The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05854381
Recruitment Status : Recruiting
First Posted : May 11, 2023
Last Update Posted : December 15, 2023
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 19, 2023
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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) [ 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

  2. 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


Secondary Outcome Measures :
  1. Frequency of HIV-1 Mfuse1-specific CD4 T cells [ Time Frame: 12 months ]
    As measured by intracellular cytokine staining (ICS) and flow cytometry

  2. Frequency of HIV-1 Mfuse1-specific CD8 T cells [ Time Frame: 12 months ]
    As measured by intracellular cytokine staining (ICS) and flow cytometry

  3. Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells [ Time Frame: 12 months ]
    As determined by flow cytometry analysis

  4. Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells [ Time Frame: 12 months ]
    As determined by flow cytometry analysis

  5. Number of participants with VIR-1388 vector viremia in plasma [ Time Frame: 12 months ]
    Detected by quantitative polymerase chain reaction(qPCR) of plasma

  6. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05854381


Contacts
Layout table for location contacts
Contact: Study Inquiry +1 415-654-5281 clinicaltrials@vir.bio

Locations
Layout table for location information
United States, Alabama
Alabama CRS Recruiting
Birmingham, Alabama, United States, 35222
Contact: Paul Goepfert, MD         
United States, Georgia
The Hope Clinic of the Emory Vaccine Center CRS Recruiting
Decatur, Georgia, United States, 30030
United States, Massachusetts
Beth Israel Deconess Medical Center VCRS Recruiting
Boston, Massachusetts, United States, 32077
Contact: Kathryn Stephenson, MD         
United States, Pennsylvania
Penn Prevention CRS Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ian Frank, MD         
University of Pittsburgh CRS Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sharon Riddler, MD MPH         
United States, Washington
Seattle Vaccine and Prevention CRS Recruiting
Seattle, Washington, United States, 98104
Contact: Julie McElrath, MD PhD MPH         
South Africa
Perinatal HIV Research Unit Recruiting
Soweto, Gauteng, South Africa, 1862
Contact: Fatima Laher, MBBCh DipHIVMan         
Isipingo Clinical Research Site Recruiting
Isipingo, Kwa-Zulu Natal, South Africa, 4110
Contact: Dishiki Jenny Kalonji, MBBCh FCPHM MMed         
Chatsworth Clinical Research Site Recruiting
Overport, Kwa-Zulu Natal, South Africa, 4092
Contact: Logashvari Naidoo, MBChB         
Sponsors and Collaborators
Vir Biotechnology, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT05854381    
Other Study ID Numbers: VIR-1388-V101
5UM1AI068614-18 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2023    Key Record Dates
Last Update Posted: December 15, 2023
Last Verified: September 2023

Layout table for additional information
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