Nipah Virus InfectionPhase 1NCT05178901
A Phase 1 Study to Evaluate Safety & Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
A Phase 1 study testing PHV02 in people with Nipah Virus Infection, run by Public Health Vaccines LLC at 1 site in United States.
Trial summary
A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nipah Virus Infection
- What is being tested?
- PHV02
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 30 May 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Booster cohort only: received PHV02 (or placebo)
- Healthy, adult, male or non-pregnant, non-lactating females
- Given written informed consent
- No clinically significant health problems
- Agree to avoid conception through Day 29
- Agree to minimize blood and body fluid exposures to others after vaccination through Day 29
- Agree to avoid exposure to immunocompromised persons after vaccination through Day 29
- Agree to avoid employment in industry involved with livestock after vaccination through Day 29
Who cannot join
- Signs or symptoms of acute COVID-19 within 1 week before vaccination.
- Prior infection with Nipah virus or suspected Henipavirus
- Healthcare worker with direct physical contact with patients
- Childcare worker in direct contact with children 5 years old or younger
- Household contact who is immunodeficient, or on immunosuppressive medication
- Hands-on food preparation job
Show all 23Show fewer
- Primary care or treatment of cattle, horses, llamas or swine
- Hepatitis B, hepatitis C, HIV-1, HIV-2, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder, ;
- History of severe reactions to any vaccine or history of severe allergies
- Receipt of another investigational vaccine within 30 days or a licensed vaccine within 14 days (live vaccine within 30 days)
- Known allergy to components of PHV02
- Injection sites obscured by tattoos or physical condition
- Significant psychiatric or medical condition or laboratory abnormality on screening
- History of Guillain Barre Syndrome or any chronic or acute neurological disorder
- Alcohol or illicit drug abuse within past 5 years
- Pregnant or lactating female
- Administration of blood or IgG within 120 days preceding study
- History of blood donation within 60 days of study
- Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or joint symptoms (athrocentesis if indicated by joint effusion), in both cases if acceptable to subject
- History of chronic autoimmune/autoinflammatory disease
- Elective surgery planned during the study period
- Subjects who have not adhered to and do not agree to adhere to local and institutional guidelines for COVID-19 prevention or testing
- Any subject from the Pioneer/Full cohort who experienced a hypersensitivity reaction to study vaccine or a single clinically significant Grade 3 adverse event or serious adverse event, unless deemed unrelated to vaccination, will be followed for safety and immunogenicity, but will not be eligible to enter the Booster Cohort
Trial locations and contacts
1 site in 1 country.
United States1 site
Johnson County Clin-Trials(JCCT)
Lenexa, Kansas, 66219
About this study
Official title: A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response and Open-Label or Single Blind Booster Study to Evaluate the Safety and Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
Read the detailed description
A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
- Conditions
- Nipah Virus Infection
- Being tested
- PHV02, Placebo
- Keywords
- henipavirus, vesicular stomatitis vector, paramyxoviridae infection, zoonotic disease
- Medical subject headings
- Henipavirus Infections, Paramyxoviridae Infections, Zoonoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHV02Biological
live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
PlaceboOther
Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| PHV02 2x10^5 pfu | Experimental | Not described Receives: Biological: PHV02 |
| PHV02 2x10^6 pfu | Experimental | Not described Receives: Biological: PHV02 |
| PHV02 2x10^7 pfu | Experimental | Not described Receives: Biological: PHV02 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| PHV02 5x10^8 pfu (Boost) | Experimental | Not described Receives: Biological: PHV02 |
| PHV02 5x10^8 pfu (Prime) | Experimental | Not described Receives: Biological: PHV02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
Measured: 42 days after vaccination
Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
Measured: 29 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start10 Jan 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nipah Virus 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Vaccines LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Responsible party
- Sponsor
- Investigators
- Thomas Monath, MD, FASTMH, Study director, Crozet BioPharmaCarlos Fierro, MD, Principal investigator, Johnson County Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178901
- Sponsor's protocol ID
- PHV02-C-101
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response and Open-Label or Single Blind Booster Study to Evaluate the Safety and Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05178901
- Acronym / sponsor ID
- PHV02-C-101
- Conditions
- Nipah Virus Infection
- Keywords
- henipavirus, vesicular stomatitis vector, paramyxoviridae infection, zoonotic disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Public Health Vaccines LLCIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 5 Jan 2022 (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.
A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
Detailed description
A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PHV02 2x10^5 pfu | Experimental | Biological: PHV02 |
| PHV02 2x10^6 pfu | Experimental | Biological: PHV02 |
| PHV02 2x10^7 pfu | Experimental | Biological: PHV02 |
| Placebo | Placebo comparator | Other: Placebo |
| PHV02 5x10^8 pfu (Boost) | Experimental | Biological: PHV02 |
| PHV02 5x10^8 pfu (Prime) | Experimental | Biological: PHV02 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- For Booster cohort only: received PHV02 (or placebo)
- Healthy, adult, male or non-pregnant, non-lactating females
- Given written informed consent
- No clinically significant health problems
- Agree to avoid conception through Day 29
Key exclusion criteria (23 listed)
- Signs or symptoms of acute COVID-19 within 1 week before vaccination.
- Prior infection with Nipah virus or suspected Henipavirus
- Healthcare worker with direct physical contact with patients
- Childcare worker in direct contact with children 5 years old or younger
- Household contact who is immunodeficient, or on immunosuppressive medication
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 |
|---|---|---|
| PHV02live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection | Biological | PHV02 2x10^5 pfu, PHV02 2x10^6 pfu, PHV02 2x10^7 pfu, PHV02 5x10^8 pfu (Boost), PHV02 5x10^8 pfu (Prime) |
| PlaceboLactated Ringer's Solution. The placebo will be administered as a single intramuscular injection | Other | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale
Time frame: 42 days after vaccination
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISA
Time frame: 29 days after vaccination
for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials
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 24 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Nipah Virus Infection
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
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.
Thomas Monath, MD, FASTMH study director
Crozet BioPharma
Carlos Fierro, MD principal investigator
Johnson County Clinical Trials
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 PHV02 in people with Nipah Virus Infection, run by Public Health Vaccines LLC 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 23 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 24 Oct 2024. 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?
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale (time frame: 42 days after 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?
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 24 Oct 2024.