Studying Cell Immune Responses to a Live Flu Vaccine in Healthy Adults

NCT01730144 | Completed

• 2 other identifiers: 13002013-I-0020
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- One form of the influenza vaccine is a nasal spray. It uses a live but weakened flu virus. Researchers want to better under how the live vaccine interacts with the body s immune system. They will test the nasal spray flu vaccine (called FluMist) against a saline (salt water) nasal spray. They will then look at blood and nasal cell samples to see how the vaccine affects these cells immune response. Objectives: \- To look at immune changes in nasal and blood cells in people who receive live flu vaccine. Eligibility: \- Healthy volunteers between 18 and 49 years of age. Design:

• Participants will have five outpatient visits for this study. Each visit will last up to 2 hours.
• At the first visit, participants will have a physical exam and medical history. They will give blood and urine samples. Nasal cell samples will also be collected.
• A week later, participants will have either the nasal spray flu vaccine or a saline spray. They will know which spray they will receive. Blood samples will be collected.
• Two days after the vaccination, they will have another physical exam. Blood and nasal cell samples will be collected.
• At the final two visits (1 week and 1 month after the vaccination), more blood samples will be collected.
• Those who had the saline spray will be able to have the actual vaccine spray at the last study visit.
• The ratio of participants who receive vaccine to those who receive saline will be 4:1.

Conditions

Normal Physiology

Keywords

Nasal Spray Vaccine; Nasal Cells

Outcome Measures

Primary Outcomes (1)

• Significant differences in transcription of selected genes in nasal mucosal epithelial and immune cells isolated from recipients of LAIV compared to pre-vaccination levels in the same cell populations isolated.

  One week prior to and 2 days after vaccine administration and on Days 7 and 28 after vaccination.

Secondary Outcomes (1)

• 1) Development of serum antibody assessed by either HAI or microneutralization (MN) assays.2) Development of 200 influenza-specific interferon-gamma (IFN- >=)-secreting cells per million lymphocytes as assessed by enzymelinked immunospo...

  One week prior to and 2 days after vaccine administration, and on Days 7 and 28 after vaccination.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males and females between 18 and 49 years of age.
• Females of child-bearing potential must have a negative serum beta-human choriogonadotropin (HCG) on Day -7 and agree to use an effective birth control method for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization). All female subjects will be considered being of child-bearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
• General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator.
• Agree to storage of blood, NP swab, and RNA specimens for future research.
• Available for the duration of the study. Subjects must be willing and able to make follow-up visits as specified by the protocol.

You may not qualify if:

• Any contraindiciations for adults for the receipt of LAIV:
• Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine,or life-threatening reactions to previous influenza vaccination.
• Currently breast-feeding.
• Evidence of upper respiratory tract illness (URI) including fever, sore throat, and rhinorrhea. Enrollment of subjects with evidence of URI on Study Day -7 will be temporarily deferred.
• Deviated nasal septum or nasal obstruction.
• Body Mass Index greater than 35.
• NIH employee involved in direct patient care, consistent with the NIH CC policy that employees should avoid patient care for 5 days following receipt of LAIV. In addition, NIH employees must not be under the supervision of the study principal or associate investigators.
• Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol.
• Seropositive to the influenza A component viruses of seasonal LAIV (serum HAI titer of greater than or equal to 1:10).
• Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the study or would render the subject unable to comply with the protocol.
• History of anaphylaxis.
• Current diagnosis of asthma or reactive airway disease (within the past 2 years).
• History of Guillain-Barr(SqrRoot)(Copyright) Syndrome.
• Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Sen A, Rothenberg ME, Mukherjee G, Feng N, Kalisky T, Nair N, Johnstone IM, Clarke MF, Greenberg HB. Innate immune response to homologous rotavirus infection in the small intestinal villous epithelium at single-cell resolution. Proc Natl Acad Sci U S A. 2012 Dec 11;109(50):20667-72. doi: 10.1073/pnas.1212188109. Epub 2012 Nov 27.

  PMID: 23188796 BACKGROUND

• Nakaya HI, Wrammert J, Lee EK, Racioppi L, Marie-Kunze S, Haining WN, Means AR, Kasturi SP, Khan N, Li GM, McCausland M, Kanchan V, Kokko KE, Li S, Elbein R, Mehta AK, Aderem A, Subbarao K, Ahmed R, Pulendran B. Systems biology of vaccination for seasonal influenza in humans. Nat Immunol. 2011 Jul 10;12(8):786-95. doi: 10.1038/ni.2067.

  PMID: 21743478 BACKGROUND

• Zhu W, Higgs BW, Morehouse C, Streicher K, Ambrose CS, Woo J, Kemble GW, Jallal B, Yao Y. A whole genome transcriptional analysis of the early immune response induced by live attenuated and inactivated influenza vaccines in young children. Vaccine. 2010 Apr 1;28(16):2865-76. doi: 10.1016/j.vaccine.2010.01.060. Epub 2010 Feb 12.

  PMID: 20153794 BACKGROUND

Study Officials

• Tara N Palmore, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2012
• First Posted: November 21, 2012
• Study Start: November 17, 2012
• Primary Completion: April 17, 2013
• Study Completion: July 12, 2019
• Last Updated: October 18, 2019

Record last verified: 2019-07-12

Locations

US (1)