ClinicalTrials.gg
CompletedNCT03284866COVENANTUpdated Oct 28, 2026Results posted

HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV

A Phase 3 interventional study of Laboratory Biomarker Analysis and Recombinant Human Papillomavirus Nonavalent Vaccine in AIDS-Related Human Papillomavirus Infection, High Grade Cervical Squamous Intraepithelial Neoplasia and HIV Infection, sponsored by AIDS Malignancy Consortium. Completed at 6 sites in 5 countries. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by AIDS Malignancy Consortium · Phase 3, Interventional, and Prevention

Updated Oct 28, 2026Results postedStudy documents posted+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
535
Allocation
Randomized
Ages
25 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in HIV Infections by AIDS Malignancy Consortium — 3 open to participants now, 4 under way, none of them phase 3. HIV Infections · AIDS Malignancy Consortium.

Enrollment
2nd of 16
535 · median 66
Started
2019
the only one that year
Phase 3
4 of 29
none open now
Registered
20th of 29
by date

Among the 29 studies in HIV Infections by AIDS Malignancy Consortium, this one is the 2nd largest by enrollment of the 16 interventional ones, is the only one that started in 2019, is one of 4 in phase 3, and was the 20th registered.

By phase

29 studies; the count open now beside each. This study's row is marked.

Observational11 · 0 open
Phase 25 · 0 open
Phase 3this study4 · 0 open
Phase 13 · 1 open
No phase2 · 1 open
Other kind2 · 1 open
Phase 1/22 · 0 open

By the year they started

First in 2008; this study’s year is marked. 1 started in 2019.

Size and results

Median enrollment 66 across the 16 interventional studies, 82 across the 13 observational. Of the 21 that completed or were terminated, 13 (62%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 29 studies in HIV Infections by AIDS Malignancy Consortium, or all of them as a file.
02

Study summary

This randomized phase III trial studies how well human papillomavirus (HPV) vaccine therapy works in reducing high-grade cervical lesions in patients with human immunodeficiency virus (HIV) and HPV. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill the HPV virus and prevent cervical lesions from developing or coming back after being removed.

Read the detailed description

At screening, potential participants will be tested for cervical human papillomavirus (HPV) infection (GeneXpert hrHPV assay and HPV DNA PCR) and undergo cervical colposcopy to confirm the absence of cervical cancer. If eligible, the participant will be randomized to receive either the 9-valent HPV vaccine or saline placebo.

Participants will return 4 and 26 weeks later for the second dose of vaccine or placebo. At week 4, participants will have cervical colposcopy and undergo cryotherapy or loop electrosurgical excisional procedure (LEEP) as appropriate. Participants undergoing cervical cryotherapy will have cervical biopsies before the treatment. Participants will be followed with HPV testing (Gene Xpert and HPV DNA PCR) at weeks 26, 52, 78, and 104, and will have cervical cytology and colposcopy with biopsies at weeks 26, 52, and 104.

03

Conditions studied

  • AIDS-Related Human Papillomavirus Infection
  • High Grade Cervical Squamous Intraepithelial Neoplasia
  • HIV Infection

Browse trials for

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • -1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load, or documentation of receipt of antiretroviral therapy; Note: the term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
  • HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected; Note: participants who are hrHPV positive with only HPV51/59 or HPV 39/68/56/66 detected are not eligible
  • Receipt of ART for at least 180 days prior to randomization
  • Participants of , defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of (e.g., barrier contraception or hormonal contraception), delaying pregnancy for at least 12 months and ideally for the duration of the study; Note: those willing to participate delay pregnancy for at least 6 months, while receiving the recombinant human papillomavirus nonavalent (9vHPV) vaccine (or placebo)
  • If the participant is of childbearing potential, she should be at least 3 months postpartum
  • score >= 70%
  • Ability to understand and the willingness to sign a written document

Exclusion criteria

Exclusion Criteria:

