Evaluating the Safety and Immune Response to a Respiratory Syncytial Virus (RSV) Vaccine in Adults, RSV-Seropositive Children, and RSV-Seronegative Infants and Children
A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, RSV MEDI ΔM2-2 Lot RSV#002A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, RSV-Seropositive Children 12 to 59 Months of Age, and RSV-Seronegative Infants and Children 6 to 24 Months of Age
1 other identifier
interventional
60
1 country
1
Brief Summary
Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and pneumonia. RSV affects almost all children within the first 2 years of life. This study will evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults, RSV-seropositive children, and RSV-seronegative infants and children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 21, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 15, 2015
December 1, 2015
3.8 years
October 21, 2011
December 14, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Summarize the frequency of solicited adverse events (AEs) and other AEs
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
List the individual clinical solicited AEs and other AEs, graded by severity. These will be displayed in tabular format and stratified by group.
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Where appropriate, chi-square or Fisher's exact test will be used to determine significant differences between groups
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Secondary Outcomes (4)
List the peak titer and duration of virus shed by each individual participant. Data will be displayed in tabular format. Mean peak titer and mean duration of shedding will be calculated.
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
List the RSV antibody titer pre- and post-vaccination for each individual participant. Data will be displayed in tabular format. Mean antibody titers will be determined.
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Determine the infectivity of the vaccine, defined as the proportion of vaccinees who either shed vaccine virus and/or had a fourfold or greater rise in serum antibody titer following vaccination
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Where appropriate, the Mann-Whitney U test or Tukey-Kramer multiple comparison post-test will be used to determine significant differences between groups
Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Study Arms (7)
Adults: Vaccine (Group 1)
EXPERIMENTALAdult participants will receive one dose of the 10\^6 RSV MEDI ΔM2-2 vaccine intranasally.
Seropositive Children: Vaccine (Group 2)
EXPERIMENTALSeropositive children will receive one dose of the 10\^6 RSV MEDI ΔM2-2 vaccine intranasally.
Seropositive Children: Placebo Vaccine (Group 2)
PLACEBO COMPARATORSeropositive children will receive one dose of the placebo vaccine intranasally.
Seronegative Infants and Children: Vaccine (Group 3)
EXPERIMENTALSeronegative infants and children will receive one dose of the 10\^5 RSV MEDI ΔM2-2 vaccine intranasally.
Seronegative Infants and Children: Placebo Vaccine (Group 3)
PLACEBO COMPARATORSeronegative infants and children will receive one dose of the placebo vaccine intranasally.
Seronegative Infants and Children: Vaccine (Group 4)
EXPERIMENTALSeronegative infants and children will receive one dose of the 10\^6 RSV MEDI ΔM2-2 vaccine intranasally.
Seronegative Infants and Children: Placebo Vaccine (Group 4)
PLACEBO COMPARATORSeronegative infants and children will receive one dose of the placebo vaccine intranasally.
Interventions
Given intranasally once at a baseline study visit, at a dose of 10\^5 or 10\^6 plaque-forming units (PFU), depending on study arm.
Given intranasally once at a baseline study visit
Eligibility Criteria
You may qualify if:
- Adult males and nonpregnant, non-nursing females 18 to 49 years old
- In good health without significant medical illness, physical examination findings, or significant laboratory abnormalities in urinalysis, complete blood count (CBC), alanine aminotransferase (ALT), or creatinine, as determined by a study physician, physician assistant, or nurse practitioner
- Available for the duration of the study
- Willing to participate in the study as evidenced by signing the informed consent document
- Female participants of childbearing potential must have negative urine pregnancy tests and must agree to use effective birth control methods (e.g., birth control pills, diaphragm and foam, condoms with spermicide, Depo-Provera) until 28 days after vaccination
You may not qualify if:
- Pregnant, as determined by a positive urine human chorionic gonadotropin (beta-HCG) test
- 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, and/or laboratory studies, including urinalysis
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the person 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 in the study or would render the person unable to comply with the protocol
- Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months prior to study entry
- History of a severe allergic reaction or anaphylaxis
- History of splenectomy
- Current diagnosis of asthma within the 2 years prior to study entry
- Positive enzyme-linked immunosorbent assay (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)
- Abnormal urinalysis/urine dip
- Known immunodeficiency syndrome
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Hopkins Center for Immunization Research
Baltimore, Maryland, 21205, United States
Related Publications (2)
Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.
PMID: 20399493BACKGROUNDHall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.
PMID: 19196675BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth A. Karron, MD
Johns Hopkins Bloomberg School of Public Health
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2011
First Posted
October 25, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
December 15, 2015
Record last verified: 2015-12