Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children

31 december 2012 uppdaterad av: National Institute of Allergy and Infectious Diseases (NIAID)

Phase I Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-Passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval

Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The primary purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11% of hospitalizations for respiratory diseases in children. This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.

This study will last for approximately 28 weeks. Infants and children 6 months to 36 months of age will be randomly assigned to one of two groups. Group 1 participants will receive 2 immunizations of rHPIV3cp45. Group 2 participants will receive 2 doses of rHPIV3cp45 placebo. Immunizations will be given as nose drops and administered at study entry and approximately 22 to 27 weeks after study entry.

On the day of immunization, a physical exam and blood collection will occur. Participants will be observed for 15 minutes after immunization for any immediate adverse effects. Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their child's temperature. They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization. Parents and guardians will be contacted by telephone daily from Day 1 to Day 18 after each immunization.

Parents or guardians will need to record their child's temperature daily for at least 17 days immediately following immunization. During this 17-day period, study visits will occur on Days 3, 6, and 12 after each dose of vaccine or placebo. Participants will undergo a nasal wash for a viral culture at all study visits. There will be additional follow-up visits occurring sometime between 49 and 63 days after the first dose and 28 to 35 days after the second dose; blood collection will occur at the follow-up visits. Additional visits may be required on selected days during the month after immunization. Infants who experience illness or side effects may be asked to return to the clinic for examination.

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21205
        • Center for Immunization Research (CIR), Johns Hopkins School of Public Health
    • Washington
      • Seattle, Washington, Förenta staterna, 98105
        • Seattle Children's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 månader till 3 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Good general health
  • HPIV3-uninfected
  • Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
  • Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus and inactivated vaccines
  • Available for the duration of the trial
  • Parent or guardian reachable by telephone for post-immunization contact
  • Parent or guardian willing to provide informed consent

Exclusion Criteria:

  • Known or suspected impairment of immunologic functions. Infants who are HIV-infected, who are bone marrow or solid organ transplant recipients, or who have received immunosuppressive therapy, including systemic corticosteroids within 30 days prior to study entry. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previously received HPIV3 vaccine
  • Previous serious vaccine-associated adverse event or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months are not excluded.
  • Born prematurely before the 37th week of pregnancy if participant is currently less than 12 months of age
  • Member of a household containing immunocompromised individuals, pregnant caregivers, or infants less than 6 months of age
  • Attends day care with infants less than 6 months of age
  • Parent or guardian unable or unwilling to suspend daycare for 14 days following each immunization. More information on this criterion can be found in the protocol.
  • Enrolled in another investigational drug or vaccine study from 30 days prior to study entry until the final follow-up blood draw

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
Participants will receive one dose of vaccine virus at study entry and between Weeks 22 and 27
Läkemedel: rHPIV3cp45
10^5 TCID50 nasal drops
Placebo-jämförare: 2
Participants will receive one dose of vaccine virus placebo at study entry and between Weeks 22 and 27
Läkemedel: rHPIV3cp45 placebo
1X-L15 nasal drops

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Frekvens av vaccinrelaterade reaktogenicitetshändelser och andra biverkningar
Tidsram: Under hela studiet
Under hela studiet
Amount of serum antibody induced by vaccine in each recipient
Tidsram: Throughout study
Throughout study

Sekundära resultatmått

Resultatmått
Tidsram
Fenotypisk stabilitet av vaccinvirusutsläpp
Tidsram: Under hela studiet
Under hela studiet
Amount of vaccine virus shed by each recipient
Tidsram: Throughout study
Throughout study
Immunogenicity of a second dose of vaccine and the protection of the first dose against re-infection with the second dose
Tidsram: From Weeks 22 to 28
From Weeks 22 to 28
Number of vaccinated infants infected with rHPIV3cp45
Tidsram: Throughout study
Throughout study
Number of vaccinated participants infected with a second dose of rHPIV3cp45
Tidsram: From Weeks 22 to 28
From Weeks 22 to 28

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbetspartners

Johns Hopkins Bloomberg School of Public Health

Utredare

  • Studiestol: Ruth A. Karron, MD, Center for Immunization Research, Johns Hopkins University School of Public Health

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2009

Primärt slutförande (Faktisk)

1 december 2011

Avslutad studie (Faktisk)

1 december 2011

Studieregistreringsdatum

Först inskickad

25 november 2009

Först inskickad som uppfyllde QC-kriterierna

25 november 2009

Första postat (Uppskatta)

30 november 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

3 januari 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 december 2012

Senast verifierad

1 december 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CIR 255

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera