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Immune Memory After Papillomavirus Vaccination (IMAP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01505049
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : July 21, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Healthy Volunteers Drug: quadrivalent HPV vaccine

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.

Study Design

Study Type : Observational
Actual Enrollment : 203 participants
Time Perspective: Prospective
Official Title: Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014
Study Start Date : January 2012
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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
we will retain lymphocyte samples for testing immune function

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
we are seeking healthy female volunteers

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505049

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Mark J Mulligan, MD Emory University
Principal Investigator: Kevin Ault, MD University of Kansas
More Information

Responsible Party: Mark Mulligan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01505049     History of Changes
Other Study ID Numbers: IRB00046117
DMID 10-0014 ( Other Identifier: Other )
First Posted: January 6, 2012    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Mark Mulligan, Emory University:
human papillomavirus

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs