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

Status: Completed
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
United States
Florida
CenExel RCA
Hollywood
Time Frame
Start Date: 2024-02-05
Completion Date: 2024-09-23
Participants
Target number of participants: 36
Treatments
Experimental: Group A, Low Dose PHV01
Group A (10 subjects) PHV01 @ 10\^5 pfu/dose given once
Experimental: Group B, Medium Dose PHV01
Group B (10 subjects) PHV01 @ 10\^6 pfu/dose given once
Experimental: Group C, Hjigh Dose PHV01
Group C (10 subjects) PHV01 @ 10\^7 pfu/dose given once
Placebo_comparator: Group D, Placebo
Group D (6 subjects) Placebo given once
Sponsors
Collaborators: Biomedical Advanced Research and Development Authority
Leads: Public Health Vaccines LLC

This content was sourced from clinicaltrials.gov

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