Immune Memory After Papillomavirus Vaccination

NCT ID: NCT01505049

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Healthy Volunteers

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

quadrivalent HPV vaccine

Intervention Type: DRUG

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.

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Gardasil if the trade name of the quadrivalent HPV vaccine.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Mark Mulligan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark J Mulligan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Kevin Ault, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

DMID 10-0014

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00046117

Identifier Type: -

Identifier Source: org_study_id