Immune Memory After Papillomavirus Vaccination (IMAP-1)
|ClinicalTrials.gov Identifier: NCT01505049|
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : July 21, 2015
|Condition or disease||Intervention/treatment|
|Healthy Volunteers||Drug: quadrivalent HPV vaccine|
|Study Type :||Observational|
|Actual Enrollment :||203 participants|
|Official Title:||Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Previously received all three doses of HPV vaccine
This group will consist of 78 women ages 18 to 30 who have received their third dose of vaccine three or more years ago. Recruitment of this group was completed in Sept 2012.
Previously received two doses of HPV vaccine
This group will consist of 78 women ages 18 to 30 who have received two doses of the HPV vaccine. The second dose must have been received six or more months ago.
Drug: quadrivalent HPV vaccine
For the group who have received two prior doses of vaccine, the third and final dose of vaccine will be given. For the unvaccinated cohort, women will receive all three doses of the vaccine. The second dose of the vaccine will be given two months after the first dose. The third and final dose of the vaccine will be given six months after the first dose.
Other Name: Gardasil if the trade name of the quadrivalent HPV vaccine.
This group will consist of 45 women who have not received their HPV vaccination. Women ages 18-26 are eligible for this cohort. Recruitment for this group was completed in January 2013.
- To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells [ Time Frame: 2 years after first vaccination ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505049
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Mark J Mulligan, MD||Emory University|
|Principal Investigator:||Kevin Ault, MD||University of Kansas|