HPV InfectionPhase 4NCT04982614
HPV Vaccination in HIV Infected and HIV Uninfected Adolescents in Eswatini
A Phase 4 study testing Gardasil ® 9 in people with HPV Infection and Hiv, run by Columbia University at 5 sites in Eswatini.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 26 years
- Conditions the study is for
- HPV Infection, Hiv, HPV Vaccine
- What is being tested?
- Gardasil ® 9
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,403 participants
- Where
- 5 sitesEswatini
- Study dates
- 31 Mar 2022to 9 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Eswatini5 sites
AHF Lamvelase
Manzini
AHF Manzini
Manzini
Raleigh Fitkin Memorial Hospital
Manzini
AHF Matsapha
Matsapha
Baylor College of Medicine - Bristol Myers-Squibb Children's Clinical Centre of Excellence
Mbabane
About this study
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
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.
Read the 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.
- Conditions
- HPV Infection, Hiv, HPV Vaccine
- Being tested
- Gardasil ® 9
- Keywords
- HPV, Adolescents living with HIV, HPV immunogenicity, Vaccine adherence
- Medical subject headings
- Papillomavirus Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil ® 9Biological
Also called Human Papillomavirus 9-valent Vaccine, Recombinant, 9vHPV vaccine
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
| Study group | Role | What they receive |
|---|---|---|
| 2-dose regimen group | Experimental | 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. Receives: Biological: Gardasil ® 9 |
| 3-dose regimen group (SOC) | Active comparator | 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. Receives: Biological: Gardasil ® 9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV Geometric Mean Antibody Titer (IgG)
Serum antibodies against HPV antigen (IgG). Geometric mean titer will be summarized by treatment group, and the ratios of mean GMTs between treatment and control.
Measured: Month 7 (4 weeks post Month 6 vaccine dose)
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
Measured: Month 7 (4 weeks post Month 6 vaccine dose)
Secondary outcomes (2)
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.
Measured: Up to 6 months
Number of Participants Completing Vaccination Series
Number of eligible participants completing the 2-dose or 3-dose regimens will be tallied.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start31 Mar 2022
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Jhpiego, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Elaine J. Abrams, MD, Columbia University
- Investigators
- Elaine Abrams, MD, Principal investigator, Columbia UniversityXolisile Dlamini, Principal investigator, Ministry of Health Eswatini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982614
- Sponsor's protocol ID
- AAAT6912
- Other IDs
- 7200AA19CA 00003
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2021
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing plan is still under development. The plan will follow all in-country requirements for research conducted in Eswatini.
Publications
Nuwagaba-Biribonwoha H, Lamb MR, Dlamini X, Zerbe A, Anabwani-Richter FA, Zech JM, Hsu A, Mabuza N, Lukhele NM, Fayorsey R, Sahabo R, Nkambule R, El-Sadr WM, Abrams EJ. Immunogenicity of 2 versus 3 dose HPV vaccination by HIV infection status in Eswatini. Vaccine. 2026 Jul 11;85:128692. doi: 10.1016/j.vaccine.2026.128692. Epub 2026 May 16.
PubMed 42142523
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04982614
- Acronym / sponsor ID
- AAAT6912
- Conditions
- HPV Infection, Hiv, HPV Vaccine
- Keywords
- HPV, Adolescents living with HIV, HPV immunogenicity, Vaccine adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,403 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Jhpiego, Merck Sharp & Dohme LLC
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-dose regimen group | Experimental | Biological: Gardasil ® 9Boys 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. |
| 3-dose regimen group (SOC) | Active comparator | Biological: Gardasil ® 9HIV-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. |
Who may qualify
- Ages
- 9 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil ® 9Also: Human Papillomavirus 9-valent Vaccine, Recombinant, 9vHPV vaccineGARDASIL 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 | Biological | 2-dose regimen group, 3-dose regimen group (SOC) |
Primary outcome
Anti-HPV Geometric Mean Antibody Titer (IgG)
Time frame: Month 7 (4 weeks post Month 6 vaccine dose)
Serum antibodies against HPV antigen (IgG). Geometric mean titer will be summarized by treatment group, and the ratios of mean GMTs between treatment and control.
Number of Seroconversions
Time frame: Month 7 (4 weeks post Month 6 vaccine dose)
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
2 secondary outcomes
Number of Participants With Serious Adverse Events (SAE)
Time frame: Up to 6 months
Number of Participants Completing Vaccination Series
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42142523Nuwagaba-Biribonwoha H, Lamb MR, Dlamini X, Zerbe A, Anabwani-Richter FA, Zech JM, Hsu A, Mabuza N, Lukhele NM, Fayorsey R, Sahabo R, Nkambule R, El-Sadr WM, Abrams EJ. Immunogenicity of 2 versus 3 dose HPV vaccination by HIV infection status in Eswatini. Vaccine. 2026 Jul 11;85:128692. doi: 10.1016/j.vaccine.2026.128692. Epub 2026 May 16.
- Individual participant dataSharing planned: No. Data sharing plan is still under development. The plan will follow all in-country requirements for research conducted in Eswatini.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Abrams, MD principal investigator
Columbia University
Xolisile Dlamini principal investigator
Ministry of Health Eswatini
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gardasil ® 9 in people with HPV Infection and Hiv, run by Columbia University at 5 sites in Eswatini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HPV Geometric Mean Antibody Titer (IgG) (time frame: Month 7 (4 weeks post Month 6 vaccine dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.