Nipah Virus InfectionPhase 1NCT06221813
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects
A Phase 1 study testing PHV02 and Lactated Ringer's in people with Nipah Virus Infection, run by Public Health Vaccines LLC at 3 sites in United States.
Trial summary
The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Nipah Virus Infection
- What is being tested?
- PHV02 and Lactated Ringer's
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jan 2024to 2 Oct 2024
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or non-pregnant, non-lactating females
- Given written informed consent
- No clinically significant health problems
- Negative test for SARS-CoV-2
- Agree to avoid conception through Day 57
- Agree to minimize blood and body fluid exposures to others after vaccination through Day 57
- Agree to avoid exposure to immunocompromised persons after vaccination through Day 57
- Agree to avoid employment in industry involved with livestock after vaccination through Day 57
Who cannot join
- Prior infection with Nipah virus, related Henipaviruses or Ebola virus
- Prior infection with vesicular stomatitis virus (VSV)
- Received VSV-vectored vaccine or Ebola vaccine
- BMI < 18.5 or ≥ 35
- Healthcare worker with direct physical contact with patients
- Childcare worker in direct contact with children 5 years old or younger
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- Household contact who is immunodeficient, or on immunosuppressive medication
- Hands-on food preparation job
- Primary care or treatment of cattle, horses, 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 investigational product up to 30 days prior to, or planned receipt within 196 days after randomization, or ongoing participation in another interventional clinical trial.
- Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines) or planned receipt of non-live or live vaccine within 60 days after first study immunization (30 days after the 2nd vaccination).
- 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 (arthrocentesis if indicated by joint effusion), in both cases if acceptable to subject
- Elective surgery planned during the study period
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cenexel ACT (Anaheim Clinical Trials)
Anaheim, California, 92801
Cenexel RCA (Research Centers of America)
Hollywood, Florida, 33024
Cenexel JBR (JBR Clinical Research)
Salt Lake City, Utah, 84107
About this study
Official title: A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults
The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are:
- which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart?
- what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units [pfu]) or placebo on Day 1 and Day 29 and will be followed for 197 days.
- Conditions
- Nipah Virus Infection
- Being tested
- PHV02, Lactated Ringer's
- Keywords
- live, attenuated vaccine, Nipah virus, PHV02, recombinant vesicular stomatitis virus
- Medical subject headings
- Henipavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHV02Biological
Nipah virus vaccine
Lactated Ringer'sBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (first 60 subjects) PHV02 high dose | Experimental | Not described Receives: Biological: PHV02 |
| Cohort 1 (first 60 subjects) PHV02 medium dose | Experimental | Not described Receives: Biological: PHV02 |
| Cohort 1 (first 60 subjects) PHV02 low dose | Experimental | Not described Receives: Biological: PHV02 |
| Cohort 1 (first 60 subjects) Placebo | Placebo comparator | Not described Receives: Biological: Lactated Ringer's |
| Cohort 2 (next 60 subjects) PHV02 high dose | Experimental | Not described Receives: Biological: PHV02 |
| Cohort 2 (next 60 subjects) PHV02 medium dose | Experimental | Not described Receives: Biological: PHV02 |
| Cohort 2 (next 60 subjects) PHV02 low dose | Experimental | Not described Receives: Biological: PHV02 |
| Cohort 2 (next 60 subjects) Placebo | Placebo comparator | Not described Receives: Biological: Lactated Ringer's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with local injection site and systemic adverse events (AEs)
Measured: 14 days after each dose
Percentage of participants with joint related symptoms, rash and unsolicited AEs
Measured: 28 days after each dose
Percentage of participants with neurologic AEs
Measured: Study Days 1-57
Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)
Measured: From time of injection through final study visit (Day 197)
Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva
Measured: From time of injection through Day 43
Proportion of participants who seroconvert compared to Day 1
Measured: Day 29 and Day 57
Geometric mean titers of IgG and ELISA neutralizing antibodies
Measured: Day 1, 29, 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start26 Jan 2024
- Primary completion30 Sep 2024
- Study completion2 Oct 2024
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 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
- 120 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
- Joan Fusco, PhD, Study chair, Public Health VaccinesThomas P Monath, MD, Study director, Quigley BiopharmaGray P Heppner, MD, Study director, Quigley Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221813
- Sponsor's protocol ID
- PHV02-C-102
- Status last verified
- Jun 2025
- First submitted
- 15 Jan 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monath TP, Nichols R, Feldmann F, Griffin A, Haddock E, Callison J, Meade-White K, Okumura A, Lovaglio J, Hanley PW, Clancy CS, Shaia C, Rida W, Fusco J. Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease. Front Immunol. 2023 Sep 4;14:1216225. doi: 10.3389/fimmu.2023.1216225. eCollection 2023.
PubMed 37731485
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults
- ClinicalTrials.gov ID
- NCT06221813
- Acronym / sponsor ID
- PHV02-C-102
- Conditions
- Nipah Virus Infection
- Keywords
- live, attenuated vaccine, Nipah virus, PHV02, recombinant vesicular stomatitis virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Public Health Vaccines LLCIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 24 Jan 2024 (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.
The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are:
- which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart?
- what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units [pfu]) or placebo on Day 1 and Day 29 and will be followed for 197 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (first 60 subjects) PHV02 high dose | Experimental | Biological: PHV02 |
| Cohort 1 (first 60 subjects) PHV02 medium dose | Experimental | Biological: PHV02 |
| Cohort 1 (first 60 subjects) PHV02 low dose | Experimental | Biological: PHV02 |
| Cohort 1 (first 60 subjects) Placebo | Placebo comparator | Biological: Lactated Ringer's |
| Cohort 2 (next 60 subjects) PHV02 high dose | Experimental | Biological: PHV02 |
| Cohort 2 (next 60 subjects) PHV02 medium dose | Experimental | Biological: PHV02 |
| Cohort 2 (next 60 subjects) PHV02 low dose | Experimental | Biological: PHV02 |
| Cohort 2 (next 60 subjects) Placebo | Placebo comparator | Biological: Lactated Ringer's |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, adult, male or non-pregnant, non-lactating females
- Given written informed consent
- No clinically significant health problems
- Negative test for SARS-CoV-2
- Agree to avoid conception through Day 57
Key exclusion criteria (23 listed)
- Prior infection with Nipah virus, related Henipaviruses or Ebola virus
- Prior infection with vesicular stomatitis virus (VSV)
- Received VSV-vectored vaccine or Ebola vaccine
- BMI < 18.5 or ≥ 35
- Healthcare worker with direct physical contact with patients
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 |
|---|---|---|
| PHV02Nipah virus vaccine | Biological | Cohort 1 (first 60 subjects) PHV02 high dose, Cohort 1 (first 60 subjects) PHV02 low dose, Cohort 1 (first 60 subjects) PHV02 medium dose, Cohort 2 (next 60 subjects) PHV02 high dose, Cohort 2 (next 60 subjects) PHV02 low dose, Cohort 2 (next 60 subjects) PHV02 medium dose |
| Lactated Ringer'sPlacebo | Biological | Cohort 1 (first 60 subjects) Placebo, Cohort 2 (next 60 subjects) Placebo |
Primary outcome
Percentage of participants with local injection site and systemic adverse events (AEs)
Time frame: 14 days after each dose
Percentage of participants with joint related symptoms, rash and unsolicited AEs
Time frame: 28 days after each dose
Percentage of participants with neurologic AEs
Time frame: Study Days 1-57
Percentage of participants with medically-attended AEs (MAAEs) and serious AEs (SAEs)
Time frame: From time of injection through final study visit (Day 197)
Proportion of participants with recombinant vesicular stomatitis virus (rVSV) RNA (Cohort 1 only) in plasma, urine and saliva
Time frame: From time of injection through Day 43
Proportion of participants who seroconvert compared to Day 1
Time frame: Day 29 and Day 57
Geometric mean titers of IgG and ELISA neutralizing antibodies
Time frame: Day 1, 29, 57
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 8 Jun 2025.
- Background: PubMed 37731485Monath TP, Nichols R, Feldmann F, Griffin A, Haddock E, Callison J, Meade-White K, Okumura A, Lovaglio J, Hanley PW, Clancy CS, Shaia C, Rida W, Fusco J. Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease. Front Immunol. 2023 Sep 4;14:1216225. doi: 10.3389/fimmu.2023.1216225. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Joan Fusco, PhD study chair
Public Health Vaccines
Thomas P Monath, MD study director
Quigley Biopharma
Gray P Heppner, MD study director
Quigley Biopharma
3 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 PHV02 and Lactated Ringer's in people with Nipah Virus Infection, run by Public Health Vaccines LLC at 3 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 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Percentage of participants with local injection site and systemic adverse events (AEs) (time frame: 14 days after each dose). The study lists 7 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 NCT06221813, 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 8 Jun 2025.