Cytomegalovirus (CMV)Phase 1NCT07801456
A Clinical Study to Evaluate the Safety and Immunogenicity of a Higher Dose of the Study Vaccine, VIR-1388, in HCMV-seropositive Adult Participants Without HIV
A Phase 1 study testing VIR-1388 in people with Cytomegalovirus (CMV) and HIV (Human Immunodeficiency Virus), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
This study is to test an experimental HIV Vaccine. About 12 participants, aged 18-55 years and who already have cytomegalovirus (CMV) will take part in this study. Participants will come to the clinic for scheduled visits about 21 times over 12 months. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus (CMV), HIV (Human Immunodeficiency Virus)
- 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
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2026to 2 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- At least 18 years old at screening and up to 55 years old on day of enrollment.
- Access to a participating clinical research site and willingness to be followed for the planned duration of the study.
- Demonstrates an understanding of the study and is able and willing to provide informed consent.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
- In good general health according to the clinical judgment of the site investigator.
- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgment of the site investigator.
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- Willing to not donate blood, sperm, or other tissues until after the last required protocol clinic visit.
- CMV seropositive
- Systolic blood pressure of 90 to < 140 mmHg and diastolic blood pressure of 50 to < 90 mmHg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mmHg systolic and 90 mmHg diastolic. A single measurement ≥ 160 systolic mmHg or 100 mmHg diastolic during the current study evaluation is exclusionary.
- Male volunteers with partners of pregnancy potential must agree to have their partners use contraception through the end of the study.
- Women who are not of pregnancy potential or male volunteers. Any individual may be enrolled if they are not of pregnancy potential
- Willingness to receive HIV test results.
- Hemogram/complete blood count (CBC)
- Hemoglobin:
- ≥ 11.0 g/dL for women
- ≥ 13.0 g/dL for men
- White blood cell (WBC) count = 2,500 to 12,000 cells/mm3 (WBC over 12,000/mm3 is not exclusionary if further evaluation shows general good health and if approval is granted).
- Platelets = 125,000 to 550,000 cells/mm3.
- Alanine aminotransferase (ALT) < 1.25 × upper limit of institutional reference range
- Aspartate aminotransferase (AST) (< 1.25 × upper limit of normal (ULN)) based on institutional normal range
- Alkaline phosphatase (ALP) ≤ 1.1 × ULN based on institutional normal range
- Serum creatinine ≤ 1.1 × ULN based on institutional normal range
- Total measured serum calcium level >8.5 mg/dL.
- Direct bilirubin levels < 7.7 mic mol/L (0.45mg/dL) and total bilirubin < 22.5 mic mol/L (1.3 mg/dL) (volunteers known to have Gilbert's Syndrome with an abnormal total bilirubin are not excluded)
- Gamma-glutamyl transferase (GGT) < 1.1 × ULN based on institutional normal range
- Negative HIV-1 and -2 blood test
- Negative hepatitis B surface antigen (HBsAg).
- Negative anti-hepatitis C virus (HCV) antibodies or negative HCV nucleic acid test if the anti-HCV is positive.
- All volunteers must use condoms for the duration of the study. ALL volunteers regardless of sex, reproductive status, or sex of partner(s) must use condoms as a barrier method to mitigate against potential VIR-1388 transmission to their partner(s) (in the event that shedding occurs).
Who cannot join
- Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires approval.
- Of pregnancy potential, pregnant, or breastfeeding.
- Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life of more than 7 days (or unknown half-life) within the past year, approval is required for enrollment.
- Use of (val)acyclovir, (val)ganciclovir, letermovir, foscarnet, or another antiviral with anti-CMV activity within 30 days prior to the first vaccination. Chronic or suppressive use of (val)acyclovir is not permitted. Short-term use (defined as less than 10 days) of (val)acyclovir is permitted at standard doses provided there have been no more than 2 courses of (val)acyclovir over the last 6 months. Topical use is not exclusionary.
- Investigational HIV vaccine(s) or CMV-based vaccine received in prior vaccine trials. For volunteers who have received control/placebo in a TB vaccine trial, eligibility will be determined on a case-by-case basis.
- Investigational vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be considered for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, eligibility will be determined on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined on a case-by-case basis.
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- Receipt of any of the following within 4 weeks prior to enrollment:
- Live replicating vaccine
- Any mRNA-based vaccine with FDA licensure, FDA Emergency Use Authorization (EUA), or WHO Emergency Use Listing (EUL)
- ACAM2000 vaccine > 28 days prior with a vaccination scab still present
- Receipt of any vaccines that are not covered in the exclusion criteria #5-7 within 14 days prior to enrollment. Please note this includes replication incompetent vaccines such as the Jynneos vaccine for the prevention of mpox (formerly known as monkeypox) disease.
- Initiation of antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires approval.
- Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as glucocorticoid use, ≥ prednisone 10 mg/day within 3 months prior to enrollment.
- Autoimmune disease, current or history of (not exclusionary: mild, well controlled psoriasis).
- Asthma is exclusionary if the volunteer has ANY of the following:
- Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year; OR
- Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or coexisting conditions unrelated to asthma); OR
- Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA]); OR
- Uses more than 1 medication for maintenance therapy daily. Combination inhalers such as LABA + inhaled corticosteroids are considered one medication. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires approval.
- Asplenia or functional asplenia.
- Active duty and reserve US military personnel.
- Any other chronic or clinically significant condition that, in the clinical judgment of the investigator, would jeopardize the safety or rights of the study participant, including but not limited to: clinically significant forms of substance use or alcohol use disorder(s), serious psychiatric disorders, any suicide attempt within the past 1 year (if between 1 and 2 years, consult for approval), or cancer that, in the clinical judgment of the site investigator, has potential for recurrence (excluding basal cell carcinoma).
- Diabetes mellitus (DM) type 1 or type 2. Not exclusionary: Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with type 2 DM that is well controlled on hypoglycemic agent(s) may be considered on a case-by-case basis, provided that the HgbA1c is ≤ 8% within the last 6 months (sites may draw these at screening).
- Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) diagnosed by a clinician, or current therapeutic systemic anticoagulation for any clinical indication. Systemic anticoagulation includes oral anticoagulants (eg, warfarin, dabigatran, rivaroxaban, apixaban, edoxaban), injectable anticoagulants (eg, low-molecular-weight heparin, unfractionated heparin), or other similar prescription anticoagulants. For other conditions previously treated with systemic anticoagulants for any therapeutic (non-prophylactic) indication, eligibility may be considered on a case-by-case basis.
- Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of intravenous drug use or substantial difficulty with previous blood draws.
- Seizure disorder: History of seizure(s) within past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
- History of serious reaction (eg, hypersensitivity, anaphylaxis) to any related vaccine or component of the study-vaccine regimen (eg, Histidine, Trehalose dihydrate).
- History of angioedema: Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- History of generalized urticaria within the past year.
- Have intimate contact with immunocompromised individuals. Intimate contacts are defined as individuals who come into contact with the study participant through sexual relations or mucosal kissing, or who share personal items that may be in contact with the participant's body fluids. In this context, immunocompromised partners are defined as individuals who would have anticipated poor outcomes with a primary CMV infection in the opinion of the site investigator (eg, transplant recipient).
- Have intimate contact with a pregnant partner or a partner planning to become pregnant during the course of the study.
- Healthcare provider who routinely comes into unmasked contact with immunosuppressed patients or pregnant women.
- Person with primary caregiving interactions with children less than 2 years of age, as determined by the site investigator.
- Childcare worker who routinely provides care to children under the age of 2 years old.
