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)

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis (Other)

Overall Status

Completed

CT.gov ID

NCT01008813

Collaborator

GlaxoSmithKline (Industry)

306

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: adjuvanted A(H1N1)v influenza vaccine Biological: non-adjuvanted A(H1N1)v influenza vaccine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

306 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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)

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: adjuvanted A(H1N1)v influenza vaccine Two injections at day 0 and day 21	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 Other Names: Pandemrix
Experimental: non-adjuvanted A(H1N1)v influenza vaccine Two injection at day 0 and day 21	Biological: 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)

Arm

Intervention/Treatment

Experimental: adjuvanted A(H1N1)v influenza vaccine

Two injections at day 0 and day 21

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

Other Names:

Pandemrix

Experimental: non-adjuvanted A(H1N1)v influenza vaccine

Two injection at day 0 and day 21

Biological: 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)

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

To evaluate the safety (local and general adverse events) between the two study vaccines [From week 0 to week 48]
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]
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]
To compare the sustainability of the immune response induced by two injections of the study [Day 21 and Day 42]
To explore the post-vaccinal cellular immune response of the two study vaccines [Day 42]
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]
To assess vaccination failures and describe the clinical presentation of influenza in the study population [Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Henri Mondor	Créteil	France	94010
2	Hopital du Kremlin Bicêtre Service de médecine interne	Kremlin Bicëtre	France	94275
3	Hôpital Saint-Louis	Paris	France	75010
4	Service des Maladies Infectieuses et Tropicales, Hopital Tenon	Paris	France	75020
5	CIC de Vaccinologie Cochin Pasteur, hôpital Cochin	Paris	France	75679
6	Hôpital Gustave Dron, Service Maladies Infectieuses	Tourcoing	France	59208