HIV InfectionsPhase 2NCT00339040

Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

A Phase 2 study testing Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) in people with HIV Infections and Sexually Transmitted Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years. Read more about this study

Who is it for?: Ages 7 to 12 years
Conditions the study is for: HIV Infections, Sexually Transmitted Diseases
What is being tested?: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 34 sitesin 2 countries
Study dates: Oct 2006to Aug 2009
Phase: Phase 2
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 7 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children ages ≥ 7 to < 12 years of age.
A confirmed diagnosis of HIV infection, defined as two positive assays from two different samples. The two results may be in any combination of the following:
at any age: Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), Ribonucleic acid (RNA) PCR
age > 4 weeks: p24 antigen detection
age >18 months: licensed ELISA (Enzyme-linked immunosorbent assay) with confirmatory Western Blot
CD4% ≥ 15 at the time of screening is required (Note that this is a minimum requirement, and that for Stratum C the CD4% needs to be ≥ 25).

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For Strata A and B: Currently stable (≥ 3 months) on highly active antiretroviral therapy (HAART) regimen, defined as three or more antiretrovirals from at least two different therapeutic classes, or therapy with the combination of azidothymidine, lamivudine, and abacavir.
For stratum C no antiretroviral therapy is required.
Parent or legal guardian able and willing to provide signed informed consent.
Negative urine pregnancy test sensitive to 25 International Unit (IU) beta-human chorionic gonadotropin (HCG) for girls who are menstruating (child bearing potential).
Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception, one of which must be a barrier method. A barrier method of contraception (condoms or cervical cap) together with another reliable form of contraception (condoms a , with a spermicidal agent; a diaphragm or cervical cap with spermicide; an intrauterine device [IUD]; or hormonal-based contraception) must be used while on this study. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission
Males participating in the study must not attempt to impregnate a woman, or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom.

Who cannot join

Body temperature ≥ 101 F or ≥ 38.3 C, orally determined, within 72 hours prior to the first and each subsequent injection. Subjects may be vaccinated any time in the next seven days thereafter, provided that the site investigator is satisfied that the febrile illness has ended.
Total bilirubin ≥ 5 x Upper Limit of Normal (ULN) at screening.
Alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 5 x ULN at screening in the absence of other explained causes (as determined by the site investigator) at screening.
Serum creatinine ≥ 1.5 mg/dL at screening.
Absolute neutrophil count ≤ 750 cells/mm3 at screening.
Hemoglobin ≤ 9.9 g/dL at screening.

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Platelet count ≤ 75,000 cells/mm³ at screening.
Presence of an acute opportunistic non-bacterial or bacterial infection requiring therapy at the time of enrollment; the subject may be entered once he/she is stable on appropriate anti-infective therapy.
Chemotherapy for active malignancy.
Other known or suspected disease of the immune system, or immunosuppressive therapy.
Prior treatment with immunosuppressive or immunomodulation therapy within 60 days of screening.
Prior treatment with three or more week-long courses of corticosteroids (≥ 2.0 mg/kg or ≥ 20 mg total of prednisone-equivalent) within one year of screening; or any systemic (oral or parenteral) steroids (≥ 2.0 mg/kg or ≥ 20 mg total of prednisone-equivalent for ≥ 3 days) within 30 days of study entry.
Prior vaccinations with inactivated vaccines received within two weeks of any dose of study vaccine, and no other vaccinations may be planned for two weeks after each dose of study vaccine.
Prior vaccinations with live vaccines received within three weeks before any dose of study vaccine, and no other vaccinations may be planned for two weeks after each dose of study vaccine.
Prior diagnosis of sexually transmitted infections (STIs), genital warts, or juvenile recurrent papillomatosis.
History of any severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
Known allergies to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]).
Previous treatment with any immune globulin preparation or blood-derived products within the six months prior to the first injection and none may be planned during the study.
Known coagulation disorder that would contraindicate Intramuscular (IM) injections.
Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.
Breastfeeding.

Trial locations and contacts

34 sites in 2 countries.

