HIV I Infection
Conditions
Keywords
HIV, Vaccine, CMV, Cytomegalovirus
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.
Interventions
BIOLOGICALVIR-1388
VIR-1388 is given by subcutaneous injection
BIOLOGICALPlacebo
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
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Vaccine Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells | 12 months | As determined by flow cytometry analysis |
| Frequency of HIV-1 Mfuse1-specific CD4 T cells | 12 months | As measured by intracellular cytokine staining (ICS) and flow cytometry |
| Number of participants with VIR-1388 vector viremia in plasma | 12 months | Detected by quantitative polymerase chain reaction(qPCR) of plasma |
| Frequency of HIV-1 Mfuse1-specific CD8 T cells | 12 months | As measured by intracellular cytokine staining (ICS) and flow cytometry |
| 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 |
| Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells | 12 months | As determined by flow cytometry analysis |
Countries
South Africa, United States
Outcome results
None listed