- A volunteer with a history of a potential immune-mediated medical condition (PIMMC), either active or remote. Specific examples are listed in Appendix F (AESI index). Not exclusionary: (1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms; (2) mild psoriasis or other mild, uncomplicated, localized, or dermatologic condition that does not require ongoing systemic treatment; (3) remote history (>10 years ago) of Kawasaki disease without sequelae; (4) celiac disease well controlled for 6 months with diet only.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Alabama CRS (Site # 31788)
Birmingham, Alabama, 35222
Beth Israel Deaconess Medical Center / BIDMC VCRS (Site #32077)
Boston, Massachusetts, 02215
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Higher Dose of the HCMV-HIV Vaccine Candidate VIR-1388, in HCMV-seropositive Adult Participants Without HIV
This study is to test an experimental HIV Vaccine. About 12 participants, aged 18-55 years and who already have cytomegalovirus (CMV) will take part in this study. Participants will come to the clinic for scheduled visits about 21 times over 12 months.
- Being tested
- VIR-1388, Placebo
- Keywords
- Vaccine, HIV Vaccine, Healthy Participants
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-1388Biological
Treatment 1 (T1): VIR-1388, 6.9 × 10^7 ffu to be administered as three 1 mL subcutaneous (SC) injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3).
PlaceboBiological
Control 1 (C1): Placebo for VIR-1388 [HT Diluent Placebo] to be administered as three 1 mL SC injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3).
| Study group | Role | What they receive |
|---|---|---|
| VIR-1388 | Experimental | VIR-1388 will be administered subcutaneously at study week 0 (month 0) and week 12 (month 3). Receives: Biological: VIR-1388 |
| Placebo | Placebo comparator | Placebo will be administered subcutaneously at study week 0 (month 0) and week 12 (month 3). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Local Reactions
Local reactogenicity signs and symptoms will be collected for a minimum of 14 days following receipt of any study product
Measured: Day of vaccination through 14 days after each vaccination
Number of Participants with Systemic Reactions
Systemic reactogenicity signs and symptoms will be collected for a minimum of 14 days following receipt of any study product
Measured: Day of vaccination through 14 days after each vaccination
Number of Participants with Serious Adverse Events (SAEs)
Measured: Throughout the study, through 40 weeks after the last study product administration
Number of Participants with Medically Attended Adverse Events (MAAEs)
Measured: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events of Special Interest (AESIs)
Measured: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events Leading to Early Study Withdrawal
Measured: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Product
Measured: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events
Measured: Day of vaccination through 30 days after each vaccination
Magnitude of HIV-1 Mfuse1-Specific CD4 T-Cell Responses
Level of CD4 T-cell responses to HIV-1 Mfuse1, which contains parts of Gag, Pol, and Nef. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
Measured: Baseline and 4 and 8 weeks after each vaccination
Magnitude of HIV-1 Mfuse1-Specific CD8 T-Cell Responses
Level of CD8 T-cell responses to HIV-1 Mfuse1, which contains parts of Gag, Pol, and Nef. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
Measured: Baseline and 4 and 8 weeks after each vaccination
Function of HIV-1 Mfuse1-Specific CD4 T-Cell Responses
Function of CD4 T-cell responses to HIV-1 Mfuse1, as measured using intracellular cytokine staining (ICS) and flow cytometry
Measured: Baseline and 4 and 8 weeks after each vaccination
Function of HIV-1 Mfuse1-Specific CD8 T-Cell Responses
Function of CD8 T-cell responses to HIV-1 Mfuse1, as measured using intracellular cytokine staining (ICS) and flow cytometry
Measured: Baseline and 4 and 8 weeks after each vaccination
Phenotypic Profile of HIV-1 Mfuse1-Specific CD4 T-Cell Responses
Characteristics of CD4 T cells that respond to HIV-1 Mfuse1, as measured using flow cytometry
Measured: Baseline and 4 and 8 weeks after each vaccination
Phenotypic Profile of HIV-1 Mfuse1-Specific CD8 T-Cell Responses
Characteristics of CD8 T cells that respond to HIV-1 Mfuse1, as measured using flow cytometry
Measured: Baseline and 4 and 8 weeks after each vaccination
Secondary outcomes (9)
Number of Participants With VIR-1388 Detected in Plasma