Country

City, postcode or hospital

34 sites in 2 countries

United States32 sites

Usc La Nichd Crs
Alhambra, California, 91803
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 80045
Children's Hosp. of Boston NICHD CRS
Boston, Massachusetts, 02115
Boston Medical Center Ped. HIV Program NICHD CRS
Boston, Massachusetts, 02118
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, 60608
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, 60612
Chicago Children's CRS
Chicago, Illinois, 60614
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
DUMC Ped. CRS
Durham, North Carolina, 27710
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33316
Connecticut Children's Med. Ctr.
Hartford, Connecticut, 06106
Texas Children's Hosp. CRS
Houston, Texas, 77030
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, 90806
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 90095-1752
St. Jude/UTHSC CRS
Memphis, Tennessee, 38105
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33136
Children's Hosp.
New Orleans, Louisiana, 70118
Nyu Ny Nichd Crs
New York, New York, 10016
Rutgers - New Jersey Medical School CRS
Newark, New Jersey, 07103
Children's Hosp. of Orange County
Orange, California, 92868-3874
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 14642
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103
Univ. of California San Francisco NICHD CRS
San Francisco, California, 94143
Seattle Children's Hospital CRS
Seattle, Washington, 98105
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794-8111
Bronx-Lebanon CRS
The Bronx, New York, 10457
Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20010
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, 01605

Other trials in United States

Puerto Rico2 sites

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 00935
San Juan City Hosp. PR NICHD CRS
San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in HIV Infected Children 7 to 12 Years of Age

Read the detailed description

Genital HPV infection is the most common sexually transmitted infection in the world and may lead to genital warts, anogenital dysplasias, and invasive cancers. HIV infected people and others with compromised immunity are at greater risk for HPV-related complications. In particular, researchers are concerned about the risk of HPV infection to women, who may be infected by their male partners, especially if these partners engage in anal intercourse. HIV infected women tend to have multiple types of HPV (associated with a greater risk of HPV-related disease), are less likely to clear HPV-related conditions, and are more likely to progress to HPV-related disease. The quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine to be tested in this study was safe and generally well tolerated in previous studies conducted in healthy and HPV-exposed adolescents, young adults, and older women. However, it is still unclear if the vaccine will be safe and will elicit a similar immune response in younger children. The purpose of this study is to evaluate the safety and immunogenicity of the novel quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine in HIV infected children 7 to 12 years of age.

This study had two stages and lasted at least 108 weeks. In Stage I, participants were stratified by CD4 percentage (CD4%) nadir and CD4% at study screening (Stratum A: CD4% Nadir < 15 and CD4% ≥ 15 at screening, Stratum B: CD4% Nadir ≥ 15 and < 25 and CD4% ≥ 15 at screening, Stratum C: CD4% Nadir ≥ 25 and CD4% ≥ 25 at screening). Within each stratification group, they were randomly assigned to one of two arms. During Stage I, Arm A (QHPV:Quadrivalent human papillomavirus vaccine) participants received 3 doses of vaccine, while Arm B (Placebo/QHPV) participants received 3 doses of placebo. Participants did not know whether they were receiving vaccine or placebo. Participants received their assigned intervention at study entry and Weeks 8 and 24. At Week 96, Stage II began, and all study participants were told if they received vaccine or placebo in Stage I. Arm A participants received an additional dose of vaccine at Week 96; Arm B participants received doses of vaccine at Weeks 96, 104, and 120. Over the course of the study, there were at least 12 study visits. A physical exam and blood collection occurred at most visits; medical history occurred at selected visits.

After each vaccination, participants were observed for at least 30 minutes to monitor for any allergic reactions possibly resulting from the vaccination. For 15 days following vaccination, parents or guardians were asked to complete a "report card" with details of each child's signs and symptoms. Three days after each vaccination, parents or guardians of study participants were contacted by telephone and asked about any adverse events that a child may have experienced.

Conditions: HIV Infections, Sexually Transmitted Diseases
Being tested: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV), Placebo/QHPV
Keywords: HPV
Medical subject headings: HIV Infections, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)Biological
Also called QHPV
QHPV at week 0, 8, 24 and 96.
Placebo/QHPVOther
Placebo at week 0, 8, 24 and QHPV at week 96, 104, 120.

Study groups in NCT00339040
Study group	Role	What they receive
Arm A: QHPV	Active comparator	QHPV at week 0, 8, 24, 96. Receives: Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
Arm B: Placebo/QHPV	Other	Placebo at week 0, 8, 24; QHPV at week 96, 104, 120. Receives: Other: Placebo/QHPV

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1="Mild", Grade 2="Moderate", Grade 3="Severe", Grade 4="Potentially Life-Threatening". All grade 3 and higher signs, symptoms, and laboratory toxicities were included.
Measured: Within 14 days of first three doses of vaccination
Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, "Treatment related", "Non-treatment related", "Baseline", "Possibly treatment related".
Measured: Within 14 days of first three doses of vaccination
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion
Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.
Measured: At week 28 after beginning the vaccination series
Serum Anti-HPV Antibody Titers (cLIA)
Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)
Measured: Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.

