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Protocol Details

A Pilot Study for Collection of Anti-Influenza A Immune Plasma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

09-I-0226

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male
Min Age: 18
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

Children;
Female

Special Instructions

Currently Not Provided

Keywords

Antibody Treatment;
Immune Therapy;
Infectious Diseases;
IVIG;
Plasma Apheresis

Recruitment Keyword(s)

H1N1 influenza;
Swine Flu

Condition(s)

H1N1 Influenza;
Swine Flu

Investigational Drug(s)

IVIG

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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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Eligibility

INCLUSION CRITERIA:

1. Provide written informed consent before initiation of any study procedures.

2. Male, age greater than or equal to 18 years old, and less than 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). Subjects must not be symptomatic, must be afebrile for greater than or equal to 7 days, and must enroll within 12 months of onset of illness.

- Vaccination with a licensed influenza vaccine. Enrollment must occur greater than or equal to 14 days,and less than or equal to 12 months from date of vaccination.

- Note: 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

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, 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

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 100mL 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 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.

PLASMA DONATION CRITERIA (all of the following):

1. Anti-Influenza A H1N1 HAI titer of 1:160 or greater and H3N2 HAI titer of at least 1:40

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


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Citations:

Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15.

Bean WJ, Schell M, Katz J, Kawaoka Y, Naeve C, Gorman O, Webster RG. Evolution of the H3 influenza virus hemagglutinin from human and nonhuman hosts. J Virol. 1992 Feb;66(2):1129-38.

de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM 4-1479
10 CENTER DR
BETHESDA MD 20814
(301) 496-8029
rdavey@niaid.nih.gov

Richard T. Davey Jr., M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM 4-1479
10 CENTER DR
BETHESDA MD 20814
(301) 496-8029
rdavey@niaid.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00984451

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