Adenoviral InfectionPhase 1NCT03160339
A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047
A Phase 1 study testing PXVX0047 Vaccine and Teva Ad4/Ad7 Vaccine in people with Adenoviral Infection, run by Emergent BioSolutions at 2 sites in United States.
Trial summary
PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoviral Infection
- What is being tested?
- PXVX0047 Vaccine and Teva Ad4/Ad7 Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 27 Nov 2017
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Age 18 to 35
- Seronegative for Ad4 and Ad7 by CPE-based assay
- (if female of childbearing potential) Using an acceptable method of contraception
- If male, subject agrees to use a highly effective method of contraception with female sexual partners of childbearing potential
- Able and willing to provide informed consent for study participation
Who cannot join
- Current acute febrile illness
- Current acute gastrointestinal illness
- Clinically significant cardiac, respiratory, or gastrointestinal disease
- (if female of childbearing potential) Pregnant or nursing, or who plan to become pregnant or nurse during the study
- Persons with occupations which may create an increased risk of transmission of vaccine virus (including but not limited to health care workers, child or elderly care providers, food handlers or preparers) who also have expected occupational contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
- Expected household contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
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- Laboratory evidence of infection with Hepatitis B/C or HIV.
- History of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
- Inability to swallow capsules or tablets whole without chewing or crushing.
- Immunosuppressed individuals, including those treated or planned to be treated with systemic immunosuppressive medications within the 30 days prior to enrollment through 30 days after study treatment.
- Concomitant or planned use of other vaccines, investigational agents, cidofovir, ribavirin, or medications expected by the Investigator to have antiviral activity against adenovirus within 30 days prior to enrollment through Day 29.
- Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
- Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Vermont Medical Center
Burlington, Vermont, 05401
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Phase 1 Two-Arm, Randomized, Double-blind, Active-controlled Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral)
PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.
- Conditions
- Adenoviral Infection
- Being tested
- PXVX0047 Vaccine, Teva Ad4/Ad7 Vaccine
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PXVX0047 VaccineBiological
PXVX0047 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in PXVX 0047 are unattenuated strains propagated in A549 human adenocarcinomic alveolar basal epithelial cells.
Teva Ad4/Ad7 VaccineBiological
Teva Ad4/Ad7 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in Teva Ad4/Ad7 are unattenuated strains propagated in WI-38 human diploid fibroblast cells.
| Study group | Role | What they receive |
|---|---|---|
| PXVX0047 treatment group | Experimental | Subjects will receive PXVX0047 vaccine and Teva Placebo-to-Match Receives: Biological: PXVX0047 Vaccine |
| Teva Ad4/Ad7 treatment group | Active comparator | Subjects will receive Teva Ad4/Ad7 vaccine and PXVX0047 Placebo-to-Match Receives: Biological: Teva Ad4/Ad7 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events
Incidence of severity of solicited adverse events include abdominal pain, nausea, vomiting, diarrhea, cough, nasal congestion, dyspnea, sore throat, headache, fever fatigue chills myalgia, arthralgia
Measured: From Day 1 through Day 15
Evaluate the safety and tolerability of PXVX0047 by documenting the incidence and severity of adverse events that are not solicited.
Unsolicited adverse events include clinical significant laboratory abnormalities
Measured: From Day 1 through Day 29
Evaluate the induction of anti-Ad4 neutralizing activity by measuring the Ad4 and Ad7 seroconversion rate
The Ad4 seroconversion rate is defined as the percent of subjects seroconverted (i.e. with a 4-fold or greater rise over baseline in neutralizing antibody titer) to Ad4 as determined by cytopathic-effect (CPE)-based assay
Measured: From Day 1 to Day 29
Evaluate the induction of anti-Ad7 neutralizing activity by measuring the Ad7 seroconversion rate
The Ad7 seroconversion rate is defined as the percent of subjects seroconverted (i.e. with a 4-fold or greater rise over baseline in neutralizing antibody titer) to Ad7 as determined by cytopathic-effect (CPE)-based assay
Measured: From Day 1 to Day 29
Secondary outcomes (16)
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the GI tract
Shedding of Ad4 via the GI tract, as assessed by rectal swabs
Measured: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the GI tract
Shedding of Ad7 via the GI tract, as assessed by rectal swabs
Measured: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the respiratory tract
Shedding of Ad4 via the respiratory tract, as assessed by throat swabs.
