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

NCT ID: NCT01017172

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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HIV-1 Infection Cancer Immunosuppression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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serologic testing

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not willing to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HIVCENTER

UNKNOWN

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role lead

Responsible Party

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HIVCENTER, JW Goethe University Clinic

Principal Investigators

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Markus Bickel, MD

Role: STUDY_DIRECTOR

JW Goethe University Clinic

Christoph Stephan, MD

Role: STUDY_CHAIR

JW Goethe University Clinic

Hans R Brodt, MD

Role: PRINCIPAL_INVESTIGATOR

JW Goethe University Clinic

Locations

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Hivcenter

Frankfurt, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus Bickel, MD

Role: CONTACT

Phone: +49 69 6301 7478

Email: [email protected]

Christoph Stephan, MD

Role: CONTACT

Phone: +49 69 6301 7478

Email: [email protected]

Facility Contacts

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Markus Bickel, MD

Role: primary

Christoph Stephan, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 23924590 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21324375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21148530 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20559034 (View on PubMed)

Other Identifiers

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JWG11.2009

Identifier Type: -

Identifier Source: org_study_id