Immune Memory After Papillomavirus Vaccination (IMAP-1)
Vaccines for human papillomavirus (HPV) have been available in the United States since 2006. Early studies have shown a high rate of effectiveness of these vaccines, however it is not known how long this protection will last. The IMAP study will look at various parts of the immune system and potential markers for long lived immune responses to this vaccine.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014|
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
we will retain lymphocyte samples for testing immune function
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
Three groups of patients will be recruited for this study. One group will be women who have completed all three vaccinations. The second group will be women who are overdue for their final vaccination. We also recruit women who have not been vaccinated previously.
Please refer to this study by its ClinicalTrials.gov identifier: 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|