Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680454
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2022-12-12
Brief Title:
A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine
Sponsor:
Beijing Health Guard Biotechnology Inc
Organization:
Beijing Health Guard Biotechnology Inc
Study Overview
Official Title:
A Phase I Trial in Healthy Chinese Women Ages 18-45 to Evaluate the Safety and Tolerability Profile of Recombinant Nonavalent Types 61116183133455258 Human Papillomavirus HPV Vaccine Escherichia Coli
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent Types 61116183133455258 Human Papillomavirus HPV Vaccine Escherichia Coli in healthy women ages 18-45
Detailed 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 61116183133455258 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None