AcnePhase 1/2NCT07013747
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
A Phase 1/2 study testing Acne mRNA vaccine in people with Acne, run by Sanofi Pasteur, a Sanofi Company at 4 sites in United States.
Trial summary
The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne
- What is being tested?
- Acne mRNA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Jul 2025to 13 Mar 2030
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
- Clinical diagnosis of mild facial acne vulgaris with:
- IGA score of mild (grade 2 on the 5-grade IGA scale) AND
- between 10 to 24 non-inflammatory lesions (ie, open and closed comedones) AND
- between 5 to 19 inflammatory lesions (ie, papules and pustules) AND
- no nodulocystic lesions (ie, nodules and cysts)
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID 19) vaccine
- Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
- Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
- Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection
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- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
United States4 sites, 4 recruiting
- Recruiting
Moore Clinical Research - Brandon- Site Number : 8400007
Brandon, Florida, 33511
- Recruiting
Encino Research Center- Site Number : 8400008
Encino, California, 91436
- Recruiting
Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
Jacksonville, Florida, 32216
- Recruiting
DelRicht Research- Site Number : 8400003
New Orleans, Louisiana, 70115
About this study
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne
The purpose of the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.
- Conditions
- Acne
- Being tested
- Acne mRNA vaccine, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acne mRNA vaccineBiological
Pharmaceutical form: suspension for injection Route of administration: intramuscular
PlaceboOther
Pharmaceutical form: liquid solution for injection Route of administration: intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Cohort Arm 1 | Experimental | Participants will receive 2 Acne mRNA Vaccine injections Receives: Biological: Acne mRNA vaccine |
| Sentinel Cohort Arm 2 | Placebo comparator | Participants will receive 2 Placebo injections Receives: Other: Placebo |
| Main Cohort Arm 1 | Experimental | Participants will receive 2 Acne mRNA Vaccine injections Receives: Biological: Acne mRNA vaccine |
| Main Cohort Arm 2 | Placebo comparator | Participants will receive 2 Placebo injections Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
Measured: In 30 minutes after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
pre-listed in the participant diary [PDi] and in the case report form [CRF]
Measured: Up to 7 days after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
Measured: Up to 28 days after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
Measured: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
Measured: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
Presence of all SAEs
Measured: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
Presence of out-of-range biological test results (including shift from baseline values)
Measured: Through 7 days after administration (Day 08)
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
Measured: At 2 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
Measured: At 2 months post last administration
Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Presence of all SAEs and AESIs
Measured: Up to 38 months after first administration
Secondary outcomes (12)
Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers
Measured: From baseline (Day 01) to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face
Measured: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
Measured: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
Measured: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
Measured: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
Measured: In 30 minutes after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
pre-listed in the participant diary [PDi] and in the case report form [CRF]
Measured: Up to 7 days after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
Measured: Up to 28 days after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
Measured: Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
Measured: Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
Presence of all SAEs
Measured: Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
Presence of out-of-range biological test results (including shift from baseline values)
Measured: Through 7 days after administration (Day 08)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start3 Jul 2025
- Primary completion19 Jun 2029 (estimated)
- Study completion13 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study will consist of a Core Study followed by an optional Long-Term Extension. Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013747
- Sponsor's protocol ID
- VBE00009
- Other IDs
- 2025-520677-39, U1111-1315-4645, 2025
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Efficacy and Immunogenicity of an Acne mRNA Vaccine Candidate in Participants With Mild Acne
- ClinicalTrials.gov ID
- NCT07013747
- Acronym / sponsor ID
- VBE00009
- Conditions
- Acne
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 19 Jun 2029 (estimated)
- Study completion
- 13 Mar 2030 (estimated)
- First posted
- 10 Jun 2025 (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 the VBE00009 study is to evaluate the safety, efficacy and immunogenicity of 2 administrations of the Acne mRNA vaccine candidate at single dose level in participants aged 18 to 45 years with mild acne. This study will consist of a Core Study followed by an optional Long-Term Extension (LTE). Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long term effects of the vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study will consist of a Core Study followed by an optional Long-Term Extension. Core Study will include a Sentinel Cohort and a Main Cohort, with the Sentinel Cohort assessing the safety in a stepwise manner.
| Arm | Type | Receives |
|---|---|---|
| Sentinel Cohort Arm 1 | Experimental | Biological: Acne mRNA vaccineParticipants will receive 2 Acne mRNA Vaccine injections |
| Sentinel Cohort Arm 2 | Placebo comparator | Other: PlaceboParticipants will receive 2 Placebo injections |
| Main Cohort Arm 1 | Experimental | Biological: Acne mRNA vaccineParticipants will receive 2 Acne mRNA Vaccine injections |
| Main Cohort Arm 2 | Placebo comparator | Other: PlaceboParticipants will receive 2 Placebo injections |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests as judged by the investigator
- Clinical diagnosis of mild facial acne vulgaris with:
Key exclusion criteria (9 listed)
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the first study intervention administration; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA coronavirus disease 2019 (COVID 19) vaccine
- Previous history of or undergoing (suspected or confirmed) myocarditis and/or pericarditis and/or myopericarditis
- Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy
- Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection
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 |
|---|---|---|
| Acne mRNA vaccinePharmaceutical form: suspension for injection Route of administration: intramuscular | Biological | Main Cohort Arm 1, Sentinel Cohort Arm 1 |
| PlaceboPharmaceutical form: liquid solution for injection Route of administration: intramuscular | Other | Main Cohort Arm 2, Sentinel Cohort Arm 2 |
Primary outcome
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
Time frame: In 30 minutes after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
Time frame: Up to 7 days after each administration
pre-listed in the participant diary [PDi] and in the case report form [CRF]
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
Time frame: Up to 28 days after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
Time frame: Up to 6 months after each administration
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
Time frame: Up to 6 months after each administration
Presence of all SAEs
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
Time frame: Through 7 days after administration (Day 08)
Presence of out-of-range biological test results (including shift from baseline values)
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
Time frame: At 2 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
Time frame: At 2 months post last administration
Long-Term Extension - Sentinel and Main Cohort Arm 1 and 2: Number of participants with serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: Up to 38 months after first administration
Presence of all SAEs and AESIs
12 secondary outcomes
Core Study - Sentinel and Main Cohort Arm 1 and 2: Vaccine-antigen-specific serum antibody titers
Time frame: From baseline (Day 01) to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of inflammatory acne lesions on face
Time frame: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of inflammatory acne lesions on face
Time frame: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Absolute change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
Time frame: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Percentage change from baseline (Day 01) in the number of non-inflammatory acne lesions on face
Time frame: At 1 month post first administration to 6 months post last administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs)
Time frame: In 30 minutes after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with solicited injection site and systemic reactions
Time frame: Up to 7 days after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with unsolicited AEs reported
Time frame: Up to 28 days after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with medically attended adverse events (MAAEs)
Time frame: Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with AEs of special interest (AESIs)
Time frame: Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with serious AEs (SAEs)
Time frame: Up to 6 months after each administration
Core Study - Main Cohort Arm 1 and 2: Number of participants with out-of-range biological test results
Time frame: Through 7 days after administration (Day 08)
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 9 Jul 2026.
- VBE00009 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Trial Transparency email recommended (Toll free for US & Canada) contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acne mRNA vaccine in people with Acne, run by Sanofi Pasteur, a Sanofi Company at 4 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Study - Sentinel Cohort Arm 1 and 2: Number of participants with unsolicited systemic adverse events (AEs) (time frame: In 30 minutes after each administration). The study lists 10 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 9 Jul 2026.