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| Name | Class |
|---|---|
| University of Witwatersrand, South Africa | OTHER |
| Botswana Harvard Health Partnership | UNKNOWN |
| Ministry of Health, Rwanda | OTHER_GOV |
| Fred Hutchinson Cancer Center |
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The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.
The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV.
Participants will be randomized 1:1 into two different Groups.
The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18 |
|
| Group 2 | Active Comparator | Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GARDASIL®9 | Biological | GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18. | Efficacy will be measured by the incidence of persistent infection from at least one of these HPV 16/18/31/33/45/52/58, where persistence is defined as a positive test at two consecutive visits at least 4.5 months apart. | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV. | This will be evaluated by comparing the occurrence of serious adverse events reported among each study arm. | 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
Assigned female at birth
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| Name | Affiliation | Role |
|---|---|---|
| Ruanne Barnabas, MBChB, MSc, DPhil | Massachusetts General Hospital | Principal Investigator |
| Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H | Wits RHI, University of The Witwatersrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botswana Harvard Health Partnership | Gaborone | 0000 | Botswana | |||
| Ministry of Health and Center for Family Health Research |
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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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| OTHER |
| National Cancer Institute (NCI) | NIH |
| Karolinska Institutet | OTHER |
Participants will be randomized 1:1 into two different Groups. Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18. Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18.
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| Menveo®/Menactra® | Biological | Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines. |
|
| Kigali |
| Kigali |
| +250 |
| Rwanda |
| Wits RHI, University of the Witwatersrand | Johannesburg | Gauteng | 2001 | South Africa |
| 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 |