xu
Yan
Y
Xiang
Songjie
S
Yang
Jihong
J
Chen
Xiaofang
X
D000914:Antibodies, Viral / Q000097:blood; D036022:Capsid Proteins / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D005260:Female; D052163:Human papillomavirus 6 / Q000276:immunology; D006801:Humans; D007223:Infant; D007822:Laryngeal Neoplasms / Q000628:therapy*; D008297:Male; D010212:Papilloma / Q000628:therapy*; D027383:Papillomaviridae / Q000276:immunology*; D010865:Pilot Projects; D014764:Viral Proteins
D000914:Antibodies, Viral; D036022:Capsid Proteins; D014764:Viral Proteins; C091560:L1 protein, Human papillomavirus type 6