ParainfluenzaPhase 1NCT00641017
Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine
A Phase 1 study testing rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine in people with Parainfluenza and Virus Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. Read more about this study
- Who is it for?
- Ages 6 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Parainfluenza, Virus Diseases
- What is being tested?
- rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2012
- 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
Adult Inclusion Criteria:
- In good health
- Available for the duration of the trial
- Available for post-inoculation telephone contact
- For females, must agree to use effective birth control methods for the duration of the study
Seropositive Children Inclusion Criteria:
- In good health
- Seropositive for HPIV1
- Available for the duration of the study
Seronegative Infants and Children Inclusion Criteria:
- In good health
- Seronegative for HPIV1 antibody
- Available for the duration of the study
Adult Exclusion Criteria:
- Neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Condition, in the opinion of the investigator, that will not allow the participant to comply with the protocol
- Alcohol or drug abuse
- History of anaphylaxis
- History of splenectomy
- Diagnosis of asthma within 2 years of study entry
- HIV-infected
- Hepatitis C infection
- Hepatitis B infection
- Abnormal urinalysis
- Known immunodeficiency syndrome
- Current use of nasal or systemic steroid medications
- Receipt of blood products within 3 months of study entry
- Current smoker unwilling to stop smoking for the duration of the study. The decision to exclude a potential subject is made by the investigator based upon the potential subject's medical history and physical examination.
- Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine
- Receipt of live vaccine within 4 weeks or a killed vaccine within 2 weeks or immune globin within 3 months prior to receiving the investigational vaccine
- Previous immunization with an HPIV1 vaccine
- Known hypersensitivity to any vaccine component
- Participants whose profession and/or personal responsibilities involve caring for children less than 6 months of age or for immunosuppressed individuals
- Persistent systolic blood pressure more than 140 mm Hg or diastolic pressure more than 90 mm Hg
- Body mass index (BMI) more than 35
- Pregnant or breastfeeding
Seropositive and Seronegative Infants and Children Exclusion Criteria:
- Known or suspected impairment of immunological functions as determined by the investigator
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with HPIV1 vaccine
- Current use of nasal or systemic steroid medications
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including reactive airway disease as determined by the investigator
- Member of household that includes an immunocompromised individual or infant less than 6 months of age
- Attends day care with infants less than 6 months of age or immunosuppressed individuals. More information about this criterion can be found in the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or while study is occurring
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Parainfluenza Type 1 Virus Vaccine, rHPIV1 84/del170/942A, Lot PIV1 #104A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV1-Seropositive Children 15 to 59 Months of Age, and HPIV1-Seronegative Infants and Children 6 to 59 Months of Age
Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.
Read the detailed description
HPIV1 infection can result in severe respiratory illness that often leads to the hospitalization of infants and young children. HPIV1 is responsible for approximately 6% of all pediatric hospitalizations for respiratory tract diseases and is a main cause of severe lower respiratory tract diseases, including pneumonia and bronchiolitis in children less than 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 5 main volunteer group: first in adults (group 1 and 2), and then in seropositive children (group 3). The last 2 groups will be seronegative infants and children that are split into 2 dosing groups; one group of seronegative infants and children will receive a lower dose of vaccine (group 4) and a second group of seronegative infants and children (group 5) will receive a higher dose of vaccine. This study will last approximately 8 weeks per group. Additional information about each of the groups is as follows:
Groups 1 and 2 will consist of 35 adults total, 18 to 49 years of age. These groups will receive one immunization with rHPIV1 84/del170/942A at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood and urine tests will occur at selected visits. A urine pregnancy test will occur for females at study entry. Follow-up phone reports will also be required on Day 56.
Enrollment into Group 3 will begin only after safety data from Groups 1 and 2 are evaluated. Group 3 will consist of 15 seropositive children, 15 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood and urine tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Enrollment into Group 4 will begin only after safety data from Group 3 are evaluated. Group 4 will consist of 21-30 seronegative infants and children, 6 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Enrollment into Group 5 will begin only after safety data from Group 4 are evaluated. Group 5 will consist of 21-30 seronegative infants and children 6 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. The immunization will be given as nose drops. The vaccine dosage that participants receive in Group 5 will be greater than the dose in Group 4. Study visits will occur on Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
- Conditions
- Parainfluenza, Virus Diseases
- Being tested
- rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine, Placebo
- Medical subject headings
- Paramyxoviridae Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineBiological
Live attenuated Human Parainfluenza Type 1 Virus Vaccine
PlaceboBiological
Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 and 2 - Adults | Experimental | One immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry Receives: Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine |
| 3A - Seropositive Children | Experimental | One immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry Receives: Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine |
| 3B - Seropositive Children | Placebo comparator | One dose of 1x10^6 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry Receives: Biological: Placebo |
| 4A - Seronegative Infants and Children | Experimental | One immunization of 1x10^5 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry Receives: Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine |
| 4B - Seronegative Infants and Children | Placebo comparator | One dose of 1x10^5 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry Receives: Biological: Placebo |
| 5A - Seronegative Infants and Children | Experimental | One immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry Receives: Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine |
| 5B - Seronegative Infants and Children | Placebo comparator | One dose of rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reaction events and other adverse events in each cohort
Measured: Throughout study
Amount of vaccine virus shed by each participant
Measured: Throughout study
Amount of serum antibody and mucosal antibody induced by the vaccine in each participant
Measured: Throughout study
Secondary outcomes (2)
Phenotypic stability of vaccine virus shed
Measured: Throughout study
Number of vaccinated children and infants infected with rHPIV1
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ParainfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Ruth A. Karron, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641017
- Sponsor's protocol ID
- CIR 248
- Status last verified
- Feb 2013
- First submitted
- 5 Mar 2008
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bartlett EJ, Amaro-Carambot E, Surman SR, Collins PL, Murphy BR, Skiadopoulos MH. Introducing point and deletion mutations into the P/C gene of human parainfluenza virus type 1 (HPIV1) by reverse genetics generates attenuated and efficacious vaccine candidates. Vaccine. 2006 Mar 24;24(14):2674-84. doi: 10.1016/j.vaccine.2005.10.047. Epub 2005 Nov 15.
PubMed 16364511Bartlett EJ, Castano A, Surman SR, Collins PL, Skiadopoulos MH, Murphy BR. Attenuation and efficacy of human parainfluenza virus type 1 (HPIV1) vaccine candidates containing stabilized mutations in the P/C and L genes. Virol J. 2007 Jul 2;4:67. doi: 10.1186/1743-422X-4-67.
PubMed 17605811Karron RA, San Mateo J, Thumar B, Schaap-Nutt A, Buchholz UJ, Schmidt AC, Bartlett EJ, Murphy BR, Collins PL. Evaluation of a Live-Attenuated Human Parainfluenza Type 1 Vaccine in Adults and Children. J Pediatric Infect Dis Soc. 2015 Dec;4(4):e143-6. doi: 10.1093/jpids/piu104. Epub 2014 Nov 12.
PubMed 26582883
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Parainfluenza Type 1 Virus Vaccine, rHPIV1 84/del170/942A, Lot PIV1 #104A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV1-Seropositive Children 15 to 59 Months of Age, and HPIV1-Seronegative Infants and Children 6 to 59 Months of Age
- ClinicalTrials.gov ID
- NCT00641017
- Acronym / sponsor ID
- CIR 248
- Conditions
- Parainfluenza, Virus Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Study start
- Mar 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Mar 2008 (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.
Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.
Detailed description
HPIV1 infection can result in severe respiratory illness that often leads to the hospitalization of infants and young children. HPIV1 is responsible for approximately 6% of all pediatric hospitalizations for respiratory tract diseases and is a main cause of severe lower respiratory tract diseases, including pneumonia and bronchiolitis in children less than 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 5 main volunteer group: first in adults (group 1 and 2), and then in seropositive children (group 3). The last 2 groups will be seronegative infants and children that are split into 2 dosing groups; one group of seronegative infants and children will receive a lower dose of vaccine (group 4) and a second group of seronegative infants and children (group 5) will receive a higher dose of vaccine. This study will last approximately 8 weeks per group. Additional information about each of the groups is as follows:
Groups 1 and 2 will consist of 35 adults total, 18 to 49 years of age. These groups will receive one immunization with rHPIV1 84/del170/942A at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood and urine tests will occur at selected visits. A urine pregnancy test will occur for females at study entry. Follow-up phone reports will also be required on Day 56.
Enrollment into Group 3 will begin only after safety data from Groups 1 and 2 are evaluated. Group 3 will consist of 15 seropositive children, 15 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood and urine tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Enrollment into Group 4 will begin only after safety data from Group 3 are evaluated. Group 4 will consist of 21-30 seronegative infants and children, 6 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Enrollment into Group 5 will begin only after safety data from Group 4 are evaluated. Group 5 will consist of 21-30 seronegative infants and children 6 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. The immunization will be given as nose drops. The vaccine dosage that participants receive in Group 5 will be greater than the dose in Group 4. Study visits will occur on Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 and 2 - Adults | Experimental | Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineOne immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry |
| 3A - Seropositive Children | Experimental | Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineOne immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry |
| 3B - Seropositive Children | Placebo comparator | Biological: PlaceboOne dose of 1x10^6 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry |
| 4A - Seronegative Infants and Children | Experimental | Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineOne immunization of 1x10^5 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry |
| 4B - Seronegative Infants and Children | Placebo comparator | Biological: PlaceboOne dose of 1x10^5 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry |
| 5A - Seronegative Infants and Children | Experimental | Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineOne immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry |
| 5B - Seronegative Infants and Children | Placebo comparator | Biological: PlaceboOne dose of rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| rHPIV1 84/del170/942A, Lot PIV1 #104A vaccineLive attenuated Human Parainfluenza Type 1 Virus Vaccine | Biological | 1 and 2 - Adults, 3A - Seropositive Children, 4A - Seronegative Infants and Children, 5A - Seronegative Infants and Children |
| PlaceboPlacebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine | Biological | 3B - Seropositive Children, 4B - Seronegative Infants and Children, 5B - Seronegative Infants and Children |
Primary outcome
Frequency of vaccine-related reaction events and other adverse events in each cohort
Time frame: Throughout study
Amount of vaccine virus shed by each participant
Time frame: Throughout study
Amount of serum antibody and mucosal antibody induced by the vaccine in each participant
Time frame: Throughout study
2 secondary outcomes
Phenotypic stability of vaccine virus shed
Time frame: Throughout study
Number of vaccinated children and infants infected with rHPIV1
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Background: PubMed 16364511Bartlett EJ, Amaro-Carambot E, Surman SR, Collins PL, Murphy BR, Skiadopoulos MH. Introducing point and deletion mutations into the P/C gene of human parainfluenza virus type 1 (HPIV1) by reverse genetics generates attenuated and efficacious vaccine candidates. Vaccine. 2006 Mar 24;24(14):2674-84. doi: 10.1016/j.vaccine.2005.10.047. Epub 2005 Nov 15.
- Background: PubMed 17605811Bartlett EJ, Castano A, Surman SR, Collins PL, Skiadopoulos MH, Murphy BR. Attenuation and efficacy of human parainfluenza virus type 1 (HPIV1) vaccine candidates containing stabilized mutations in the P/C and L genes. Virol J. 2007 Jul 2;4:67. doi: 10.1186/1743-422X-4-67.
- Derived from this study: PubMed 26582883Karron RA, San Mateo J, Thumar B, Schaap-Nutt A, Buchholz UJ, Schmidt AC, Bartlett EJ, Murphy BR, Collins PL. Evaluation of a Live-Attenuated Human Parainfluenza Type 1 Vaccine in Adults and Children. J Pediatric Infect Dis Soc. 2015 Dec;4(4):e143-6. doi: 10.1093/jpids/piu104. Epub 2014 Nov 12.
Related trials for Parainfluenza
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Not yet recruitingObservational study
ELderly REspiratory VIral Cohort
Influenza Viruses, Respiratory Syncytial Virus (RSV)
RecruitingPhase 2
PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
RecruitingPhase 3
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
Lower Respiratory Tract Infection, Parainfluenza
Active, not recruiting
Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses
Respiratory Tract Infections
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.
Ruth A. Karron, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
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 rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine in people with Parainfluenza and Virus Diseases, 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?
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 25 Feb 2013. 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?
Frequency of vaccine-related reaction events and other adverse events in each cohort (time frame: Throughout study). 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 NCT00641017, which also lists 3 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 25 Feb 2013.