  • Current sexually transmitted infection (STI) requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9
  • Uncontrolled intercurrent illness that would limit compliance with study requirements
  • Prior hysterectomy with removal of the cervix
  • Prior treatment for cervical HSIL
  • Prior history of cervical, vulvar, or vaginal cancer
  • Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless show no invasive cancer
  • Known bleeding diathesis
  • Prior HPV vaccination
  • Current or planned use of anticoagulants other than aspirin or non-steroidal anti-inflammatory agents
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
535 participants (actual)

Study arms

  • Experimental
    Arm I, recombinant HPV 9-valent vaccine

    Patients receive Recombinant Human Papillomavirus Nonavalent Vaccine (Gardasil 9) IM at baseline, 4, and 26 weeks in the absence of disease progression or unacceptable toxicity, with sample collection for Laboratory Biomarker Analysis.

    Other: Laboratory Biomarker Analysis · Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

  • Placebo comparator
    Arm II, saline

    Patients receive saline placebo vaccine IM at baseline, 4, and 26 weeks, with sample collection for Laboratory Biomarker Analysis.

    Other: Laboratory Biomarker Analysis · Other: Saline

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • Given IM

    Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine, Recombinant HPV 9-valent Vaccine

  • OtherSaline

    Given IM

    Also known as: Sodium Chloride 0.9%

06

What researchers measure

Primary outcomes

  1. Occurrence of Cervical High-grade Squamous Intraepithelial Lesions (HSIL) or Cervical Cancer

    For each arm (vaccine and placebo), the HSIL or cancer event rate will be estimated using its point estimate and 95% Poisson confidence intervals. Poisson regression analyses will be used to compare the two arms with respect to event rate. In addition, time to event from week 4 to 52 will be described using the Kaplan-Meier method for each arm, and the two arms will be compared with respect to time to event using the log-rank test.

    Time frame: After week 4 study visit to week 52 post-randomization

Secondary outcomes

  1. Occurrence of Cervical HSIL or Invasive Cancer From Weeks 52-104

    The event rate for each arm from week 52 to week 104 for women who are event-free at 52 weeks will be estimated using its point estimate and 95% Poisson confidence interval. Poisson regression will be used to compare the two groups with respect to the event rate from week 52 to 104.

    Time frame: After week 52 to week 104

  2. Predictors of Sustained Absence of Cervical HSIL Through Week 104 and HPV Clearance

    Role of baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA, ART use, age, sexual behavior, and vaccination use will be investigated. Poisson regression analyses will be used to determine if these factors are associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. These analyses will also control for use of LEEP or cryotherapy.

    Time frame: At baseline through week 104

  3. Incident Cervical Vaccine Type HPV Infections

    Incident cervical vaccine type HPV infections are defined as HPV infections detected at 2 consecutive timepoints and assessed using type specific HPV DNA polymerase chain reaction (PCR) Vaccine and placebo participants will be compared with respect to these proportions using the chi-square test corrected for continuity.

    Time frame: Up to week 104

  4. Abnormal Cervical Cytology

    The proportion of women with abnormal cervical cytology at baseline, week 26, 52, and 104 will be reported and compared between arms.

    Time frame: Baseline, week 26, 52, and 104

  5. Prevalent Vulvar HSIL or Cancer

    The prevalence of vulvar HSIL or cancer at baseline will be estimated using the binomial proportion and its 95% confidence interval.

    Time frame: Up to week 4

  6. Incident Vulvar HSIL or Cancer

    The proportion of women who acquire vulvar HSIL or cancer among those negative for vulvar HSIL or cancer at baseline for both intervention arms will be estimated as a binomial proportion for both groups. The chi-square test corrected for continuity will be used to compare arms with respect to the proportions who acquire vulvar HSIL during the study.

    Time frame: Up to week 104

  7. Number of Participants Stratified by the Presence or Absence of Incident Vulvar HSIL/Cancers.

    Due to insufficient number of participants with outcome assessments, association (Logistic regression) analysis with clinical and demographic factors was not performed

    Time frame: Up to week 104

Other outcomes

  1. HPV Type Distributions

    Will characterize the HPV type distribution in baseline histology specimens and compare this to the types observed among incident cervical and vulvar HSIL lesions. Specifically, will compare the number and proportion of vaccine-type and non-vaccine type lesions between arms.

