An observational study in Cervical Intraepithelial Neoplasia, Cervical Cancer and Vaginal Intraepithelial Neoplasia, sponsored by Jun Zhang. Completed at 1 site in China. Open to female participants aged 10 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Jun Zhang · Observational
The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).
This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.
Participants who participated in the bridging study (Unique Protocol ID:HPV-PRO-006-2, Identifiers: NCT02562508) and received at least one dose will be recruited.
Exclusion Criteria:
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
Procedure: 3 doses of HPV 16/18 bivalent vaccine
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
Procedure: 2 doses of HPV 16/18 bivalent vaccine
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
Procedure: 3 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody)
To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1
Time frame: Month 18 and 30
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody)
To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 18 and 30 months after the dose 1
Time frame: Month 18 and 30
All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded
Time frame: between 7 months and 30months after the dose1
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Jun Zhang