Immune Memory After Papillomavirus Vaccination

NCT01505049 | Completed DMC

• 2 other identifiers: IRB00046117DMID 10-0014
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

immunology; vaccination; human papillomavirus

Outcome Measures

Primary Outcomes (1)

• To examine markers of immune memory in women receiving quadrivalent HPV vaccine including antibody levels and memory B cells

  2 years after first vaccination

Study Arms (3)

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

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.

Interventions

quadrivalent HPV vaccine 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.

Also known as: Gardasil if the trade name of the quadrivalent HPV vaccine.

Previously received two doses of HPV vaccine

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

we are seeking healthy female volunteers

You may qualify if:

• Female ages 18-26 inclusive (18-30 for women who have been previously vaccinated
• 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.
• Able to give informed consent
• Negative urine pregnancy test at enrollment

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

we will retain lymphocyte samples for testing immune function

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Mark J Mulligan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Kevin Ault, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

US (1)