Respiratory Syncytial Virus Infections Clinical Trial
— CP149Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV), in Healthy Children 6 to <24 Months of Age
| Verified date | July 2012 |
| Source | MedImmune LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
| Status | Completed |
| Enrollment | 49 |
| Est. completion date | April 2010 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Months to 23 Months |
| Eligibility |
Inclusion Criteria: - Male or female whose age on the day of randomization is 6 to <24 months (reached 6th month birthday and not yet reached 2nd year birthday) - Subject is seronegative to both RSV and PIV3 at screening - Subject was the product of normal full term pregnancy (defined as >36 weeks gestation) - Subject is in general good health - Subject's legal representative is available by telephone - Written informed consent and HIPAA authorization (if applicable) obtained from the subject's legal representative - Subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator - Subject is available to complete the follow-up period, which will be through the end of RSV season (provisionally defined as 01/Apr for the United States) or 180 days after the final dose of study vaccine, whichever is later - Subject's legal representative must be willing and able to bring the subject to the study site for evaluation of respiratory illness in accordance with the protocol Exclusion Criteria: - Any fever (equal to or greater than 100.4°F [equal to or greater than 38.0°C], regardless of route) or lower respiratory illness (Section 4.1.2) within 7 days prior to randomization - Moderate or severe nasal congestion that in the investigator's opinion could prevent intranasal delivery of vaccine - 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 study vaccine dosing, except that infrequent use of over-the-counter medications such as pain relievers are permitted according to the judgment of the investigator - Any current or expected receipt of immunosuppressive agents including steroids (2 mg/kg per day of prednisone or its equivalent, or equal to or greater than 20 mg/day if the subject weighs >10 kg, given daily or on alternate days for equal to or greater than 14 days); children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for equal to or greater than 30 days; the use of topical steroids is permitted according to the judgment of the investigator - History of receipt of blood transfusion or expected receipt through 30 days following final study vaccine dosing - History of receipt of immunoglobulin products or expected receipt through 30 days after study vaccine dosing - Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 30 days after final study vaccine dosing - 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 study vaccine dose - Receipt of any inactivated (i.e., non-live) vaccine or rotavirus vaccine within 14 days prior to randomization or expected receipt within a 14-day window around any study vaccine dose - Known or suspected immunodeficiency, including HIV - Living in the same home or enrolled in the same classroom at day care with infants <24 months of age (only one child per household may be enrolled into the study) - Contact with pregnant caregiver - A household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after any study vaccine dose - A household contact who is a health care provider in contact with immunocompromised patients or who is a day care provider for infants under the age of 6 months - History of allergic reaction to any component of the study vaccine - Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject - Known or suspected active or chronic hepatitis infection - History of medical diagnosis of asthma, reactive airway disease, wheezing requiring medication, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically confirmed apnea, hospitalization for respiratory illness or mechanical ventilation - Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study - Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | THe Children's Hospital | Aurora | Colorado |
| United States | University of Maryland, Baltimore | Baltimore | Maryland |
| United States | United Medical Associates | Binghamton | New York |
| United States | Tufts-New England Medical Center | Boston | Massachusetts |
| United States | Craig A. Spiegel, MD | Bridgeton | Missouri |
| United States | Children's Memorial Hospital | Chicago | Illinois |
| United States | University Consultants in Allergy and Immunology | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | MetroHealth Medical Center | Cleveland | Ohio |
| United States | University Hospitals case Medical Center | Cleveland | Ohio |
| United States | Arkansas Pediatric Research Division | Conway | Arkansas |
| United States | North Georgia Clinical Research Center | Dalton | Georgia |
| United States | University of Texas Health Science Center of Houston Medical School | Houston | Texas |
| United States | Marshall University Joan C. Edwards School of Medicine | Huntington | West Virginia |
| United States | Arkansas Pediatric Clinic | Little Rock | Arkansas |
| United States | Miami Children's Hospital | Miami | Florida |
| United States | Withrop University Hospital | Mineola | New York |
| United States | West Virginia University Health Science Center | Morgantown | West Virginia |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Bear Care Pediatrics | Ogden | Utah |
| United States | Meridian Clinical Research, LLC | Omaha | Nebraska |
| United States | Pediatric Partners | Palm Beach Gardens | Florida |
| United States | Primary Physicians Research, Inc. | Pittsburgh | Pennsylvania |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Sanford Children's Specialty Clinic | Sioux Falls | South Dakota |
| United States | Copperview Medical Center | South Jordan | Utah |
