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

• ClinicalTrials.gov Identifier: NCT05854381
• Recruitment Status: Recruiting
• First Posted: May 11, 2023
• Last Update Posted: December 15, 2023
• Sponsor: Vir Biotechnology, Inc.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); HIV Vaccine Trials Network
• Information provided by (Responsible Party): Vir Biotechnology, Inc.

Tracking Information

• First Submitted Date: April 12, 2023
• First Posted Date: May 11, 2023
• Last Update Posted Date: December 15, 2023
• Actual Study Start Date: September 19, 2023
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 2, 2023)

• Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs) [ Time Frame: 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
• Incidence of solicited local site and systemic reactogenicity events [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 2, 2023)

• Frequency of HIV-1 Mfuse1-specific CD4 T cells [ Time Frame: 12 months ]
  As measured by intracellular cytokine staining (ICS) and flow cytometry
• Frequency of HIV-1 Mfuse1-specific CD8 T cells [ Time Frame: 12 months ]
  As measured by intracellular cytokine staining (ICS) and flow cytometry
• Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells [ Time Frame: 12 months ]
  As determined by flow cytometry analysis
• Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells [ Time Frame: 12 months ]
  As determined by flow cytometry analysis
• Number of participants with VIR-1388 vector viremia in plasma [ Time Frame: 12 months ]
  Detected by quantitative polymerase chain reaction(qPCR) of plasma
• Number of participants with VIR-1388 vector shedding in saliva and urine [ Time Frame: 12 months ]
  Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: HIV I Infection

Intervention

• Biological: VIR-1388
  VIR-1388 is given by subcutaneous injection
• 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

Study Arms

• Experimental: VIR-1388, 5×10^4 ffu
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
  Intervention: Biological: VIR-1388
• Experimental: VIR-1388, 5×10^5 ffu
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
  Intervention: Biological: VIR-1388
• Experimental: VIR-1388, 5×10^6 ffu
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
  Intervention: Biological: VIR-1388
• Placebo Comparator: Placebo
  Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections.
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 2, 2023): 95
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2027
• Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Study Inquiry; +1 415-654-5281; clinicaltrials@vir.bio

• Listed Location Countries: South Africa, United States

Administrative Information

• NCT Number: NCT05854381
• Other Study ID Numbers: VIR-1388-V101; 5UM1AI068614-18 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vir Biotechnology, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vir Biotechnology, Inc.
• Original Study Sponsor: Same as current

Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• HIV Vaccine Trials Network

• Investigators: Not Provided
• PRS Account: Vir Biotechnology, Inc.
• Verification Date: September 2023