Secondary outcomes (3)

CD4 Count Over Time
Measured: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
CD4 Percent Over Time
Measured: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time
Measured: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Aug 2009

First posted20 Jun 2006 (estimated)
Study startOct 2006
Primary completionAug 2009
Study completionAug 2009

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 (6)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00339040
Sponsor's protocol ID: P1047
Other IDs: 10163, PACTG P1047
Status last verified: Jan 2019
First submitted: 19 Jun 2006
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Ault KA, Giuliano AR, Edwards RP, Tamms G, Kim LL, Smith JF, Jansen KU, Allende M, Taddeo FJ, Skulsky D, Barr E. A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine. Vaccine. 2004 Aug 13;22(23-24):3004-7. doi: 10.1016/j.vaccine.2004.02.020.
PubMed 15297048
Brown DR, Fife KH, Wheeler CM, Koutsky LA, Lupinacci LM, Railkar R, Suhr G, Barr E, Dicello A, Li W, Smith JF, Tadesse A, Jansen KU. Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine. Vaccine. 2004 Jul 29;22(21-22):2936-42. doi: 10.1016/j.vaccine.2003.11.059.
PubMed 15246630
Poland GA, Jacobson RM, Koutsky LA, Tamms GM, Railkar R, Smith JF, Bryan JT, Cavanaugh PF Jr, Jansen KU, Barr E. Immunogenicity and reactogenicity of a novel vaccine for human papillomavirus 16: a 2-year randomized controlled clinical trial. Mayo Clin Proc. 2005 May;80(5):601-10. doi: 10.4065/80.5.601.
PubMed 15887427
Levin MJ, Moscicki AB, Song LY, Fenton T, Meyer WA 3rd, Read JS, Handelsman EL, Nowak B, Sattler CA, Saah A, Radley DR, Esser MT, Weinberg A; IMPAACT P1047 Protocol Team. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. J Acquir Immune Defic Syndr. 2010 Oct;55(2):197-204. doi: 10.1097/QAI.0b013e3181de8d26.
PubMed 20574412
P1047 ORAL PRESENTATION at the 25th International Papillomavirus Conference May 8-14 2009, Malmö, Sweden given by Anna Barbara Moscicki. Safety and immunogenicity of Gardasil® in HIV-infected children. Moscicki AB, Weinberg A, Song LY, Handelsman E, Patterson J, Saah A, Radley D, Read JS, Sattler C and Levin MJ for IMPAACT P1047 team.
Weinberg A, Song LY, Handelsman E, Moscicki AB, Patterson J, Saah A, Radley D, Esser M, Read J, and Levin MJ for IMPAACT P1047 Team. The P1047 data up to week 28 have been analyzed and presented to 15th CROI as abstract and poster #619a: Safety and Immunogenicity of a Quadrivalent Vaccine to Prevent Human Papilloma Virus (HPV) in HIV-Infected Children: IMPAACT P1047.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in HIV Infected Children 7 to 12 Years of Age
ClinicalTrials.gov ID: NCT00339040
Acronym / sponsor ID: P1047
Conditions: HIV Infections, Sexually Transmitted Diseases
Keywords: HPV
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Oct 2006
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 20 Jun 2006 (estimated)
Results: Posted 16 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm A: QHPV	Active comparator	Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)QHPV at week 0, 8, 24, 96.
Arm B: Placebo/QHPV	Other	Other: Placebo/QHPVPlacebo at week 0, 8, 24; QHPV at week 96, 104, 120.

