HIV InfectionsPhase 4NCT01111162
H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients
A Phase 4 study testing H1N1 vaccination in people with HIV Infections, run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- H1N1 vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or any measurable HIV RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- > 18 years
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedures.
- Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral therapy and not intending to start treatment within the next 30 days.
Who cannot join
- Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).
- Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV.
- Participation in a novel H1N1 influenza vaccine study in the past two years.
- Proven history, by RT-PCR, of novel influenza H1N1 infection, or, has a positive influenza diagnostic testing since June 2009 (specificity to H1N1 not required) prior to study entry.
- Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 1 week prior to study entry.
- Scheduled administration of any live virus vaccine or inactivated vaccine at or between entry and the Day 21 visit. NOTE: Live or inactivated vaccines expected to be administered between study entry and the Day 21 visit should be excluded to prevent potential interference with immunogenicity responses and confounding safety results. Regular seasonal flu vaccination will be allowed if is separated more than 7 days from the administration of the H1N1 vaccine.
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- Received a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study
- An acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry.
- Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment, or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection).
- Active neoplastic disease (excluding non-melanoma skin cancer, and HPV-related cervical dysplasia, CIN grades 1, 2 or 3).
- Long term use of glucocorticoids, including oral or parenteral prednisone or equivalent (more than 2.0 mg/kg per day or more than 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the past 3 months (nasal and topical steroids are allowed).
- Received immunoglobulin or other blood products
- Current diagnosis of uncontrolled major psychiatric disorder.
- History of Guillain-Barré Syndrome in the subject or subject's family (parents, siblings, half siblings, or children).
- Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania. Clinical Trials Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluating the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Infected Patients
The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness.
Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.
- Conditions
- HIV Infections
- Being tested
- H1N1 vaccination
- Keywords
- HIV, H1N1 vaccination, HIV infected individuals
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1N1 vaccinationBiological
Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles Receives: Biological: H1N1 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care).
Safety was assessed via
- Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses.
- Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination.
Measured: 21-28 days
Immunogenicity
Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.
Measured: 21-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Tebas, University of Pennsylvania
- Investigators
- Pablo Tebas, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111162
- Sponsor's protocol ID
- Upenn HIV-H1N1-001
- Status last verified
- Jun 2016
- First submitted
- 13 Apr 2010
- Last updated
- 12 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tebas P, Frank I, Lewis M, Quinn J, Zifchak L, Thomas A, Kenney T, Kappes R, Wagner W, Maffei K, Sullivan K; Center for AIDS Research and Clinical Trials Unit of the University of Pennsylvania. Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals. AIDS. 2010 Sep 10;24(14):2187-92. doi: 10.1097/QAD.0b013e32833c6d5c.
PubMed 20616698
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT01111162
- Acronym / sponsor ID
- Upenn HIV-H1N1-001
- Conditions
- HIV Infections
- Keywords
- HIV, H1N1 vaccination, HIV infected individuals
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 12 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness.
Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: H1N1 vaccinationNovartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis of HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or any measurable HIV RNA viral load in the chart. Serum HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- > 18 years
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedures.
- Subject should be 1) on stable antiretroviral therapy as outlined in the DHHS treatment guidelines for HIV-1 infected individuals OR 2) not on antiretroviral therapy and not intending to start treatment within the next 30 days.
Key exclusion criteria (15 listed)
- Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).
- Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV.
- Participation in a novel H1N1 influenza vaccine study in the past two years.
- Proven history, by RT-PCR, of novel influenza H1N1 infection, or, has a positive influenza diagnostic testing since June 2009 (specificity to H1N1 not required) prior to study entry.
- Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 1 week prior to study entry.
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 |
|---|---|---|
| H1N1 vaccinationNovartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles | Biological | Vaccine |
Primary outcome
Safety
Time frame: 21-28 days
To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care). Safety was assessed via 1. Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses. 2. Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post each vaccination.
Immunogenicity
Time frame: 21-28 days
Immunologic response, defined as HAI titer ≥ 1:40, at 21 days after vaccine dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20616698Tebas P, Frank I, Lewis M, Quinn J, Zifchak L, Thomas A, Kenney T, Kappes R, Wagner W, Maffei K, Sullivan K; Center for AIDS Research and Clinical Trials Unit of the University of Pennsylvania. Poor immunogenicity of the H1N1 2009 vaccine in well controlled HIV-infected individuals. AIDS. 2010 Sep 10;24(14):2187-92. doi: 10.1097/QAD.0b013e32833c6d5c.
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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.
Pablo Tebas principal investigator
University of Pennsylvania
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 H1N1 vaccination in people with HIV Infections, run by University of Pennsylvania at 1 site in United States.
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 15 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: finished, as of the sponsor's last update on 12 Jul 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 21-28 days). The study lists 2 primary outcomes in all. 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 NCT01111162, which also lists 1 linked publication.
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 12 Jul 2016.