Back to results

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

Primary Purpose

HPV Infection, Hiv, HPV Vaccine

Status

Active

Phase

Phase 4

Locations

Swaziland

Study Type

Interventional

Intervention

Gardasil ® 9

About this trial

This is an interventional prevention trial for HPV Infection focused on measuring HPV, Adolescents living with HIV, HPV immunogenicity, Vaccine adherence

Eligibility Criteria

9 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For people living with HIV receiving two-dose regimen:

Females 9-26 years and males 9-14 years,
Documented HIV infection,
Aware of HIV+ status,
Currently receiving antiretroviral treatment (ART) for HIV infection for at least six months,
Living in Eswatini,
For individuals 18+ years: able to provide informed consent,
For individuals 15-17 years: able to provide informed assent,
For individuals 9-14 years of age: able to provide informed assent AND accompanied by an adult caregiver who is able to give informed consent,
Intending to remain in the vicinity of the study sites for the study period

For reference group of HIV-uninfected women receiving three-dose regimen:

Females 15-26 years,
Documented negative HIV test at baseline
Living in Eswatini,
Able to provide informed assent (15-17 years) or informed consent (18-26 years)
Intending to remain in the vicinity of the study sites for the study period

Exclusion Criteria:

For all participants:

Diagnosis of other immunosuppressive diseases or receipt of immunosuppressive medications,
Diagnosis of other acute or chronic illness,
Receipt of other vaccinations within 2-3 weeks before or after study vaccination,
Receipt of blood-derived products within 6 months before or during the study,
Previous receipt of an HPV vaccine,
Currently pregnant,
Known allergies to a vaccine component

Sites / Locations

Bulembu Clinic
Hlathikhulu Government Hospital
AHF Lamvelase
AHF Manzini
Raleigh Fitkin Memorial Hospital
AHF Matsapha
Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence
Good Shephard Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2-dose regimen group

3-dose regimen group (SOC)

Arm Description

Boys and girls (aged 9-14 years) and young women (aged 15-26 years) living with HIV will receive a two-dose regimen of the HPV vaccine at baseline (Month 0) and Month 6.

HIV-uninfected young women (aged 15-26 years) will receive the standard of care three-dose regimen of the HPV vaccine at baseline (Month 0), Month 2 and Month 6.

Outcomes

Primary Outcome Measures

Anti-HPV geometric mean antibody titers

Serum antibodies against HPV antigens (IgG, IFNg, TNF, IL2, CXCL10, granzyme, perforin, PTX3). Geometric mean titers will be summarized by treatment group, and the ratios of mean GMTs between treatment and control and their 95% confidence intervals calculated around point estimates.

Number of seroconversions

Number of participants who seroconvert, defined as having no HPV antibodies pre-vaccination, but detectable HPV antibodies at 4 weeks post month 6 vaccine dose

Secondary Outcome Measures

Number of participants with serious adverse events (SAE)

Number of participants who reported experiences of SAE. SAE is defined as those that experienced death, life-threatening conditions or hospitalizations.

Number of participants completing vaccination series

Number of eligible participants completing the 2-dose or 3-dose regimens will be tallied.

Full Information

NCT ID

NCT04982614

First Posted

July 20, 2021

Last Updated

September 1, 2023

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT04982614

Brief Title

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

Official Title

A Multi-site, Open-label Non-inferiority Trial to Assess Immunogenicity of Two Doses of the Nonavalent Human Papillomavirus (HPV) Vaccine Among Children, Adolescents and Young Adults (9-26 Years) Living With HIV vs Three Doses of Nonavalent HPV Vaccine Among HIV Uninfected Young Women (15-26 Years) in Eswatini

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a multi-site, open-label non-inferiority study of the 9vHPV vaccine among a population of children, adolescents and young women living with HIV in Eswatini. This protocol seeks to assess immunogenicity of a two-dose 9vHPV vaccine regimen among girls and boys (9-14 years) and young women (15-26 years) living with HIV on antiretroviral therapy versus a three-dose 9vHPV vaccine regimen among HIV uninfected young women (15-26 years) in Eswatini. The secondary objectives include examining the safety profiles of the two-dose 9vHPV regimen in those living with HIV and the three-dose 9vHPV regimen in HIV-uninfected young women, as well as measuring the completion of the vaccination series among those living with HIV and those who are not infected with HIV.