Who may qualify

Ages: 7 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (12 listed)

Children ages ≥ 7 to < 12 years of age.
A confirmed diagnosis of HIV infection, defined as two positive assays from two different samples. The two results may be in any combination of the following:
at any age: Deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), Ribonucleic acid (RNA) PCR
age > 4 weeks: p24 antigen detection
age >18 months: licensed ELISA (Enzyme-linked immunosorbent assay) with confirmatory Western Blot

Key exclusion criteria (21 listed)

Body temperature ≥ 101 F or ≥ 38.3 C, orally determined, within 72 hours prior to the first and each subsequent injection. Subjects may be vaccinated any time in the next seven days thereafter, provided that the site investigator is satisfied that the febrile illness has ended.
Total bilirubin ≥ 5 x Upper Limit of Normal (ULN) at screening.
Alanine transaminase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≥ 5 x ULN at screening in the absence of other explained causes (as determined by the site investigator) at screening.
Serum creatinine ≥ 1.5 mg/dL at screening.
Absolute neutrophil count ≤ 750 cells/mm3 at screening.

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
Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)Also: QHPVQHPV at week 0, 8, 24 and 96.	Biological	Arm A: QHPV
Placebo/QHPVPlacebo at week 0, 8, 24 and QHPV at week 96, 104, 120.	Other	Arm B: Placebo/QHPV

Primary outcome

Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)
Time frame: Within 14 days of first three doses of vaccination
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). The grades used are: Grade 1="Mild", Grade 2="Moderate", Grade 3="Severe", Grade 4="Potentially Life-Threatening". All grade 3 and higher signs, symptoms, and laboratory toxicities were included.
Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment
Time frame: Within 14 days of first three doses of vaccination
Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (December 2004). All grade 3 and higher signs, symptoms, and laboratory toxicities attributed to study treatment were included. The relationship between the Adverse Events and the vaccination were evaluated by study team and assigned to, for example, "Treatment related", "Non-treatment related", "Baseline", "Possibly treatment related".
Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion
Time frame: At week 28 after beginning the vaccination series
Serum anti-HPV 6, 11, 16, and 18 antibody was measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units [mMU]/mL). Sero-positivity was defined as an anti-HPV titer ≥20, 16, 20, and 24 mMU/mL, for HPV types 6, 11, 16, and 18, respectively.
Serum Anti-HPV Antibody Titers (cLIA)
Time frame: Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.
Geometric means of Type-specific Serum anti-HPV antibody titers (cLIA)

3 secondary outcomes

CD4 Count Over Time
Time frame: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
CD4 Percent Over Time
Time frame: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.
HIV-1 Viral Load (Ribonucleic Acid [RNA] Copies/ml) Over Time
Time frame: Arm A week 0, 8, 12, 24, 28, 72, 96, 100 and 108; Arm B week 0, 8, 12, 24, 28, 72, 96, 100, 104, 108, 120, and 124.

Results and safety

Results posted to the registry on 16 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A QHPV	96	94
Arm B Placebo/QHPV	30	29

Primary outcome: Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs)

Time frame: Within 14 days of first three doses of vaccination. Number (95% Confidence Interval). Unit: percent of participants

Measure	Arm A QHPV n = 96	Arm B Placebo/QHPV n = 30
Value	7.3 (3.0 to 14.5)	6.7 (0.8 to 22.1)

Arm A QHPV vs Arm B Placebo/QHPV: p = 1.00, Fisher Exact

Population analysed: Any participant who received at least one study vaccine/placebo were included in the safety analysis.

Primary outcome: Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) Attributed to Study Treatment

Time frame: Within 14 days of first three doses of vaccination. Number (95% Confidence Interval). Unit: percent of participants

Measure	Arm A QHPV n = 96	Arm B Placebo/QHPV n = 30
Value	0 (0 to 0)	0 (0 to 0)

Population analysed: Any participant who received at least one study vaccine/placebo were included in the safety analysis

Primary outcome: Percent of Participants With Human Papillomavirus (HPV) Type-Specific Seroconversion

Time frame: At week 28 after beginning the vaccination series. Number (95% Confidence Interval). Unit: percent of participants

Measure	Arm A QHPV n = 96	Arm B Placebo/QHPV n = 30
Serotype 6	100.0 (95.9 to 100.0)	0.0 (0.0 to 12.8)
Serotype 11	100.0 (95.9 to 100.0)	0.0 (0.0 to 12.8)
Serotype 16	100.0 (95.9 to 100.0)	3.7 (0.1 to 19.0)
Serotype 18	96.7 (90.6 to 99.3)	0.0 (0.0 to 12.8)

Population analysed: The type-specific results are reported for participants remaining after exclusion of those with protocol violations, unevaluable specimens, or the presence of type-specific sero-positive antibody at baseline.