Measured: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the respiratory tract
Shedding of Ad7 via the respiratory tract, as assessed by throat swabs.
Measured: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad4 viremia
Presence of Ad4 viremia in the blood
Measured: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad7 viremia
Presence of Ad7 viremia in the blood
Measured: Days 4, 8, 15, 22, and 29
Evaluate the immunogenicity of PXVX0047 by measuring Ad4 seroconversion rates
The Ad4 seroconversion rates, measured independently, determined by luciferase and CPE-based assays
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring Ad7 seroconversion rates
The Ad7 seroconversion rates, measured independently, determined by luciferase and CPE-based assays
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad4 seroconversion rates
The cumulative Ad4 seroconversion rates, measured independently, where cumulative seroconversion through a particular visit is defined as having seroconverted at or prior to that visit.
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad7 seroconversion rates
The cumulative Ad7 seroconversion rates, measured independently, where cumulative seroconversion through a particular visit is defined as having seroconverted at or prior to that visit.
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
The geometric mean titer (GMT) of neutralizing antibodies to Ad4, measured independently
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
The geometric mean titer (GMT) of neutralizing antibodies to Ad7, measured independently
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad4 viruses
The fold-rise over baseline in neutralizing antibodies to Ad4, measured independently
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad7 viruses
The fold-rise over baseline in neutralizing antibodies to Ad7, measured independently
Measured: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad4 viruses
The cellular immune responses to Ad4, measured independently
Measured: At Days 29 and 57.
Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad7 viruses
The cellular immune responses to Ad7, measured independently
Measured: At Days 29 and 57.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 May 2017
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoviral InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160339
- Sponsor's protocol ID
- PXVX-AD-047-001
- Status last verified
- Mar 2024
- First submitted
- 15 May 2017
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beaty S, Collins N, Karasavvas N, Kuschner R, Hang J, Adhikari A, Maljkovic Berry I, Fung C, Walls S, Betancourt E, Mendy J, Lock M, Gierman E, Bennett S, Shabram P, Warfield K. A Phase 1 Two-Arm, Randomized, Double-Blind, Active-Controlled Study of Live, Oral Plasmid-Derived Adenovirus Type 4 and Type 7 Vaccines in Seronegative Adults. Vaccines (Basel). 2023 Jun 12;11(6):1091. doi: 10.3390/vaccines11061091.
PubMed 37376480
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
- A Phase 1 Two-Arm, Randomized, Double-blind, Active-controlled Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral)
- ClinicalTrials.gov ID
- NCT03160339
- Acronym / sponsor ID
- PXVX-AD-047-001
- Conditions
- Adenoviral Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 19 May 2017 (actual)
- 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.
PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.
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 |
|---|---|---|
| PXVX0047 treatment group | Experimental | Biological: PXVX0047 VaccineSubjects will receive PXVX0047 vaccine and Teva Placebo-to-Match |
| Teva Ad4/Ad7 treatment group | Active comparator | Biological: Teva Ad4/Ad7 VaccineSubjects will receive Teva Ad4/Ad7 vaccine and PXVX0047 Placebo-to-Match |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female
- Age 18 to 35
- Seronegative for Ad4 and Ad7 by CPE-based assay
- (if female of childbearing potential) Using an acceptable method of contraception
- If male, subject agrees to use a highly effective method of contraception with female sexual partners of childbearing potential
Key exclusion criteria (13 listed)
- Current acute febrile illness
- Current acute gastrointestinal illness
- Clinically significant cardiac, respiratory, or gastrointestinal disease
- (if female of childbearing potential) Pregnant or nursing, or who plan to become pregnant or nurse during the study
- Persons with occupations which may create an increased risk of transmission of vaccine virus (including but not limited to health care workers, child or elderly care providers, food handlers or preparers) who also have expected occupational contact with children less than 7 years of age, pregnant or nursing women, women of childbearing potential not using an acceptable method of contraception, or chronically ill or immunosuppressed individuals through Day 29.
