Recruitment

Recruitment Status
Completed

Inclusion Criteria

General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
Agree to storage of blood specimens for future research
Female participants of child-bearing potential must agree to use effective birth control methods 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 participants 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 specimens for future research
Female participants of child-bearing potential must agree to use effective birth control methods 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 participants 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.
Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, and for safety considerations and because of the need for isolation.
Available for the duration of the trial
Willingness to participate in the study as evidenced by signing the informed consent document

Exclusion Criteria

Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
Positive urine drug toxicology test indicating narcotic use/dependency
...
Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
Positive urine drug toxicology test indicating narcotic use/dependency
Current diagnosis of asthma or reactive airway disease (within the past 2 years)
Currently breastfeeding
Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
History of asplenia
History of anaphylaxis
Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
The decision to exclude a potential participant is determined by medical history and a clinician's clinical judgment based on the physical examination.
A current smoker includes anyone stating they currently smoke any amount of a tobacco product.
Allergy to oseltamivir as determined by participant report
Known immunodeficiency syndrome
Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
Allergy to eggs or egg products
Positive hepatitis B virus surface antigen (HBsAg) by ELISA
Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
History of Guillain-Barré Syndrome
Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than two times the upper normal limit will be exclusionary at baseline, prior to vaccination.
Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
Travel on a cruise ship within 14 days prior to study vaccination
Travel to the Southern Hemisphere within 14 days prior to study vaccination
Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1)

Summary

Conditions
Influenza A Virus, H7N9 Subtype
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 49 years
Gender
Both males and females

Description

H7N9 AI viruses have recently caused a large outbreak of severe respiratory disease in humans in China. A vaccine for use in the event of an H7N9 AI pandemic is an important research priority. Previous studies have shown that when subjects who received a live bird flu vaccine received a subsequent "...

H7N9 AI viruses have recently caused a large outbreak of severe respiratory disease in humans in China. A vaccine for use in the event of an H7N9 AI pandemic is an important research priority. Previous studies have shown that when subjects who received a live bird flu vaccine received a subsequent "booster" dose of inactivated bird flu vaccine, a vigorous antibody response was detected. The inactivated vaccine served as a way to probe the immune response to the initial live vaccine. The purpose of this study is to evaluate the safety, infectivity, and immunogenicity of a live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine in healthy adults, and to administer a booster dose of an inactivated subvirion H7N9 influenza vaccine 3 months later. This study will enroll healthy adults who are willing to remain in an isolation unit in an inpatient clinic for several days during the study. They will be randomly assigned to receive either one dose (Group 1) or two doses (Group 2) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine, which will be delivered by a nasal spray device. Participants in both groups will receive one "booster" dose of inactivated subvirion H7N9 influenza vaccine 3 months later in an outpatient setting. All participants will be admitted to the inpatient clinic and will receive one dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine 2 days after entering the clinic. Participants will remain in the inpatient clinic for approximately 9 days after receiving the vaccine. While in the clinic, participants will undergo medical history reviews, blood collections, urine collections, physical examinations, nasal wash procedures, and vital sign measurements. Participants in Group 1 will attend a study visit at Day 28 and undergo a medical history review, blood collection, and a nasal wash. Participants in Group 2 will be readmitted to the inpatient clinic 2 days prior to receiving a second dose of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine at Day 28. They will remain in the clinic for approximately 9 days after receiving the vaccine; while in the clinic, they will take part in the same study procedures as during the first inpatient visit. All participants will attend a study visit at Day 56 and undergo a medical history review, blood collection, and a nasal wash. At Day 98, all participants will receive one "booster" dose of the inactivated subvirion H7N9 influenza vaccine, as outpatients. They will attend additional study visits on Days 101, 105, 112, 126, 154, and 180, which may include medical history reviews; physical examinations; and urine, blood, and nasal secretion collections.

Inclusion Criteria

General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
Agree to storage of blood specimens for future research
Female participants of child-bearing potential must agree to use effective birth control methods 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 participants 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 specimens for future research
Female participants of child-bearing potential must agree to use effective birth control methods 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 participants 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.
Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, and for safety considerations and because of the need for isolation.
Available for the duration of the trial
Willingness to participate in the study as evidenced by signing the informed consent document

Exclusion Criteria

Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
Positive urine drug toxicology test indicating narcotic use/dependency
...
Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
After admission to the unit, nicotine patches will be provided to current smokers who request them for the inpatient portion of the study.
Positive urine drug toxicology test indicating narcotic use/dependency
Current diagnosis of asthma or reactive airway disease (within the past 2 years)
Currently breastfeeding
Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
Receipt of another investigational vaccine or drug within 30 days prior to study vaccination
History of asplenia
History of anaphylaxis
Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
The decision to exclude a potential participant is determined by medical history and a clinician's clinical judgment based on the physical examination.
A current smoker includes anyone stating they currently smoke any amount of a tobacco product.
Allergy to oseltamivir as determined by participant report
Known immunodeficiency syndrome
Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study vaccination
Allergy to eggs or egg products
Positive hepatitis B virus surface antigen (HBsAg) by ELISA
Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
History of Guillain-Barré Syndrome
Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than two times the upper normal limit will be exclusionary at baseline, prior to vaccination.
Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to vaccination
Travel on a cruise ship within 14 days prior to study vaccination
Travel to the Southern Hemisphere within 14 days prior to study vaccination
Positive ELISA and confirmatory Western blot tests for human immunodeficiency virus-1 (HIV-1)

Tracking Information

NCT #
NCT01995695
Collaborators
University of Rochester
Investigators
  • Principal Investigator: John Treanor, M.D. University of Rochester
  • John Treanor, M.D. University of Rochester
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