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There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally.
This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time.
This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine schedule | Active Comparator | Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months |
|
| Extended schedule | Experimental | Two doses of 9vHPV vaccine at an expanded dosing schedule of 0/6 months with a third dose given at month 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonavalent HPV vaccine | Biological | Routine dosing form and dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV16/18 geometric mean titers (GMTs) at month 7 | Anti-HPV16/18 GMTs at month 7 (1 month post 3rd dose in Group 1 and 1 month post 2nd dose in Group 2) | Month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval) | Month 24 | |
| Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV6/11/31/33/45/52/58 GMTs at month 7 (1 month post 3rd dose in Group 1 and 1 month post 2nd dose in Group 2) | Month 7 | |
| Anti-HPV16/18 GMTs at month 6 (one-dose data) in the extended vaccine schedule group | Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deborah Money, MD | Contact | 6048752194 | deborah.money@ubc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Positive Health Services - Fraser Health | Not yet recruiting | Surrey | British Columbia | V3T 0G9 | Canada |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Month 24 |
| Incidence, type, and severity of 9vHPV significant adverse events in WLWH | Month 24 |
| Incidence rates of abnormal cervical cytology and histology, and breakthrough persistent HPV infection | Month 24 |
| Peak anti-HPV16/18 GMTs to 1 dose at month 1 | Month 1 |
| Viral and bacterial co-infection in the development of cervical dysplasia and vaccine breakthrough HPV infection in WLWH | Month 0-24 |
| Uptake of HPV vaccination in WLWH aged 18-45 across Canada prior to study | Month 0 |
| University of British Columbia | Recruiting | Vancouver | British Columbia | V6H 2N1 | Canada |
|
| Health Sciences Centre | Not yet recruiting | Winnipeg | Manitoba | R3A1R9 | Canada |
|
| Hamilton Health Sciences | Not yet recruiting | Hamilton | Ontario | L8S1A4 | Canada |
|
| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B1W8 | Canada |
|
| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G2C4 | Canada |
|
| Centre Hospitalier Universitaire Sainte-Justine | Recruiting | Montreal | Quebec | H3T1C5 | Canada |
|
| McGill University Health Centre | Not yet recruiting | Montreal | Quebec | H4A3J1 | Canada |
|
| Centre Hospitalier de l'Université Laval | Recruiting | Québec | Quebec | G1V4G2 | Canada |
|
| Regina General Hospital | Not yet recruiting | Regina | Saskatchewan | S4P0W5 | Canada |
|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |