Parainfluenza Virus 3, HumanPhase 1NCT01254175
Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children
A Phase 1 study testing rHPIV3cp45 Vaccine in people with Parainfluenza Virus 3, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
Trial summary
Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Parainfluenza Virus 3, Human
- What is being tested?
- rHPIV3cp45 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2010to Feb 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 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/guardian(s) of participants can demonstrate their understanding of the study (by taking a multiple choice questionnaire), sign the informed consent, and agree to vaccine administration following a detailed explanation of the study
- Seronegative for HPIV3, as defined by serum antibody titer hemagglutination inhibition (HAI) less than or equal to 1:8, as determined within 30 days prior to inoculation
- Medical history has been reviewed and a physical examination indicates that participant is in good health
- In the view of the site investigator, participant has received routine immunizations appropriate for age, administered at least 2 weeks prior to study entry (inactivated and subunit vaccines and rotavirus vaccine), or at least 4 weeks prior to study entry (live vaccines except rotavirus vaccine)
- Available for the entire study period and parent/guardian can be reached by telephone for post-inoculation contacts
- For children born to HIV-infected women, the child can be considered HIV-uninfected if he/she has either two negative polymerase chain reaction (PCR) tests with one collected at greater than 1 month of age and one collected at greater than 4 months of age, or two negative antibody tests
- If there is an immunocompromised child in the household who is less than 5 years of age, his/her last CD4 count must be greater than 15%
Who cannot join
- Known or suspected impairment of immunological functions, HIV infection, or currently (within the 30 days prior to study entry) receiving immunosuppressive therapy, including systemic corticosteroids (NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable.)
- Bone marrow/solid organ transplant recipients
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with HPIV3 vaccine
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
Show all 19Show fewer
- Lung or heart disease, including reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy in the 12 months before study entry may also be enrolled.
- Premature infants (born before 37 weeks gestation) if less than 12 months of age
- Members of a household which contains immunocompromised individuals (including, but not limited to, those with HIV-related immunodeficiency, defined as CD4 count less than 300 within the 6 months prior to study entry, or any household members who have received chemotherapy within the 12 months prior to study entry). More information on this criterion can be found in the protocol.
- Members of a household that contains infants less than 6 months of age
- 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. (Facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.)
- Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or until the final follow-up blood draw
- Temporary Exclusion Criteria:
- The following exclusion criteria are temporary or self-limiting conditions, and once resolved (after 24 hours and three normal measurements for fever) the infant may be enrolled, if otherwise eligible.
- Fever (rectal temperature of greater than or equal to 100.7 F), acute upper respiratory illness (including nasal congestion significant enough to interfere with successful vaccination), or acute otitis media
- Received any killed or subunit vaccine or rotavirus vaccine within the last 2 weeks; any live vaccine, except rotavirus, within the last 4 weeks; or gamma globulin (or other antibody products) within the past 3 months
- Received short-term systemic antibiotics for an acute illness within the 5 days prior to vaccination, or is currently receiving long-term prophylactic antibiotics (NOTE: Topical steroids, topical antibiotics, or topical antifungal preparations are permitted.)
- Received aspirin or aspirin-containing products within the 30 days prior to study entry
- Infants born at less than 37 weeks gestation will be deferred from participation until they are at least 12 months of age
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, 60612
Chicago Children's CRS
Chicago, Illinois, 60614
DUMC Ped. CRS
Durham, North Carolina, 27710
Miller Children's Hosp. Long Beach CA NICHD CRS
Long Beach, California, 90806
Columbia IMPAACT CRS
New York, New York, 10032
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 92103
Seattle Children's Hospital CRS
Seattle, Washington, 98105
About this study
Official title: Phase 1 Study to Determine the Safety, Infectivity, Immunogenicity and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval
Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.
Read the detailed description
Human parainfluenza viruses can cause serious respiratory tract disease in infants and children under 5 years of age, and approximately 25% of children under 5 years of age have experienced a clinically significant parainfluenza virus infection. HPIV3, one of the four types of the parainfluenza virus, can cause pneumonia, bronchiolitis, croup, and bronchitis, and virtually all children have experienced primary HPIV3 infections by the time they are 3 to 4 years of age. In the United States, HPIV3 is responsible for approximately 11% of hospitalizations for respiratory diseases in children. Because HPIV3-associated lower respiratory illness typically occurs in the first year of life, the need exists for an HPIV3 vaccine that is safe and effective in infants. The purpose of this study is to evaluate the safety and immunogenicity of two doses of a live attenuated HPIV3 vaccine in infants and young children.
