Evaluating the Safety and Immune Response to a Live H7N9 Influenza Virus Vaccine Followed by an Inactivated H7N9 Influenza Virus Vaccine, Given at Varying Intervals
Phase 1 Evaluation of the Optimal Interval Between Priming With a Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H7N9 Disease Followed by Boost With a Non-adjuvanted Inactivated H7N9 Influenza Vaccine
National Institute of Allergy and Infectious Diseases (NIAID)
This date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)
Study Completion
February 2015
Actual (reported)
Brief Summary
H7N9 viruses have caused a recent outbreak of severe illness in humans in China. The purpose of this study is to evaluate the safety and immune response of an H7N9 A/Anhui/13 ca influenza virus vaccine followed by an inactivated subvirion H7N9 vaccine at varying intervals.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
100 participants
Study completion date
February 2015
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
May 2014
Date type not reported
This date has not been verified as actual or estimated.
Measurement of the ability of the pLAIV vaccine to induce priming by assessing the response to a subsequent dose of pIIV
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of the optimal interval between the priming with pLAIV and the subsequent boost with pIIV
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Determination of whether 1 dose or 2 doses of pLAIV followed by a pIIV boost is sufficient to induce an optimal immune response
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Frequency of vaccine-related reactogenicity events (REs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Frequency of other adverse events (AEs) for 2 doses of pLAIV vaccine followed by a single dose of inactivated pIIV and compare to 2 doses of pIIV alone
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Secondary Outcomes (4)
Number of vaccinees infected with the H7N9 Anhui 2013/AA ca recombinant vaccine candidate
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of the amount of vaccine virus shed by each recipient
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Measurement of amount of serum and nasal wash antibody induced by the vaccine
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Capacity of the H7N9 Anhui 2013/AA ca recombinant vaccine candidate to elicit HAI and neutralizing antibodies to future H7 influenza viruses
Measured through participants' last study visit: 90 days after receiving the last vaccine (Cohorts 1-4) or Day 118 (Cohort 5)
Study Arms (5)
Cohort 1
EXPERIMENTAL
Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0 and one dose at Day 28. They will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month later.
Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0 and one dose at Day 28. They will then receive one dose of the inactivated subvirion H7N9 vaccine 2 months later.
H7N9 A/Anhui/13 ca influenza virus vaccineBiological
Participants will receive approximately 10\^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device.
Cohort 1Cohort 2Cohort 3Cohort 4
Inactivated subvirion H7N9 vaccineBiological
Eligibility Criteria
Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
You may qualify if:
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, for safety considerations, and because of the need for isolation.
General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
100 participants (actual enrollment reported by the registry).
Study Design
Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
May 2014
Date type not reported
This date has not been verified as actual or estimated.
Cohort 3
EXPERIMENTAL
Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0. They will then receive one dose of the inactivated subvirion H7N9 vaccine 2 months later.
Participants will receive one dose of the H7N9 A/Anhui/13 ca influenza virus vaccine at Day 0. They will then receive one dose of the inactivated subvirion H7N9 vaccine 1 month later.
Participants will receive one dose of the inactivated subvirion H7N9 vaccine at Day 0 and one dose at Day 28.
Biological: Inactivated subvirion H7N9 vaccine
Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection.
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
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Agree to storage of blood specimens for future research
Available for the duration of the trial
Willingness to participate in the study as evidenced by signing the informed consent document
Female participants of childbearing 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 childbearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study.
You may not qualify if:
Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test
Currently breastfeeding
Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing
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
Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine
Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8)
Positive urine drug toxicology test indicating narcotic use/dependency
Have 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 participant in the trial or would render the participant unable to comply with the protocol
History of anaphylaxis
Allergy to oseltamivir as determined by participant report
Current diagnosis of asthma or reactive airway disease (within the past 2 years)
History of Guillain-Barré Syndrome
Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory test (e.g., Western blot or HIV-1/HIV-2 differentiation assay) for human immunodeficiency virus-1 (HIV-1)
Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for hepatitis C virus (HCV)
+14 more criteria
Contact the study team to confirm eligibility.
Primary Completion
February 2015
Actual (reported)
Study Completion
February 2015
Actual (reported)
Last Updated
March 30, 2015
Record last verified: 2015-03
Source record
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Source: ClinicalTrials.gov.
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