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

NCT01017172 | Unknown Phase 4

• 1 other identifier: JWG11.2009
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1 Infection; Cancer; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

serologic testing OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not willing to participate

Sponsors & Collaborators

• Goethe University: lead
• HIVCENTER: collaborator

Study Sites (1)

Hivcenter

Frankfurt, 60590, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 23924590 DERIVED

• 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.

  PMID: 21324375 DERIVED

• 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.

  PMID: 21148530 DERIVED

• 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.

  PMID: 20559034 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Markus Bickel, MD

  JW Goethe University Clinic

  STUDY DIRECTOR

• Christoph Stephan, MD

  JW Goethe University Clinic

  STUDY CHAIR

• Hans R Brodt, MD

  JW Goethe University Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Bickel, MD

CONTACT

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

Christoph Stephan, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 20, 2009

Record last verified: 2009-11

Locations

DE (1)