## Protocol Section
### Identification Module
**NCT ID:** NCT06436274

**Acronym:** HOPE II

**Brief Title:** Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.

**Official Title:** Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.

#### Organization Study ID Info
**ID:** 2024P000880
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2027-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Witwatersrand, South Africa

**Class:** OTHER

**Name:** Botswana Harvard AIDS Institute Partnership

**Class:** OTHER_GOV

**Name:** Ministry of Health, Rwanda

**Class:** OTHER

**Name:** Fred Hutchinson Cancer Center

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Ruanne Barnabas, MBChB, MSc, DPhil.

**Investigator Title:** Chief of the Division of Infectious Diseases

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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 one HPV vaccination prior to HIV diagnosis.

**Detailed Description:** 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.

* 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

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.

### Conditions Module

**Conditions:**

- Human Papilloma Virus

- Hiv

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 750

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18

**Intervention Names:**

- Biological: GARDASIL®9

- Biological: Menveo®/Menactra®

**Label:** Group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18

**Intervention Names:**

- Biological: GARDASIL®9

- Biological: Menveo®/Menactra®

**Label:** Group 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

- Group 2

**Description:** GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

**Name:** GARDASIL®9

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Group 1

- Group 2

**Description:** Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.

**Name:** Menveo®/Menactra®

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18 before their HIV diagnosis.

**Time Frame:** 18 Months

#### Secondary Outcomes

**Description:** This will be evaluated by comparing the occurrence of serious adverse events reported among each study arm.

**Measure:** Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.

**Time Frame:** 18 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Assigned female at birth
2. Age 16 years and above on the day of signing the informed consent form
3. Living with HIV with confirmed test results or clinic records
4. History of receiving a single dose of an HPV vaccine before HIV diagnosis
5. Self-reported sexually active in the last six months
6. Lives within the study area and willing to provide updated locator information over the course of the study
7. Does not have an autoimmune, degenerative, or genetic disease
8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)
9. No other Investigator-determined factor would limit participation in the trial
10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
11. The participant has a cervix

Exclusion Criteria:

1. Anyone with cervical abnormality on examination
2. Anyone with an allergy to vaccine components or yeast

**Gender Based:** True

**Gender Description:** Assigned female at birth

**Minimum Age:** 16 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** IDCRU@mgh.harvard.edu

**Name:** Diane Kanjilal, FNP

**Phone:** 617-643-9958

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Mass General Brigham

**Name:** Ruanne Barnabas, MBChB, MSc, DPhil

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Wits RHI, University of The Witwatersrand

**Name:** Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018307

- Term: Neoplasms, Squamous Cell

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13131

- Name: Papilloma

- Relevance: HIGH

- As Found: Papilloma

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20451

- Name: Neoplasms, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010212

- Term: Papilloma

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
