1.
ClinicalTrials.gov; 09/02/2024; TrialID: NCT06265012
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06265012
ABSTRACT
Condition:
Marburg Virus DiseaseIntervention:
Biological: PHV01;Biological: PlaceboPrimary 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
2.
ClinicalTrials.gov; 06/12/2021; TrialID: NCT05178901
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05178901
ABSTRACT
Condition:
Nipah Virus InfectionIntervention:
Biological: PHV02;Other: PlaceboPrimary outcome:
Number of participants with treatment-related adverse events as assessed by the Toxicity Grading Scale;Number of participants with Nipah-specific antibody and neutralizing antibody responses as assessed by ELISACriteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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