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Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine

7. november 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H2N2 (A/Ann Arbor/6/60 ca Recombinant), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N2 Infection in the Event of a Pandemic

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 H2N2 influenza vaccine candidate.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

H2N2 influenza viruses emerged in the 1950s replacing the then circulating H1N1 human influenza virus. The first cases occurred in China in 1956, and disease became widespread in 1956-1957, resulting in the "Asian Influenza" pandemic that was responsible for between 1 and 4 million deaths worldwide. H2N2 viruses have not circulated since 1968, when they were replaced by H3N2 influenza viruses and the resurgence of H1N1 viruses. For this reason, a large proportion of the population is now susceptible to infection with H2N2 influenza. If this subtype re-emerges, it could potentially cause the next pandemic. This vaccine, therefore, is an important priority in the development of vaccines against potential pandemic influenza strains.

This vaccine trial will be conducted in the Center for Immunization Research isolation unit in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD). The study will be initiated between April 1st and December 20th, 2008, when wild-type influenza is unlikely to be circulating in the Baltimore area.

An individual's participation in the study will last approximately 90 days. All participants will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination, participants will remain in isolation at the study site for at least nine days or until rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and nasal wash will occur each day during the isolation period. Blood collection will occur in isolation beginning on Day 7 until release. Follow-up outpatient visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up visits will include serum collection, nasal wash, and interim medical history.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

22

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 H2N2 influenza vaccine trial or in any study of an avian influenza vaccine
  • Seropositive to the H2N2 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
  • Known immunodeficiency syndrome
  • Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
  • History of a surgical splenectomy
  • Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
  • Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
  • Travel to the Southern Hemisphere within 14 days prior to study entry
  • Travel on a cruise ship within 14 days prior to study entry
  • Direct contact with live poultry within the 14 days prior to the study or after study completion.
  • Receipt of another investigational vaccine or drug within 30 days prior to study entry
  • Allergy to eggs or egg products
  • Pregnant or breastfeeding

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Deltagerne vil modtage 2 doser vaccine med 4 til 8 ugers mellemrum (28-62 dage)
Biologisk: H2N2 1960 AA ca recombinant vaccine
Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mængden af ​​vaccinevirus udskilt af hver deltager
Tidsramme: Gennem hele studiet
Gennem hele studiet
Hyppighed af vaccinerelaterede reaktogenicitetsbegivenheder og andre uønskede hændelser
Tidsramme: Gennem hele studiet
Gennem hele studiet
Mængden af ​​serum og næseskylleantistof induceret af vaccinen
Tidsramme: Gennem hele studiet
Gennem hele studiet

Sekundære resultatmål

Resultatmål
Tidsramme
Fænotypisk stabilitet af vaccinevirusudskillelse
Tidsramme: Gennem hele studiet
Gennem hele studiet
Bestem, om immunogeniciteten forstærkes af en anden dosis vaccine, og om den første dosis af vaccinen begrænser replikationen af ​​den anden dosis
Tidsramme: Gennem hele studiet
Gennem hele studiet
Number of participants infected with the H2N2 1960 AA ca recombinant vaccine
Tidsramme: Throughout study
Throughout study
T-cell mediated and innate immune responses against the H2N2 1960 AA ca recombinant vaccine
Tidsramme: Throughout study
Throughout study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Johns Hopkins Bloomberg School of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Primær færdiggørelse (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

25. juli 2008

Først indsendt, der opfyldte QC-kriterier

25. juli 2008

Først opslået (Skøn)

28. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. november 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. november 2008

Sidst verificeret

1. juli 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIR 247

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