Evaluating a new vaccine for Marburg virus in healthy adults
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 study is testing a new vaccine for the Marburg virus in healthy adults to see if it is safe and helps the body build protection against the virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Public Health Vaccines LLC Industry-sponsored |
| Locations | 1 site (Hollywood, Florida) |
| Trial ID | NCT06265012 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to assess the safety and immune response of a live, attenuated vaccine candidate, PHV01, against the Marburg virus in healthy adult participants. The study involves a randomized, single-blind, placebo-controlled approach, where participants will receive either the vaccine or a placebo in ascending dose cohorts. Safety will be evaluated through a sentinel group at each dose level, followed by the administration of the vaccine to the remaining participants. The trial will monitor participants for 181 days to measure the immunologic response, specifically looking for Marburg-specific antibodies.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-60 who meet specific health criteria and are willing to participate in the trial.
Not a fit: Patients with a history of Marburg virus infection, related filoviruses, or certain chronic health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide a crucial preventive measure against Marburg virus disease, potentially saving lives in outbreak situations.
How similar studies have performed: While this approach is novel in the context of Marburg virus, similar vaccine strategies have shown promise in other viral diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Hollywood, Florida
- CenExel RCA — Hollywood, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Terry Piedra
- Email: t.piedra@cenexel.com
- Phone: 305-596-3125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.