Paramyxoviridae InfectionsPhase 1NCT00308412
Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants
A Phase 1 study testing rHPIV3cp45 in people with Paramyxoviridae Infections and Virus Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Paramyxoviridae Infections, Virus Diseases
- What is being tested?
- rHPIV3cp45
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2010
- 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
- Good general health
- Full term infant, born later than the 36th week of pregnancy
- Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
- Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus vaccine
- Available for the duration of the trial
- Parent or guardian reachable by telephone for post-immunization contact
- Parent or guardian willing to provide informed consent
- For Group 2 participants, serum hemagglutination-inhibiting (HAI) titers to HPIV3 of or less than 1:8
Who cannot join
- Known or suspected impairment of immunologic functions. Infants who are HIV infected, who are bone marrow or solid organ transplant recipients, or who are using immunosuppressive therapy, including systemic corticosteroids, are excluded. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previously received PIV3 vaccine
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children 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 for at least 12 months are not excluded.
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- Born prematurely before the 37th week of pregnancy
- Member of a household containing immunocompromised individuals, pregnant caregivers, or infants less than 6 months of age
- Attends day care with infants less than 6 months of age
- Parent or guardian unable or unwilling to suspend daycare for 14 days following each immunization. More information on this criterion can be found in the protocol.
- Currently enrolled in another investigational drug or vaccine study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research, Johns Hopkins University
Baltimore, Maryland, 21205
About this study
Official title: Phase 1 Study to Determine the Safety, Infectivity, and Tolerability of Two Doses of Live Attenuated Recombinant Cold Passaged (cp) 45 Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3 102A, Delivered as Nose Drops to Infants 6 to 12 Months of Age, and to HPIV3 Seronegative Infants and Children 6 to 36 Months of Age
Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.
Read the detailed description
HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11% of hospitalizations for respiratory diseases in children. This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.
This study will last for a maximum of 180 days. Infants will be enrolled into one of two study groups, Group 1 or Group 2. Depending on the study location, groups will enroll either sequentially or concurrently. Within each group, infants will be randomly assigned to receive 2 immunizations of rHPIV3cp45 or placebo. Immunizations will be given as nose drops. Immunizations will be given at study entry and approximately 4 to 10 weeks after study entry.
On the day of immunization, a physical exam, vital signs measurement, blood collection, and medical history will occur. Infants will be observed for 15 minutes after immunization for any immediate adverse effects. Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their infant's temperature. They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization. Parents and guardians will be contacted by telephone on days without study visits, from Day 1 to Day 19 and on Day 180 after immunization, and asked about any illnesses or adverse effects they have observed in their immunized infants.
Parents or guardians will need to record their infant's temperature daily for at least the 17 days immediately following immunization. During this 17-day period, there will be at least 6 study visits associated with each immunization; visits will occur on the day of immunization and approximately 3, 7, 10, 14, and 17 days after immunization. At all study visits, infants will undergo a physical exam and vital signs measurement. Group 1 participants will also undergo a nasal wash for a viral culture. There will be additional follow-up visits occurring sometime between 28 and 70 days after the first dose and 28 to 35 days after the second dose; blood collection will occur at the follow-up visits. Additional visits may be required on selected days during the month after immunization. Infants who experience illness or side effects may be asked to return to the clinic for examination. Parents or guardians will be made aware of whether their infant received the HPIV vaccine or placebo 18 days after the second immunization or in the event of a lower respiratory tract illness.
- Conditions
- Paramyxoviridae Infections, Virus Diseases
- Being tested
- rHPIV3cp45, Placebo
- Keywords
- Respiratory Tract Infection
- Medical subject headings
- Paramyxoviridae Infections, Virus Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHPIV3cp45Biological
Placebo for rHPIV3cp45 vaccine is 1X L-15.
