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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06265012
Other study ID # PHV01-C-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 5, 2024
Est. completion date September 16, 2024

Study information

Verified date February 2024
Source Public Health Vaccines LLC
Contact Terry Piedra
Phone 305-596-3125
Email t.piedra@cenexel.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date September 16, 2024
Est. primary completion date April 17, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PHV01
Marburg virus vaccine
Placebo
Lactated Ringer's Solution

Locations

Country Name City State
United States CenExel RCA Hollywood Florida

Sponsors (2)

Lead Sponsor Collaborator
Public Health Vaccines LLC Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Solicited Adverse Events (AEs) Incidence and severity of solicited injection site [(arm pain, local tenderness, erythema (redness), and induration (swelling/firmness)] and systemic AEs Study Days 1-15
Primary Unsolicited AEs Incidence and severity of unsolicited AEs Study Days 1-29
Primary Other AEs Incidence and severity of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) Study Days 1-181
Primary 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 Injection through 28 days
Primary Immunogenicity, Neutralizing antibodies (NEUT) PsVNT50 and PsVNT80 MARV GP-specific neutralizing antibodies titers Injection through 28 days
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