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

Phase 4

Completed

• Conditions: HIV; Human Papillomavirus
• Interventions: Biological: Gardasil; Biological: Cervarix

• Registration Number: NCT01386164
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-08
• Primary Completion: 2012-12
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-15
• Last Update Posted: 2013-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• 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.

Read More

Exclusion Criteria

• 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gardasil®	Gardasil	-
Cervarix®	Cervarix	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Secretion of pro- and antiinflammatory cytokines from PBMC's stimulated with innate stimuli measured by Luminex or Elisa	Day 0, Day 45, Day 180, Day 210 and Day 365
Type-specific HPV-DNA from cervical and genital swab material	Day 0 and Day 210
CD4 cell count and HIV viral load	Day 0, Day 45, Day 180, Day 210 and Day 365
Occurrence and intensity of solicited local symptoms	Day 0-6 after each vaccination	Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized.
Occurrence, intensity and relationship to vaccination of solicited general symptoms	Day 0-6 after each vaccination	Participants will complete a vaccination diary with regards to general symptoms. Number and intensity of generalized symptoms will be listed and summarized in a form.
Occurrence of SAEs	Throughout the active phase of the study (up to Day 210)
Occurrence of clinically relevant abnormalities in hematological and biochemical parameters	Throughout the active phase of the study (up to Day 210)	Clinical significant changes in hemoglobin, ALAT, basic phosphatase and creatinine compared to baseline values will be listed and summarized.
Geometric mean titres of HPV-16 and HPV-18 and total Immunoglobulin G (IgG) titers in cervicovaginal secretion (CVS) from female participants	Day 0, Day 210 and Day 365
Geometric mean titres of serum HPV-6 and HPV-11 antibody measured by a competitive Luminex immunoassay (cLIA)	To be measured at day 0, day 45, day 180, day 210 and day 365
% of participants seropositive for anti-HPV-6, -11 -18, -31, -33, -45, -52 and -58	Day 0, Day 45, Day 180, Day 210, Day 365	% of participants seropositive for anti-HPV-6, -11 as measured by a competitive Luminex immunoassay (cLIA) and % of participants seropositive for anti-HPV-18, -31, -33, -45, -52 and -58 antibodies as measured by either Pseudovirion-Based Neutralization Assay (PBNA)

Trial Locations

Locations (1)

Department of Infectious Diseases, Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark