Marburg Virus DiseasePhase 1PHV01NCT06265012
Study to Evaluate the Recombinant VSV (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects
A Phase 1 study testing PHV01 in people with Marburg Virus Disease, run by Public Health Vaccines LLC at 1 site in United States.
Trial summary
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, Marburg Virus glycoprotein [MARV GP] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Marburg Virus Disease
- What is being tested?
- PHV01
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 23 Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years
- Given written informed consent
- No clinically significant health problems
- Negative test for SARS-CoV-2
- 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
Who cannot join
- Prior infection with Marburg virus, related filovirus, or Ebola virus
- Prior infection with vesicular stomatitis virus (VSV)
- Received any VSV-vectored vaccine
- BMI of ≥ 35
- Household contact who is immunodeficient, or on immunosuppressive medication
- Hepatitis B, hepatitis C, HIV-1, HIV-2, history of long COVID, diabetes, atopic dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory disorder, malignancy, chronic or active neurologic disorder
Show all 20Show fewer
- History of severe reactions to any vaccine or history of severe allergies
- Receipt of investigational product up to 30 days prior to randomization
- Receipt of licensed or authorized non-live vaccines within 14 days of planned study immunization (30 days for live vaccines).
- Known allergy to components of PHV01
- 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 60 days preceding study
- Administration of systemic chronic immunosuppressants (defined as more than 14 days) or other immune modifying drugs within 6 months of study entry
- 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
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Single-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, MARV GP Vaccine) in Healthy Adults
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, Marburg Virus glycoprotein [MARV GP] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:
- Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?
- What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?
Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days.
Read the detailed description
Participants will be randomly assigned to vaccine or placebo in four dose cohorts, starting with evaluation of safety using a sentinel group at each dose level, followed by dosing of the rest of the group in the next cohort. That next cohort will also dose the sentinel group with the next higher dose.
- Conditions
- Marburg Virus Disease
- Being tested
- PHV01, Placebo
- Keywords
- live, attenuated vaccine, Marburg virus, PHV01 (rVSV-MARV GP) vaccine, recombinant vesicular stomatitis virus
- Medical subject headings
- Marburg Virus Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHV01Biological
Marburg virus vaccine
PlaceboBiological
Lactated Ringer's Solution
| Study group | Role | What they receive |
|---|---|---|
| Group A, Low Dose PHV01 | Experimental | Group A (10 subjects) PHV01 @ 10^5 pfu/dose given once Receives: Biological: PHV01 |
| Group B, Medium Dose PHV01 | Experimental | Group B (10 subjects) PHV01 @ 10^6 pfu/dose given once Receives: Biological: PHV01 |
| Group C, Hjigh Dose PHV01 | Experimental | Group C (10 subjects) PHV01 @ 10^7 pfu/dose given once Receives: Biological: PHV01 |
| Group D, Placebo | Placebo comparator | Group D (6 subjects) Placebo given once Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited Adverse Events (AEs)
Incidence and severity of solicited injection site [(arm pain, local tenderness, erythema (redness), and induration (swelling/firmness)] and systemic AEs
Measured: Study Days 1-15
Unsolicited AEs
Incidence and severity of unsolicited AEs
Measured: Study Days 1-29
Other AEs
Incidence and severity of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Measured: Study Days 1-181
Immunogenicity, Antibodies (Ab)
Geometric mean titers (GMT) of Marburg GP protein-specific IgG antibody as measured by enzyme-linked immunosorbent assay (ELISA) on days 1 and 29
Measured: Injection through 28 days
Immunogenicity, Neutralizing antibodies (NEUT)
PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers
Measured: Injection through 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start5 Feb 2024
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marburg Virus DiseaseStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Vaccines LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Joan Fusco, PhD, Study chair, Public Health VaccinesRichard Kenney, MD, Study director, Public Health Vaccines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265012
- Sponsor's protocol ID
- PHV01-C-101
- Acronym
- PHV01
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2024
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Single-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, MARV GP Vaccine) in Healthy Adults
- ClinicalTrials.gov ID
- NCT06265012
- Acronym / sponsor ID
- PHV01 / PHV01-C-101
- Conditions
- Marburg Virus Disease
- Keywords
- live, attenuated vaccine, Marburg virus, PHV01 (rVSV-MARV GP) vaccine, recombinant vesicular stomatitis virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Public Health Vaccines LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 20 Feb 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.
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP [Angola] (PHV01, Marburg Virus glycoprotein [MARV GP] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:
- Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?
- What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?
Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days.
Detailed description
Participants will be randomly assigned to vaccine or placebo in four dose cohorts, starting with evaluation of safety using a sentinel group at each dose level, followed by dosing of the rest of the group in the next cohort. That next cohort will also dose the sentinel group with the next higher dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A, Low Dose PHV01 | Experimental | Biological: PHV01Group A (10 subjects) PHV01 @ 10^5 pfu/dose given once |
| Group B, Medium Dose PHV01 | Experimental | Biological: PHV01Group B (10 subjects) PHV01 @ 10^6 pfu/dose given once |
| Group C, Hjigh Dose PHV01 | Experimental | Biological: PHV01Group C (10 subjects) PHV01 @ 10^7 pfu/dose given once |
| Group D, Placebo | Placebo comparator | Biological: PlaceboGroup D (6 subjects) Placebo given once |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years
- Given written informed consent
- No clinically significant health problems
- Negative test for SARS-CoV-2
- Agree to avoid conception through Day 29
Key exclusion criteria (20 listed)
- Prior infection with Marburg virus, related filovirus, or Ebola virus
- Prior infection with vesicular stomatitis virus (VSV)
- Received any VSV-vectored vaccine
- BMI of ≥ 35
- 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 |
|---|---|---|
| PHV01Marburg virus vaccine | Biological | Group A, Low Dose PHV01, Group B, Medium Dose PHV01, Group C, Hjigh Dose PHV01 |
| PlaceboLactated Ringer's Solution | Biological | Group D, Placebo |
Primary outcome
Solicited Adverse Events (AEs)
Time frame: Study Days 1-15
Incidence and severity of solicited injection site [(arm pain, local tenderness, erythema (redness), and induration (swelling/firmness)] and systemic AEs
Unsolicited AEs
Time frame: Study Days 1-29
Incidence and severity of unsolicited AEs
Other AEs
Time frame: Study Days 1-181
Incidence and severity of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Immunogenicity, Antibodies (Ab)
Time frame: Injection through 28 days
Geometric mean titers (GMT) of Marburg GP protein-specific IgG antibody as measured by enzyme-linked immunosorbent assay (ELISA) on days 1 and 29
Immunogenicity, Neutralizing antibodies (NEUT)
Time frame: Injection through 28 days
PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers
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 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Marburg Virus Disease
Not yet recruitingPhase 1
A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of a Preventative Vaccine for Marburg Virus (mRNA-1519) in Healthy Adult Participants
Marburg Virus Disease (MVD)
Active, not recruitingPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Marburg Virus Disease
Active, not recruitingPhase 2
A Trial to Evaluate Safety, Tolerability, and Immune Responses of an Investigational Monovalent Chimpanzee Adenoviral Vectored Marburg Virus Vaccine in Healthy Adults
Marburg Virus Disease
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
Richard Kenney, MD study director
Public Health Vaccines
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 PHV01 in people with Marburg Virus Disease, 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 7 inclusion and 20 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 5 Sep 2025. 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?
Solicited Adverse Events (AEs) (time frame: Study Days 1-15). The study lists 5 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 5 Sep 2025.