HPV Vaccine Trial in Costa Rica (CVT)

Stacked bar graph. Y-axis is proportion, in percent. X-axis is clinically unmasked cervical lesions, grade: CIN2+, n=61. A gray bar at the bottom of the stack represents the unknown HPV types, at seven percent. An orange bar is stacked on top of that, representing non-carcinogenic HPV types at eleven percent. A blue bar is stacked on top of that, representing HPV 35, 39, 51, 56, or 59, at forty one percent. A yellow bar is stacked at the top and represents HPV 52 or 58, at forty one percent.

HPV Vaccine Protection Outweighs Risk of Cervical Lesions from Non-Preventable HPV Types

Jaimie Shing, Ph.D., M.P.H., and colleagues conduct the first study to observe and evaluate clinical unmasking following HPV vaccination.

The HPV Vaccine Trial in Costa Rica (CVT) is a collaboration between investigators in Costa Rica and the National Cancer Institute. CVT was a blinded, randomized, phase III clinical trial of the bivalent HPV-16/18 virus-like particle (VLP) vaccine developed by investigators at NCI and other research institutions and manufactured by GlaxoSmithKline Biologicals. Its aims were to evaluate vaccine efficacy, immunological correlates of long-term vaccine success and failure, and other factors of immunological and etiological interest. The trial was initiated in June 2004 and enrollment of 7,466 women was completed in December 2005.

Trial staff followed enrolled women for a period of four years. Eligible participants were consented and randomized to receive three doses of the HPV 16/18 VLP or Havrix (Hepatitis A) vaccine over a period of six months. At entry and throughout follow-up, women were carefully monitored and received state-of-the-art screening for cervical neoplasia.

In addition to strong evidence for vaccine safety and efficacy, data from the trial demonstrated that three doses of the HPV vaccine may not be necessary, as similar vaccine efficacy against cervical HPV 16/18 infection was observed among women who received two, and even a single dose, after more than 10 years of follow-up.

For more information, contact Aimée Kreimer, Ph.D.

Publications

Shing JZ, et al. Precancerous cervical lesions caused by non-vaccine-preventable HPV types after vaccination with the bivalent AS04-adjuvanted HPV vaccine: an analysis of the long-term follow-up study from the randomised Costa Rica HPV Vaccine Trial. Lancet Oncol 2022.
Porras C, Tsang SH, et al. Efficacy of the bivalent HPV vaccine against HPV 16/18- associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial. Lancet Oncol 2020.
Kreimer AR, Sampson JS, et al. Evaluation of Durability of a Single Dose of the Bivalent HPV Vaccine: The CVT Trial. JNCI 2020.
Tsang SH, Sampson JS, et al. Durability of Cross-Protection by Different Schedules of the Bivalent HPV Vaccine: The CVT Trial. JNCI 2020.
Herrero R, Wacholder S, Rodriguez AC, et al. Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine: a community-based randomized clinical trial in Guanacaste, Costa Rica. Cancer Discov 2011.
Herrero R, Hildesheim A, Rodriguez AC, et al. Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica. Vaccine 2008.

Search all publications from the CVT study.

Requests for CVT Data and Specimens

We encourage collaborations with outside investigators. Requests for CVT data will be reviewed for completeness and suitability. If requesting CVT data and specimens, outside investigators will submit a concept and, if it is accepted, they will be partnered with a CVT team member to develop a full proposal. Proposals will require CVT Working Group approval.

To request an application and information packet, please email the CVT coordinator. Please specify if you are requesting data only or data and specimens.

Infections and Immunoepidemiology Branch - Research Areas