Clinical trial NCT05854381: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: HIV I Infection
Keywords: HIV
Vaccine
CMV
Cytomegalovirus
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: HIV Vaccine Trials Network
First posted: 2023-05-11
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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

Primary outcomes:
measure: Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)
timeFrame: 12 months
measure: Incidence of solicited local site and systemic reactogenicity events
timeFrame: 14 days after administration of each dose
Secondary outcomes:
measure: Frequency of HIV-1 Mfuse1-specific CD4 T cells
timeFrame: 12 months
measure: Frequency of HIV-1 Mfuse1-specific CD8 T cells
timeFrame: 12 months
measure: Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells
timeFrame: 12 months
measure: Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells
timeFrame: 12 months
measure: Number of participants with VIR-1388 vector viremia in plasma
timeFrame: 12 months
measure: Number of participants with VIR-1388 vector shedding in saliva and urine
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama CRS
state: Alabama
city: Decatur
country: United States
facility: The Hope Clinic of the Emory Vaccine Center CRS
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deconess Medical Center VCRS
state: Massachusetts
city: Philadelphia
country: United States
facility: Penn Prevention CRS
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh CRS
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Vaccine and Prevention CRS
state: Washington
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre CRS
state: Gauteng
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit
state: Gauteng
city: Isipingo
country: South Africa
facility: Isipingo Clinical Research Site
state: Kwa-Zulu Natal
city: Overport
country: South Africa
facility: Chatsworth Clinical Research Site
state: Kwa-Zulu Natal
Study officials:
References: