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Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial
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Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial
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Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial
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Journal Article
Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial
2015
Overview
•A dose-ranging study of a novel E. coli-expressed HPV 16/18 vaccine candidate.•This is the first study of the immunogenicity of this recombinant HPV 16/18 vaccine.•This vaccine was well-tolerated and appeared immunogenic in young women aged 18–25.
This study aimed to investigate the dosage, immunogenicity and safety profile of a novel human papillomavirus (HPV) types 16 and 18 bivalent vaccine produced by E. coli.
This randomized, double-blinded, controlled phase 2 trial enrolled women aged 18–25 years in China. Totally 1600 eligible participants were randomized to receive 90μg, 60μg, or 30μg of the recombinant HPV 16/18 bivalent vaccine or the control hepatitis B vaccine on a 0, 1 and 6 month schedule. The designated doses are the combined micrograms of HPV16 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.
All but one of the seronegative participants who received 3 doses of the HPV vaccines seroconverted at month 7 for anti-HPV 16/18 neutralizing antibodies and IgG antibodies. For HPV 16, the geometric mean titers (GMTs) of the neutralizing antibodies were similar between the 60μg (GMT=10,548) and 90μg (GMT=12,505) HPV vaccine groups and were significantly higher than those in the 30μg (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.
The prokaryotic-expressed HPV vaccine is safe and immunogenic in women aged 18–25 years. The 60μg dosage formulation was selected for further investigation for efficacy.
Clinical trials registration: NCT01356823.
Publisher
Elsevier Ltd,Elsevier Limited
Subject
/ Adult
/ Antibodies, Neutralizing - blood
/ China
/ Drug-Related Side Effects and Adverse Reactions - epidemiology
/ Drug-Related Side Effects and Adverse Reactions - pathology
/ E coli
/ Female
/ geometry
/ Human papillomavirus 16 - genetics
/ Human papillomavirus 16 - immunology
/ Human papillomavirus 18 - genetics
/ Human papillomavirus 18 - immunology
/ Humans
/ Papillomavirus Vaccines - administration & dosage
/ Papillomavirus Vaccines - adverse effects
/ Papillomavirus Vaccines - immunology
/ Randomized controlled clinical trial
/ Safety
/ Vaccine
/ Vaccines
/ Vaccines, Synthetic - administration & dosage
/ Vaccines, Synthetic - adverse effects
/ Vaccines, Synthetic - immunology
/ women
