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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-29
SponsorInstitut d'Investigació Biomèdica de Bellvitge

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Nonavalent HPV vaccine (9vHPV)

Treatment groups

80 Participants
are divided into 2 treatment groups