Paramyxoviridae InfectionsPhase 1NCT00366782
Safety of and Immune Response to a Cow/Human Parainfluenza Virus Vaccine (rB/HPIV3) in Healthy Infants, Children, and Adults
A Phase 1 study testing rB/HPIV3 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, children, and adults. Read more about this study
- Who is it for?
- Ages 6 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Paramyxoviridae Infections, Virus Diseases
- What is being tested?
- rB/HPIV3
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Good general health
- Available for the duration of the trial
- Reachable by telephone for post-vaccination contact
- Female participants willing to use acceptable methods of contraception
- Good general health and age-appropriate development, as determined by physical exam and medical history review
- Seropositive for human parainfluenza type 3 virus (HPIV3), as defined by a serum hemagglutination-inhibition (HI) antibody titer of more than 1:8
Show all 15Show fewer
- Available for the duration of the trial
- Parent or guardian willing to provide informed consent
- Parent or guardian reachable by telephone for post-vaccination contact
- Inclusion Criteria for Seronegative Infant and Child Participants:
- Good general health and age-appropriate development, as determined by physical exam and medical history review
- Seronegative for HPIV3, as defined by serum HI antibody titer of 1:8 or less within 28 days of first vaccination
- Available for the duration of the trial
- Parent or guardian willing to provide informed consent
- Parent or guardian reachable by telephone for post-vaccination contact
Who cannot join
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the participant to understand and cooperate with the study
- Medical, work-related, or family problems as a result of alcohol or illicit drug use in the 12 months prior to study entry
- History of severe allergic reaction or anaphylaxis
- Absence of spleen
- Diagnosis of asthma within the 2 years prior to study entry
Show all 33Show fewer
- HIV-1 infected
- Hepatitis C virus infected
- Positive for hepatitis B surface antigen (HBsAg)
- Abnormal blood or urine tests
- Known immunodeficiency syndrome
- Blood products, including immunoglobulin, within the 3 months prior to study entry
- Immune globulin within 3 months of vaccination
- Current smoker unwilling to stop smoking for the duration of the study
- Participation in another investigational vaccine or drug trial within 30 days of vaccination or while participating in this study
- Live vaccine within 4 weeks of vaccination
- Killed vaccine within 2 weeks of vaccination
- Previous immunization with PIV3 vaccine
- Known hypersensitivity to any vaccine component
- Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
- Work and/or personal responsibilities that involve caring for children less than 6 months of age or immunosuppressed individuals
- Pregnancy or breastfeeding
- Known or suspected impairment of immune system, including maternal history of positive HIV test, previous receipt of immunosuppressive therapy including systemic corticosteroids, or receipt of bone marrow/solid organ. Participants who have received topical steroids are not excluded.
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with PIV3 vaccine
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Lung or heart disease, including reactive airway disease. Participants with clinically insignificant cardiac abnormalities not requiring treatment are not excluded. More information on this criterion can be found in the protocol.
- Clinically significant abnormality in liver function test (seropositive participants only)
- Clinically significant abnormality in complete blood count (CBC) (seronegative participants only)
- Member of a household that includes a pregnant woman, an immunocompromised individual, or an infant less than 6 months of age
- Attends day care with infants less than 6 months of age, pregnant caregivers, or immunosuppressed individuals
- Parent or guardian unwilling to suspend day care for 14 days following vaccination. More information on this criterion can be found in the protocol.
- Participation in another investigational vaccine or drug trial within 30 days of first vaccination or while participating in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Immunization Research
Baltimore, Maryland, 21205
About this study
Official title: A Phase 1 Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Chimeric Bovine/Human Parainfluenza Type 3 Virus Vaccine, rB/HPIV3, Lot PIV3 #101A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV3-Seropositive Children 15 to 59 Months of Age, and 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, children, and adults.
Read the detailed description
HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most common 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, chimeric bovine/human, attenuated intranasal HPIV3 vaccine, rB/HPIV3. This vaccine combines modified human HPIV3 with a related, modified cow virus, bovine parainfluenza type 3 virus (BPIV3). Vaccinations will be given as nose drops to healthy adults, children seropositive for HPIV3, and infants and children seronegative for HPIV3.
