| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19104 |
| Conditions: |
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Influenza Due to Influenza A Virus Subtype H1N1 |
| Purpose: |
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Background:
- The influenza virus can cause infections that lead to fever, cough, muscle aches,
diarrhea, and headaches, and can even be fatal in some people. A new type of influenza,
called novel H1N1 influenza (or swine flu), affects people of all ages and in some
situations has been reported to have a higher rate of death than seasonal influenza.
- Currently, treatments are available for this influenza, but there is concern that the
rate of complications or even death from this infection is still high despite
treatment, and that over time this virus may become resistant to these treatments.
Researchers are interested in developing a possible new treatment that uses antibodies
against this virus.
Objectives:
- To collect plasma (the liquid component of blood containing antibodies) from people who
have high levels of antibodies against the novel H1N1 influenza virus because they either
have been previously infected with the virus or have been vaccinated against the infection.
Eligibility:
- Healthy individuals between 18 and 60 years of age who are eligible to donate blood.
- Individuals must have previously either recovered from novel H1N1 influenza or have
been vaccinated against the infection, and may be subject to other restrictions on
participating in National Institutes of Health research studies.
Design:
- Participants will undergo apheresis, an outpatient procedure in which researchers will
collect plasma containing antibodies against the influenza virus by drawing blood into
a special machine that separates blood cells from the liquid portion under sterile
conditions and then returns the blood cells to the donor.
- Volunteers will be screened with blood tests to ensure that they are eligible to
participate and donate blood.
- Volunteers are asked to undergo 3 sessions of apheresis; if willing, they can volunteer
to participate in up to 10 sessions.
- After plasma is collected, it will be tested to ensure that it can be used to safely
develop treatments for patients who have novel H1N1 flu.
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| Study summary: |
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Influenza A/H1N1 (commonly referred to as "swine flu") is a novel influenza virus. Most
people will not have immunity to it. As of November 15, 2009, worldwide more than 206
countries have reported laboratory confirmed cases of pandemic influenza H1N1 2009. As many
countries have stopped counting individual cases, particularly of milder illness, the case
count is likely to be significantly lower than the actual number of cases that have
occurred. However, compilation statistics suggest that as of November 22, 2009, more than 3
million people worldwide have been infected with H1N1 with at least 8000 deaths attributed
to the virus. Mortality likely remains significantly higher than seasonal influenza.
Circulating 2009 H1N1 isolates are highly resistant to amantadine and rimantadine.
Additionally there is concern this virus may also acquire oseltamivir resistance that is
seen in circulating seasonal H1N1 virus. Due to the limited therapeutic options for
influenza and significant morbidity despite treatment, additional therapeutics for H1N1 are
warranted. The objective of this protocol is collection anti-influenza A H1N1 immune plasma
from human volunteers. This protocol does not administer any investigational product, but
rather collects plasma from subjects with a high titer anti-influenza H1N1 2009 antibody
titer (convalescent survivors of influenza A/H1N1 infection or recipients of the H1N1
vaccine).
Following screening of potential subjects to screen out those who are not eligible to
participate in plasma donations and to determine there likelihood of having antibodies to
influenza A/H1N1 20009 by recent infection or immunization, enrolled subjects will receive a
baseline physical and laboratory examination. Eligible subjects with high influenza A/H1N1
2009 hemagglutination inhibition (HAI) titers will then be scheduled for three (and up to
ten) plasma collection sessions. Following testing of the collected plasma for potential
pathogens, it may be used as a therapeutic plasma, and/or it may be used for the
manufacturing of high titer anti-H1N1 intravenous immune globulin (IVIG). Both options
would support clinical trials aimed at developing additional therapeutics for H1N1
infection. |
| Criteria: |
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- INCLUSION CRITERIA:
1. Provide written informed consent before initiation of any study procedures.
2. Between the ages of 18 and 60 years old
3. History suggestive of having anti-influenza A/H1N1 2009 antibodies (either of
the following):
- An influenza like illness (e.g. fever, chills, malaise, cough, myalgias and nausea)
consistent with influenza A/H1N1 2009. Subjects must not be symptomatic and be at
least 7 days since the resolution of fever, and enroll within 12 months of illness.