Primary outcome: Serum Anti-HPV Antibody Titers (cLIA)

Time frame: Arm A week 0, 28, 72, 96, 97, 100; Arm B week 0, 28, 72, 96, 97, 100, 124.. Geometric mean (95% Confidence Interval). Unit: milli-Merck units [mMU]/mL

Measure	Arm A QHPV n = 96	Arm B Placebo/QHPV n = 30
Serotype 6 study entry	3.8 (3.5 to 4.1)	4.1 (3.4 to 4.9)
Serotype 6 week 28	544.2 (395.4 to 749.1)	4.5 (3.7 to 5.4)
Serotype 6 week 72	256.4 (196.5 to 334.7)	4.3 (3.6 to 5.1)
Serotype 6 week 96	227.9 (167.3 to 310.3)	4.5 (3.6 to 5.8)
Serotype 6 week 97	1604.8 (1162.0 to 2216.1)	17.1 (7.1 to 41.5)
Serotype 6 week 100	2473.6 (1770.2 to 3456.4)	79.7 (43.7 to 145.3)
Serotype 6 week 124	–	678.8 (396.4 to 1162.2)
Serotype 11 study entry	4.1 (3.9 to 4.2)	4.0 (4.0 to 4.0)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from the time when participants started to receive study treatment until study completion and before August 10, 2009 (primary completion date).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A QHPV	5 of 96 (5.2%)	93 of 96 (96.9%)	Not reported
Arm B Placebo/QHPV	2 of 30 (6.7%)	30 of 30 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15297048Ault KA, Giuliano AR, Edwards RP, Tamms G, Kim LL, Smith JF, Jansen KU, Allende M, Taddeo FJ, Skulsky D, Barr E. A phase I study to evaluate a human papillomavirus (HPV) type 18 L1 VLP vaccine. Vaccine. 2004 Aug 13;22(23-24):3004-7. doi: 10.1016/j.vaccine.2004.02.020.
Background: PubMed 15246630Brown DR, Fife KH, Wheeler CM, Koutsky LA, Lupinacci LM, Railkar R, Suhr G, Barr E, Dicello A, Li W, Smith JF, Tadesse A, Jansen KU. Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine. Vaccine. 2004 Jul 29;22(21-22):2936-42. doi: 10.1016/j.vaccine.2003.11.059.
Background: PubMed 15887427Poland GA, Jacobson RM, Koutsky LA, Tamms GM, Railkar R, Smith JF, Bryan JT, Cavanaugh PF Jr, Jansen KU, Barr E. Immunogenicity and reactogenicity of a novel vaccine for human papillomavirus 16: a 2-year randomized controlled clinical trial. Mayo Clin Proc. 2005 May;80(5):601-10. doi: 10.4065/80.5.601.
Results publication: PubMed 20574412Levin MJ, Moscicki AB, Song LY, Fenton T, Meyer WA 3rd, Read JS, Handelsman EL, Nowak B, Sattler CA, Saah A, Radley DR, Esser MT, Weinberg A; IMPAACT P1047 Protocol Team. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. J Acquir Immune Defic Syndr. 2010 Oct;55(2):197-204. doi: 10.1097/QAI.0b013e3181de8d26.
Results publicationP1047 ORAL PRESENTATION at the 25th International Papillomavirus Conference May 8-14 2009, Malmö, Sweden given by Anna Barbara Moscicki. Safety and immunogenicity of Gardasil® in HIV-infected children. Moscicki AB, Weinberg A, Song LY, Handelsman E, Patterson J, Saah A, Radley D, Read JS, Sattler C and Levin MJ for IMPAACT P1047 team.
Results publicationWeinberg A, Song LY, Handelsman E, Moscicki AB, Patterson J, Saah A, Radley D, Esser M, Read J, and Levin MJ for IMPAACT P1047 Team. The P1047 data up to week 28 have been analyzed and presented to 15th CROI as abstract and poster #619a: Safety and Immunogenicity of a Quadrivalent Vaccine to Prevent Human Papilloma Virus (HPV) in HIV-Infected Children: IMPAACT P1047.

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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.

Myron J. Levin, MD study chair

Pediatric Infectious Diseases Section, University of Colorado Health Sciences Center

34 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 21 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jan 2012). 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?

Percent of Participants Developing Grade 3 or 4 Adverse Events (AEs) (time frame: Within 14 days of first three doses of vaccination). The study lists 4 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 NCT00339040, which also lists 6 linked publications.

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 5 Nov 2021.