Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

HIV Infections Clinical Trial

Official title:

A Randomized Phase II Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008813
• Other study ID #: 2009-016226-13
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2009
• Last updated: December 21, 2011
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

A 1-year multicenter, randomized, single-blinded, phase II trial, stratified on HAART. The purpose of this trial is to evaluate the immunogenicity and safety of a A(H1N1)French National Agency for Research on AIDS and Viral Hepatitis influenza vaccine, administered with or without adjuvant, in HIV-infected patients after one or two injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Able to give written consent

• Covered by French Social Security

• HIV-infected (infection attested by the patient's chart)

• Patients treated by HAART for at least 6 months, with a viral load inferior to 50 copies/mL on at least 2 last visits

• Patients without any treatment for HIV for at least 6 months and without any indication to start a treatment in the following 3 months

• Patients followed for their HIV-infection in an ANRS center and whose home is close to the center in case of influenza-like illness, consultation and hospitalization in the center where he is followed if necessary

• For women with childbearing potential, using an effective method of contraception, and willing to undergo urine pregnancy tests prior to each vaccination.

Exclusion Criteria:

• Pregnancy

• Receipt of chemotherapy, immunotherapy (IL2, IL7, IV Ig), or corticosteroids within 3 months prior to enrolment

• Thrombopenia inferior to 20 000/mm3

• Febrile episode (at least 38°C rectal or if at least 37,5°C measured orally) within one week prior to vaccination

• Opportunistic infection (treated for less than 1 month)

• Co-infection with HCV and treated with IFNa

• Influenza (clinically or virologically documented) in the last 6 months

• History of documented auto-immune disease (lupus, systemic inflammatory disease, ...)

• Child C cirrhosis

• Solid organ transplant recipient

• Intolerance to 1 component of the vaccine

• Other immunization received within 3 weeks prior to inclusion or planned until after the last vaccine injection.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• adjuvanted A(H1N1)v influenza vaccine
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (3,8 microgram) adjuvanted with AS 03A
• non-adjuvanted A(H1N1)v influenza vaccine
Two intramuscular injections at day 0 and day 21 of FLU D-PAN H1N1 [A/California/7/2009 (H1N1)v] (15 microgram)

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil
France	Hopital du Kremlin Bicêtre Service de médecine interne	Kremlin Bicëtre
France	CIC de Vaccinologie Cochin Pasteur, hôpital Cochin	Paris
France	Hôpital Saint-Louis	Paris
France	Service des Maladies Infectieuses et Tropicales, Hopital Tenon	Paris
France	Hôpital Gustave Dron, Service Maladies Infectieuses	Tourcoing

Sponsors (2)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis	GlaxoSmithKline

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the immunogenicity and safety of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients after two injections.		Day 42	No
Secondary	To evaluate the safety (local and general adverse events) between the two study vaccines		From week 0 to week 48	No
Secondary	To evaluate the immunogenicity of a A(H1N1)v influenza vaccine, administered with or without adjuvant, in HIV-infected patients receiving antiretroviral therapy or not		Day 21 and Day 42	No
Secondary	To describe the factors influencing the response to the vaccine (such as age, sex, tobacco use, HAART, CD4 count and nadir, HIV viral load, ...)		From week 0 to week 48	No
Secondary	To compare the sustainability of the immune response induced by two injections of the study		Day 21 and Day 42	No
Secondary	To explore the post-vaccinal cellular immune response of the two study vaccines		Day 42	No
Secondary	To compare the consequences of the A(H1N1)v influenza vaccine, with or without adjuvant, on the HIV infection parameters (CD4 count, HIV viral load)		Week 48	No
Secondary	To assess vaccination failures and describe the clinical presentation of influenza in the study population		Week 48	No

External Links

•   legal sponsor's website