Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine

NCT00734175 | Completed Phase 1

• 1 other identifier: CIR 251
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H6N1 influenza vaccine candidate.

Conditions

Influenza; Virus Diseases

Keywords

Vaccine; Influenza

Outcome Measures

Primary Outcomes (3)

• Frequency of vaccine-related reactogenicity events and other adverse events

  Throughout study

• Amount of vaccine virus shed by each participant

  Throughout study

• Amount of serum and nasal wash antibody induced by the vaccine

  Throughout study

Secondary Outcomes (5)

• Number of participants infected with the H6N1 Teal HK 97/AA ca recombinant vaccine

  Throughout study

• Phenotypic stability of vaccine virus shed

  Throughout study

• Determine whether immunogenicity is enhanced by a second dose of vaccine, and whether the first dose of vaccine restricts replication of the second dose

  Throughout study

• T-cell mediated and innate immune responses against the H6N1 Teal HK 97/AA ca recombinant vaccine

  Throughout study

• Development of serum bank so that the capacity of the H6N1 Teal HK 97/AA ca recombinant vaccine to elicit HA1 and neutralizing antibodies to future H6 influenza viruses can be tested

  Throughout study

Study Arms (1)

1

EXPERIMENTAL

Participants will receive 2 doses of vaccine 4 to 8 weeks (28-62 days) apart

Biological: H6N1 Teal HK 97/AA ca recombinant vaccine

Interventions

H6N1 Teal HK 97/AA ca recombinant vaccine BIOLOGICAL

Approximately 0.2 ml of 10\^7 TCID50 doses of vaccine administered intranasally

1

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 18-49 years old
• General good health
• Available for the duration of the trial
• If female, 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:

• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
• Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
• Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
• Previous enrollment in an H6N1 influenza vaccine trial or in any study of an avian influenza vaccine
• Seropositive to the H6N1 influenza A virus (serum HAI titer \>1:8)
• Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
• Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
• Any condition that, in the opinion of the investigator, would interfere with the study
• History of anaphylaxis
• Allergy to oseltamivir as determined by subject report
• Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
• History of Guillain-Barre Syndrome
• HIV-1-infected
• Hepatitis C-infected
• Positive hepatitis B virus surface antigen

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building

Baltimore, Maryland, United States

Location

Related Publications (4)

• Eichelberger M, Golding H, Hess M, Weir J, Subbarao K, Luke CJ, Friede M, Wood D. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007. Vaccine. 2008 Aug 12;26(34):4299-303. doi: 10.1016/j.vaccine.2008.06.012. Epub 2008 Jun 26.

  PMID: 18582523 BACKGROUND

• Hampson AW. Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singap. 2008 Jun;37(6):510-7.

  PMID: 18618064 BACKGROUND

• Wright PF. Vaccine preparedness--are we ready for the next influenza pandemic? N Engl J Med. 2008 Jun 12;358(24):2540-3. doi: 10.1056/NEJMp0803650. No abstract available.

  PMID: 18550873 BACKGROUND

• Talaat KR, Karron RA, Luke CJ, Thumar B, McMahon BA, Chen GL, Lamirande EW, Jin H, Coelingh KL, Kemble G, Subbarao K. An open label Phase I trial of a live attenuated H6N1 influenza virus vaccine in healthy adults. Vaccine. 2011 Apr 12;29(17):3144-8. doi: 10.1016/j.vaccine.2011.02.043. Epub 2011 Mar 4.

  PMID: 21377509 DERIVED

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

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: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: August 7, 2009

Record last verified: 2008-09

Locations

US (1)