- Vaccination with a licensed or H1N1 vaccine at least 14 days following the last
vaccination in the series, and enroll within 12 months of vaccination.
- Some subjects may meet both requirements and enrollment should be within 12 months of
the most recent event (illness or vaccination)
4. Adequate clinical parameters (all of the following):
- Afebrile (temperature < 38 Degrees C)
- Systolic blood pressure > 100 and < 180 mmHg
- Diastolic blood pressure > 50 and < 100 mmHg
- Heart rate between 50-100 beats/minute (Individuals site blood establishments SOP's
may also permit healthy athletic subjects with heart rates < 50 beats/minutes to
donate plasma, and if so then subjects with heart rates < 50 beats/minutes may
participate in this study)
5. Weight greater than or equal to 110 pounds (50 kg)
6. Adequate peripheral venous access for plasma donation (as judged by the examiner)
7. Willingness to have samples stored
8. Females of child-bearing potential must (one of the following):
- Be surgically sterile
- Be abstinent (or willing to be) 4 weeks prior to date of screening evaluation through
the last plasma donation procedure (up to 240 days following enrollment in the
protocol))
- Use oral contraceptives, or other form of hormonal birth control including hormonal
vaginal rings or transdermal patches, and have been using these for 3 months prior to
date of screening evaluation through the last plasma donation procedure (up to 240
days)
- Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening
evaluation through the last apheresis session (up to 240 days)
- Use (by ensuring her male partner(s) uses) barrier contraception (condom) or other
equivalent methods as birth control 4 weeks prior to date of screening evaluation
through the last plasma donation procedure (up to 240 days)
EXCLUSION CRITERIA:
1. Any sign of active influenza, (as judged by the investigator) including but not
limited to:
- Subjective or documented fever (> 38 Degrees C)
- Cough
- Shortness of breath
- Diarrhea
2. Has a medical history of
- Thrombocytopenia or other blood dyscrasias
- Congestive heart failure
- Pulmonary hypertension
- Bleeding diathesis or therapeutic anticoagulation
- Human immunodeficiency virus (HIV)/AIDS
- Hepatitis B
- Hepatitis C
- Known history of hepatitis after the 11th birthday
- Trypanosomiasis (Chagas' disease and sleeping sickness)
- Leishmaniasis (Kala-azar)
- Filariasis
- Q fever
- Yaws
3. History of cancer that meets any one of the following criteria:
- Leukemia or lymphoma: permanent deferral
- Melanoma: 10 year deferral (with exception of melanoma-in-situ: defer until
biopsy site is healed)
- Squamous cell or basal cell cancer of skin, or cervical carcinoma-in-situ: defer
until excision site is healed
- All other cancers: defer for two years since end of treatment
4. Medication history that includes any of the following:
- Current use of oral or parenteral steroids, high-dose inhaled steroids (> 800
microg/day of beclomethasone dipropionate or equivalent) or other
immunosuppressive or cytotoxic drugs
- Finasteride (Proscar, Propecia) within the last 1 month
- Isotretinoin (Accutane) within the last 1 month
- Acitretin (Soriatane) within the last 3 years
- Etretinate (Tegison) at any time
- Dutasteride (Avodart) within the last 6 months
- Growth hormone made from human pituitary glands at any time
- Beef insulin from the United Kingdom at any time
- Warfarin (Coumadin) within the last 1 week
- Antibiotics within the prior 48 hours
5. Has ever had any of the following:
- Sexual contact with someone known to have HIV
- Had a relative with Creutzfeldt-Jakob Disease, or been told that this disease is
inherited within the family
- Received blood transfusion in the United Kingdom
- History of receiving money, drugs or other payment for sex
- History of receiving clotting factor concentrates
- History of a dura mater graft
- History of babesiosis
- For male donors, history of sexual contact with another male
- Used needles to take drugs, steroids, or other medications not prescribed by a
physician
- Was born, lived in, had blood donation in or ever had sexual contact with anyone
who lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea,
Gabon, Niger, or Nigeria after 1977
- History of living 3 or more months total (need not be consecutive) in the UK
from 1980-1996
- History of living 5 or more years total (need not be consecutive) in Europe
since 1980
- History of living 6 or more months total (need not be consecutive) on a U.S.
