HIV-1 InfectionPhase 4NCT01017172
Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adult Patients
A Phase 4 study testing serologic testing in people with HIV-1 Infection and Cancer, run by Goethe University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection, Cancer, Immunosuppression
- What is being tested?
- serologic testing
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- age >18
- HIV-1 infection
- cancer
- immunosuppressive treatment
Who cannot join
- not willing to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hivcenter
Frankfurt, 60590
Markus Bickel, MD, +49 69 6301 7478, markus.bickel@hivcenter.de
Christoph Stephan, MD, +49 69 6301 7478, christoph.stephan@hivcenter.de
About this study
Official title: Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
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.
Read the 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.
- Conditions
- HIV-1 Infection, Cancer, Immunosuppression
- Being tested
- serologic testing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serologic testingOther
Serologic testing will be performed baseline, day 21 and day 42
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients
Measured: 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
Measured: baseline
To evaluate potential adverse reactions of the H1N1 vaccine
Measured: baseline, day 21, day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- HIVCENTER
- Investigators
- Markus Bickel, MD, Study director, JW Goethe University ClinicChristoph Stephan, MD, Study chair, JW Goethe University ClinicHans R Brodt, MD, Principal investigator, JW Goethe University Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017172
- Sponsor's protocol ID
- JWG11.2009
- Status last verified
- Nov 2009
- First submitted
- 19 Nov 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23924590Gueller 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.
PubMed 21324375Bickel 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.
PubMed 21148530Bickel 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.
PubMed 20559034
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immune Response to Adjuvanted A(H1N1)v Influenza Vaccine in HIV-1 Infected and Immunosuppressed Adults
- ClinicalTrials.gov ID
- NCT01017172
- Acronym / sponsor ID
- JWG11.2009
- Conditions
- HIV-1 Infection, Cancer, Immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- HIVCENTER
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- written informed consent
- age >18
- HIV-1 infection
- cancer
- immunosuppressive treatment
Key exclusion criteria (1 listed)
- not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serologic testingSerologic testing will be performed baseline, day 21 and day 42 | Other | – |
Primary outcome
To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients
Time frame: baseline, day 21, day 42
2 secondary outcomes
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
Time frame: baseline
To evaluate potential adverse reactions of the H1N1 vaccine
Time frame: baseline, day 21, day 42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
- Derived from this study: PubMed 23924590Bickel 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.
- Derived from this study: PubMed 21324375Gueller 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.
- Derived from this study: PubMed 21148530Bickel 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.
- Derived from this study: PubMed 20559034Bickel 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.
- Institute HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Bickel, MD study director
JW Goethe University Clinic
Christoph Stephan, MD study chair
JW Goethe University Clinic
Hans R Brodt, MD principal investigator
JW Goethe University Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing serologic testing in people with HIV-1 Infection and Cancer, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Bickel, MD (+49 69 6301 7478, markus.bickel@hivcenter.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the immunogenicity via anti-hemagglutinin responses following an adjuvanted H1N1 vaccination in HIV-positive and immunosuppressed adult patients (time frame: baseline, day 21, day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017172, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.