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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01017172
• Other study ID #: JWG11.2009
• Status: Recruiting
• Phase: Phase 4
• First received: November 19, 2009
• Last updated: November 19, 2009
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2009
• Source: Goethe University
• Contact: Markus Bickel, MD
• Phone: +49 69 6301 7478
• Email: markus.bickel[@]hivcenter.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written informed consent

• age >18

• HIV-1 infection

• cancer

• immunosuppressive treatment

Exclusion Criteria:

• not willing to participate

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer
• HIV-1 Infection
• Immunosuppression

Intervention

Other:
• serologic testing
Serologic testing will be performed baseline, day 21 and day 42

Locations

Country	Name	City	State
Germany	Hivcenter	Frankfurt

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	HIVCENTER

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To evaluate potential adverse reactions of the H1N1 vaccine		baseline, day 21, day 42	Yes

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