    Time frame: Up to week 104

  2. HPV Strain Variant Analysis of Cervical and Vulvar HSIL Specimens

    For study participants who have the same HPV type in HSIL specimens at baseline and follow-up time points, sequencing will be performed to determine whether or not HSIL is caused by an identical HPV strain. Will use all available pairs of baseline and follow-up HSIL caused by the same HPV type. Will report the proportion of these pairs with the same HPV strain in both treatment arms. Additionally, will report the rates of HSIL caused by new vaccine type infections. We will compare the two study groups using a chi-square test. This will be a descriptive analysis only as no sufficient data on which to power this analysis.

    Time frame: Up to week 104

  3. Tissue Microarray Library of Cervical Specimens for Biomarker Analysis and Discovery

    Specimen banking objective. There is no pre-specified statistical analysis plan for this objective. Any future studies using these specimens will need to receive separate approval by NCI and CTEP.

    Time frame: Up to week 104

  4. hrHPV Type Distribution in the Anus

    McNemar's chi-square test to compare the prevalence of that type in the anus and cervix will be used. For each hrHPV type, chi-square analyses will be used to compare the two HPV vaccination groups with respect to the distribution of that type in the (anus, cervix). Will report the proportion of incident cervical infections that were preceded by anal detection of the same type.

    Time frame: Up to week 104

  5. hrHPV Type Prevalence in the Anus

    McNemar's chi-square test to compare the prevalence of that type in the anus and cervix will be used. For each hrHPV type, chi-square analyses will be used to compare the two HPV vaccination groups with respect to the distribution of that type in the (anus, cervix). Will report the proportion of incident cervical infections that were preceded by anal detection of the same type.

    Time frame: Up to week 104

  6. Vaccine-induced Antibody Titers

    Will explore the antibody titers for the vaccine type found in the HSIL in these women as compared to those without HSIL caused by that type. Analysis of vaccine titers between those with incident vaccine type HPV infections that persist for 2 or more study visits and those that do not will be performed.

    Time frame: Up to week 104

07

Results

Posted Oct 28, 2026

Participant flow

Participant flow — Overall Study
MilestoneArm I, Recombinant HPV 9-valent VaccineArm II, Saline
Started265270
Discontinued before the initiation of treatment21
Intention to treat population238252
Per protocol population232249
Completed225237
Not completed4033

Outcome measures

PrimaryOccurrence of Cervical High-grade Squamous Intraepithelial Lesions (HSIL) or Cervical Cancer

For each arm (vaccine and placebo), the HSIL or cancer event rate will be estimated using its point estimate and 95% Poisson confidence intervals. Poisson regression analyses will be used to compare the two arms with respect to event rate. In addition, time to event from week 4 to 52 will be described using the Kaplan-Meier method for each arm, and the two arms will be compared with respect to time to event using the log-rank test.

Time frame:
After week 4 study visit to week 52 post-randomization
Reported as:
Number · events per 100 person-years
Occurrence of Cervical High-grade Squamous Intraepithelial Lesions (HSIL) or Cervical Cancer
events per 100 person-yearsArm I, Recombinant HPV 9-valent VaccineArm II, Saline
Intention to treat set16.4 (11.6 to 23.0)21.3 (15.9 to 28.6)
Per protocol set16.8 (12.0 to 23.7)21.6 (16.1 to 29.0)
Statistical analysis
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Poisson Regression · p = 0.1251 (One-sided p-value) · Incidence rate ratio: 0.77 · 95% CI .49 to 1.2
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Log Rank · p = 0.24
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Poisson regression · p = 0.13 (one-sided p-value) · Incidence rate ratio: 0.78 · 95% CI .50 to 1.22
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Log Rank · p = 0.2113
SecondaryOccurrence of Cervical HSIL or Invasive Cancer From Weeks 52-104

The event rate for each arm from week 52 to week 104 for women who are event-free at 52 weeks will be estimated using its point estimate and 95% Poisson confidence interval. Poisson regression will be used to compare the two groups with respect to the event rate from week 52 to 104.