There are four groups in this study. Group 1 will consist of adults who will receive the higher dose of rB/HPIV3. Group 2 will consist of seropositive children who will be randomly assigned to receive the higher dose of rB/HPIV3 or placebo. Group 2 will not begin enrollment until the completion of Group 1 safety data review. Participants of both Groups 1 and 2 will be monitored for 10 days post vaccination for respiratory illness and for fever by self-reported temperature logs; these participants will be followed for a maximum of 28 days. Blood collection will occur at study entry and on Day 28; additional blood collection may occur up to 28 days prior to vaccination. Clinical assessments and nasal washes will occur at study entry and selected study visits. Group 1 participants will be contacted by phone on Day 180; Group 2 participants' parents or guardians will be contacted by phone on Days 1, 2, 8, 9, 11, and 180; study staff will ask about any illnesses or adverse events that may have occurred.
Groups 3 and 4 will consist of seronegative infants and children. Group 3 will not begin enrollment until the completion of Group 2 safety data review. Children in Group 3 will be randomly assigned to receive the lower dose of rB/HPIV3 or placebo. Group 4 will not begin enrollment until the completion of Group 3 safety data review. Children in Group 4 will be randomly assigned to receive the higher dose of rB/HPIV3 or placebo. Participants of both Groups 3 and 4 will be monitored closely for 28 days postvaccination for respiratory illness and for fever by self-reported temperature logs; these participants will be followed for a maximum of 56 days. Blood collection will occur at study entry and on Day 56. Clinical assessments and nasal washes will occur at study entry and most study visits. Participants' parents or guardians will be contacted by phone periodically post vaccination; study staff will ask about any illnesses or adverse events they may have observed in their infants or children.
- Conditions
- Paramyxoviridae Infections, Virus Diseases
- Being tested
- rB/HPIV3, Placebo
- Keywords
- Respiratory Tract Disease, Bovine, Chimeric Vaccine
- Medical subject headings
- Paramyxoviridae Infections, Virus Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rB/HPIV3Biological
Live attenuated rB/HPIV3 vaccine given at a dose of 10^6 TCID50
rB/HPIV3Biological
Live attenuated rB/HPIV3 vaccine given at a dose of 10^5 TCID50
PlaceboBiological
Placebo for rB/HPIV3 vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One vaccination with rB/HPIV3 vaccine (at higher dose) given as nose drops to adults 18 to 49 years of age Receives: Biological: rB/HPIV3 |
| 2 | Experimental | One vaccination with rB/HPIV3 vaccine (at higher dose) given as nose drops to HPIV3-seropositive children 15 to 59 months of age). This arm may enroll after Arm 1 depending on the effect of the vaccine on Arm 1. Receives: Biological: rB/HPIV3 |
| 3 | Experimental | One vaccination with rB/HPIV3 vaccine (at lower dose) given as nose drops to seronegative children or infants 6 to 36 months of age. This arm may enroll after Arm 2. Receives: Biological: rB/HPIV3 |
| 4 | Experimental | One vaccination with rB/HPIV3 vaccine (at higher dose) given as nose drops to seronegative children or infants 6 to 36 months of age. This arm may enroll after Arm 2. Receives: Biological: rB/HPIV3 |
| 5 | Placebo comparator | One vaccination with placebo vaccine given as nose drops to adults, HPIV3-seropositive children, or seronegative children or infants 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 (Days 0 to 10 for adult and seropositive groups, Days 0 to 28 for seronegative groups)
Measured: Throughout study
Quantifying the amount of vaccine virus shed by each recipient
Measured: Throughout study
Determining the amount of serum antibody and mucosal antibody induced by the vaccine in each recipient
Measured: Throughout study
Secondary outcomes (2)
Determining the phenotypic stability of vaccine virus shed
Measured: Throughout study
Determining the number of vaccinated children and infants infected with rB/HPIV3 vaccine virus
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 Aug 2006 (estimated)
- Study startMar 2007
- Primary completionFeb 2011
- Study completionJun 2011
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
- 51 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
- NCT00366782
- Sponsor's protocol ID
- CIR 231
- Other IDs
- WIRB Protocol Number 20061455
- Status last verified
- Feb 2012
- First submitted
- 17 Aug 2006
- Last updated
- 1 Mar 2012
- 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 DP, Walker RE, Lee MS, Reisinger KS, Ward JI, Yogev R, Blatter MM, Yeh SH, Karron RA, Sangli C, Eubank L, Coelingh KL, Cordova JM, August MJ, Mehta HB, Chen W, Mendelman PM. A bovine parainfluenza virus type 3 vaccine is safe and immunogenic in early infancy. J Infect Dis. 2005 Apr 1;191(7):1116-22. doi: 10.1086/428092. Epub 2005 Feb 22.