This study will enroll healthy, HPIV3 seronegative infants and children 6 months to 36 months of age. Participants will be randomly assigned to receive either the HPIV3 vaccine or a placebo vaccine. At a baseline study visit, all participants will undergo a medical history review, physical examination, vital sign measurements, and a nasal wash procedure. They will then receive their assigned vaccine in the form of nose drops. Participants will remain in the study clinic for 30 minutes after the vaccination for monitoring. Participants' parents will receive a thermometer and will record participants' temperature for 18 days after the vaccination. Study staff will call participants' parents on Days 1-18, 84, 112, and 140 to monitor participants' temperature and medical status. Study visits will occur 3, 6, 12, and 56 days after the vaccination, and participants will undergo similar tests and procedures as at the vaccination visit; a blood collection will also occur at Day 56. Six months after the first vaccination, all participants will return to the clinic and receive the second vaccination. All study procedures and study visits that followed the first vaccination will be repeated, and participants' last follow-up visit will occur 31 days after the second vaccination.
- Conditions
- Parainfluenza Virus 3, Human
- Being tested
- rHPIV3cp45 Vaccine, Placebo Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHPIV3cp45 VaccineBiological
10^5 TCID^50 of rHPIV3cp45 vaccine, delivered as nose drops
Placebo VaccineBiological
Placebo vaccine, delivered as nose drops
| Study group | Role | What they receive |
|---|---|---|
| rHPIV3cp45 Vaccine | Experimental | Participants will receive one dose of the rHPIV3cp45 vaccine at baseline and a second dose at Month 6. Receives: Biological: rHPIV3cp45 Vaccine |
| Placebo Vaccine | Placebo comparator | Participants will receive one dose of the placebo vaccine at baseline and a second dose at Month 6. Receives: Biological: Placebo Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study
Measured: Measured at Days 0-18 after each vaccination
Proportion of participants that develop 4-fold or greater rises in hemagglutination inhibition (HAI) antibody titer following 2 doses of vaccine
Measured: Measured through 31 days after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parainfluenza Virus 3, HumanStudies 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
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Coleen K. Cunningham, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254175
- Sponsor's protocol ID
- P1096
- Other IDs
- 11796, IMPAACT P1096
- Status last verified
- Dec 2014
- First submitted
- 2 Dec 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karron RA, Belshe RB, Wright PF, Thumar B, Burns B, Newman F, Cannon JC, Thompson J, Tsai T, Paschalis M, Wu SL, Mitcho Y, Hackell J, Murphy BR, Tatem JM. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J. 2003 May;22(5):394-405. doi: 10.1097/01.inf.0000066244.31769.83.
PubMed 12792378Durbin AP, Karron RA. Progress in the development of respiratory syncytial virus and parainfluenza virus vaccines. Clin Infect Dis. 2003 Dec 15;37(12):1668-77. doi: 10.1086/379775. Epub 2003 Nov 20.
PubMed 14689350
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Safety, Infectivity, Immunogenicity and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval
- ClinicalTrials.gov ID
- NCT01254175
- Acronym / sponsor ID
- P1096
- Conditions
- Parainfluenza Virus 3, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Dec 2010 (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 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.
Detailed description
Human parainfluenza viruses can cause serious respiratory tract disease in infants and children under 5 years of age, and approximately 25% of children under 5 years of age have experienced a clinically significant parainfluenza virus infection. HPIV3, one of the four types of the parainfluenza virus, can cause pneumonia, bronchiolitis, croup, and bronchitis, and virtually all children have experienced primary HPIV3 infections by the time they are 3 to 4 years of age. In the United States, HPIV3 is responsible for approximately 11% of hospitalizations for respiratory diseases in children. Because HPIV3-associated lower respiratory illness typically occurs in the first year of life, the need exists for an HPIV3 vaccine that is safe and effective in infants. The purpose of this study is to evaluate the safety and immunogenicity of two doses of a live attenuated HPIV3 vaccine in infants and young children.
