High-risk HPV (Any Strain), HPV, Human Papillomavirus (HPV) Infections
Conditions
Keywords
Cervical cancer, Cervical Intraepithelial Neoplasia Grade I/ II/ III (CIN I/II/III), Squamous Intraepithelial Lesions of the Cervix, High/ Low Grade, Human Papillomavirus (HPV) Infections, High-risk HPV, HPV-16/ 18, HPV DNA Tests, HPV Vaccines, HPV Nonavalent Vaccine, Gardasil-9, 9vHPV
Brief summary
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.
Interventions
BIOLOGICALNonavalent HPV vaccine (9vHPV)
Nonavalent HPV vaccine (9vHPV/ Gardasil-9™). Sterile suspension, 0.5 ml dose, intramuscular, prepared from the highly purified viruslike particles (VLPs) of the major capsid L1 protein from 9 HPV types: 6/11/16/18/31/33/45/52/58. 9vHPV is currently indicated in the EU in individuals from 9 years of age for the prevention of diseases caused by vaccine's 9 HPV types: genital warts (HPV6 and 11) and premalignant lesions and cancers affecting the cervix, vulva, vagina and anus (HPV16, 18, 31, 22, 45, 52 and 58). It was authorized for marketing in the EU on June 9th, 201
Sponsors
Institut d'Investigació Biomèdica de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is randomized trial with two arms. First arm will receive one dose of the nonavalent vaccine and the second unvaccined arm will serve as a control.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). | 7 months | To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in the HPV neutralization capacity of vaccine-induced antibodies in serum and cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine | 7 months | To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). |
| The difference in HPV viral load in cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). | 7 months | To analyse the differences in the HPV viral load in cervical samples at 6 months between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®). |
| Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples | 7 months | To analyse urine samples at month 6 to detect neutralizing antibodies to HPV 16, 18, 31, 33, 45, 52, 58, and the infective capacity of HPV 16, 18, 31, 33, 45, 52, 58 virions and to measure HPV 16, 18, 31, 33, 45, 52, 58 viral load |
| The difference in infectivity reduction and vaccine induced antibodies among different HPV types. | 7 months | To analyse differences in infectivity reduction and vaccine induced antibodies among different HPV types included in the 9-valent vaccine. |
Countries
Sierra Leone
Contacts
CONTACTMiquel Àngel Pavón Ribas PhD
CONTACTElena Ruiz Puig
Outcome results
None listed