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Respiratory Syncytial Virus InfectionsPhase 1NCT01459198

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 1 study testing RSV MEDI ΔM2-2 vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 months to 49 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
RSV MEDI ΔM2-2 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Aug 2011to Aug 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
  • Healthy children 12 to 59 months of age, whose parent/guardian understands and signs the study informed consent and agrees to vaccine administration following a detailed explanation of the study
Show all 13Show fewer
  • Seropositive for RSV, defined by serum RSV neutralizing antibody titer greater than 1:40
  • Person's history has been reviewed and they have undergone a physical examination indicating that s/he is in good health
  • Available for the duration of the study
  • Healthy children 6 to 24 months of age whose parents/guardians can understand and sign the informed consent and agree to vaccine administration following detailed explanation of the study
  • Seronegative for RSV antibody, defined by serum RSV neutralizing antibody titer less than 1:40 determined within 30 days prior to inoculation
  • Person's history has been reviewed and they have undergone a physical examination indicating that s/he is in good health
  • Available for the duration of the study

Who cannot join

  • 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
Show all 46Show fewer
  • 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
  • Receipt of blood products (including immunoglobulin) within the 3 months prior to study entry
  • Current smoker unwilling to stop smoking for the duration of the study
  • Previous enrollment in an RSV vaccine study
  • Known hypersensitivity to any vaccine component
  • Has professional and/or personal responsibilities that involve caring for children younger than 59 months of age or for immunosuppressed individuals
  • Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
  • Body mass index (BMI) greater than 35
  • Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previous immunization with an RSV vaccine
  • Previous serious vaccine-associated adverse event (AE) or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including any wheezing event or reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
  • Member of a household that includes an immunocompromised individual or infants younger than 6 months of age, other than a study participant
  • Attends day care with infants younger than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Note: children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
  • Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previous immunization with an RSV vaccine
  • Previous serious vaccine-associated AE or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including any wheezing event or reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
  • Member of a household that includes an immunocompromised individual or infants younger than 6 months of age, other than a study participant
  • Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
  • Temporary Exclusion Criteria for All Participants:
  • The following are temporary or self-limiting conditions and, once resolved, the person may be enrolled, if otherwise eligible. If the period of temporary exclusion is more than 56 days for adults or more than 30 days for RSV-seronegative children, the person will need to be rescreened. If the period of temporary exclusion is more than 56 days for RSV-seropositive children, a pre-inoculation serum antibody will need to be collected.
  • Fever (adult oral temperature of greater than or equal to 100.4°F [38°C] or pediatric rectal temperature of greater than or equal to 100.4°F [38°C]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis), or nasal congestion significant enough to interfere with successful vaccination, or otitis media
  • Has received any killed vaccine or live attenuated rotavirus vaccine within the 2 weeks prior to study entry, any other live vaccine within the 4 weeks prior to study entry, or gamma globulin (or other antibody products) within the 3 months prior to study entry
  • Has received another investigational vaccine or investigational drug within 28 days of receiving this investigational RSV vaccine
  • Has received antibiotics or systemic or nasal steroid therapy for acute illness within the 3 days prior to vaccination (steroid skin creams or lotions and topical antibiotics or antifungal preparations are permitted)
  • Infant or child participant has received salicylate (aspirin) or salicylate-containing products within the 1 month prior to study entry
  • Infants born at less than 37 weeks gestation and less than 1 year of age

Trial locations and contacts

1 site in 1 country.

United States1 site

  • John Hopkins Center for Immunization Research

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

The purpose of this study is to evaluate the safety and immune response of the RSV MEDI ΔM2-2 vaccine in the four groups of participants. The study vaccine will be evaluated in adults, in RSV-seropositive children, and in a dose-ranging study in two groups of RSV-seronegative infants and children.

Being tested
RSV MEDI ΔM2-2 vaccine, Placebo vaccine
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSV MEDI ΔM2-2 vaccineBiological

    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.

  • Placebo vaccineBiological

    Given intranasally once at a baseline study visit

Study groups in NCT01459198
Study groupRoleWhat they receive
Adults: Vaccine (Group 1)ExperimentalAdult participants will receive one dose of the 10^6 RSV MEDI ΔM2-2 vaccine intranasally.
Receives: Biological: RSV MEDI ΔM2-2 vaccine
Seropositive Children: Vaccine (Group 2)ExperimentalSeropositive children will receive one dose of the 10^6 RSV MEDI ΔM2-2 vaccine intranasally.
Receives: Biological: RSV MEDI ΔM2-2 vaccine
Seropositive Children: Placebo Vaccine (Group 2)Placebo comparatorSeropositive children will receive one dose of the placebo vaccine intranasally.
Receives: Biological: Placebo vaccine
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.
Receives: Biological: RSV MEDI ΔM2-2 vaccine
Seronegative Infants and Children: Placebo Vaccine (Group 3)Placebo comparatorSeronegative infants and children will receive one dose of the placebo vaccine intranasally.
Receives: Biological: Placebo vaccine
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.
Receives: Biological: RSV MEDI ΔM2-2 vaccine
Seronegative Infants and Children: Placebo Vaccine (Group 4)Placebo comparatorSeronegative infants and children will receive one dose of the placebo vaccine intranasally.
Receives: Biological: Placebo vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Summarize the frequency of solicited adverse events (AEs) and other AEs

    Measured: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

  2. List the individual clinical solicited AEs and other AEs, graded by severity. These will be displayed in tabular format and stratified by group.

    Measured: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

  3. Where appropriate, chi-square or Fisher's exact test will be used to determine significant differences between groups

    Measured: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

Secondary outcomes (4)

  1. 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: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

  2. 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: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

  3. 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: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

  4. Where appropriate, the Mann-Whitney U test or Tukey-Kramer multiple comparison post-test will be used to determine significant differences between groups

    Measured: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01459198
Sponsor's protocol ID
CIR 275
Status last verified
Dec 2015
First submitted
21 Oct 2011
Last updated
15 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20399493

  • Hall 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.

    PubMed 19196675

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV MEDI ΔM2-2 vaccine in people with Respiratory Syncytial Virus Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summarize the frequency of solicited adverse events (AEs) and other AEs (time frame: Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01459198, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.

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