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Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

1 juin 2017 mis à jour par: University of North Carolina, Chapel Hill

Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women

The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

99

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Porto Rico
      • San Juan, Porto Rico, 00936-5067
        • University of Puerto Rico, Medical Sciences Campus
  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90027
        • Childrens Hospital of Los Angeles
    • District of Columbia
      • Washington, D.C., District of Columbia, États-Unis, 20010
        • Childrens National Medical Center
    • Florida
      • Fort Lauderdale, Florida, États-Unis, 33316
        • Childrens Diagnostic & Treatment Center
      • Miami, Florida, États-Unis, 33101
        • University of Miami School of Medicine
      • Tampa, Florida, États-Unis, 33606
        • USF College of Medicine
    • Illinois
      • Chicago, Illinois, États-Unis, 60614
        • Childrens Memorial Hospital
      • Chicago, Illinois, États-Unis, 60612
        • Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • University of Maryland
    • New York
      • New York, New York, États-Unis, 10128
        • Mount Sinai Medical Center
      • The Bronx, New York, États-Unis, 10467
        • Montefiore Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Childrens Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, États-Unis, 38105
        • St Jude Childrens Research Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

16 ans à 23 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Young women age 16 years and 0 days to 23 years and 364 days
  • HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA > 1,000 copies/ml
  • HIV treatment history that falls in one of the following categories:

Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry

  • Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
  • Anticipated ability and willingness to complete all study vaccines and evaluations
  • Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria:

  • History of any prior vaccination with an HPV vaccine
  • Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
  • Previous allergic reaction to any constituents of the HPV vaccine
  • Pregnancy
  • Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
  • Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
  • Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
  • Receipt of any routine vaccine within four weeks prior to study entry
  • Receipt of any immune globulin or plasma product within six months prior study entry
  • Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
  • Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
  • Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
  • Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
  • Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for > 2 consecutive weeks)
  • Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
  • Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
  • If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: A: HAART naive or no HAART in past 6 months
Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (HAART) for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Biologique: HPV vaccine for strains -6, -11, -16, and -18
All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Comparateur actif: B: HAART atleast 6 months/ 2 viral loads <400 in last 6 months
Participants who have been receiving highly active antiretroviral therapy (HAART) for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Biologique: HPV vaccine for strains -6, -11, -16, and -18
All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
Délai: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.
Week 28
HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)
Délai: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.
Week 28
HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)
Délai: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.
Week 28
HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)
Délai: Week 28
The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.
Week 28

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6
Délai: Week 28
Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.
Week 28
Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11
Délai: Week 28
Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.
Week 28
Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16
Délai: Week 28
Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.
Week 28
Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18
Délai: Week 28
Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.
Week 28
Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine
Délai: Entry, Week 8, and Week 24
When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.
Entry, Week 8, and Week 24
Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6.
Délai: Week 48
Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.
Week 48
Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11.
Délai: Week 48
Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24
Week 48
Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16.
Délai: Week 48
Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24
Week 48
Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18.
Délai: Week 48
Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24
Week 48
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).
Délai: Week 24
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.
Week 24
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).
Délai: Week 24
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.
Week 24
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).
Délai: Week 24
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.
Week 24
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).
Délai: Week 24
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.
Week 24
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).
Délai: Week 48
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Week 48
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).
Délai: Week 48
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Week 48
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).
Délai: Week 48
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Week 48
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).
Délai: Week 48
Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
Week 48
Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination
Délai: Week 48

Participants' perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:

After getting vaccinated against HPV …

  1. You feel that condom use during sex is less necessary.
  2. You feel it is still just as important to have as few sexual partners as possible.
  3. You feel that it is less important to talk to your sex partners about safe sex.
  4. You think it is still just as important to use a condom every time you have sex.
  5. You will be less worried about having unprotected sex. Those who were categorized in the "lower need for safer sexual behaviors (NSSB)" group had a summary score that was less than the median and those in the "higher NSSB" group had a summary score that was equal to or higher than the median.
Week 48
Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)
Délai: Week 48
To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline "12-item Knowledge About HPV and HPV Vaccine" measure was used to evaluate the need for safer sexual behaviors.
Week 48
Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.
Délai: Day 1 through Week 24
Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.
Day 1 through Week 24
Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).
Délai: Day 1 through Week 24
Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.
Day 1 through Week 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of North Carolina, Chapel Hill

Les enquêteurs

  • Chaise d'étude: Jessica A. Kahn, M.D., M.P.H., Adolescent Trials Network
  • Chaise d'étude: Kathleen Squires, M.D., Adolescent Trials Network

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2008

Achèvement primaire (Réel)

1 février 2011

Achèvement de l'étude (Réel)

1 février 2011

Dates d'inscription aux études

Première soumission

2 juillet 2008

Première soumission répondant aux critères de contrôle qualité

2 juillet 2008

Première publication (Estimation)

4 juillet 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juillet 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2017

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ATN 064

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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