Bird FluPhase 1NCT01006798
Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1
A Phase 1 study testing Ad4-H5-Vtn and Sanofi Pasteur Influenza Virus Vaccine, H5N1 in people with Bird Flu and Influenza, run by Emergent BioSolutions at 4 sites in United States.
Trial summary
The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Ad4-H5-Vtn and Sanofi Pasteur Influenza Virus Vaccine, H5N1
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Sep 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults and their healthy adult household contacts.
Who cannot join
- Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18.
- Childcare workers who have direct contact with children 5 years old and younger.
- Resides with Household Contacts who are under the age of 18 or over the age of 65.
- Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
- Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
University of Kentucky
Lexington, Kentucky, 40536
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464
University of Rochester
Rochester, New York, 14642
About this study
Official title: Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn
The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers.
Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
Read the detailed description
At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56 days. Volunteers will be followed for 168 days post-third vaccination.
- Being tested
- Placebo, Ad4-H5-Vtn, Sanofi Pasteur Influenza Virus Vaccine, H5N1
- Keywords
- Virus Diseases, Respiratory Tract Diseases, Vaccine
- Medical subject headings
- Influenza in Birds, Influenza, Human, Virus Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Placebo for Ad4-H5-Vtn
enteric coated capsule containing no vaccine virus
Ad4-H5-VtnBiological
Also called Adenovirus Serotype 4-vectored H5N1 Influenza Vaccine
a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration
Sanofi Pasteur Influenza Virus Vaccine, H5N1Biological
Also called FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1, licensed H5N1 vaccine
Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | three vaccinations of 10^7vp Ad4-H5-Vtn or placebo Receives: Other: Placebo; Biological: Ad4-H5-Vtn; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1 |
| Cohort 2 | Experimental | three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo Receives: Other: Placebo; Biological: Ad4-H5-Vtn; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1 |
| Cohort 3 | Experimental | three vaccinations of 10^9 Ad4-H5-Vtn or placebo Receives: Other: Placebo; Biological: Ad4-H5-Vtn; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1 |
| Cohort 4 | Experimental | three vaccinations of 10^10 Ad4-H5-Vtn or placebo Receives: Other: Placebo; Biological: Ad4-H5-Vtn; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1 |
| Cohort 5 | Experimental | three vaccinations of 10^11 Ad4-H5-Vtn or placebo Receives: Other: Placebo; Biological: Ad4-H5-Vtn; Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs
Measured: Throughout trial (reactogenicity for 7 days following each vaccination)
Immunogenicity (humoral) defined by H5 HAI titer
Measured: At all available timepoints
Secondary outcomes (3)
Immunogenicity (humoral), defined by Ad4 antibody response
Measured: At all available timepoints
Replication/excretion of Ad4-H5-Vtn virus
Measured: Throughout trial
Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion
Measured: Throughout trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
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 Bird FluStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Gurwith, M.D., J.D., Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006798
- Sponsor's protocol ID
- PXVX-H5-103-001
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2009
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khurana S, Coyle EM, Manischewitz J, King LR, Ishioka G, Alexander J, Smith J, Gurwith M, Golding H. Oral priming with replicating adenovirus serotype 4 followed by subunit H5N1 vaccine boost promotes antibody affinity maturation and expands H5N1 cross-clade neutralization. PLoS One. 2015 Jan 28;10(1):e0115476. doi: 10.1371/journal.pone.0115476. eCollection 2015.
PubMed 25629161Gurwith M, Lock M, Taylor EM, Ishioka G, Alexander J, Mayall T, Ervin JE, Greenberg RN, Strout C, Treanor JJ, Webby R, Wright PF. Safety and immunogenicity of an oral, replicating adenovirus serotype 4 vector vaccine for H5N1 influenza: a randomised, double-blind, placebo-controlled, phase 1 study. Lancet Infect Dis. 2013 Mar;13(3):238-50. doi: 10.1016/S1473-3099(12)70345-6. Epub 2013 Jan 29.
PubMed 23369412
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4-vectored H5N1 Influenza Candidate Vaccine - Ad4-H5-Vtn
- ClinicalTrials.gov ID
- NCT01006798
- Acronym / sponsor ID
- PXVX-H5-103-001
- Keywords
- Virus Diseases, Respiratory Tract Diseases, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Nov 2009 (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.
The purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of Ad4-H5-Vtn in volunteers (Vaccinees) who receive three doses of the study vaccine or placebo. In addition, transmission of Ad4-H5-Vtn will be evaluated in all Household Contacts residing with the vaccinated volunteers.
Vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
Detailed description
At least 160 healthy Vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. In each dosage cohort Vaccinees will be randomly assigned to receive 3 doses of either Ad4-H5-Vtn or placebo separated by approximately 56 days. Volunteers will be followed for 168 days post-third vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Other: Placebo, Biological: Ad4-H5-Vtn, Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1three vaccinations of 10^7vp Ad4-H5-Vtn or placebo |
| Cohort 2 | Experimental | Other: Placebo, Biological: Ad4-H5-Vtn, Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1three vaccinations of the 10^8vp Ad4-H5-Vtn or placebo |
| Cohort 3 | Experimental | Other: Placebo, Biological: Ad4-H5-Vtn, Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1three vaccinations of 10^9 Ad4-H5-Vtn or placebo |
| Cohort 4 | Experimental | Other: Placebo, Biological: Ad4-H5-Vtn, Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1three vaccinations of 10^10 Ad4-H5-Vtn or placebo |
| Cohort 5 | Experimental | Other: Placebo, Biological: Ad4-H5-Vtn, Biological: Sanofi Pasteur Influenza Virus Vaccine, H5N1three vaccinations of 10^11 Ad4-H5-Vtn or placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults and their healthy adult household contacts.
Key exclusion criteria (5 listed)
- Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18.
- Childcare workers who have direct contact with children 5 years old and younger.
- Resides with Household Contacts who are under the age of 18 or over the age of 65.
- Received or plans to receive licensed inactivated 2009 H1N1 influenza vaccine from 14 days prior to 14 days after any study vaccination.
- Received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.
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 |
|---|---|---|
| PlaceboAlso: Placebo for Ad4-H5-Vtnenteric coated capsule containing no vaccine virus | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| Ad4-H5-VtnAlso: Adenovirus Serotype 4-vectored H5N1 Influenza Vaccinea live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| Sanofi Pasteur Influenza Virus Vaccine, H5N1Also: FDA-licensed inactivated monovalent Influenza Virus Vaccine, H5N1, licensed H5N1 vaccineSingle administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo. | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs
Time frame: Throughout trial (reactogenicity for 7 days following each vaccination)
Immunogenicity (humoral) defined by H5 HAI titer
Time frame: At all available timepoints
3 secondary outcomes
Immunogenicity (humoral), defined by Ad4 antibody response
Time frame: At all available timepoints
Replication/excretion of Ad4-H5-Vtn virus
Time frame: Throughout trial
Transmission to household contacts as measured by AE assessment and antibody response and viral replication/excretion
Time frame: Throughout trial
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 18 Mar 2024.
- Background: PubMed 25629161Khurana S, Coyle EM, Manischewitz J, King LR, Ishioka G, Alexander J, Smith J, Gurwith M, Golding H. Oral priming with replicating adenovirus serotype 4 followed by subunit H5N1 vaccine boost promotes antibody affinity maturation and expands H5N1 cross-clade neutralization. PLoS One. 2015 Jan 28;10(1):e0115476. doi: 10.1371/journal.pone.0115476. eCollection 2015.
- Results publication: PubMed 23369412Gurwith M, Lock M, Taylor EM, Ishioka G, Alexander J, Mayall T, Ervin JE, Greenberg RN, Strout C, Treanor JJ, Webby R, Wright PF. Safety and immunogenicity of an oral, replicating adenovirus serotype 4 vector vaccine for H5N1 influenza: a randomised, double-blind, placebo-controlled, phase 1 study. Lancet Infect Dis. 2013 Mar;13(3):238-50. doi: 10.1016/S1473-3099(12)70345-6. Epub 2013 Jan 29.
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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.
Marc Gurwith, M.D., J.D. study director
Emergent BioSolutions
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ad4-H5-Vtn and Sanofi Pasteur Influenza Virus Vaccine, H5N1 in people with Bird Flu and Influenza, run by Emergent BioSolutions at 4 sites 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 1 inclusion and 5 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Safety, defined as the frequency and severity of vaccine-related reactogenicity events and reported AEs (time frame: Throughout trial (reactogenicity for 7 days following 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 NCT01006798, 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 18 Mar 2024.