Safety of a Live Attenuated Human Parainfluenza Virus Type 2 (HPIV2) Vaccine for Adults, Children, and Infants

NCT01139437 | Completed Phase 1 DMC

• 1 other identifier: CIR 258
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants and young children. This study will test the safety of and immune response to an HPIV2 vaccine aimed at infants and children.

Conditions

Human Parainfluenza Virus 2

Keywords

Vaccine; HPIV2; Infants

Outcome Measures

Primary Outcomes (3)

• Safety, as determined by frequency of adverse events

  Measured at baseline, for 11 days after vaccination, and at 1 month follow-up

• Immunogenicity, as determined by ability to cause an immunological reaction and amount of antibody induced by the vaccine

  Measured at baseline and at 1 month

• Infectivity, as determined by amount of vaccine shed by each recipient

  Measured at baseline, for 11 days after vaccination, and at 1 month follow-up

Secondary Outcomes (2)

• Phenotypic stability of the vaccine virus shed

  Measured at baseline and at 1 month

• Number of vaccinated infants and children infected with HPIV2

  Measured at baseline, for 11 days after vaccination, and at 1 month follow-up

Study Arms (7)

Adults

EXPERIMENTAL

Adults ages 18 to 49 years of age. Open label.

Biological: Standard Dose HPIV2 Vaccine

Seropositive children - vaccine

EXPERIMENTAL

Children ages 15 to 59 months of age who already have HPIV2 antibodies receiving the HPIV2 vaccine.

Biological: Standard Dose HPIV2 Vaccine

Seronegative infants and children - low dose vaccine

EXPERIMENTAL

Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of the HPIV2 vaccine.

Biological: Low dose HPIV2 vaccine

Seronegative infants and children - standard dose vaccine

EXPERIMENTAL

Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of the HPIV2 vaccine.

Biological: Standard Dose HPIV2 Vaccine

Seropositive children - placebo

PLACEBO COMPARATOR

Children ages 15 to 59 months of age who already have HPIV2 antibodies receiving a placebo.

Other: Placebo

Seronegative infants and children - low dose placebo

PLACEBO COMPARATOR

Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of placebo.

Other: Placebo

Seronegative infants and children - standard dose placebo

PLACEBO COMPARATOR

Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of placebo.

Other: Placebo

Interventions

Standard Dose HPIV2 Vaccine BIOLOGICAL

10\^6 tissue culture infectious dose 50% (TCID50) administered intranasally in a single dose

Adults; Seronegative infants and children - standard dose vaccine; Seropositive children - vaccine

Low dose HPIV2 vaccine BIOLOGICAL

10\^5 TCID50 administered in a single dose

Seronegative infants and children - low dose vaccine

Placebo OTHER

Matched placebo

Seronegative infants and children - low dose placebo; Seronegative infants and children - standard dose placebo; Seropositive children - placebo

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 49 years old
• In good health, measured by lack of significant medical illness, physical examination findings, or significant laboratory abnormalities of urinalysis, complete blood count (CBC), ALT, or creatinine, as determined by the investigator

You may not qualify if:

• Pregnancy
• Breastfeeding
• Females of childbearing potential who are unwilling to practice effective birth control
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, or laboratory studies, including urinalysis
• Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the participant to understand and cooperate with the study protocol
• Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the study or would render the participant unable to comply with the protocol
• Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• History of a severe allergic reaction or anaphylaxis
• History of splenectomy
• Diagnosis of asthma within the past 2 years
• Positive enzyme-linked immunoassay (ELISA) and confirmatory Western blot tests for HIV-1
• Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV)
• Positive ELISA hepatitis B surface antigen (HBsAg) test
• Abnormal urinalysis or urine dip
• Known immunodeficiency syndrome

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Johns Hopkins University, Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Murphy BR, Prince GA, Collins PL, Van Wyke Coelingh K, Olmsted RA, Spriggs MK, Parrott RH, Kim HW, Brandt CD, Chanock RM. Current approaches to the development of vaccines effective against parainfluenza and respiratory syncytial viruses. Virus Res. 1988 Aug;11(1):1-15. doi: 10.1016/0168-1702(88)90063-9.

  PMID: 2845680 BACKGROUND

• Nolan SM, Skiadopoulos MH, Bradley K, Kim OS, Bier S, Amaro-Carambot E, Surman SR, Davis S, St Claire M, Elkins R, Collins PL, Murphy BR, Schaap-Nutt A. Recombinant human parainfluenza virus type 2 vaccine candidates containing a 3' genomic promoter mutation and L polymerase mutations are attenuated and protective in non-human primates. Vaccine. 2007 Aug 21;25(34):6409-22. doi: 10.1016/j.vaccine.2007.06.028. Epub 2007 Jul 3.

  PMID: 17658669 BACKGROUND

Study Officials

• Ruth A. Karron, MD

  Johns Hopkins University, Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 8, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)