| United States | Rockwood Clinic Research Center | Spokane | Washington |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | St. Vincent Mercy Medical Center Mercy Children's Hospital | Toledo | Ohio |
| United States | Advanced Pediatrics | Vienna | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC |
United States,
Bernstein DI, Malkin E, Abughali N, Falloon J, Yi T, Dubovsky F; MI-CP149 Investigators. Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children. Pedi — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Solicited Adverse Events (SEs) After Dose 1 | The SEs for this study included fever = 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | Yes |
| Primary | Number of Participants With SEs After Dose 2 | The SEs for this study included fever = 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | Yes |
| Primary | Number of Participants With SEs After Dose 3 | The SEs for this study included fever = 100.4°F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, laryngitis, and epistaxis. | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Yes |
| Primary | Number of Participants With Adverse Events (AEs) After Dose 1 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 1. | Days 0-28 after Dose 1 (Dose 1 was on Day 0) | Yes |
| Primary | Number of Participants With AEs After Dose 2 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 2. | Days 0-28 after Dose 2 (Dose 2 was on Day 48-64) | Yes |
| Primary | Number of Participants With AEs After Dose 3 | Unsolicited AEs reported by 1 or more participants in either treatment group through 28 days post Dose 3. | Days 0-28 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | Yes |
| Primary | Number of Subjects With Medically-attended Lower Respiratory Illnesses (MA-LRIs) | An MA-LRI was a healthcare provider-confirmed diagnosis of 1 or more of the following: wheezing, pneumonia, croup, rhonchi (not cleared with cough or suctioning), rales, bronchitis, bronchiolitis, apnea. | Days 0 to 180 days after final dose or the end of the RSV season, whichever was later | Yes |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | Events resulting in death; were life-threatening; resulted in inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and may have jeopardized the participant and required medical/surgical intervention to prevent one of the above outcomes. | Days 0-28 after any dose | Yes |
| Primary | Number of Participants With Significant New Medical Conditions (SNMCs) | A SNMC is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. | Day 0 through 180 days after the final dose or through the end of the RSV season, whichever was later | Yes |
| Secondary | Number of Participants Shedding Vaccine-like Virus at Any Time During Study Participation | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7, 12, and 28 after each dose and during visits for pre-specified illness symptoms occurring Day 0 through 28-34 days post each dose. | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 1 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 2 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 7 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 7-10 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 12 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 12-18 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Number of Participants Shedding Vaccine-like Virus at 28 Days After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Number of Participants With Shedding of Vaccine-like Virus on Any Day During Days 0-28 After Dose 3 | Number of participants with nasal wash specimens that were positive for RSV or PIV3 by culture and identified as vaccine-type virus by RT-PCR. | Days 0-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Baseline | Pre-dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Baseline (Day 0 prior to Dose 1) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 1 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 2 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum Antibodies to RSV at Day 28 Post Dose 3 | Post dose GMT of serum antibody response to RSV as measured by microneutralization assay. Limit of quantification is 5. For results reported as < 5, a value of 2.5 was imputed. | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies to PIV3 at Baseline | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Baseline (Day 0 prior to Dose 1) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 1 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 2 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Geometric Mean Titers (GMTs) of Serum HAI Antibodies to PIV3 Day 28 Post Dose 3 | Post dose GMT of serum antibody response to PIV3 as measured by HAI assay. Limit of quantification is 4. For results reported as < 4, a value of 2 was imputed. | Day 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Number of Participants With Seroresponse to RSV 28 Days After Dose 1 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Number of Participants With Seroresponse to RSV 28 Days After Dose 2 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Number of Participants With Seroresponse to RSV 28 Days After Dose 3 | Seroresponse is equal to or greater than a 4-fold rise in RSV antibody from baseline as measured by microneutralization assay. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
| Secondary | Number of Participants With Seroresponse to PIV3 28 Days After Dose 1 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 1 (Dose 1 was on Day 0) | No |
| Secondary | Number of Participants With Seroresponse to PIV3 28 Days After Dose 2 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 2 (Dose 2 was on Day 48-64) | No |
| Secondary | Number of Participants With Seroresponse to PIV3 28 Days After Dose 3 | Seroresponse is equal to or greater than a 4-fold rise in PIV3 antibody from baseline as measured by HAI assay. | Days 28-34 after Dose 3 (Dose 3 was 48-64 days after Dose 2) | No |
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