Immunogenicity and safety of an XXXX -produced bivalent @entity1799 and 18) vaccine: A randomized controlled phase 2 clinical trial.

@entity1 @entity1799 @entity1082 @entity526
BACKGROUND: This study aimed to investigate the dosage, immunogenicity and safety profile of a novel @entity1082 ) types 16 and 18 bivalent vaccine produced by @entity526 . METHODS: This randomized, double-blinded, controlled phase 2 trial enrolled @entity1 aged 18-25 years in China. Totally 1600 eligible @entity1 were randomized to receive 90 g, 60 g, or 30 g of the recombinant @entity1799 /18 bivalent vaccine or the control hepatitis B vaccine on a 0, 1 and 6 month schedule. The designated doses are the combined micrograms of @entity1799 and 18 VLPs with dose ratio of 2:1. The immunogenicity of the vaccines was assessed by measuring anti-HPV 16 and 18 neutralizing antibodies and total IgG antibodies. Safety of the vaccine was assessed. RESULTS: All but one of the seronegative @entity1 who received 3 doses of the HPV vaccines seroconverted at month 7 for anti-HPV 16/18 neutralizing antibodies and IgG antibodies. For @entity1799 , the geometric mean titers (GMTs) of the neutralizing antibodies were similar between the 60 g (GMT=10,548) and 90 g (GMT=12,505) HPV vaccine groups and were significantly higher than those in the 30 g (GMT=7596) group. For HPV 18, the GMTs of the neutralizing antibodies were similar among the 3 groups. The HPV vaccine was well tolerated. No vaccine-associated serious adverse events were identified. CONCLUSION: The prokaryotic-expressed HPV vaccine is safe and immunogenic in @entity1 aged 18-25 years. The 60 g dosage formulation was selected for further investigation for efficacy. CLINICAL TRIALS REGISTRATION: NCT01356823.
