To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV

HIV I Infection Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the HCMV-HIV Vaccine Candidate VIR-1388 in Adult Participants With Overall Good Health and Without HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854381
• Other study ID #: VIR-1388-V101
• Secondary ID: 5UM1AI068614-18
• Status: Recruiting
• Phase: Phase 1
• Start date: September 19, 2023
• Est. completion date: November 2027

Study information

• Verified date: September 2023
• Source: Vir Biotechnology, Inc.
• Contact: Study Inquiry
• Phone: +1 415-654-5281
• Email: clinicaltrials[@]vir.bio
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.

Description:

This is a Phase 1, randomized, double-blind, placebo-controlled, multicenter study in adults aged 18 to 55 years in overall good health and without HIV. Participants will be enrolled concurrently into 1 of 3 dose levels of VIR-1388 or placebo. The overall study design includes 2 study parts, Part A and Part B. Part A will be a lead-in phase enrolling a limited number of HCMV seropositive persons of non-childbearing potential (PONCBP) with a frequent safety monitoring schedule. Part B will expand enrollment into a broader population of HCMV-seropositive participants, including persons of childbearing potential required to use 2 forms of contraception and maintains a similar overall safety monitoring schedule as Part A . There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: November 2027
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• In overall good health as determined by medical history, physical exam, and laboratory values
• HIV uninfected
• CMV seropositive
• Willing to use condoms during intercourse for the duration of the study
• Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
• Childbearing status
• Part A: Only participants of non-childbearing potential
• Part B: Participants of childbearing potential must be on 2 forms of contraception and not planning on becoming pregnant for the duration of the study

Exclusion Criteria:

• Participant is immunocompromised
• Participant has an autoimmune disorder
• Immunocompromised individuals
• Participants having intimate contact with immunocompromised individuals
• Participants having intimate contact with a pregnant partner or partner planning to become pregnant
• Participants who are breastfeeding

Related Conditions & MeSH terms

• HIV I Infection

Intervention

Biological:
• VIR-1388
VIR-1388 is given by subcutaneous injection
• Placebo
The HT Diluent Placebo is HT buffer (20 mM histidine, 10% trehalose-dihydrate, pH 7.2) and contains no active ingredient and will be administered by subcutaneous injection

Locations

Country	Name	City	State
South Africa	Isipingo Clinical Research Site	Isipingo	Kwa-Zulu Natal
South Africa	Chatsworth Clinical Research Site	Overport	Kwa-Zulu Natal
South Africa	Perinatal HIV Research Unit	Soweto	Gauteng
United States	Alabama CRS	Birmingham	Alabama
United States	Beth Israel Deconess Medical Center VCRS	Boston	Massachusetts
United States	The Hope Clinic of the Emory Vaccine Center CRS	Decatur	Georgia
United States	Penn Prevention CRS	Philadelphia	Pennsylvania
United States	University of Pittsburgh CRS	Pittsburgh	Pennsylvania
United States	Seattle Vaccine and Prevention CRS	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Vir Biotechnology, Inc.	HIV Vaccine Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)	Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017	12 months
Primary	Incidence of solicited local site and systemic reactogenicity events	Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017	14 days after administration of each dose
Secondary	Frequency of HIV-1 Mfuse1-specific CD4 T cells	As measured by intracellular cytokine staining (ICS) and flow cytometry	12 months
Secondary	Frequency of HIV-1 Mfuse1-specific CD8 T cells	As measured by intracellular cytokine staining (ICS) and flow cytometry	12 months
Secondary	Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells	As determined by flow cytometry analysis	12 months
Secondary	Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells	As determined by flow cytometry analysis	12 months
Secondary	Number of participants with VIR-1388 vector viremia in plasma	Detected by quantitative polymerase chain reaction(qPCR) of plasma	12 months
Secondary	Number of participants with VIR-1388 vector shedding in saliva and urine	Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine	12 months