military base in Europe from 1980-1996 (specifically from 1980 through 1990 in
Belgium, the Netherlands, or Germany, and from 1980 through 1996 in Spain,
Portugal, Italy, or Greece)
6. Within the 8 weeks prior to enrollment:
- Was vaccinated with the small pox vaccine, or was in close contact with someone
who was vaccinated (i.e., close family member)
7. Within the 4 months prior to enrollment has had:
- A blood donation of a double unit of red cells
8. Within the 12 months prior to enrollment has:
- Received any blood or blood component
- Donated blood at a paid donation center (donations at a hospital blood
establishment do not apply)
- History of tattoo application
- History of unsafe (multiple-use equipment) acupuncture, or piercing practices
- Received an organ transplant
- Received a bone or skin graft
- Lived with someone who has any type of hepatitis
- Been incarcerated for more than 72 hours
- Oral or inhalation use of illegal drugs (i.e., those not prescribed by a
physician)
- Had or has been treated (with or without confirmatory diagnosis) for syphilis or
gonorrhea
9. Within the last 12 months has had sexual contact with (any of the following):
- An individual having viral hepatitis
- A prostitute or anyone else who takes money or drugs or other payment for sex
- Anyone who has ever used needles to take drugs, steroids, or anything else not
prescribed by their doctor
- Anyone who has hemophilia or has used clotting factor concentrates
- For females, a male who has ever had sexual contact with another male
10. Participation in medical research that includes:
- Protocols that are currently ongoing or will start during the duration of this
study that require more than 100cc of blood to be given in any 8-week period of
time
- Administration of any unlicensed drug within the last 3 months or during the
duration of this study
- Administration of any unlicensed vaccine (with the exception of vaccination
against H1N1) within the last 12 months or during the duration of this study,
with the exception of unlicensed H1N1 vaccine
11. Subjects that have participated in previous plasma collection, or other cell
component collection within the last 3 months may have restrictions to participation
based on the site plasma collection SOP. In this scenario, discussion should occur
with the blood establishment to ensure eligibility to donate plasma.
12. Currently pregnant
PLASMA DONATION CRITERIA (all of the following):
1. Anti-Influenza A H1N1 2009 (A/California/07/2009 H1N1) titer of 1:160 or greater
2. Adequate laboratory parameters from screening (must meet all of the criteria below)
- Hemoglobin level of greater than or equal to 12.5 g/dL
- HCT greater than or equal to 38%
- Platelets greater than or equal to 150 times 10 (3)/micorL
- Total serum protein greater than or equal to 6.0 grams /100 mL of blood
- Quantitative immune globulin levels (all of the following)
- Ig A greater than or equal to 90 mg/dL
- Ig G greater than or equal 650 mg/dL
- Ig M greater than or equal 35 mg/dL
- Review of other screening labs should ensure no other underlying medical
condition that would increase subject's risk of apheresis.
3. Negative serologic and molecular tests for blood borne pathogens, to include:
- Anti-HIV-1/2
- Anti-HTLV-I/II
- Anti-HCV
- HBsAg (hepatitis B surface antigen)
- Serologic test for syphilis (PK-TP)
- HIV NAT
- HCV NAT
- WNV NAT
- Testing for Anti-HBc (hepatitis B core antibody) is a special case. A negative
test is required for all components that will be issued as FFP or thawed plasma.
A positive test result is acceptable for plasma that will undergo further
manufacture into IVIG. Therefore, all subjects will be screened for anti-HBc,
and those subjects found reactive (if other tests are negative) may have their
components quarantined and labeled to indicate that they are only for use for
further manufacture into IVIG. |
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| Study is available at: |
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Hospital of the University of Pennsylvania
Philadelphia, PA 19104
United States
Primary Contact:
Carol DiGiorgio
Email: carol.digiorgio@uphs.upenn.edu
Phone: 215-349-8092 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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