Detailed Description

Cervical cancer remains a significant threat to public health worldwide and remains the leading cause of cancer-associated mortality in women in Sub Saharan Africa. Cervical cancer-associated morbidity and mortality is preventable through HPV vaccination, and screening and treatment of pre-cancerous lesions. To date, there is no nationwide HPV vaccination program in Eswatini and the country is not eligible for Global Alliance for Vaccines and Immunization (GAVI) procurement of HPV vaccines, and yet the triad of HIV, sexually transmitted infections (STI) and cervical cancer generates a severe disease burden warranting immediate introduction of this intervention. Given the global limitations in vaccine supply and the high cost for procurement, country programs, including in Eswatini, must optimize vaccine resources in order to maximize HPV vaccine coverage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV Infection, Hiv, HPV Vaccine

Keywords

HPV, Adolescents living with HIV, HPV immunogenicity, Vaccine adherence

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1403 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2-dose regimen group

Arm Type

Experimental

Arm Description

Boys and girls (aged 9-14 years) and young women (aged 15-26 years) living with HIV will receive a two-dose regimen of the HPV vaccine at baseline (Month 0) and Month 6.

Arm Title

3-dose regimen group (SOC)

Arm Type

Active Comparator

Arm Description

HIV-uninfected young women (aged 15-26 years) will receive the standard of care three-dose regimen of the HPV vaccine at baseline (Month 0), Month 2 and Month 6.

Intervention Type

Biological

Intervention Name(s)

Gardasil ® 9

Other Intervention Name(s)

Human Papillomavirus 9-valent Vaccine, Recombinant, 9vHPV vaccine

Intervention Description

GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer, and Genital warts (condyloma acuminata) caused by Human Papillomavirus (HPV). 0.5-mL suspension for intramuscular injection as a single-dose vial and prefilled syringe at the following regimen/schedule: 9 through 14 years - 2-dose at 0, 6 to 12 months OR 3-dose at 0, 2, 6 months 15 through 45 years - 3-dose at 0, 2, 6 months

Primary Outcome Measure Information:

Title

Anti-HPV geometric mean antibody titers

Description

Time Frame

Month 7 (4 weeks post Month 6 vaccine dose)

Title

Number of seroconversions

Description

Number of participants who seroconvert, defined as having no HPV antibodies pre-vaccination, but detectable HPV antibodies at 4 weeks post month 6 vaccine dose

Time Frame

Month 7 (4 weeks post Month 6 vaccine dose)

Secondary Outcome Measure Information:

Title

Number of participants with serious adverse events (SAE)

Description

Number of participants who reported experiences of SAE. SAE is defined as those that experienced death, life-threatening conditions or hospitalizations.

Time Frame

Up to 6 months

Title

Number of participants completing vaccination series

Description

Number of eligible participants completing the 2-dose or 3-dose regimens will be tallied.

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For people living with HIV receiving two-dose regimen: Females 9-26 years and males 9-14 years, Documented HIV infection, Aware of HIV+ status, Currently receiving antiretroviral treatment (ART) for HIV infection for at least six months, Living in Eswatini, For individuals 18+ years: able to provide informed consent, For individuals 15-17 years: able to provide informed assent, For individuals 9-14 years of age: able to provide informed assent AND accompanied by an adult caregiver who is able to give informed consent, Intending to remain in the vicinity of the study sites for the study period For reference group of HIV-uninfected women receiving three-dose regimen: Females 15-26 years, Documented negative HIV test at baseline Living in Eswatini, Able to provide informed assent (15-17 years) or informed consent (18-26 years) Intending to remain in the vicinity of the study sites for the study period Exclusion Criteria: For all participants: Diagnosis of other immunosuppressive diseases or receipt of immunosuppressive medications, Diagnosis of other acute or chronic illness, Receipt of other vaccinations within 2-3 weeks before or after study vaccination, Receipt of blood-derived products within 6 months before or during the study, Previous receipt of an HPV vaccine, Currently pregnant, Known allergies to a vaccine component

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elaine Abrams, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xolisile Dlamini

Organizational Affiliation

Ministry of Health Eswatini

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bulembu Clinic

City

Bulembu

Country

Swaziland

Facility Name

Hlathikhulu Government Hospital

City

Hlatikulu

Country

Swaziland

Facility Name

AHF Lamvelase

City

Manzini

Country

Swaziland

Facility Name

AHF Manzini

City

Manzini

Country

Swaziland

Facility Name

Raleigh Fitkin Memorial Hospital

City

Manzini

Country

Swaziland

Facility Name

AHF Matsapha

City

Matsapha

Country

Swaziland

Facility Name

Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence

City

Mbabane

Country

Swaziland

Facility Name

Good Shephard Hospital

City

Siteki

Country

Swaziland

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data sharing plan is still under development. The plan will follow all in-country requirements for research conducted in Eswatini.

Learn more about this trial

HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini

We'll reach out to this number within 24 hrs