Evaluating the Safety and Immune Response to an H5N1 Influenza Vaccine in People Who Have Previously Received an H5N1 or H7N3 Influenza Vaccine and in People Who Have Never Received a Live Attenuated Influenza Vaccine

NCT01443663 | Completed Phase 1 DMC

• 1 other identifier: CIR 277
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have previously received one of two versions of an H5N1 vaccine or have previously received an H7N3 vaccine and in people who have not previously received any live attenuated influenza vaccine (LAIV).

Conditions

H5N1 Influenza

Outcome Measures

Primary Outcomes (1)

• Characterize the kinetics and magnitude of the antibody response (measured by hemagglutination inhibition assay [HI] and microneutralization assay [MN]) to a single 45 micrograms dose of H5N1 vaccine

  Measured through the 6 months following participants' last vaccination

Secondary Outcomes (2)

• Assess the reactogenicity of the H5N1 vaccine in previous recipients of LAIV

  Measured through the 6 months following participants' last vaccination

• Assess the immune response to the inactivated H5N1 vaccine (A/VN/1203/04)

  Measured through the 6 months following participants' last vaccination

Study Arms (5)

Group 1 (Previously Received H5N1 VN 04 ca Vaccine)

EXPERIMENTAL

Participants will have previously received two doses of 10\^7.5 tissue culture infectious dose (TCID)50 of H5N1 A/VN/1203/04 x A/AA/6/60 ca LAIV (H5N1 VN 04 ca). In this study, they will receive one dose of the H5N1 vaccine at baseline.

Biological: H5N1 Vaccine

Group 2 (Previously Received H5N1 HK 03 ca Vaccine)

EXPERIMENTAL

Participants will have previously received two doses of 10\^7.5 TCID50 of H5N1 A/HK/213/03 x A/AA/6/60 ca LAIV (H5N1 HK 03 ca). In this study, they will receive one dose of the H5N1 vaccine at baseline.

Biological: H5N1 Vaccine

Group 3 (Previously Received H7N3 ca Vaccine)

EXPERIMENTAL

Participants will have previously received two doses of 10\^7.5 TCID50 of H7N3 A/ck/BC/CN-6/04 x A/AA/6/60 ca LAIV (H7N3 ca). In this study, they will receive one dose of the H5N1 vaccine at baseline.

Biological: H5N1 Vaccine

Group 4 (Have Not Previously Received LAIV)

EXPERIMENTAL

Participants will have not previously received an LAIV of any kind. In this study, they will receive one dose of the H5N1 vaccine at baseline.

Biological: H5N1 Vaccine

Group 5 (Have Not Previously Received LAIV)

EXPERIMENTAL

Participants will have not previously received an LAIV of any kind. In this study, they will receive two doses of the H5N1 vaccine at baseline and Day 28.

Biological: H5N1 Vaccine

Interventions

H5N1 Vaccine BIOLOGICAL

Vaccine will be administered intramuscularly (IM) in the deltoid muscle at baseline for participants in Groups 1-4 and at baseline and Day 28 for participants in Group 5.

Group 1 (Previously Received H5N1 VN 04 ca Vaccine); Group 2 (Previously Received H5N1 HK 03 ca Vaccine); Group 3 (Previously Received H7N3 ca Vaccine); Group 4 (Have Not Previously Received LAIV); Group 5 (Have Not Previously Received LAIV)

Eligibility Criteria

• Age: 22 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In general good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
• Available for the duration of the trial
• Willing to participate in the study as evidenced by signing the informed consent document
• Willing to allow storage and testing of laboratory samples for future research
• Received two doses of live attenuated H5N1 or H7N3 vaccine in a prior trial (Study Groups 1, 2, and 3) or LAIV and H5 naïve (Study Groups 4 and 5)
• Willing to forego seasonal LAIV for the duration of the trial (until 6 months after the last vaccination)
• Female participants must agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.

You may not qualify if:

• Pregnant, as determined by a positive beta-human choriogonadotropin (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
• Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months prior to study entry
• 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
• History of life-threatening reaction to prior influenza vaccine
• Current diagnosis of asthma or reactive airway disease (within the 2 years prior to study entry)
• Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for HIV-1
• Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay \[RIBA\]) for hepatitis C virus (HCV)
• Positive hepatitis B virus surface antigen (HBsAg) by ELISA
• Known immunodeficiency syndrome
• History of Guillain-Barré syndrome
• Use of chronic oral or intravenous administration (greater than or equal to 14 days) of immunosuppressive doses of steroids, i.e., prednisone greater than 10 mg per day, immunosuppressants or other immune-modifying drugs within 30 days of starting this study

Sponsors & Collaborators

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

Study Sites (1)

Centers for Immunization Research (CIR) - John Hopkins Bloomburg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

• Goji NA, Nolan C, Hill H, Wolff M, Noah DL, Williams TB, Rowe T, Treanor JJ. Immune responses of healthy subjects to a single dose of intramuscular inactivated influenza A/Vietnam/1203/2004 (H5N1) vaccine after priming with an antigenic variant. J Infect Dis. 2008 Sep 1;198(5):635-41. doi: 10.1086/590916.

  PMID: 18694338 BACKGROUND

• Galli G, Hancock K, Hoschler K, DeVos J, Praus M, Bardelli M, Malzone C, Castellino F, Gentile C, McNally T, Del Giudice G, Banzhoff A, Brauer V, Montomoli E, Zambon M, Katz J, Nicholson K, Stephenson I. Fast rise of broadly cross-reactive antibodies after boosting long-lived human memory B cells primed by an MF59 adjuvanted prepandemic vaccine. Proc Natl Acad Sci U S A. 2009 May 12;106(19):7962-7. doi: 10.1073/pnas.0903181106. Epub 2009 Apr 27.

  PMID: 19416838 BACKGROUND

• Talaat KR, Luke CJ, Khurana S, Manischewitz J, King LR, McMahon BA, Karron RA, Lewis KD, Qin J, Follmann DA, Golding H, Neuzil KM, Subbarao K. A live attenuated influenza A(H5N1) vaccine induces long-term immunity in the absence of a primary antibody response. J Infect Dis. 2014 Jun 15;209(12):1860-9. doi: 10.1093/infdis/jiu123. Epub 2014 Mar 5.

  PMID: 24604819 DERIVED

Study Officials

• Kawsar R. Talaat, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

US (1)