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

Primary Purpose

Paramyxoviridae Infections, Virus Diseases

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

rHPIV3cp45

rHPIV3cp45 placebo

About this trial

This is an interventional prevention trial for Paramyxoviridae Infections focused on measuring Respiratory Tract Infection

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Center for Immunization Research (CIR), Johns Hopkins School of Public Health
Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of vaccine-related reactogenicity events and other adverse events

Amount of serum antibody induced by vaccine in each recipient

Secondary Outcome Measures

Amount of vaccine virus shed by each recipient

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

Number of vaccinated infants infected with rHPIV3cp45

Number of vaccinated participants infected with a second dose of rHPIV3cp45

Phenotypic stability of vaccine virus shed

Full Information

NCT ID

NCT01021397

First Posted

November 25, 2009

Last Updated

December 31, 2012

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Johns Hopkins Bloomberg School of Public Health

1. Study Identification

Unique Protocol Identification Number

NCT01021397

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paramyxoviridae Infections, Virus Diseases

Keywords

Respiratory Tract Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

rHPIV3cp45

Intervention Description

10^5 TCID50 nasal drops

Intervention Type

Drug

Intervention Name(s)

rHPIV3cp45 placebo

Intervention Description

1X-L15 nasal drops

Primary Outcome Measure Information:

Title

Frequency of vaccine-related reactogenicity events and other adverse events

Time Frame

Throughout study

Title

Amount of serum antibody induced by vaccine in each recipient

Time Frame

Throughout study

Secondary Outcome Measure Information:

Title

Amount of vaccine virus shed by each recipient

Time Frame

Throughout study

Title

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

Time Frame

From Weeks 22 to 28

Title

Number of vaccinated infants infected with rHPIV3cp45

Time Frame

Throughout study

Title

Number of vaccinated participants infected with a second dose of rHPIV3cp45

Time Frame

From Weeks 22 to 28

Title

Phenotypic stability of vaccine virus shed

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth A. Karron, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16406170

Citation

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.

Results Reference

background

PubMed Identifier

12083844

Citation

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.

Results Reference

background

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

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