Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128661
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2005-08-08
Brief Title:
Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Double-Blind Controlled Randomized Phase III Study of the Efficacy of an HPV1618 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia CIN2 CIN3 Adenocarcinoma In Situ AIS and Invasive Cervical Cancer Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica
Status:
COMPLETED
Status Verified Date:
2019-02
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:
RATIONALE Chemoprevention is the use of certain drugs to keep cancer form forming growing or coming back Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer
PURPOSE This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants
PURPOSE This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants
Detailed Description:
OBJECTIVES
Primary
Demonstrate the efficacy of the candidate vaccine human papillomavirus 1618 HPV 1618 L1 virus-like particle VLPAS04 vaccine compared with control in preventing grade 2 or 3 cervical intraepithelial neoplasia adenocarcinoma in situ of the cervix or invasive cervical cancer CIN2 associated with HPV 16 or HPV 18 cervical infection in younger healthy participants who are negative for HPV DNA by polymerase chain reaction PCR for the corresponding HPV type at months 0 and 6
Secondary
Determine the duration of protection against HPV 16 or HPV 18 cervical infection in participants treated with the HPV 1618 L1 VLPAS04 vaccine
Determine the safety of this vaccine in these participants regardless of their initial HPV 1618 DNA status
Evaluate the efficacy of the candidate vaccine HPV 1618 L1 VLPAS04 vaccine compared with control in preventing CIN2 associated with any oncogenic HPV type cervical infection in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6
Compare the efficacy of the candidate vaccine with control in preventing CIN2 associated with HPV 16 or HPV 18 cervical infection detected within the lesional component of the cervical tissue specimen by PCR in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6 and by enzyme-linked immunosorbent assay ELISA at month 0
Compare the efficacy of the candidate vaccine with control in preventing persistent HPV 16 or HPV 18 cervical infection in these participants
Determine the immunogenicity of HPV 1618 L1 VLPAS04 vaccine by ELISA and V5J4 monoclonal antibody inhibition enzyme immunoassay in the first 600 participants randomized to receive HPV 1618 L1 VLPAS04 vaccine
OUTLINE This is a randomized controlled double-blind parallel-group study Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive human papillomavirus 1618 L1 virus-like particleAS04 vaccine intramuscularly IM once in months 0 1 and 6
Arm II Participants receive hepatitis A vaccine Havrix IM once in months 0 1 and 6
After completion of study treatment participants are followed at 6 months and then at least annually for 3 years
PROJECTED ACCRUAL Approximately 7500 participants will be accrued for this study
Primary
Demonstrate the efficacy of the candidate vaccine human papillomavirus 1618 HPV 1618 L1 virus-like particle VLPAS04 vaccine compared with control in preventing grade 2 or 3 cervical intraepithelial neoplasia adenocarcinoma in situ of the cervix or invasive cervical cancer CIN2 associated with HPV 16 or HPV 18 cervical infection in younger healthy participants who are negative for HPV DNA by polymerase chain reaction PCR for the corresponding HPV type at months 0 and 6
Secondary
Determine the duration of protection against HPV 16 or HPV 18 cervical infection in participants treated with the HPV 1618 L1 VLPAS04 vaccine
Determine the safety of this vaccine in these participants regardless of their initial HPV 1618 DNA status
Evaluate the efficacy of the candidate vaccine HPV 1618 L1 VLPAS04 vaccine compared with control in preventing CIN2 associated with any oncogenic HPV type cervical infection in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6
Compare the efficacy of the candidate vaccine with control in preventing CIN2 associated with HPV 16 or HPV 18 cervical infection detected within the lesional component of the cervical tissue specimen by PCR in participants who are negative for HPV DNA by PCR for the corresponding HPV type at months 0 and 6 and by enzyme-linked immunosorbent assay ELISA at month 0
Compare the efficacy of the candidate vaccine with control in preventing persistent HPV 16 or HPV 18 cervical infection in these participants
Determine the immunogenicity of HPV 1618 L1 VLPAS04 vaccine by ELISA and V5J4 monoclonal antibody inhibition enzyme immunoassay in the first 600 participants randomized to receive HPV 1618 L1 VLPAS04 vaccine
OUTLINE This is a randomized controlled double-blind parallel-group study Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive human papillomavirus 1618 L1 virus-like particleAS04 vaccine intramuscularly IM once in months 0 1 and 6
Arm II Participants receive hepatitis A vaccine Havrix IM once in months 0 1 and 6
After completion of study treatment participants are followed at 6 months and then at least annually for 3 years
PROJECTED ACCRUAL Approximately 7500 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSK-590299009 | OTHER | GSK Bio | None |
| NCI-04-C-N191 | None | None | None |
| NCI-590299009 | None | None | None |