HIV I InfectionPhase 1NCT05854381
To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
A Phase 1 study testing VIR-1388 in people with HIV I Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV I Infection
- What is being tested?
- VIR-1388
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 19 Sep 2023to 19 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Alabama CRS
Birmingham, Alabama, 35222
Beth Israel Deconess Medical Center VCRS
Boston, Massachusetts, 32077
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98104
South Africa4 sites
Isipingo Clinical Research Site
Isipingo, KwaZulu-Natal, 4110
Chatsworth Clinical Research Site
Overport, KwaZulu-Natal, 4092
Setshaba Research Centre CRS
Soshanguve, Gauteng, 0152
Perinatal HIV Research Unit
Soweto, Gauteng, 1862
About this study
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
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
Read the 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.
- Conditions
- HIV I Infection
- Being tested
- VIR-1388, Placebo
- Keywords
- HIV, Vaccine, CMV, Cytomegalovirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-1388Biological
VIR-1388 is given by subcutaneous injection
PlaceboBiological
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 group | Role | What they receive |
|---|---|---|
| VIR-1388, 5×10^4 ffu | Experimental | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. Receives: Biological: VIR-1388 |
| VIR-1388, 5×10^5 ffu | Experimental | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. Receives: Biological: VIR-1388 |
| VIR-1388, 5×10^6 ffu | Experimental | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. Receives: Biological: VIR-1388 |
| Placebo | Placebo comparator | Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of unsolicited, treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), new-onset chronic diseases (NOCDs) and medically attended adverse events (MAAEs)
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
Measured: 12 months
Incidence of solicited local site and systemic reactogenicity events
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
Measured: 14 days after administration of each dose
Secondary outcomes (6)
Frequency of HIV-1 Mfuse1-specific CD4 T cells
As measured by intracellular cytokine staining (ICS) and flow cytometry
Measured: 12 months
Frequency of HIV-1 Mfuse1-specific CD8 T cells
As measured by intracellular cytokine staining (ICS) and flow cytometry
Measured: 12 months
Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells
As determined by flow cytometry analysis
Measured: 12 months
Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells
As determined by flow cytometry analysis
Measured: 12 months
Number of participants with VIR-1388 vector viremia in plasma
Detected by quantitative polymerase chain reaction(qPCR) of plasma
Measured: 12 months
Number of participants with VIR-1388 vector shedding in saliva and urine
Detected by quantitative polymerase chain reaction(qPCR) of saliva and urine
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start19 Sep 2023
- Primary completion19 Sep 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854381
- Sponsor's protocol ID
- HVTN 142/VIR-1388-V101
- Other IDs
- 5UM1AI068614-18
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05854381
- Acronym / sponsor ID
- HVTN 142/VIR-1388-V101
- Conditions
- HIV I Infection
- Keywords
- HIV, Vaccine, CMV, Cytomegalovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VIR-1388, 5×10^4 ffu | Experimental | Biological: VIR-1388Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
| VIR-1388, 5×10^5 ffu | Experimental | Biological: VIR-1388Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
| VIR-1388, 5×10^6 ffu | Experimental | Biological: VIR-1388Study intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
| Placebo | Placebo comparator | Biological: PlaceboStudy intervention will be administered at Day 1 and Day 85 via subcutaneous (SC) injections. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIR-1388VIR-1388 is given by subcutaneous injection | Biological | VIR-1388, 5×10^4 ffu, VIR-1388, 5×10^5 ffu, VIR-1388, 5×10^6 ffu |
| PlaceboThe 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 | Biological | Placebo |
Primary outcome
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
6 secondary outcomes
Frequency of HIV-1 Mfuse1-specific CD4 T cells
Time frame: 12 months
Frequency of HIV-1 Mfuse1-specific CD8 T cells
Time frame: 12 months
Memory phenotype of HIV-1 Mfuse1-specific CD4 T cells
Time frame: 12 months
Memory phenotype of HIV-1 Mfuse1-specific CD8 T cells
Time frame: 12 months
Number of participants with VIR-1388 vector viremia in plasma
Time frame: 12 months
Number of participants with VIR-1388 vector shedding in saliva and urine
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIR-1388 in people with HIV I Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.