InfluenzaPhase 2NCT00307177
Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma
A Phase 2 study testing Trivalent inactivated influenza vaccine and Trivalent Baculovirus-expressed Influenza HA vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this research is to compare reactions and antibody responses following receipt of different doses of the experimental influenza vaccine or standard influenza vaccine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent inactivated influenza vaccine and Trivalent Baculovirus-expressed Influenza HA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Apr 2005
- Phase
- Phase 2
- 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
- Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included.
- Patients in complete clinical remission and determined to have no evidence of active disease (NED).
- Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status less than or equal to 2.
- Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy.
- Patients with a non-metastatic secondary solid tumor or malignancies not currently (< 3 months) being treated will be included.
- Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent.
Who cannot join
- Patients with Hodgkin's disease, and T-cell lymphoma.
- Patients undergoing antineoplastic therapy.
- Patients who have received chemotherapy within the past 3 months.
- Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months.
- Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent).
- Splenectomized individuals will not be included.
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- Known allergy to eggs or other components of vaccine (e.g., thimerosal).
- Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: acute febrile illness, known chronic liver disease; significant renal disease; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV dyspnea; unstable or progressive neurologic disorder; insulin-dependent diabetes mellitus).
- Concomitant use of investigational vaccines and/or other medications within 4 weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion.
- Previous exposure to parenteral immunoglobulins or other blood product within 6 months prior to enrollment into the study.
- Subject is enrolled in a conflicting clinical trial.
- Use of experimental vaccines or medications within one month of study entry.
- Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.
- Patients with a known history or risk factors (IV drug abuse or casual sex within the past year) of Hepatitis B, Hepatitis C, or Human Immunodeficeincy Virus.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study
The purpose of this research is to compare reactions and antibody responses following receipt of different doses of the experimental influenza vaccine or standard influenza vaccine.
Read the detailed description
Influenza is a common respiratory infection caused by viruses. Epidemics of influenza occur each winter and are responsible for more than 20,000 deaths each year in the United States. Most of these deaths occur among elderly persons and among people of all ages who suffer from a chronic disease. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. This research study will test an experimental influenza vaccine consisting of the important flu virus protein that stimulates protection. It is produced by genetic techniques in cultured cells and allows higher doses of the protein to be used. Influenza vaccines made this way have been given to humans in the past and the vaccine was well tolerated. It is expected that higher doses of this vaccine can be given with minimal reactions, as well as whether such a vaccine stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than standard doses of the licensed influenza vaccine. This study will evaluate the reactogenicity and immunogenicity of a recombiant influenza vaccine in non-Hodgkin's B cell lymphoma.
- Conditions
- Influenza
- Being tested
- Trivalent inactivated influenza vaccine, Trivalent Baculovirus-expressed Influenza HA vaccine
- Keywords
- influenza vaccine, baculovirus, immunogenicity, lymphoma
- Medical subject headings
- Influenza, Human, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent inactivated influenza vaccineBiological
Standard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0.
Trivalent Baculovirus-expressed Influenza HA vaccineBiological
Trivalent Baculovirus-expressed influenza HA vaccine (Recombinant rHA0): Arms B, C and D receive 15 mcg, 45 mcg or 135 mcg IM dose on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Arm D | Experimental | 25 subjects receive Recombinant rHA0 vaccine at 135 mcg per rHA0, via IM injection on Day 0 Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
| Arm C | Experimental | 25 subjects receive Recombinant rHA0 vaccine at 45 mcg per rHA0, via IM injection on Day 0 Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
| Arm B | Experimental | 25 subjects receive Recombinant rHA0 vaccine at 15 mcg per rHA0, via IM injection on Day 0 Receives: Biological: Trivalent Baculovirus-expressed Influenza HA vaccine |
| Arm A | Active comparator | 25 subjects receive Standard TIV at 15 mcg HA per virus, in a total volume of 0.5 mL, by deep intramuscular (IM) injection on Day 0 Receives: Biological: Trivalent inactivated influenza vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startAug 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307177
- Sponsor's protocol ID
- 04-036
- Status last verified
- Nov 2006
- First submitted
- 24 Mar 2006
- Last updated
- 5 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study
- ClinicalTrials.gov ID
- NCT00307177
- Acronym / sponsor ID
- 04-036
- Conditions
- Influenza
- Keywords
- influenza vaccine, baculovirus, immunogenicity, lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005
- First posted
- 27 Mar 2006 (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 research is to compare reactions and antibody responses following receipt of different doses of the experimental influenza vaccine or standard influenza vaccine.
Detailed description
Influenza is a common respiratory infection caused by viruses. Epidemics of influenza occur each winter and are responsible for more than 20,000 deaths each year in the United States. Most of these deaths occur among elderly persons and among people of all ages who suffer from a chronic disease. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. This research study will test an experimental influenza vaccine consisting of the important flu virus protein that stimulates protection. It is produced by genetic techniques in cultured cells and allows higher doses of the protein to be used. Influenza vaccines made this way have been given to humans in the past and the vaccine was well tolerated. It is expected that higher doses of this vaccine can be given with minimal reactions, as well as whether such a vaccine stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than standard doses of the licensed influenza vaccine. This study will evaluate the reactogenicity and immunogenicity of a recombiant influenza vaccine in non-Hodgkin's B cell lymphoma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm D | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccine25 subjects receive Recombinant rHA0 vaccine at 135 mcg per rHA0, via IM injection on Day 0 |
| Arm C | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccine25 subjects receive Recombinant rHA0 vaccine at 45 mcg per rHA0, via IM injection on Day 0 |
| Arm B | Experimental | Biological: Trivalent Baculovirus-expressed Influenza HA vaccine25 subjects receive Recombinant rHA0 vaccine at 15 mcg per rHA0, via IM injection on Day 0 |
| Arm A | Active comparator | Biological: Trivalent inactivated influenza vaccine25 subjects receive Standard TIV at 15 mcg HA per virus, in a total volume of 0.5 mL, by deep intramuscular (IM) injection on Day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included.
- Patients in complete clinical remission and determined to have no evidence of active disease (NED).
- Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status less than or equal to 2.
- Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy.
- Patients with a non-metastatic secondary solid tumor or malignancies not currently (< 3 months) being treated will be included.
Key exclusion criteria (14 listed)
- Patients with Hodgkin's disease, and T-cell lymphoma.
- Patients undergoing antineoplastic therapy.
- Patients who have received chemotherapy within the past 3 months.
- Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months.
- Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent).
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 |
|---|---|---|
| Trivalent inactivated influenza vaccineStandard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0. | Biological | Arm A |
| Trivalent Baculovirus-expressed Influenza HA vaccineTrivalent Baculovirus-expressed influenza HA vaccine (Recombinant rHA0): Arms B, C and D receive 15 mcg, 45 mcg or 135 mcg IM dose on Day 0. | Biological | Arm B, Arm C, Arm D |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trivalent inactivated influenza vaccine and Trivalent Baculovirus-expressed Influenza HA vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 6 inclusion and 14 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 5 Dec 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 5 Dec 2014.