Immune Memory After Papillomavirus Vaccination

Healthy Volunteers Clinical Trial

— IMAP-1  

Official title:

Immune Memory After Papillomavirus Vaccination (IMAP-I) Study . DMID 10-0014

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505049
• Other study ID #: IRB00046117
• Secondary ID: DMID 10-0014
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: July 20, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells		2 years after first vaccination	No