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Discovering the causes of cancer and the means of prevention
 

Single-Dose HPV Vaccination among Young Adult Women in Costa Rica: The PRISMA*-ESCUDDO Trial

Cervical cancer, which affects more than half a million women around the world annually, could be nearly eliminated with a combination of increased uptake of the prophylactic human papillomavirus (HPV) vaccine, and cervical cancer screening and diagnostic follow-up and treatment of precancers. Yet, globally, fewer than 20 percent of young girls receive HPV vaccination and a similarly low proportion of women receive cervical cancer screening. Rapid gains in access to and uptake of HPV vaccination are needed to avert the millions of projected HPV-related cervical cancers expected over the coming decades as the population of the globe ages.

Public Health Benefit

Researchers are conducting the PRISMA study to see if one dose of HPV vaccine reduces the risk of HPV infection in women, compared to no vaccine, which is the standard in the majority of the world. If one dose is sufficient, vaccinating women could help to accelerate the timeline for cervical cancer control. 

Study Rationale and Background

In the non-randomized extension of the Costa Rica HPV Vaccine trial (CVT), investigators reported long-term protection against HPV 16 and HPV 18 infections and stable antibody levels among women who received a single dose of the bivalent HPV vaccine more than a decade earlier. These observations raise the possibility that a single dose of HPV vaccine may offer sufficient durable protection and set the basis for two ongoing clinical trials conducted by NCI and ACIB (acibfunin.com): ESCUDDO (efficacy trial, Clinical trials identifier: NCT03180034) and PRIMAVERA (immunobridging trial, Clinical trials identifier: NCT03728881). This research question is also being investigated in other trials, including the DoRIS trial in Tanzania (immunogenicity trial, Clinical trials identifier: NCT02834637), the KenSHE trial in Kenya (efficacy trial, Clinical trials identifier: NCT03675256), and the HANDS HPV trial in the Gambia (immunogenicity trial, Clinical trials identifier: NCT03832049).

Study Design

PRISMA will vaccinate approximately 5000 women in Costa Rica aged 18 to 30 years. The women will be randomized in a blinded fashion to one of three vaccine arms (one dose of the nonavalent vaccine, one dose of bivalent vaccine, or one dose of active control Tdap vaccine). After vaccination, the women will be followed every six months for three years to determine total reduction of incident cervical HPV infections that persist six or more months among women regardless of cervical HPV status at time of HPV vaccination. To further generate data on the potential of a single-dose to protect against HPV infections at non-cervical anatomic sites where HPV causes cancer, the trial will also investigate reductions in oral and anal HPV 16/18 infections afforded by one dose compared to no vaccination. 

In the U.S., Cervarix® and GARDASIL®9 are currently approved for three doses in individuals 15 years and older. By generating data on the efficacy of single-dose HPV vaccination at multiple anatomic sites and evaluating the impact and cost-effectiveness of an age-expanded single-dose HPV vaccination program in a middle-income country, NCI advances its goal of providing data to recommending bodies in order to consider changes to policy.
See the PRISMA trial Clinicaltrials.gov (NCT05237947).

*PRISMA (PRevencIón del Cáncer Cervical con una Sola dosis de vacuna contra VPH en Mujeres Adultas jóvenes)

For more information, contact Dr. Aimée Kreimer.

Infections and Immunoepidemiology Branch - Research Areas