Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden

Launched by MIRIAM ELFSTRÖM · May 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether giving the HPV vaccine and doing HPV screening together can help reduce the number of HPV infections and cervical cancer cases in women in Sweden. The researchers want to see if offering this to women aged 22-27 will help eliminate HPV more quickly in the population.

To participate, women must be between 22 and 26 years old, living in Sweden, and agree to join the study. They should not have opted out of the screening program. Those who participate will receive HPV testing and be offered the Gardasil 9 vaccine, even if they have received a different version of the vaccine before. However, women with certain health conditions or who are currently pregnant cannot join the study. Participants can expect to be screened for HPV and receive the vaccine if they choose to take part. This trial is currently recruiting women who meet the eligibility criteria.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Eligible women will include resident women within the age range of 22-26, who have not opted out of the screening program and who consent to participate in the study.
• • Women who respond to the invitation and attend screening will be screened with HPV testing by the current routine practise. Women who consent to participate will also be offered HPV vaccination. The HPV vaccine (Gardasil 9) will be offered regardless of whether the woman reports having had prior vaccination with a first-generation vaccine (Gardasil 4) and regardless of screening test result.
• Exclusion Criteria:
• • 1. Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine.For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
• • 2. Known history of immune-related disorders
• • 3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
• • 4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
• • 5. Current pregnancy (reported)
• • 6. Women with a total hysterectomy