PubMed 15747247Lee MS, Greenberg DP, Yeh SH, Yogev R, Reisinger KS, Ward JI, Blatter MM, Cho I, Holmes SJ, Cordova JM, August MJ, Chen W, Mehta HB, Coelingh KL, Mendelman PM. Antibody responses to bovine parainfluenza virus type 3 (PIV3) vaccination and human PIV3 infection in young infants. J Infect Dis. 2001 Oct 1;184(7):909-13. doi: 10.1086/323150. Epub 2001 Aug 15.
PubMed 11509996Madhi 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 16406170Karron RA, Thumar B, Schappell E, Surman S, Murphy BR, Collins PL, Schmidt AC. Evaluation of two chimeric bovine-human parainfluenza virus type 3 vaccines in infants and young children. Vaccine. 2012 Jun 6;30(26):3975-81. doi: 10.1016/j.vaccine.2011.12.022. Epub 2011 Dec 14.
PubMed 22178099
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Chimeric Bovine/Human Parainfluenza Type 3 Virus Vaccine, rB/HPIV3, Lot PIV3 #101A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV3-Seropositive Children 15 to 59 Months of Age, and HPIV3-Seronegative Infants and Children 6 to 36 Months of Age
- ClinicalTrials.gov ID
- NCT00366782
- Acronym / sponsor ID
- CIR 231
- Conditions
- Paramyxoviridae Infections, Virus Diseases
- Keywords
- Respiratory Tract Disease, Bovine, Chimeric Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 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 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Aug 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, children, and adults.
Detailed description
HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most common 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, chimeric bovine/human, attenuated intranasal HPIV3 vaccine, rB/HPIV3. This vaccine combines modified human HPIV3 with a related, modified cow virus, bovine parainfluenza type 3 virus (BPIV3). Vaccinations will be given as nose drops to healthy adults, children seropositive for HPIV3, and infants and children seronegative for HPIV3.
There are four groups in this study. Group 1 will consist of adults who will receive the higher dose of rB/HPIV3. Group 2 will consist of seropositive children who will be randomly assigned to receive the higher dose of rB/HPIV3 or placebo. Group 2 will not begin enrollment until the completion of Group 1 safety data review. Participants of both Groups 1 and 2 will be monitored for 10 days post vaccination for respiratory illness and for fever by self-reported temperature logs; these participants will be followed for a maximum of 28 days. Blood collection will occur at study entry and on Day 28; additional blood collection may occur up to 28 days prior to vaccination. Clinical assessments and nasal washes will occur at study entry and selected study visits. Group 1 participants will be contacted by phone on Day 180; Group 2 participants' parents or guardians will be contacted by phone on Days 1, 2, 8, 9, 11, and 180; study staff will ask about any illnesses or adverse events that may have occurred.