Detection of VIR-1388 viremia by quantitative polymerase chain reaction (qPCR) in plasma
Measured: Vaccination Day 1 through Study Day 365
Number of Participants With VIR-1388 Detected in Saliva
Detection of VIR-1388 shedding by qPCR in saliva
Measured: Vaccination Day 1 through Study Day 365
Number of Participants With VIR-1388 Detected in Urine
Detection of VIR-1388 shedding by qPCR in urine
Measured: Vaccination Day 1 through Study Day 365
Magnitude of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints responses to VIR-1388derived HIV-1 Mfuse1 (containing portions of Gag, Pol and Nef)
Level of CD4 T-cell responses to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
Measured: Additional timepoints during the study, including 2 weeks after each vaccination, and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Magnitude of HIV-1 Mfuse1-Specific CD8 T-Cell Responses at Additional Timepoints
Level of CD8 T-cell responses to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
Measured: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Function of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints
Function of CD4 T-cell responses to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay
Measured: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Function of HIV-1 Mfuse1-Specific CD8 T-Cell Responses at Additional Timepoints
Function of CD8 T-cell responses to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay
Measured: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Phenotypic Profile of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints
Characteristics of CD4 T cells that respond to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay
Measured: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination.
Phenotypic Profile of HIV-1 Mfuse1-Specific CD8 T-Cell Responses at Additional Timepoints
Characteristics of CD8 T cells that respond to HIV-1 Mfuse1 at additional timepoints in participants who have a response in the primary assay
Measured: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV)Studies 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
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801456
- Sponsor's protocol ID
- HVTN 146
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Higher Dose of the HCMV-HIV Vaccine Candidate VIR-1388, in HCMV-seropositive Adult Participants Without HIV
- ClinicalTrials.gov ID
- NCT07801456
- Acronym / sponsor ID
- HVTN 146
- Keywords
- Vaccine, HIV Vaccine, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 3 Sep 2026 (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.
This study is to test an experimental HIV Vaccine. About 12 participants, aged 18-55 years and who already have cytomegalovirus (CMV) will take part in this study. Participants will come to the clinic for scheduled visits about 21 times over 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIR-1388 | Experimental | Biological: VIR-1388VIR-1388 will be administered subcutaneously at study week 0 (month 0) and week 12 (month 3). |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo will be administered subcutaneously at study week 0 (month 0) and week 12 (month 3). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (29 listed)
- At least 18 years old at screening and up to 55 years old on day of enrollment.
- Access to a participating clinical research site and willingness to be followed for the planned duration of the study.
- Demonstrates an understanding of the study and is able and willing to provide informed consent.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
- In good general health according to the clinical judgment of the site investigator.
Key exclusion criteria (35 listed)
- Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires approval.
- Of pregnancy potential, pregnant, or breastfeeding.
- Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life of more than 7 days (or unknown half-life) within the past year, approval is required for enrollment.
- Use of (val)acyclovir, (val)ganciclovir, letermovir, foscarnet, or another antiviral with anti-CMV activity within 30 days prior to the first vaccination. Chronic or suppressive use of (val)acyclovir is not permitted. Short-term use (defined as less than 10 days) of (val)acyclovir is permitted at standard doses provided there have been no more than 2 courses of (val)acyclovir over the last 6 months. Topical use is not exclusionary.
- Investigational HIV vaccine(s) or CMV-based vaccine received in prior vaccine trials. For volunteers who have received control/placebo in a TB vaccine trial, eligibility will be determined on a case-by-case basis.
