A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age

NCT ID: NCT00508651

Last Updated: 2011-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-04-30

Brief Summary

The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3) seronegative at baseline and to infants 1 to < 3 months of age regardless of baseline serostatus.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multidose Phase 1/2a multicenter study designed to evaluate the safety, tolerability, viral shedding, immunogenicity, and genotypic and phenotypic stability of MEDI-560 in infants 1 to < 12 months of age. Three doses of MEDI-560 at a dosage level of 10^5 TCID50 were administered 0, 2, and 4 months after enrollment to a 30-participant cohort of 6 to < 12 month-old HPIV3 seronegative children randomized 2:1 to MEDI-560 vs placebo. A second 160-participant cohort of 1 to < 3 month-old infants not screened for baseline serostatus was planned but was not opened to enrollment for reasons other than safety. Participants were followed for safety through 180 days post last dose. Nasal wash specimens were collected at screening and Days 7, 12, and 28 following each dose and during unscheduled illness visits to assess vaccine virus shedding and genotypic and phenotypic stability of any shed vaccine virus. Blood was collected at screening to determine eligibility and prior to Dose 1 for baseline serostatus. Blood for assessment of antibodies to HPIV3 was collected approximately 7 to 12 days after Dose 1 and Dose 3 and 1 month after each dose for antibodies to PIV3.

Conditions

Healthy

Keywords

parainfluenza virus, children, vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1 MEDI-560

MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM Luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.

Group Type: EXPERIMENTAL

MEDI-560

Intervention Type: BIOLOGICAL

MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.

Cohort 1 Placebo

Placebo was a frozen preparation filled into Becton Dickinson\^TM Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo was a frozen preparation filled into Becton Dickinson\^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Interventions

MEDI-560

MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson\^TM luer slip tip syringes. Each 0.2 mL dose contained 10\^5 TCID50 of MEDI-560 in a sucrose phosphate glutamate buffer.

Intervention Type: BIOLOGICAL

Placebo

Placebo was a frozen preparation filled into Becton Dickinson\^TM luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female whose age on the day of randomization falls within one of the two age cohorts:

Cohort 1: 6 to < 12 months (≥ 6 months of age and not yet reached their 1st year birthday); Cohort 2: 1 to < 3 months (> 28 days of age and not yet reached their 3rd month birthday)

2. Cohort 1 only: Participant is seronegative to HPIV3 at screening as determined by ELISA; or the legal representative is willing to provide access to data documenting that the participant was screened for another MedImmune trial after written informed consent was obtained, and that the participant is seronegative to HPIV3 within 21 days prior to randomization into MI-CP150 as determined by ELISA at MedImmune

3. Participant was the product of a normal full term pregnancy, defined as 36-42 weeks gestation

4. Participant is in general good health

5. Participant's legal representative is available by telephone

6. Written informed consent and Health Insurance Portability and Accountability Act authorization (if applicable) obtained from the participant's legal representative

7. Participant's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator

8. Participant is available to complete the follow-up period of 180 days after the final dose of investigational product as required by the protocol

9. Participant's legal representative is willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol

Exclusion Criteria

1. Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness within 7 days prior to randomization

2. Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of investigational product

3. Cohort 1 only: weight < the fifth percentile for age on the day of randomization

4. Cohort 2 only: history of low birth-weight (ie, < 2,500 grams at birth) or weight < fifth percentile for age on the day of randomization

5. Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt through the protocol-specified blood collection 28 days after each investigational product dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator

6. Any current or expected receipt of immunosuppressive agents including steroids (≥ 2 mg/kg per day of prednisone or its equivalent, or ≥ 20 mg/day if the participant weighs >10 kg, given daily or on alternate days for ≥ 14 days); children in this category should not receive investigational product until immunosuppressive agents including corticosteroid therapy have been discontinued for ≥ 30 days; the use of topical steroids is permitted according to the judgment of the investigator

7. History of receipt of blood transfusion or expected receipt through 30 days after final investigational product dosing

8. History of receipt of immunoglobulin products or expected receipt through 30 days after final investigational product dosing

9. Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final investigational product dosing

10. Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization or expected receipt within a 28-day window around any dose

11. Receipt of any inactivated (eg, non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any dose

12. Known or suspected immunodeficiency, including human immunodeficiency virus

13. Living in the same home or enrolled in the same classroom at day care with infants < 24 months of age within 28 days after each dose (only one child per household may be enrolled into the study)

14. Contact with pregnant caregiver within 28 days after each dose

15. Household contact with an immunocompromised person within 28 days after each dose; the participant should also avoid close contact with immunocompromised individuals for at least 28 days after each investigational product dose

16. Household contact within 28 days after each dose with a healthcare worker who has direct patient care responsibilities or household contact within 28 days after each dose with someone who is a day care provider or preschool teacher for children < 24 months of age

17. History of allergic reaction to any component of the investigational product

18. Previous medical history or evidence of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the participant

19. Known or suspected active or chronic hepatitis infection

20. History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, bronchoconstriction or treatment with a β2 agonist (eg, albuterol), cystic fibrosis, chronic lung disease of prematurity (eg, bronchopulmonary dysplasia), chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation

21. A family member or a household contact who is an employee of the research center or otherwise involved with the conduct of the study

22. Any condition that, in the opinion of the investigator, might interfere with investigational product evaluation

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 11 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

MedImmune, LLC

Principal Investigators

Judith Falloon, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Children's Investigational Research Program

Bentonville, Arkansas, United States

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

Madera Family Medical Group

Madera, California, United States

Allergy Medical Group of the North Area

Roseville, California, United States

Miami Children's Hospital

Miami, Florida, United States

Homestead Clinical Research

Naranja, Florida, United States

University of South Florida College of Medicine Department of Pediatrics

Tampa, Florida, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Michael W. Simon, M.D.

Lexington, Kentucky, United States

Tulane University

New Orleans, Louisiana, United States

Tufts-New England Medical Center

Boston, Massachusetts, United States

Meridian Clinical Research LLC

Omaha, Nebraska, United States

Children's Lung Specialists Ltd.

Las Vegas, Nevada, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Duke Health Center- Pickett Road

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Oklahoma State University Center for Health Sciences

Tulsa, Oklahoma, United States

St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Belleview Pediactric Assoc.

Pittsburgh, Pennsylvania, United States

Holston Medical Group

Kingsport, Tennessee, United States

Dixie Pediatrics

St. George, Utah, United States

University Physicians Internal Medicine

Huntington, West Virginia, United States

Countries

United States

References

Bernstein DI, Falloon J, Yi T. A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants. Vaccine. 2011 Sep 16;29(40):7042-8. doi: 10.1016/j.vaccine.2011.07.031. Epub 2011 Jul 22.

Reference Type: RESULT

PMID: 21782874 (View on PubMed)

Other Identifiers

MI-CP150

Identifier Type: -

Identifier Source: org_study_id

NCT01150799

Identifier Type: -

Identifier Source: nct_alias