Clinical trial NCT01017172: Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients
Official title: Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1 Infection
Cancer
Immunosuppression
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: HIVCENTER
First posted: 2009-11-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients after one and two injections.

Detailed description: The efficacy of an adjuvanted A(H1N1)v influenza vaccine in HIV-infected and immunosuppressed patients is unknown. Therefore we aim to investigate the immunoresponse as assessed by a anti-hemagglutinin assay before, 21 days after the first and 21 days after the second vaccination. The safety of the vaccination will be recorded by a standardized questionaire.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* age \>18
* HIV-1 infection
* cancer
* immunosuppressive treatment

Exclusion Criteria:

* not willing to participate

Primary outcomes:
measure: To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients
timeFrame: baseline, day 21, day 42
Secondary outcomes:
measure: To evaluate the effect of pre-existing anti-influenza immunity and recent history of seasonal influenza and H5N1 vaccination on seroresponses to the H1N1 influenza vaccine
timeFrame: baseline
measure: To evaluate potential adverse reactions of the H1N1 vaccine
timeFrame: baseline, day 21, day 42
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Hivcenter
Study officials:
affiliation: JW Goethe University Clinic
name: Markus Bickel, MD
role: STUDY_DIRECTOR
affiliation: JW Goethe University Clinic
name: Christoph Stephan, MD
role: STUDY_CHAIR
affiliation: JW Goethe University Clinic
name: Hans R Brodt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bickel M, Lassmann C, Wieters I, Doerr HW, Herrmann E, Wicker S, Brodt HR, Stephan C, Allwinn R, Jung O. Immune response after a single dose of the 2010/11 trivalent, seasonal influenza vaccine in HIV-1-infected patients and healthy controls. HIV Clin Trials. 2013 Jul-Aug;14(4):175-81. doi: 10.1310/hct1404-175.
citation: Gueller S, Allwinn R, Mousset S, Martin H, Wieters I, Herrmann E, Serve H, Bickel M, Bug G. Enhanced immune response after a second dose of an AS03-adjuvanted H1N1 influenza A vaccine in patients after hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2011 Oct;17(10):1546-50. doi: 10.1016/j.bbmt.2011.02.004. Epub 2011 Feb 13.
citation: Bickel M, von Hentig N, Wieters I, Khaykin P, Nisius G, Haberl A, Stephan C, Herrmann E, Doerr HW, Brodt HR, Allwinn R. Immune response after two doses of the novel split virion, adjuvanted pandemic H1N1 influenza A vaccine in HIV-1-infected patients. Clin Infect Dis. 2011 Jan 1;52(1):122-7. doi: 10.1093/cid/ciq003.
citation: Bickel M, Wieters I, Khaykin P, Nisius G, Haberl A, Stephan C, Von Hentig N, Herrmann E, Doerr HW, Brodt HR, Allwinn R. Low rate of seroconversion after vaccination with a split virion, adjuvanted pandemic H1N1 influenza vaccine in HIV-1-infected patients. AIDS. 2010 Jun 1;24(9):F31-5. doi: 10.1097/QAD.0b013e3283398da1.