Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV

HPV Vaccination and Infectivity Reduction in HPV-positive Women

This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses.

Our hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.

Inclusion Criteria:

• Born female
• Aged between 18-29 years old;
• Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
• Willing to participate in the study and have signed the informed consent form;
• In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
• Willing to be tested for HIV;
• Are HIV negative at the screening visit;
• Not pregnant;
• Able to pass a Test of Understanding (TOU);
• Willing to provide cervical, urine and blood samples;
• Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;
• Have no visible suspicious cervical lesions on examination.
• Agree to a pregnancy test at screening and before any HPV vaccination.

Exclusion Criteria:

• They have been previously vaccinated against HPV;
• They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
• They are HIV positive or immunocompromised;
• They are pregnant or planning to get pregnant in the next 12 months;
• They are less than three months post-partum or currently breastfeeding;
• They are allergic to one of the vaccine components or to latex;
• They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose
• The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.