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

HIV Clinical Trial

— HIPAVAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386164
• Other study ID #: LTN0001
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2011
• Last updated: August 15, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Human Papillomavirus

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Infectious Diseases, Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Avidity of HPV-16 and -18 serum antibodies measured by ELISA		Day 0, Day 45, Day 180, Day 210 and Day 365	No
Secondary	Frequencies of HPV-16 and HPV-18 T-cells measured by flow cytometry		Day 0, Day 45, Day 180, Day 210 and Day 365	No
Secondary	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	No
Secondary	B-cell profile measured by Flow cytometry		Day 0, Day 45, Day 180, Day 210 and Day 365	No
Secondary	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	No
Secondary	Type-specific HPV-DNA from cervical and genital swab material		Day 0 and Day 210	No
Secondary	CD4 cell count and HIV viral load		Day 0, Day 45, Day 180, Day 210 and Day 365	No
Secondary	Occurrence and intensity of solicited local symptoms	Participants will complete a vaccination diary with regards to local symptoms. Number and intensity of local symptoms will be listed and summarized.	Day 0-6 after each vaccination	Yes
Secondary	Occurrence, intensity and relationship to vaccination of solicited general symptoms	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.	Day 0-6 after each vaccination	Yes
Secondary	Occurrence of SAEs		Throughout the active phase of the study (up to Day 210)	Yes
Secondary	Occurrence of clinically relevant abnormalities in hematological and biochemical parameters	Clinical significant changes in hemoglobin, ALAT, basic phosphatase and creatinine compared to baseline values will be listed and summarized.	Throughout the active phase of the study (up to Day 210)	Yes
Secondary	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	No
Secondary	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	No
Secondary	% of participants seropositive for anti-HPV-6, -11 -18, -31, -33, -45, -52 and -58	% 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)	Day 0, Day 45, Day 180, Day 210, Day 365	No