Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects

ABSTRACT

ConditionMarburg Virus Disease

InterventionBiological PHV01;Biological Placebo

Primary outcome:Solicited Adverse Events (AEs);Unsolicited AEs;Other AEs;Immunogenicity, Antibodies (Ab);Immunogenicity, Neutralizing antibodies (NEUT)

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