Time frame:
After week 52 to week 104
Reported as:
Number · events per 100 person-years
Occurrence of Cervical HSIL or Invasive Cancer From Weeks 52-104
events per 100 person-yearsArm I, Recombinant HPV 9-valent VaccineArm II, Saline Placebo
Occurrence of Cervical HSIL or Invasive Cancer From Weeks 52-1044.87 (2.53 to 9.34)4.90 (2.55 to 9.41)
Statistical analysis
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline Placebo · Poisson Regression · p = 0.9913 · Incidence rate ratio: 0.99 · 95% CI 0.39 to 2.50
SecondaryPredictors of Sustained Absence of Cervical HSIL Through Week 104 and HPV Clearance

Role of baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA, ART use, age, sexual behavior, and vaccination use will be investigated. Poisson regression analyses will be used to determine if these factors are associated with of sustained absence of cervical HSIL and clearance of HPV infections after cryotherapy or LEEP. These analyses will also control for use of LEEP or cryotherapy.

Time frame:
At baseline through week 104

Results for this outcome have not been posted.

SecondaryIncident Cervical Vaccine Type HPV Infections

Incident cervical vaccine type HPV infections are defined as HPV infections detected at 2 consecutive timepoints and assessed using type specific HPV DNA polymerase chain reaction (PCR) Vaccine and placebo participants will be compared with respect to these proportions using the chi-square test corrected for continuity.

Time frame:
Up to week 104

Results for this outcome have not been posted.

SecondaryAbnormal Cervical Cytology

The proportion of women with abnormal cervical cytology at baseline, week 26, 52, and 104 will be reported and compared between arms.

Time frame:
Baseline, week 26, 52, and 104
Reported as:
Count of participants · Participants
Abnormal Cervical Cytology
ParticipantsArm I, Recombinant HPV 9-valent VaccineArm II, Saline
Baseline — NILM9789
Baseline — >=ASCUS164174
Week 26 — NILM160160
Week 26 — >=ASCUS7492
Week 52 — NILM167173
Week 52 — >=ASCUS5560
Week 104 — NILM174180
Week 104 — >=ASCUS4650
Statistical analysis
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Chi-squared · p = 0.4265
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Chi-squared · p = 0.2566
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Chi-squared · p = 0.8107
  • Arm I, Recombinant HPV 9-valent Vaccine vs Arm II, Saline · Chi-squared · p = 0.8299
SecondaryPrevalent Vulvar HSIL or Cancer

The prevalence of vulvar HSIL or cancer at baseline will be estimated using the binomial proportion and its 95% confidence interval.

Time frame:
Up to week 4
Reported as:
Count of participants · Participants
Prevalent Vulvar HSIL or Cancer
ParticipantsArm I, Recombinant HPV 9-valent VaccineArm II, Saline Placebo
Prevalent Vulvar HSIL or Cancer24
SecondaryIncident Vulvar HSIL or Cancer

The proportion of women who acquire vulvar HSIL or cancer among those negative for vulvar HSIL or cancer at baseline for both intervention arms will be estimated as a binomial proportion for both groups. The chi-square test corrected for continuity will be used to compare arms with respect to the proportions who acquire vulvar HSIL during the study.

Time frame:
Up to week 104
Reported as:
Count of participants · Participants
Incident Vulvar HSIL or Cancer
ParticipantsArm I, Recombinant HPV 9-valent VaccineArm II, Saline
Incident Vulvar HSIL or Cancer10
SecondaryNumber of Participants Stratified by the Presence or Absence of Incident Vulvar HSIL/Cancers.

Due to insufficient number of participants with outcome assessments, association (Logistic regression) analysis with clinical and demographic factors was not performed

Time frame:
Up to week 104
Reported as:
Count of participants · Participants
Number of Participants Stratified by the Presence or Absence of Incident Vulvar HSIL/Cancers.
ParticipantsArm I, Recombinant HPV 9-valent VaccineArm II, Saline
Participants with incident vulvar HSIL/Cancer10
Participants with no incident vulvar HSIL/Cancer13
Other pre-specifiedHPV Type Distributions

Will characterize the HPV type distribution in baseline histology specimens and compare this to the types observed among incident cervical and vulvar HSIL lesions. Specifically, will compare the number and proportion of vaccine-type and non-vaccine type lesions between arms.

Time frame:
Up to week 104

Results for this outcome have not been posted.

Other pre-specifiedHPV Strain Variant Analysis of Cervical and Vulvar HSIL Specimens

For study participants who have the same HPV type in HSIL specimens at baseline and follow-up time points, sequencing will be performed to determine whether or not HSIL is caused by an identical HPV strain. Will use all available pairs of baseline and follow-up HSIL caused by the same HPV type. Will report the proportion of these pairs with the same HPV strain in both treatment arms. Additionally, will report the rates of HSIL caused by new vaccine type infections. We will compare the two study groups using a chi-square test. This will be a descriptive analysis only as no sufficient data on which to power this analysis.

Time frame:
Up to week 104

Results for this outcome have not been posted.

Other pre-specifiedTissue Microarray Library of Cervical Specimens for Biomarker Analysis and Discovery

Specimen banking objective. There is no pre-specified statistical analysis plan for this objective. Any future studies using these specimens will need to receive separate approval by NCI and CTEP.

Time frame:
Up to week 104

Results for this outcome have not been posted.

Other pre-specifiedhrHPV Type Distribution in the Anus

McNemar's chi-square test to compare the prevalence of that type in the anus and cervix will be used. For each hrHPV type, chi-square analyses will be used to compare the two HPV vaccination groups with respect to the distribution of that type in the (anus, cervix). Will report the proportion of incident cervical infections that were preceded by anal detection of the same type.

Time frame:
Up to week 104

Results for this outcome have not been posted.

Other pre-specifiedhrHPV Type Prevalence in the Anus

McNemar's chi-square test to compare the prevalence of that type in the anus and cervix will be used. For each hrHPV type, chi-square analyses will be used to compare the two HPV vaccination groups with respect to the distribution of that type in the (anus, cervix). Will report the proportion of incident cervical infections that were preceded by anal detection of the same type.

Time frame:
Up to week 104

Results for this outcome have not been posted.

Other pre-specifiedVaccine-induced Antibody Titers

Will explore the antibody titers for the vaccine type found in the HSIL in these women as compared to those without HSIL caused by that type. Analysis of vaccine titers between those with incident vaccine type HPV infections that persist for 2 or more study visits and those that do not will be performed.

Time frame:
Up to week 104

Results for this outcome have not been posted.

Adverse events

Collected over AE data is based on all study follow-ups until week 104. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I, Recombinant HPV 9-valent Vaccine4/265 (1.5%)16/265 (6%)20/265 (7.5%)
Arm II, Saline3/270 (1.1%)20/270 (7.4%)22/270 (8.1%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventArm I, Recombinant HPV 9-valent VaccineArm II, Saline
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHERNeoplasms benign, malignant and unspecified (incl cysts and polyps)7/2658/270
PREGNANCY LOSSPregnancy, puerperium and perinatal conditions2/2650/270
ANEMIABlood and lymphatic system disorders1/2651/270
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHERBlood and lymphatic system disorders1/2650/270
GASTROINTESTINAL DISORDERS - OTHERGastrointestinal disorders1/2650/270
SEPSISInfections and infestations1/2650/270
SEPSISInjury, poisoning and procedural complications1/2650/270
HYPOGLYCEMIAMetabolism and nutrition disorders1/2650/270
PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS - OTHERPregnancy, puerperium and perinatal conditions1/2650/270
SURGICAL AND MEDICAL PROCEDURES - OTHERSurgical and medical procedures1/2651/270
Most frequent other events
Most frequent other events
EventArm I, Recombinant HPV 9-valent VaccineArm II, Saline
PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS - OTHERPregnancy, puerperium and perinatal conditions9/26512/270
HYPERTENSIONVascular disorders7/2656/270
SURGICAL AND MEDICAL PROCEDURES - OTHERSurgical and medical procedures0/2652/270
ANEMIABlood and lymphatic system disorders1/2651/270
SOFT TISSUE NECROSIS LOWER LIMBMusculoskeletal and connective tissue disorders1/2650/270
DIZZINESSNervous system disorders1/2650/270
VAGINAL DISCHARGEReproductive system and breast disorders1/2650/270
BRONCHIAL OBSTRUCTIONRespiratory, thoracic and mediastinal disorders0/2651/270