Groups 3 and 4 will consist of seronegative infants and children. Group 3 will not begin enrollment until the completion of Group 2 safety data review. Children in Group 3 will be randomly assigned to receive the lower dose of rB/HPIV3 or placebo. Group 4 will not begin enrollment until the completion of Group 3 safety data review. Children in Group 4 will be randomly assigned to receive the higher dose of rB/HPIV3 or placebo. Participants of both Groups 3 and 4 will be monitored closely for 28 days postvaccination for respiratory illness and for fever by self-reported temperature logs; these participants will be followed for a maximum of 56 days. Blood collection will occur at study entry and on Day 56. Clinical assessments and nasal washes will occur at study entry and most study visits. Participants' parents or guardians will be contacted by phone periodically post vaccination; study staff will ask about any illnesses or adverse events they may have observed in their infants or children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: rB/HPIV3One vaccination with rB/HPIV3 vaccine (at higher dose) given as nose drops to adults 18 to 49 years of age |
| 2 | Experimental | Biological: rB/HPIV3One vaccination with rB/HPIV3 vaccine (at higher dose) given as nose drops to HPIV3-seropositive children 15 to 59 months of age). This arm may enroll after Arm 1 depending on the effect of the vaccine on Arm 1. |
| 3 | Experimental | Biological: rB/HPIV3One vaccination with rB/HPIV3 vaccine (at lower dose) given as nose drops to seronegative children or infants 6 to 36 months of age. This arm may enroll after Arm 2. |
| 4 | Experimental | Biological: rB/HPIV3One vaccination with rB/HPIV3 vaccine (at higher dose) given as nose drops to seronegative children or infants 6 to 36 months of age. This arm may enroll after Arm 2. |
| 5 | Placebo comparator | Biological: PlaceboOne vaccination with placebo vaccine given as nose drops to adults, HPIV3-seropositive children, or seronegative children or infants |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Good general health
- Available for the duration of the trial
- Reachable by telephone for post-vaccination contact
- Female participants willing to use acceptable methods of contraception
- Good general health and age-appropriate development, as determined by physical exam and medical history review
Key exclusion criteria (33 listed)
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the participant to understand and cooperate with the study
- Medical, work-related, or family problems as a result of alcohol or illicit drug use in the 12 months prior to study entry
- History of severe allergic reaction or anaphylaxis
- Absence of spleen
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 |
|---|---|---|
| rB/HPIV3Live attenuated rB/HPIV3 vaccine given at a dose of 10^6 TCID50 | Biological | 1, 2, 4 |
| rB/HPIV3Live attenuated rB/HPIV3 vaccine given at a dose of 10^5 TCID50 | Biological | 3 |
| PlaceboPlacebo for rB/HPIV3 vaccine | Biological | 5 |
Primary outcome
Frequency of vaccine-related reactogenicity events (REs) that occur during the acute monitoring phase of the study (Days 0 to 10 for adult and seropositive groups, Days 0 to 28 for seronegative groups)
Time frame: Throughout study
Quantifying the amount of vaccine virus shed by each recipient
Time frame: Throughout study
Determining the amount of serum antibody and mucosal antibody induced by the vaccine in each recipient
Time frame: Throughout study
2 secondary outcomes
Determining the phenotypic stability of vaccine virus shed
Time frame: Throughout study
Determining the number of vaccinated children and infants infected with rB/HPIV3 vaccine virus
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 1 Mar 2012.
- 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 15747247Greenberg DP, Walker RE, Lee MS, Reisinger KS, Ward JI, Yogev R, Blatter MM, Yeh SH, Karron RA, Sangli C, Eubank L, Coelingh KL, Cordova JM, August MJ, Mehta HB, Chen W, Mendelman PM. A bovine parainfluenza virus type 3 vaccine is safe and immunogenic in early infancy. J Infect Dis. 2005 Apr 1;191(7):1116-22. doi: 10.1086/428092. Epub 2005 Feb 22.
- Background: PubMed 11509996Lee MS, Greenberg DP, Yeh SH, Yogev R, Reisinger KS, Ward JI, Blatter MM, Cho I, Holmes SJ, Cordova JM, August MJ, Chen W, Mehta HB, Coelingh KL, Mendelman PM. Antibody responses to bovine parainfluenza virus type 3 (PIV3) vaccination and human PIV3 infection in young infants. J Infect Dis. 2001 Oct 1;184(7):909-13. doi: 10.1086/323150. Epub 2001 Aug 15.
- 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.
- Results publication: PubMed 22178099Karron RA, Thumar B, Schappell E, Surman S, Murphy BR, Collins PL, Schmidt AC. Evaluation of two chimeric bovine-human parainfluenza virus type 3 vaccines in infants and young children. Vaccine. 2012 Jun 6;30(26):3975-81. doi: 10.1016/j.vaccine.2011.12.022. Epub 2011 Dec 14.
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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 rB/HPIV3 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 15 inclusion and 33 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 1 Mar 2012. 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 (Days 0 to 10 for adult and seropositive groups, Days 0 to 28 for seronegative groups) (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 NCT00366782, 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 1 Mar 2012.