Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients

Conditions

Cancer, HIV-1 Infection, Immunosuppression

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.

Bickel M, Lassmann C, Wieters I, Doerr HW, Herrmann E, Wicker S, Brodt HR, Stephan C, Allwinn R, Jung O.

2013-07-019 citations

10.1310/hct1404-175

Enhanced immune response after a second dose of an AS03-adjuvanted H1N1 influenza A vaccine in patients after hematopoietic stem cell transplantation.

Gueller S, Allwinn R, Mousset S, Martin H, Wieters I, Herrmann E, Serve H, Bickel M, Bug G.

2011-02-1328 citations

10.1016/j.bbmt.2011.02.004

Immune response after two doses of the novel split virion, adjuvanted pandemic H1N1 influenza A vaccine in HIV-1-infected patients.

Bickel M, von Hentig N, Wieters I, Khaykin P, Nisius G, Haberl A, Stephan C, Herrmann E, Doerr HW, Brodt HR, Allwinn R.

2011-01-0148 citations

10.1093/cid/ciq003

Low rate of seroconversion after vaccination with a split virion, adjuvanted pandemic H1N1 influenza vaccine in HIV-1-infected patients.

Bickel M, Wieters I, Khaykin P, Nisius G, Haberl A, Stephan C, Von Hentig N, Herrmann E, Doerr HW, Brodt HR, Allwinn R.

2010-06-0156 citations

10.1097/qad.0b013e3283398da1

Interventions

OTHERserologic testing

Serologic testing will be performed baseline, day 21 and day 42

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

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

Exclusion criteria

* not willing to participate

Design outcomes

Primary

Measure	Time frame
To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients	baseline, day 21, day 42

Secondary

Measure	Time frame
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	baseline
To evaluate potential adverse reactions of the H1N1 vaccine	baseline, day 21, day 42

Countries

Germany

Contacts

Primary ContactMarkus Bickel, MD

markus.bickel@hivcenter.de+49 69 6301 7478

Backup ContactChristoph Stephan, MD

christoph.stephan@hivcenter.de+49 69 6301 7478

Outcome results

None listed