Immune Memory After Papillomavirus Vaccination (IMAP-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Mulligan, Emory University
ClinicalTrials.gov Identifier:
NCT01505049
First received: January 4, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Healthy Volunteers
Drug: quadrivalent HPV vaccine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 201
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)
Groups/Cohorts Assigned Interventions
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.
Unvaccinated Cohort
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

we are seeking healthy female volunteers

Criteria

Inclusion Criteria:

  1. Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
  2. If sexually active and enrolled in unvaccinated group, must use a reliable form of birth control for the first seven months of the study. For the purposes of this protocol a reliable form will be hormonal or barrier contraception. Intrauterine devices and a history of sterilization will also be considered reliable forms of birth control. Abstaining from sex is also a reliable form of contraception.
  3. Able to give informed consent
  4. Negative urine pregnancy test at enrollment

Exclusion Criteria:

  1. Currently pregnant, breast feeding or planning a pregnancy
  2. Underlying immunological disease, such as previously diagnosed HIV infection or history of transplantation, history of splenectomy
  3. Use of medications with potential immunological effects such as systemic corticosteroids or chemotherapy
  4. Prior therapy for cervical dysplasia or cervical cancer such as loop excision, laser ablation, cryotherapy or hysterectomy
  5. Unable to comply with protocol
  6. Severe allergic reaction (e.g., anaphylaxis) after a previous vaccine dose or to a vaccine component
  7. An acute illness, including an oral temperature of 100.4 degrees F within three days of visit

other more specific exclusions may apply to one of the three cohorts

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505049

Contacts
Contact: Mark J Mulligan, MD 404-712-9046 mmulli2@emory.edu
Contact: Karen Mask, RN 404-712-7932 karen.a.mask@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Briyana Domjahn, MPH    404-712-1370    briyana.teague.domjahn@emory.edu   
Contact: Kevin A Ault, MD    404-251-8809    kevin.ault@emory.edu   
Principal Investigator: Kevin Ault, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kevin A Ault, MD Emory University
  More Information

No publications provided

Responsible Party: Mark Mulligan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01505049     History of Changes
Other Study ID Numbers: IRB00046117, DMID 10-0014
Study First Received: January 4, 2012
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
immunology
vaccination
human papillomavirus

ClinicalTrials.gov processed this record on August 28, 2014