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

NCT01021397 | Completed Phase 1 DMC

• 1 other identifier: CIR 255
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Paramyxoviridae Infections; Virus Diseases

Keywords

Respiratory Tract Infection

Outcome Measures

Primary Outcomes (2)

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

  Throughout study

• Amount of serum antibody induced by vaccine in each recipient

  Throughout study

Secondary Outcomes (5)

• Amount of vaccine virus shed by each recipient

  Throughout study

• Immunogenicity of a second dose of vaccine and the protection of the first dose against re-infection with the second dose

  From Weeks 22 to 28

• Number of vaccinated infants infected with rHPIV3cp45

  Throughout study

• Number of vaccinated participants infected with a second dose of rHPIV3cp45

  From Weeks 22 to 28

• Phenotypic stability of vaccine virus shed

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive one dose of vaccine virus at study entry and between Weeks 22 and 27

Drug: rHPIV3cp45

2

PLACEBO COMPARATOR

Participants will receive one dose of vaccine virus placebo at study entry and between Weeks 22 and 27

Drug: rHPIV3cp45 placebo

Interventions

rHPIV3cp45 DRUG

10\^5 TCID50 nasal drops

1

rHPIV3cp45 placebo DRUG

1X-L15 nasal drops

2

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

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

Baltimore, Maryland, 21205, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• Madhi SA, Cutland C, Zhu Y, Hackell JG, Newman F, Blackburn N, Murphy BR, Belshe RB, Karron RA, Deatly AM, Gruber WC, Bernstein DI, Wright PF. Transmissibility, infectivity and immunogenicity of a live human parainfluenza type 3 virus vaccine (HPIV3cp45) among susceptible infants and toddlers. Vaccine. 2006 Mar 20;24(13):2432-9. doi: 10.1016/j.vaccine.2005.12.002. Epub 2005 Dec 20.

  PMID: 16406170 BACKGROUND

• Skiadopoulos MH, Surman SR, Riggs JM, Orvell C, Collins PL, Murphy BR. Evaluation of the replication and immunogenicity of recombinant human parainfluenza virus type 3 vectors expressing up to three foreign glycoproteins. Virology. 2002 May 25;297(1):136-52. doi: 10.1006/viro.2002.1415.

  PMID: 12083844 BACKGROUND

MeSH Terms

Conditions

Paramyxoviridae Infections; Virus Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Mononegavirales Infections; RNA Virus Infections; Infections; Respiratory Tract Diseases

Study Officials

• Ruth A. Karron, MD

  Center for Immunization Research, Johns Hopkins University School of Public Health

  STUDY CHAIR

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: November 25, 2009
• First Posted: November 30, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (2)