A Non-Randomized, Open-Label Study to Assess the Reduction of Human Papillomavirus (HPV) Viral Infectivity and Transmission in HPV16/18-Positive Women Before and After Vaccination with 9vHPV, a Multivalent L1 Virus-like Particle Vaccine, Evaluated in Cervical, Anal, Vulvar, Urine and Oral Samples Obtained After One, Two, and Three Vaccine Doses (RIFT-HPV1/RIFT-HPV2).

Conditions

Evaluation of the reduction of HPV infectivity and transmission before and after vaccination with 9vHPV

Brief summary

In-vitro infectivity evaluation (by expression of E1^E4 HPV biomarker in HaCaT keratinocytes) of cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination., Detection of HPV 6/11/16/18/31/33/45/52/58 L1 antibodies in cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination, using: -ELISA for types 16 and 18 in samples from RIFT-HPV 1 and 2 study cohorts, -cLIA for all 9vHPV-covered types in samples from RIFT-HPV 1 study cohort. This endpoint will allow associating the reduction in viral infectivity with the presence of neutralizing antibodies., -HPV16/18 virion detection (using ELISA, electronic microscopy) and HPV DNA detection and genotyping (using Anyplex/Allplex HPV28) in cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination. This endpoint will allow to identify samples of subjects with a nonproductive viral infection or undergoing natural clearance, and distinguish them from samples of subjects with productive but reduced infection due to 9vHPV vaccination.

Detailed description

-HPV 6/11/16/18/31/33/45/52/58 L1 antibody titration in serum samples collected before and after 9vHPV vaccination, using: -ELISA for types 16 and 18 in samples from RIFT-HPV 1 and 2 study cohorts, -cLIA for all 9vHPV-covered types in samples from RIFT-HPV 1 study cohort.

Related papers

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Interventions

DRUGGardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant

DRUGadsorbed)

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
In-vitro infectivity evaluation (by expression of E1^E4 HPV biomarker in HaCaT keratinocytes) of cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination., Detection of HPV 6/11/16/18/31/33/45/52/58 L1 antibodies in cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination, using: -ELISA for types 16 and 18 in samples from RIFT-HPV 1 and 2 study cohorts, -cLIA for all 9vHPV-covered types in samples from RIFT-HPV 1 study cohort. This endpoint will allow associating the reduction in viral infectivity with the presence of neutralizing antibodies., -HPV16/18 virion detection (using ELISA, electronic microscopy) and HPV DNA detection and genotyping (using Anyplex/Allplex HPV28) in cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination. This endpoint will allow to identify samples of subjects with a nonproductive viral infection or undergoing natural clearance, and distinguish them from	—

Measure

Time frame

In-vitro infectivity evaluation (by expression of E1^E4 HPV biomarker in HaCaT keratinocytes) of cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination., Detection of HPV 6/11/16/18/31/33/45/52/58 L1 antibodies in cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination, using: -ELISA for types 16 and 18 in samples from RIFT-HPV 1 and 2 study cohorts, -cLIA for all 9vHPV-covered types in samples from RIFT-HPV 1 study cohort. This endpoint will allow associating the reduction in viral infectivity with the presence of neutralizing antibodies., -HPV16/18 virion detection (using ELISA, electronic microscopy) and HPV DNA detection and genotyping (using Anyplex/Allplex HPV28) in cervical, anal, vulvar, urine and oral samples collected before and after 9vHPV vaccination. This endpoint will allow to identify samples of subjects with a nonproductive viral infection or undergoing natural clearance, and distinguish them from

—

Secondary

Measure	Time frame
-HPV 6/11/16/18/31/33/45/52/58 L1 antibody titration in serum samples collected before and after 9vHPV vaccination, using: -ELISA for types 16 and 18 in samples from RIFT-HPV 1 and 2 study cohorts, -cLIA for all 9vHPV-covered types in samples from RIFT-HPV 1 study cohort.	—

Countries

Spain

Outcome results

None listed