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 |
|---|---|---|
| PXVX0047 VaccinePXVX0047 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in PXVX 0047 are unattenuated strains propagated in A549 human adenocarcinomic alveolar basal epithelial cells. | Biological | PXVX0047 treatment group |
| Teva Ad4/Ad7 VaccineTeva Ad4/Ad7 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in Teva Ad4/Ad7 are unattenuated strains propagated in WI-38 human diploid fibroblast cells. | Biological | Teva Ad4/Ad7 treatment group |
Primary outcome
Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events
Time frame: From Day 1 through Day 15
Incidence of severity of solicited adverse events include abdominal pain, nausea, vomiting, diarrhea, cough, nasal congestion, dyspnea, sore throat, headache, fever fatigue chills myalgia, arthralgia
Evaluate the safety and tolerability of PXVX0047 by documenting the incidence and severity of adverse events that are not solicited.
Time frame: From Day 1 through Day 29
Unsolicited adverse events include clinical significant laboratory abnormalities
Evaluate the induction of anti-Ad4 neutralizing activity by measuring the Ad4 and Ad7 seroconversion rate
Time frame: From Day 1 to Day 29
The Ad4 seroconversion rate is defined as the percent of subjects seroconverted (i.e. with a 4-fold or greater rise over baseline in neutralizing antibody titer) to Ad4 as determined by cytopathic-effect (CPE)-based assay
Evaluate the induction of anti-Ad7 neutralizing activity by measuring the Ad7 seroconversion rate
Time frame: From Day 1 to Day 29
The Ad7 seroconversion rate is defined as the percent of subjects seroconverted (i.e. with a 4-fold or greater rise over baseline in neutralizing antibody titer) to Ad7 as determined by cytopathic-effect (CPE)-based assay
16 secondary outcomes
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the GI tract
Time frame: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the GI tract
Time frame: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad4 viruses via the respiratory tract
Time frame: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the shedding of Ad7 viruses via the respiratory tract
Time frame: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad4 viremia
Time frame: Days 4, 8, 15, 22, and 29
Evaluate the pharmacodynamics of PXVX0047 by measuring the presence of Ad7 viremia
Time frame: Days 4, 8, 15, 22, and 29
Evaluate the immunogenicity of PXVX0047 by measuring Ad4 seroconversion rates
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring Ad7 seroconversion rates
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad4 seroconversion rates
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring cumulative Ad7 seroconversion rates
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring geometric mean titer
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad4 viruses
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the fold-rise over baseline of neutralizing antibodies to Ad7 viruses
Time frame: Through Day 57
Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad4 viruses
Time frame: At Days 29 and 57.
Evaluate the immunogenicity of PXVX0047 by measuring the cellular immune responses to Ad7 viruses
Time frame: At Days 29 and 57.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 37376480Beaty S, Collins N, Karasavvas N, Kuschner R, Hang J, Adhikari A, Maljkovic Berry I, Fung C, Walls S, Betancourt E, Mendy J, Lock M, Gierman E, Bennett S, Shabram P, Warfield K. A Phase 1 Two-Arm, Randomized, Double-Blind, Active-Controlled Study of Live, Oral Plasmid-Derived Adenovirus Type 4 and Type 7 Vaccines in Seronegative Adults. Vaccines (Basel). 2023 Jun 12;11(6):1091. doi: 10.3390/vaccines11061091.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 PXVX0047 Vaccine and Teva Ad4/Ad7 Vaccine in people with Adenoviral Infection, run by Emergent BioSolutions at 2 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 6 inclusion and 13 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: stopped early, 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 2 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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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?
Evaluate safety and tolerability of PXVX0047 by documenting the incidence of severity of solicited adverse events (time frame: From Day 1 through Day 15). The study lists 4 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 NCT03160339, which also lists 1 linked publication.
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.