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

NCT02151344 | Completed Phase 1 DMC

• 1 other identifier: CIR 293
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza A Virus, H7N9 Subtype

Outcome Measures

Primary Outcomes (5)

• 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.

Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine

Cohort 2

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 2 months later.

Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine

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.

Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine

Cohort 4

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 1 month later.

Biological: H7N9 A/Anhui/13 ca influenza virus vaccine; Biological: Inactivated subvirion H7N9 vaccine

Cohort 5

EXPERIMENTAL

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

Interventions

H7N9 A/Anhui/13 ca influenza virus vaccine BIOLOGICAL

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 1; Cohort 2; Cohort 3; Cohort 4

Inactivated subvirion H7N9 vaccine BIOLOGICAL

Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

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

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21205, United States

Location

Study Officials

• Kawsar Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

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 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

US (1)