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(years)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
Median38.0 (32.9 to 44.2)39.5 (33.1 to 44.6)39.0 (33.0 to 44.4)
Age, Customized
Age, Customized(Participants)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
<=359385178
35.1-45115126241
45.1-655759116
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
Female265270535
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
Hispanic or Latino011
Not Hispanic or Latino179179358
Unknown or Not Reported8690176
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American184181365
White101
More than one race022
Unknown or Not Reported8087167
CD4+ cells nadir at baseline
CD4+ cells nadir at baseline(Participants)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
<200 cells per cubic mm334376
>=200 cells per cubic mm8272154
Not known150155305
Median CD4+ nadir at baseline
Median CD4+ nadir at baseline(cells per cubic millimeters)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
Median256.0 (143.0 to 389.0)242.5 (141.0 to 369.0)247.0 (142.0 to 374.0)
HIV viral load
HIV viral load(Participants)Arm I, Recombinant HPV 9-valent VaccineArm II, Saline PlaceboTotal
≥200 copies/mL151429
<200 copies/mL249255504
Missing data112

8 further baseline measures are reported on the registry.

08

Study locations

6 sites
  • Moi University School of Medicine
    Eldoret, Kenya
  • UNC Project Malawi
    Lilongwe, Malawi
  • African Cancer Institute at Stellenbosch
    Cape Town, South Africa
  • University of the Witwatersrand
    Johannesburg, South Africa
  • Uganda Cancer Institute
    Kampala, Uganda
  • University of Zimbabwe
    Harare, Zimbabwe
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

