Clinical Trials Logo

Clinical Trial Summary

This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45


Clinical Trial Description

This is a single-centre, dose-escalating, randomized, blinded and active controlled trial in healthy Chinese women ages 18-45. The positive control is Recombinant nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine. The trial will be conducted in two stages: Stage 1: A single-center, open-label trial will be carried out in 40 healthy women ages 27-45 in the enrolment order of mid-dosage group followed by high-dosage group. Each group of 20 subjects will be administered the mid-, and high-dosage form, respectively, to preliminarily evaluate the safety profile of the investigational vaccine. First, the 20 subjects in the mid-dosage group will be sequentially enrolled as two batches of 5 and 15 subjects, respectively, at an enrolment interval of no less than 3 days. One week after vaccinating all the 20 subjects in the mid-dosage group, upon confirmation of the safety profile of the investigational vaccine as acceptable, 20 subjects for the higher dosage-group will be enrolled subsequently in the same manner as those in the mid-dosage group. Subjects in each dosage group will receive a 3-dose regimen at months 0, 2 and 6. Safety of the investigational vaccine will be assessed for 30 days following each injection, and SAE will be reported for the duration of the study. In total there will be 12 scheduled visits for subjects in each dosage group throughout the study. One week after vaccinating all the 40 subjects in stage 1, if the safety profile of the investigational vaccine is confirmed to be acceptable, the study may proceed to stage 2. Stage 2: A phase I, single-center, dose-escalating, randomized and blinded (as to intra-dosage group) trial, with Gardasil9 as the positive control will be carried out in 120 healthy women ages 18-26 in the enrolment order of low-, mid-, and high-dosage groups. Each group of 40 subjects will be enrolled and randomized at a 3: 1 ratio to receive the investigational vaccine or positive control, respectively (that is, 10 of the subjects in each dosage group will receive the positive control). Firstly, the 40 subjects in the low-dosage group will be sequentially enrolled as four batches of 5, 10, 10 and 15 subjects, respectively, at an enrolment interval of no less than 3 days to get the first dose of the low-dosage investigational vaccine or positive control. Then, one week after vaccinating all the 40 subjects in the low-dosage group, upon confirmation of the safety profile of the investigational vaccine as acceptable, 40 subjects will be enrolled subsequently into the mid-dosage group in the same manner as those in the low-dosage group. Again, one week after vaccinating the 40 subjects in the mid-dosage group, if the safety profile of the investigational vaccine continues to be acceptable, another group of 40 subjects receiving the high-dosage investigational vaccine or positive control will be enrolled subsequently in the same manner as those in the low-dosage group. In both stage 1 and stage 2 of the phase I study, 5 ml of non-anticoagulative blood will be collected from trial subjects prior to dose 1 and at Month 3 and Month 7 post dose 1 to determine the levels of neutralizing antibodies and IgG antibodies to the vaccine HPV types. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05680454
Study type Interventional
Source Beijing Health Guard Biotechnology, Inc
Contact
Status Completed
Phase Phase 1
Start date September 1, 2019
Completion date May 10, 2022

See also
  Status Clinical Trial Phase
Completed NCT05458869 - Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
Completed NCT01932697 - Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer Phase 2
Completed NCT03265743 - HPV Vaccination in Women With Cystic Fibrosis N/A
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A
Completed NCT06199128 - Efficacy and Safety of Carboxymethyl Beta-glucan and Policarbophil in HPV Positive Patients
Active, not recruiting NCT01824537 - Transmission Reduction and Prevention With HPV Vaccination (TRAP-HPV) Study Phase 4
Completed NCT01265212 - Prevalence of Human Papillomavirus in Men Living in the Northern Plains N/A
Unknown status NCT01087164 - Brief Interventions to Increase HPV Vaccine Acceptance in School-based Health Centers N/A
Terminated NCT01082861 - Efficacy and Immunomodulation Study of Simultaneous Human Papillomavirus/ Hepatitis B (HPV/HBV) Vaccination Phase 4
Completed NCT00572832 - Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting N/A
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Completed NCT04133610 - HPVPro Study: Comparison of HPV Detection in Clinician-collected Cervical Swabs and Self-sampled Cervicovaginal Swabs N/A
Completed NCT00988884 - A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005) Phase 3
Not yet recruiting NCT05981807 - HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand Phase 2
Completed NCT01694875 - Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System N/A
Completed NCT01205412 - An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain N/A
Completed NCT01158209 - An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt N/A