PlaceboBiological
Placebo for rHPIV3cp45 vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Two 10^5 PFU doses of rHPIV3cp45 vaccine given as nose drops to healthy infants and children aged 6 to 36 months of age. The two doses are given 4 to 10 weeks apart. Receives: Biological: rHPIV3cp45 |
| 2 | Placebo comparator | Two placebo vaccinations given as nose drops to healthy infants and children aged 6 to 36 months of age. The two doses are given 4 to 10 weeks apart. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
Measured: For 17 days after each dose
Proportion of infants that develop fourfold or greater rises in hemagglutination-inhibition (HAI) antibody titer following two doses of vaccine
Measured: Throughout study
Secondary outcomes (5)
For the subset of infants enrolled in group 1 of the study (n=24), quantifying the amount of vaccine virus shed by each recipient
Measured: Throughout study
Assessment of the immunogenicity of a second dose of vaccine and the protection of the first dose against reinfection with the second dose
Measured: Throughout study
Determination of the number of vaccinated infants infected with rHPIV3cp45
Measured: Throughout study
Determination of the number of vaccinated subjects infected with a second dose of rHPIV3cp45 vaccine
Measured: Throughout study
Determination of the phenotypic stability of vaccine virus shed
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 posted29 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Paramyxoviridae InfectionsStudies 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
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Investigators
- Ruth A. Karron, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308412
- Sponsor's protocol ID
- CIR 215
- Other IDs
- CIR H.22.05.07.19.A1
- Status last verified
- Jul 2010
- First submitted
- 28 Mar 2006
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Durbin 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 14689350Greenberg HB, Piedra PA. Immunization against viral respiratory disease: a review. Pediatr Infect Dis J. 2004 Nov;23(11 Suppl):S254-61. doi: 10.1097/01.inf.0000144756.69887.f8.
PubMed 15577581Karron 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 12792378Madhi SA, Cutland C, Zhu Y, Hackell JG, Newman F, Blackburn N, Murphy BR, Belshe RB, Karron RA, Deatly AM, Gruber WC, Bernstein DI, Wright PF. Transmissibility, infectivity and immunogenicity of a live human parainfluenza type 3 virus vaccine (HPIV3cp45) among susceptible infants and toddlers. Vaccine. 2006 Mar 20;24(13):2432-9. doi: 10.1016/j.vaccine.2005.12.002. Epub 2005 Dec 20.
PubMed 16406170Skiadopoulos MH, Surman SR, Riggs JM, Orvell C, Collins PL, Murphy BR. Evaluation of the replication and immunogenicity of recombinant human parainfluenza virus type 3 vectors expressing up to three foreign glycoproteins. Virology. 2002 May 25;297(1):136-52. doi: 10.1006/viro.2002.1415.
PubMed 12083844
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Safety, Infectivity, and Tolerability of Two Doses of Live Attenuated Recombinant Cold Passaged (cp) 45 Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3 102A, Delivered as Nose Drops to Infants 6 to 12 Months of Age, and to HPIV3 Seronegative Infants and Children 6 to 36 Months of Age
- ClinicalTrials.gov ID
- NCT00308412
- Acronym / sponsor ID
- CIR 215
- Conditions
- Paramyxoviridae Infections, Virus Diseases
- Keywords
- Respiratory Tract Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 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
- Jun 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Mar 2006 (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 viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.
Detailed description
HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11% of hospitalizations for respiratory diseases in children. This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.
This study will last for a maximum of 180 days. Infants will be enrolled into one of two study groups, Group 1 or Group 2. Depending on the study location, groups will enroll either sequentially or concurrently. Within each group, infants will be randomly assigned to receive 2 immunizations of rHPIV3cp45 or placebo. Immunizations will be given as nose drops. Immunizations will be given at study entry and approximately 4 to 10 weeks after study entry.
On the day of immunization, a physical exam, vital signs measurement, blood collection, and medical history will occur. Infants will be observed for 15 minutes after immunization for any immediate adverse effects. Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their infant's temperature. They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization. Parents and guardians will be contacted by telephone on days without study visits, from Day 1 to Day 19 and on Day 180 after immunization, and asked about any illnesses or adverse effects they have observed in their immunized infants.
