Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults

NCT01386164 | Completed Phase 4 DMC

• 1 other identifier: LTN0001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze and compare the immunogenicity of Bivalent and Tetravalent vaccines against Human Papillomavirus in HIV-infected adult persons.

Conditions

HIV; Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA)

  Day 0, Day 45, Day 180, Day 210 and Day 365

Secondary Outcomes (15)

• Geometric mean titres of serum HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 antibody measured by Pseudovirion-Based Neutralization Assay (PBNA)

  Day 0, Day 45, Day 180, Day 210 and Day 365

• Avidity of HPV-16 and -18 serum antibodies measured by ELISA

  Day 0, Day 45, Day 180, Day 210 and Day 365

• Frequencies of HPV-16 and HPV-18 T-cells measured by flow cytometry

  Day 0, Day 45, Day 180, Day 210 and Day 365

• Frequencies of HPV-16 and -18 specific B-cells measured by B-cell ELISPOT

  Day 0, Day 45, Day 180, Day 210 and Day 365

• B-cell profile measured by Flow cytometry

  Day 0, Day 45, Day 180, Day 210 and Day 365

Study Arms (2)

Gardasil®

EXPERIMENTAL

Biological: Gardasil

Cervarix®

EXPERIMENTAL

Biological: Cervarix

Interventions

Gardasil BIOLOGICAL

Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

Also known as: Tetravalent HPV vaccine

Gardasil®

Cervarix BIOLOGICAL

Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.

Also known as: Bivalent HPV vaccine

Cervarix®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive subjects.
• Age above 18 at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Subjects whom the investigator believes can and will comply with the requirements of the protocol.
• If currently on antiretroviral therapy (ART), subjects must be compliant to triple therapy (highly active ART) and have undetectable viral load for a period of six months prior to study entry.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject has a negative pregnancy test at screening and on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period.

You may not qualify if:

• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 12).
• Pregnant or breastfeeding female.
• Previous enrollment in the study.
• Subjects whom the investigator believes cannot and/or will not comply with the requirements of the protocol (i.e. because of abuse of drugs or alcohol, dementia or given medical, psychiatric, social or work related conditions).
• Chronic administration of immunosuppressive drugs
• Cancer or autoimmune disease
• Previous allergic reaction to vaccination
• Known allergy towards on or more components of either of the test drugs.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (2)

• Toft L, Tolstrup M, Muller M, Sehr P, Bonde J, Storgaard M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity of Cervarix(R) and Gardasil(R) human papillomavirus vaccines for oncogenic non-vaccine serotypes HPV-31, HPV-33, and HPV-45 in HIV-infected adults. Hum Vaccin Immunother. 2014;10(5):1147-54. doi: 10.4161/hv.27925. Epub 2014 Feb 19.

  PMID: 24553190 DERIVED

• Toft L, Storgaard M, Muller M, Sehr P, Bonde J, Tolstrup M, Ostergaard L, Sogaard OS. Comparison of the immunogenicity and reactogenicity of Cervarix and Gardasil human papillomavirus vaccines in HIV-infected adults: a randomized, double-blind clinical trial. J Infect Dis. 2014 Apr 15;209(8):1165-73. doi: 10.1093/infdis/jit657. Epub 2013 Nov 23.

  PMID: 24273179 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; human papillomavirus vaccine, L1 type 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Lars Østergaard, MD,PhD,DmSC

  Department of Infectious Diseases, Aarhus University Hospital, Denmark

  STUDY DIRECTOR

• Lars Toft, MD

  Department of Infectious Diseases, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 30, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

DK (1)