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-1388Treatment 1 (T1): VIR-1388, 6.9 × 10^7 ffu to be administered as three 1 mL subcutaneous (SC) injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3). | Biological | VIR-1388 |
| PlaceboControl 1 (C1): Placebo for VIR-1388 [HT Diluent Placebo] to be administered as three 1 mL SC injections (total dose = 3 mL) at week 0 (month 0) and week 12 (month 3). | Biological | Placebo |
Primary outcome
Number of Participants with Local Reactions
Time frame: Day of vaccination through 14 days after each vaccination
Local reactogenicity signs and symptoms will be collected for a minimum of 14 days following receipt of any study product
Number of Participants with Systemic Reactions
Time frame: Day of vaccination through 14 days after each vaccination
Systemic reactogenicity signs and symptoms will be collected for a minimum of 14 days following receipt of any study product
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Throughout the study, through 40 weeks after the last study product administration
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events Leading to Early Study Withdrawal
Time frame: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Product
Time frame: Throughout the study and for 40 weeks after the last study product administration
Number of Participants with Adverse Events
Time frame: Day of vaccination through 30 days after each vaccination
Magnitude of HIV-1 Mfuse1-Specific CD4 T-Cell Responses
Time frame: Baseline and 4 and 8 weeks after each vaccination
Level of CD4 T-cell responses to HIV-1 Mfuse1, which contains parts of Gag, Pol, and Nef. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
Magnitude of HIV-1 Mfuse1-Specific CD8 T-Cell Responses
Time frame: Baseline and 4 and 8 weeks after each vaccination
Level of CD8 T-cell responses to HIV-1 Mfuse1, which contains parts of Gag, Pol, and Nef. Responses will be measured using intracellular cytokine staining (ICS) and flow cytometry.
Function of HIV-1 Mfuse1-Specific CD4 T-Cell Responses
Time frame: Baseline and 4 and 8 weeks after each vaccination
Function of CD4 T-cell responses to HIV-1 Mfuse1, as measured using intracellular cytokine staining (ICS) and flow cytometry
Function of HIV-1 Mfuse1-Specific CD8 T-Cell Responses
Time frame: Baseline and 4 and 8 weeks after each vaccination
Function of CD8 T-cell responses to HIV-1 Mfuse1, as measured using intracellular cytokine staining (ICS) and flow cytometry
Phenotypic Profile of HIV-1 Mfuse1-Specific CD4 T-Cell Responses
Time frame: Baseline and 4 and 8 weeks after each vaccination
Characteristics of CD4 T cells that respond to HIV-1 Mfuse1, as measured using flow cytometry
Phenotypic Profile of HIV-1 Mfuse1-Specific CD8 T-Cell Responses
Time frame: Baseline and 4 and 8 weeks after each vaccination
Characteristics of CD8 T cells that respond to HIV-1 Mfuse1, as measured using flow cytometry
9 secondary outcomes
Number of Participants With VIR-1388 Detected in Plasma
Time frame: Vaccination Day 1 through Study Day 365
Number of Participants With VIR-1388 Detected in Saliva
Time frame: Vaccination Day 1 through Study Day 365
Number of Participants With VIR-1388 Detected in Urine
Time frame: Vaccination Day 1 through Study Day 365
Magnitude of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints responses to VIR-1388derived HIV-1 Mfuse1 (containing portions of Gag, Pol and Nef)
Time frame: Additional timepoints during the study, including 2 weeks after each vaccination, and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Magnitude of HIV-1 Mfuse1-Specific CD8 T-Cell Responses at Additional Timepoints
Time frame: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Function of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints
Time frame: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Function of HIV-1 Mfuse1-Specific CD8 T-Cell Responses at Additional Timepoints
Time frame: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Phenotypic Profile of HIV-1 Mfuse1-Specific CD4 T-Cell Responses at Additional Timepoints
Time frame: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination.
Phenotypic Profile of HIV-1 Mfuse1-Specific CD8 T-Cell Responses at Additional Timepoints
Time frame: Additional timepoints during the study, including 2 weeks after each vaccination and 12 weeks, 24 weeks, and 40 weeks after second vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: 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 Cytomegalovirus (CMV) and HIV (Human Immunodeficiency Virus), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
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 29 inclusion and 35 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants with Local Reactions (time frame: Day of vaccination through 14 days after each vaccination). The study lists 14 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 Sep 2026.