1 registry update since Sep 25, 2026
Results
Results posted
posted Oct 28, 2026
Enrollment
536→535
Oct 28, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedOccurrence of cervical highCervical High-grade squamous intraepithelial lesionsSquamous Intraepithelial Lesions (HSIL) or cervical cancerCervical CancerTime frame: After week 4 study visit to week 52 post-randomization
Oct 28, 2026
Secondary outcomes
10 edited, 3 added, 10 removed
What changed in the outcomes
  • EditedOccurrence of cervicalCervical HSIL from weeksor Invasive Cancer From Weeks 52-104Time frame: After week 52 to week 104
  • EditedAbnormal cervical cytologyCervical CytologyTime frame: Baseline, week 26, 52, and 104
  • EditedPrevalent vulvarVulvar HSIL or cancerCancerTime frame: Up to week 4
  • EditedIncident vulvarVulvar HSIL or cancerCancerTime frame: Up to week 104
  • AddedPredictors of Sustained Absence of Cervical HSIL Through Week 104 and HPV ClearanceTime frame: At baseline through week 104
  • AddedIncident Cervical Vaccine Type HPV InfectionsTime frame: Up to week 104
  • AddedNumber of Participants Stratified by the Presence or Absence of Incident Vulvar HSIL/Cancers.Time frame: Up to week 104
  • RemovedRole of baseline types and quantity of HPV as predictors of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of presence of HSIL at baseline as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of CD4+ cell count as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of plasma HIV-1 RNA as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of ART use as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of age as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of sexual behavior as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedRole of vaccination use as a predictor of sustained absenceTime frame: At baseline and week 4
  • RemovedIncident cervical vaccine type HPV infections defined as infections at 2 consecutive timepoints and assessed using type specific HPV DNA polymerase chain reaction (PCR)Time frame: Up to week 104
  • RemovedClinical and demographic factors associated with incident vulvar HSIL or cancerTime frame: Up to week 104
  • Editedother outcomeHPV type distributionsType DistributionsTime frame: Up to week 104
  • Editedother outcomeHPV strain variant analysisStrain Variant Analysis of cervicalCervical and vulvarVulvar HSIL specimensSpecimensTime frame: Up to week 104
  • Editedother outcomeTissue microarray libraryMicroarray Library of cervical specimensCervical Specimens for biomarker analysisBiomarker Analysis and discoveryDiscoveryTime frame: Up to week 104
  • Editedother outcomehrHPV type distributionType Distribution in the anusAnusTime frame: Up to week 104
  • Editedother outcomehrHPV type prevalenceType Prevalence in the anusAnusTime frame: Up to week 104
  • Editedother outcomeVaccine-induced antibody titersAntibody TitersTime frame: Up to week 104
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Results posted
    Enrollment 536→535
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedOccurrence of cervical highCervical High-grade squamous intraepithelial lesionsSquamous Intraepithelial Lesions (HSIL) or cervical cancerCervical CancerTime frame: After week 4 study visit to week 52 post-randomization
    Secondary outcomes 10 edited, 3 added, 10 removed
    What changed in the outcomes
    • EditedOccurrence of cervicalCervical HSIL from weeksor Invasive Cancer From Weeks 52-104Time frame: After week 52 to week 104
    • EditedAbnormal cervical cytologyCervical CytologyTime frame: Baseline, week 26, 52, and 104
    • EditedPrevalent vulvarVulvar HSIL or cancerCancerTime frame: Up to week 4
    • EditedIncident vulvarVulvar HSIL or cancerCancerTime frame: Up to week 104
    • AddedPredictors of Sustained Absence of Cervical HSIL Through Week 104 and HPV ClearanceTime frame: At baseline through week 104
    • AddedIncident Cervical Vaccine Type HPV InfectionsTime frame: Up to week 104
    • AddedNumber of Participants Stratified by the Presence or Absence of Incident Vulvar HSIL/Cancers.Time frame: Up to week 104
    • RemovedRole of baseline types and quantity of HPV as predictors of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of presence of HSIL at baseline as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of CD4+ cell count as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of plasma HIV-1 RNA as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of ART use as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of age as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of sexual behavior as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedRole of vaccination use as a predictor of sustained absenceTime frame: At baseline and week 4
    • RemovedIncident cervical vaccine type HPV infections defined as infections at 2 consecutive timepoints and assessed using type specific HPV DNA polymerase chain reaction (PCR)Time frame: Up to week 104
    • RemovedClinical and demographic factors associated with incident vulvar HSIL or cancerTime frame: Up to week 104
    • Editedother outcomeHPV type distributionsType DistributionsTime frame: Up to week 104
    • Editedother outcomeHPV strain variant analysisStrain Variant Analysis of cervicalCervical and vulvarVulvar HSIL specimensSpecimensTime frame: Up to week 104
    • Editedother outcomeTissue microarray libraryMicroarray Library of cervical specimensCervical Specimens for biomarker analysisBiomarker Analysis and discoveryDiscoveryTime frame: Up to week 104
    • Editedother outcomehrHPV type distributionType Distribution in the anusAnusTime frame: Up to week 104
    • Editedother outcomehrHPV type prevalenceType Prevalence in the anusAnusTime frame: Up to week 104
    • Editedother outcomeVaccine-induced antibody titersAntibody TitersTime frame: Up to week 104
    + 3 other changes: verification date, registry dates and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03284866
Lead sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI), University of Arkansas, AIDS and Cancer Specimen Resource, Merck Sharp & Dohme LLC, The Emmes Company, LLC, University of California, Los Angeles
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Jul 31, 2019
Primary completion
Nov 26, 2024
Completion
Aug 5, 2025
Results posted
Oct 28, 2026
Last update
Oct 28, 2026

Study contacts

Carla Chibwesha
principal investigator · University of Witwatersrand, South Africa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent

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