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Completed

NCT Number: NCT01505049

Immune Memory After Papillomavirus Vaccination

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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Female

Study type

Observational

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

other more specific exclusions may apply to one of the three cohorts

Treatment and study plan

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.

Other names: Gardasil if the trade name of the quadrivalent HPV vaccine.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Acronym: IMAP-1

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2012
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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