This study will enroll healthy, HPIV3 seronegative infants and children 6 months to 36 months of age. Participants will be randomly assigned to receive either the HPIV3 vaccine or a placebo vaccine. At a baseline study visit, all participants will undergo a medical history review, physical examination, vital sign measurements, and a nasal wash procedure. They will then receive their assigned vaccine in the form of nose drops. Participants will remain in the study clinic for 30 minutes after the vaccination for monitoring. Participants' parents will receive a thermometer and will record participants' temperature for 18 days after the vaccination. Study staff will call participants' parents on Days 1-18, 84, 112, and 140 to monitor participants' temperature and medical status. Study visits will occur 3, 6, 12, and 56 days after the vaccination, and participants will undergo similar tests and procedures as at the vaccination visit; a blood collection will also occur at Day 56. Six months after the first vaccination, all participants will return to the clinic and receive the second vaccination. All study procedures and study visits that followed the first vaccination will be repeated, and participants' last follow-up visit will occur 31 days after the second vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rHPIV3cp45 Vaccine | Experimental | Biological: rHPIV3cp45 VaccineParticipants will receive one dose of the rHPIV3cp45 vaccine at baseline and a second dose at Month 6. |
| Placebo Vaccine | Placebo comparator | Biological: Placebo VaccineParticipants will receive one dose of the placebo vaccine at baseline and a second dose at Month 6. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parent/guardian(s) of participants can demonstrate their understanding of the study (by taking a multiple choice questionnaire), sign the informed consent, and agree to vaccine administration following a detailed explanation of the study
- Seronegative for HPIV3, as defined by serum antibody titer hemagglutination inhibition (HAI) less than or equal to 1:8, as determined within 30 days prior to inoculation
- Medical history has been reviewed and a physical examination indicates that participant is in good health
- In the view of the site investigator, participant has received routine immunizations appropriate for age, administered at least 2 weeks prior to study entry (inactivated and subunit vaccines and rotavirus vaccine), or at least 4 weeks prior to study entry (live vaccines except rotavirus vaccine)
- Available for the entire study period and parent/guardian can be reached by telephone for post-inoculation contacts
Key exclusion criteria (19 listed)
- Known or suspected impairment of immunological functions, HIV infection, or currently (within the 30 days prior to study entry) receiving immunosuppressive therapy, including systemic corticosteroids (NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable.)
- Bone marrow/solid organ transplant recipients
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with HPIV3 vaccine
- Previous serious vaccine-associated adverse event or anaphylactic reaction
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 |
|---|---|---|
| rHPIV3cp45 Vaccine10^5 TCID^50 of rHPIV3cp45 vaccine, delivered as nose drops | Biological | rHPIV3cp45 Vaccine |
| Placebo VaccinePlacebo vaccine, delivered as nose drops | Biological | Placebo Vaccine |
Primary outcome
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study
Time frame: Measured at Days 0-18 after each vaccination
Proportion of participants that develop 4-fold or greater rises in hemagglutination inhibition (HAI) antibody titer following 2 doses of vaccine
Time frame: Measured through 31 days after the second vaccination
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 3 Dec 2014.
- Background: PubMed 12792378Karron RA, Belshe RB, Wright PF, Thumar B, Burns B, Newman F, Cannon JC, Thompson J, Tsai T, Paschalis M, Wu SL, Mitcho Y, Hackell J, Murphy BR, Tatem JM. A live human parainfluenza type 3 virus vaccine is attenuated and immunogenic in young infants. Pediatr Infect Dis J. 2003 May;22(5):394-405. doi: 10.1097/01.inf.0000066244.31769.83.
- Background: PubMed 14689350Durbin AP, Karron RA. Progress in the development of respiratory syncytial virus and parainfluenza virus vaccines. Clin Infect Dis. 2003 Dec 15;37(12):1668-77. doi: 10.1086/379775. Epub 2003 Nov 20.
Related trials for Parainfluenza Virus 3, Human
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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.
Coleen K. Cunningham, MD study chair
Duke University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rHPIV3cp45 Vaccine in people with Parainfluenza Virus 3, Human, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
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 7 inclusion and 19 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 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. 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 reactogenicity events that occur during the acute monitoring phase of the study (time frame: Measured at Days 0-18 after each vaccination). 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 NCT01254175, 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 3 Dec 2014.