ParainfluenzaPhase 1NCT00186927
A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
A Phase 1 study testing Sendai virus vaccine in people with Parainfluenza and Respiratory Viral Infections, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. Read more about this study
- Who is it for?
- Ages 12 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Parainfluenza, Respiratory Viral Infections
- What is being tested?
- Sendai virus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2005to Jan 2028
- 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 12 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or legal guardian willing and able to give informed consent and comply with study requirements
- Child is greater than or equal to one year of age and less than six years of age
- Adequate blood, liver and kidney function
- Has not or will not receive other vaccinations within 30 days of receiving study vaccine
Who cannot join
- History of allergy to eggs or gentamicin
- History of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition
- Children who have a family history of primary immunodeficiency or lack history of maternal or paternal immune status
- Height or weight less than 5th percentile
- Upper respiratory tract infection (URI) or household member with URI
- Evidence of developmental delay or evolving neurological disorders
Show all 10Show fewer
- Household member or daycare contact (i.e. stay in the same room in daycare) less than 24 months of age if same room contact is expected within 14 days of vaccination or 7 days after booster, or prior to evidence of vaccine clearance
- Immunodeficient household members or other close contacts if same room contact is expected within 14 days of vaccination or 7 days after booster, or prior to evidence of vaccine clearance
- Current use of investigational or immunosuppressive drugs (e.g., steroids)
- Current use of antibiotics or antivirals
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1. Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred.
This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to develop illness. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.
Read the detailed description
The main aim of the study is to assess the tolerance and safety of escalating doses of intranasal Sendai virus in children and toddlers.
The secondary objective of the study is to assess the magnitude and duration of the immune response elicited by intranasal Sendai virus. Responses between seropositive and seronegative children will be compared.
This study also tests the safety and immunogenicity of a booster vaccination at the highest dose tolerated during primary immunization dose-escalation.
- Conditions
- Parainfluenza, Respiratory Viral Infections
- Being tested
- Sendai virus vaccine
- Keywords
- Vaccine, Sendai virus vaccine
- Medical subject headings
- Paramyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sendai virus vaccineBiological
Enders strain; a live, unmodified intranasally administered Sendai virus vaccine; given once in a dose escalation study, 5 x 10^5 to 5 x 10^7 EID(50) units.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants will be studied in three cohorts:
* Healthy seropositive children 3 years up to 6 years
* Healthy seropositive toddlers 12 months up to 24 months
* Healthy seronegative toddlers 12 months up to 24 months.
Each cohort will receive Sendai virus vaccine. Receives: Biological: Sendai virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if giving live Sendai virus (in the form of a vaccine) to children through their nose is safe (causes no serious illness)
Measured: 6 months after enrollment complete
To determine if a child's body responds to the presence of the Sendai virus by making proteins in the blood called antibodies that can find and kill the croup virus
Measured: 6 months after enrollment complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start5 May 2005
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Why it stopped: voluntary Hold because of COVID-19, all participants were off study prior to the hold.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParainfluenzaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Adderson, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186927
- Sponsor's protocol ID
- SENDAI
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2005
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Adderson E, Allison KJ, Branum K, Sealy RE, Jones BG, Surman SL, Penkert RR, Hayden RT, Russell CJ, Portner A, Slobod KS, Hurwitz JL. Intranasal Sendai Virus Vaccination of Seropositive Children 1 to 2 Years of Age in a Phase I Clinical Trial Boosts Immune Responses Toward Human Parainfluenza Virus Type 1. Vaccines (Basel). 2025 Apr 19;13(4):430. doi: 10.3390/vaccines13040430.
PubMed 40333329
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
- ClinicalTrials.gov ID
- NCT00186927
- Acronym / sponsor ID
- SENDAI
- Conditions
- Parainfluenza, Respiratory Viral Infections
- Keywords
- Vaccine, Sendai virus vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: voluntary Hold because of COVID-19, all participants were off study prior to the hold.
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 5 May 2005 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1. Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred.
This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to develop illness. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.
Detailed description
The main aim of the study is to assess the tolerance and safety of escalating doses of intranasal Sendai virus in children and toddlers.
The secondary objective of the study is to assess the magnitude and duration of the immune response elicited by intranasal Sendai virus. Responses between seropositive and seronegative children will be compared.
This study also tests the safety and immunogenicity of a booster vaccination at the highest dose tolerated during primary immunization dose-escalation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Biological: Sendai virus vaccineParticipants will be studied in three cohorts: * Healthy seropositive children 3 years up to 6 years * Healthy seropositive toddlers 12 months up to 24 months * Healthy seronegative toddlers 12 months up to 24 months. Each cohort will receive Sendai virus vaccine. |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parent or legal guardian willing and able to give informed consent and comply with study requirements
- Child is greater than or equal to one year of age and less than six years of age
- Adequate blood, liver and kidney function
- Has not or will not receive other vaccinations within 30 days of receiving study vaccine
Key exclusion criteria (10 listed)
- History of allergy to eggs or gentamicin
- History of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition
- Children who have a family history of primary immunodeficiency or lack history of maternal or paternal immune status
- Height or weight less than 5th percentile
- Upper respiratory tract infection (URI) or household member with URI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sendai virus vaccineEnders strain; a live, unmodified intranasally administered Sendai virus vaccine; given once in a dose escalation study, 5 x 10^5 to 5 x 10^7 EID(50) units. | Biological | Participants |
Primary outcome
To determine if giving live Sendai virus (in the form of a vaccine) to children through their nose is safe (causes no serious illness)
Time frame: 6 months after enrollment complete
To determine if a child's body responds to the presence of the Sendai virus by making proteins in the blood called antibodies that can find and kill the croup virus
Time frame: 6 months after enrollment complete
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Derived from this study: PubMed 40333329Adderson E, Allison KJ, Branum K, Sealy RE, Jones BG, Surman SL, Penkert RR, Hayden RT, Russell CJ, Portner A, Slobod KS, Hurwitz JL. Intranasal Sendai Virus Vaccination of Seropositive Children 1 to 2 Years of Age in a Phase I Clinical Trial Boosts Immune Responses Toward Human Parainfluenza Virus Type 1. Vaccines (Basel). 2025 Apr 19;13(4):430. doi: 10.3390/vaccines13040430.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Adderson, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sendai virus vaccine in people with Parainfluenza and Respiratory Viral Infections, run by St. Jude Children's Research Hospital 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 4 inclusion and 10 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: paused, as of the sponsor's last update on 30 Mar 2026. 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. 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?
Results are not available in the source record.
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?
To determine if giving live Sendai virus (in the form of a vaccine) to children through their nose is safe (causes no serious illness) (time frame: 6 months after enrollment complete). The study lists 2 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 NCT00186927, which also lists 1 linked publication.
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 30 Mar 2026.