Immune Memory After Papillomavirus Vaccination (IMAP-1)

Emory University

Status: Completed

Conditions: Healthy Volunteers

Treatments: Drug: quadrivalent HPV vaccine

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01505049

IRB00046117

DMID 10-0014 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy 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

Trial design

203 participants in 3 patient groups

Previously received all three doses of HPV vaccine

Description:

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

Description:

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.

Treatment:

Drug: quadrivalent HPV vaccine

Unvaccinated Cohort

Description:

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.