Parents or guardians will need to record their infant's temperature daily for at least the 17 days immediately following immunization. During this 17-day period, there will be at least 6 study visits associated with each immunization; visits will occur on the day of immunization and approximately 3, 7, 10, 14, and 17 days after immunization. At all study visits, infants will undergo a physical exam and vital signs measurement. Group 1 participants will also undergo a nasal wash for a viral culture. There will be additional follow-up visits occurring sometime between 28 and 70 days after the first dose and 28 to 35 days after the second dose; blood collection will occur at the follow-up visits. Additional visits may be required on selected days during the month after immunization. Infants who experience illness or side effects may be asked to return to the clinic for examination. Parents or guardians will be made aware of whether their infant received the HPIV vaccine or placebo 18 days after the second immunization or in the event of a lower respiratory tract illness.
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 |
|---|---|---|
| 1 | Experimental | Biological: rHPIV3cp45Two 10^5 PFU doses of rHPIV3cp45 vaccine given as nose drops to healthy infants and children aged 6 to 36 months of age. The two doses are given 4 to 10 weeks apart. |
| 2 | Placebo comparator | Biological: PlaceboTwo placebo vaccinations given as nose drops to healthy infants and children aged 6 to 36 months of age. The two doses are given 4 to 10 weeks apart. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Good general health
- Full term infant, born later than the 36th week of pregnancy
- Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
- Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus vaccine
- Available for the duration of the trial
Key exclusion criteria (11 listed)
- Known or suspected impairment of immunologic functions. Infants who are HIV infected, who are bone marrow or solid organ transplant recipients, or who are using immunosuppressive therapy, including systemic corticosteroids, are excluded. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previously received PIV3 vaccine
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
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 |
|---|---|---|
| rHPIV3cp45Placebo for rHPIV3cp45 vaccine is 1X L-15. | Biological | 1 |
| PlaceboPlacebo for rHPIV3cp45 vaccine | Biological | 2 |
Primary outcome
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study
Time frame: For 17 days after each dose
Proportion of infants that develop fourfold or greater rises in hemagglutination-inhibition (HAI) antibody titer following two doses of vaccine
Time frame: Throughout study
5 secondary outcomes
For the subset of infants enrolled in group 1 of the study (n=24), quantifying the amount of vaccine virus shed by each recipient
Time frame: Throughout study
Assessment of the immunogenicity of a second dose of vaccine and the protection of the first dose against reinfection with the second dose
Time frame: Throughout study
Determination of the number of vaccinated infants infected with rHPIV3cp45
Time frame: Throughout study
Determination of the number of vaccinated subjects infected with a second dose of rHPIV3cp45 vaccine
Time frame: Throughout study
Determination of the phenotypic stability of vaccine virus shed
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 16 Jul 2010.
- 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.
- Background: PubMed 15577581Greenberg HB, Piedra PA. Immunization against viral respiratory disease: a review. Pediatr Infect Dis J. 2004 Nov;23(11 Suppl):S254-61. doi: 10.1097/01.inf.0000144756.69887.f8.
- 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 16406170Madhi SA, Cutland C, Zhu Y, Hackell JG, Newman F, Blackburn N, Murphy BR, Belshe RB, Karron RA, Deatly AM, Gruber WC, Bernstein DI, Wright PF. Transmissibility, infectivity and immunogenicity of a live human parainfluenza type 3 virus vaccine (HPIV3cp45) among susceptible infants and toddlers. Vaccine. 2006 Mar 20;24(13):2432-9. doi: 10.1016/j.vaccine.2005.12.002. Epub 2005 Dec 20.
- Background: PubMed 12083844Skiadopoulos MH, Surman SR, Riggs JM, Orvell C, Collins PL, Murphy BR. Evaluation of the replication and immunogenicity of recombinant human parainfluenza virus type 3 vectors expressing up to three foreign glycoproteins. Virology. 2002 May 25;297(1):136-52. doi: 10.1006/viro.2002.1415.
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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.
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 rHPIV3cp45 in people with Paramyxoviridae Infections 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?
The sponsor lists 8 inclusion and 11 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 16 Jul 2010. 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 reactogenicity events (REs) that occur during the acute monitoring phase of the study (time frame: For 17 days after each dose). 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 NCT00308412, which also lists 5 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 16 Jul 2010.