NCT00641017

Brief Summary

Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

4.3 years

First QC Date

March 5, 2008

Last Update Submit

February 22, 2013

Conditions

ParainfluenzaVirus Diseases

Outcome Measures

Primary Outcomes (3)

  • Frequency of vaccine-related reaction events and other adverse events in each cohort

    Throughout study

  • Amount of vaccine virus shed by each participant

    Throughout study

  • Amount of serum antibody and mucosal antibody induced by the vaccine in each participant

    Throughout study

Secondary Outcomes (2)

  • Phenotypic stability of vaccine virus shed

    Throughout study

  • Number of vaccinated children and infants infected with rHPIV1

    Throughout study

Study Arms (7)

1 and 2 - Adults

EXPERIMENTAL

One immunization of 1x10\^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry

Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine

3A - Seropositive Children

EXPERIMENTAL

One immunization of 1x10\^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry

Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine

3B - Seropositive Children

PLACEBO COMPARATOR

One dose of 1x10\^6 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry

Biological: Placebo

4A - Seronegative Infants and Children

EXPERIMENTAL

One immunization of 1x10\^5 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry

Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine

4B - Seronegative Infants and Children

PLACEBO COMPARATOR

One dose of 1x10\^5 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry

Biological: Placebo

5A - Seronegative Infants and Children

EXPERIMENTAL

One immunization of 1x10\^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry

Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine

5B - Seronegative Infants and Children

PLACEBO COMPARATOR

One dose of rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry

Biological: Placebo

Interventions

rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineBIOLOGICAL

Live attenuated Human Parainfluenza Type 1 Virus Vaccine

1 and 2 - Adults3A - Seropositive Children4A - Seronegative Infants and Children5A - Seronegative Infants and Children
PlaceboBIOLOGICAL

Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine

3B - Seropositive Children4B - Seronegative Infants and Children5B - Seronegative Infants and Children

Eligibility Criteria

Age6 Months - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • In good health
  • Available for the duration of the trial
  • Available for post-inoculation telephone contact
  • For females, must agree to use effective birth control methods for the duration of the study
  • In good health
  • Seropositive for HPIV1
  • Available for the duration of the study
  • In good health
  • Seronegative for HPIV1 antibody
  • Available for the duration of the study

You may not qualify if:

  • Neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
  • Condition, in the opinion of the investigator, that will not allow the participant to comply with the protocol
  • Alcohol or drug abuse
  • History of anaphylaxis
  • History of splenectomy
  • Diagnosis of asthma within 2 years of study entry
  • HIV-infected
  • Hepatitis C infection
  • Hepatitis B infection
  • Abnormal urinalysis
  • Known immunodeficiency syndrome
  • Current use of nasal or systemic steroid medications
  • Receipt of blood products within 3 months of study entry
  • Current smoker unwilling to stop smoking for the duration of the study. The decision to exclude a potential subject is made by the investigator based upon the potential subject's medical history and physical examination.
  • Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (3)

  • Bartlett EJ, Amaro-Carambot E, Surman SR, Collins PL, Murphy BR, Skiadopoulos MH. Introducing point and deletion mutations into the P/C gene of human parainfluenza virus type 1 (HPIV1) by reverse genetics generates attenuated and efficacious vaccine candidates. Vaccine. 2006 Mar 24;24(14):2674-84. doi: 10.1016/j.vaccine.2005.10.047. Epub 2005 Nov 15.

    PMID: 16364511BACKGROUND

  • Bartlett EJ, Castano A, Surman SR, Collins PL, Skiadopoulos MH, Murphy BR. Attenuation and efficacy of human parainfluenza virus type 1 (HPIV1) vaccine candidates containing stabilized mutations in the P/C and L genes. Virol J. 2007 Jul 2;4:67. doi: 10.1186/1743-422X-4-67.

    PMID: 17605811BACKGROUND

  • Karron RA, San Mateo J, Thumar B, Schaap-Nutt A, Buchholz UJ, Schmidt AC, Bartlett EJ, Murphy BR, Collins PL. Evaluation of a Live-Attenuated Human Parainfluenza Type 1 Vaccine in Adults and Children. J Pediatric Infect Dis Soc. 2015 Dec;4(4):e143-6. doi: 10.1093/jpids/piu104. Epub 2014 Nov 12.

    PMID: 26582883DERIVED

MeSH Terms

Conditions

Paramyxoviridae InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Mononegavirales InfectionsRNA Virus InfectionsInfections

Study Officials

  • Ruth A. Karron, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 21, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

US(1)