Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants

NCT00308412 | Completed Phase 1 DMC

• 2 other identifiers: CIR 215CIR H.22.05.07.19.A1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 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 (REs) that occur during the acute monitoring phase of the study

  For 17 days after each dose

• Proportion of infants that develop fourfold or greater rises in hemagglutination-inhibition (HAI) antibody titer following two doses of vaccine

  Throughout study

Secondary Outcomes (5)

• For the subset of infants enrolled in group 1 of the study (n=24), quantifying the amount of vaccine virus shed by each recipient

  Throughout study

• Assessment of the immunogenicity of a second dose of vaccine and the protection of the first dose against reinfection with the second dose

  Throughout study

• Determination of the number of vaccinated infants infected with rHPIV3cp45

  Throughout study

• Determination of the number of vaccinated subjects infected with a second dose of rHPIV3cp45 vaccine

  Throughout study

• Determination of the phenotypic stability of vaccine virus shed

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Two 10\^5 PFU doses of rHPIV3cp45 vaccine given as nose drops to healthy infants and children aged 6 to 36 months of age. The two doses are given 4 to 10 weeks apart.

Biological: rHPIV3cp45

2

PLACEBO COMPARATOR

Two placebo vaccinations given as nose drops to healthy infants and children aged 6 to 36 months of age. The two doses are given 4 to 10 weeks apart.

Biological: Placebo

Interventions

rHPIV3cp45 BIOLOGICAL

Placebo for rHPIV3cp45 vaccine is 1X L-15.

1

Placebo BIOLOGICAL

Placebo for rHPIV3cp45 vaccine

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
• Full term infant, born later than the 36th week of pregnancy
• 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 vaccine
• 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
• For Group 2 participants, serum hemagglutination-inhibiting (HAI) titers to HPIV3 of or less than 1:8

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 are using immunosuppressive therapy, including systemic corticosteroids, are excluded. 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 PIV3 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
• 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.
• Currently enrolled in another investigational drug or vaccine study

Sponsors & Collaborators

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

Study Sites (1)

Center for Immunization Research, Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (5)

• Durbin AP, Karron RA. Progress in the development of respiratory syncytial virus and parainfluenza virus vaccines. Clin Infect Dis. 2003 Dec 15;37(12):1668-77. doi: 10.1086/379775. Epub 2003 Nov 20.

  PMID: 14689350 BACKGROUND

• Greenberg HB, Piedra PA. Immunization against viral respiratory disease: a review. Pediatr Infect Dis J. 2004 Nov;23(11 Suppl):S254-61. doi: 10.1097/01.inf.0000144756.69887.f8.

  PMID: 15577581 BACKGROUND

• Karron RA, Belshe RB, Wright PF, Thumar B, Burns B, Newman F, Cannon JC, Thompson J, Tsai T, Paschalis M, Wu SL, Mitcho Y, Hackell J, Murphy BR, Tatem JM. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J. 2003 May;22(5):394-405. doi: 10.1097/01.inf.0000066244.31769.83.

  PMID: 12792378 BACKGROUND

• 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

  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

Study Record Dates

• First Submitted: March 28, 2006
• First Posted: March 29, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 16, 2010

Record last verified: 2010-07

Locations

US (1)