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

• Sponsor: Vir Biotechnology, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05854381
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH), HIV Vaccine Trials Network (Other)
• Enrollment: 95
• Locations: 6
• Arms: 4
• Anticipated Duration (Months): 53
• Patients Per Site: 15.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV I Infection	Biological: VIR-1388; Biological: Placebo	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIR-1388, 5×10^4 ffu Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: VIR-1388; VIR-1388 is given by subcutaneous injection
Experimental: VIR-1388, 5×10^5 ffu Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: VIR-1388; VIR-1388 is given by subcutaneous injection
Experimental: VIR-1388, 5×10^6 ffu Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: VIR-1388; VIR-1388 is given by subcutaneous injection
Placebo Comparator: Placebo Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.	Biological: 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

Outcome Measures

Primary Outcome Measures

1. Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs) [12 months]

   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

2. Incidence of solicited local site and systemic reactogenicity events [14 days after administration of each dose]

   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

Secondary Outcome Measures

1. Frequency of HIV-1 Mfuse1-specific CD4 T cells [12 months]

   As measured by intracellular cytokine staining (ICS) and flow cytometry

2. Frequency of HIV-1 Mfuse1-specific CD8 T cells [12 months]

   As measured by intracellular cytokine staining (ICS) and flow cytometry

3. Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells [12 months]

   As determined by flow cytometry analysis

4. Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells [12 months]

   As determined by flow cytometry analysis

5. Number of participants with VIR-1388 vector viremia in plasma [12 months]

   Detected by quantitative polymerase chain reaction(qPCR) of plasma

6. Number of participants with VIR-1388 vector shedding in saliva and urine [12 months]

   Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama CRS	Birmingham	Alabama	United States	35222
2	The Hope Clinic of the Emory Vaccine Center CRS	Decatur	Georgia	United States	30030
3	Beth Israel Deconess Medical Center VCRS	Boston	Massachusetts	United States	32077
4	Penn Prevention CRS	Philadelphia	Pennsylvania	United States	19104
5	University of Pittsburgh CRS	Pittsburgh	Pennsylvania	United States	15213
6	Seattle Vaccine and Prevention CRS	Seattle	Washington	United States	98104

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vir Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT05854381
• Other Study ID Numbers: VIR-1388-V101; 5UM1AI068614-18
• First Posted: May 11, 2023
• Last Update Posted: May 11, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vir Biotechnology, Inc.: HIV; Vaccine; CMV; Cytomegalovirus

Study Results

No Results Posted as of May 11, 2023