AcnePhase 2NCT07756957
Safety of the Acne mRNA Vaccine in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne
A Phase 2 study testing Acne mRNA (messenger ribonucleic acid) vaccine in people with Acne, run by Sanofi.
Trial summary
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acne
- What is being tested?
- Acne mRNA (messenger ribonucleic acid) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 19 Feb 2029
- Phase
- Phase 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 12 to 17 years on the day of the first study intervention administration
- 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 moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)
Who cannot join
- 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 study intervention components or history of life-threatening reaction to study intervention(s) or products with the same substances
- Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
- Use of any acne-affecting treatment without an appropriate wash-out period
- Any vaccine given in the 4 weeks before or after any injection of study intervention
- Previous vaccination against C. acnes with an investigational vaccine
Show all 9Show fewer
- 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 participant's potential participation in a clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
About this study
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of an Acne mRNA Vaccine Candidate in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne.
An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population.
Read more
Study details are as follows:
- Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements.
- Once the screening period has been completed, the study duration will be up to 13 months for each participant
- Participants will be invited to a long-term extension study through a separate protocol.
- Conditions
- Acne
- Being tested
- Acne mRNA (messenger ribonucleic acid) 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 (messenger ribonucleic acid) vaccineBiological
IM injection
PlaceboBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 sub-cohort - Group 1 | Experimental | 3 injections Receives: Biological: Acne mRNA (messenger ribonucleic acid) vaccine |
| Dose 1 sub-cohort - Group 2 | Placebo comparator | 3 injections Receives: Biological: Placebo |
| Dose 2 sub-cohort - Group 3 | Experimental | 3 injections Receives: Biological: Acne mRNA (messenger ribonucleic acid) vaccine |
| Dose 2 sub-cohort - Group 4 | Placebo comparator | 3 injections Receives: Biological: Placebo |
| Dose 3 sub-cohort - Group 5 | Experimental | 3 injections Receives: Biological: Acne mRNA (messenger ribonucleic acid) vaccine |
| Dose 3 sub-cohort - Group 6 | Placebo comparator | 3 injections Receives: Biological: Placebo |
| Dose 1 main cohort - Group 7 | Experimental | 3 injections Receives: Biological: Acne mRNA (messenger ribonucleic acid) vaccine |
| Dose 2 main cohort - Group 8 | Experimental | 3 injections Receives: Biological: Acne mRNA (messenger ribonucleic acid) vaccine |
| Dose 3 main cohort - Group 9 | Experimental | 3 injections Receives: Biological: Acne mRNA (messenger ribonucleic acid) vaccine |
| Main cohort - Group 10 | Placebo comparator | 3 injections Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsolicited systemic AEs (Adverse Events)
Presence of unsolicited systemic adverse events (AEs) reported
Measured: 30 minutes after each injection
Solicited injection site and systemic adverse reactions
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])
Measured: 8 days, including the day of each injection
Unsolicited AEs
Presence of unsolicited adverse events (AEs) reported
Measured: 28 days, including the day of each injection
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Measured: Up to 2 months after last injection
Out-of-range biological test results (including shift from baseline values)
Measured: Within 8 days after each injection, including the day of injection
Secondary outcomes (5)
Percentage change from baseline in total number of acne lesions on the face
Measured: At 2 months after last injection
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Measured: Up to 13 months
Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face
Measured: At 1 month after first injection until 9 months after last injection
Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face
Measured: At 1 month after first injection until 9 months after last injection
Absolute and percentage change from baseline in total number of acne lesions on the face
Measured: At 1 month after first injection until 9 months after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion19 Jul 2028 (estimated)
- Study completion19 Feb 2029 (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 SanofiThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756957
- Sponsor's protocol ID
- VBE21128
- Other IDs
- U1111-1334-7693
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- 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 18 Sep 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 of an Acne mRNA Vaccine Candidate in Adolescents 12 to 17 Years of Age With Moderate to Severe Acne
- ClinicalTrials.gov ID
- NCT07756957
- Acronym / sponsor ID
- VBE21128
- Conditions
- Acne
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 19 Jul 2028 (estimated)
- Study completion
- 19 Feb 2029 (estimated)
- First posted
- 11 Aug 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.
The purpose of this study is to assess the safety profile of intramuscular injections of the Acne mRNA vaccine at 3 dose levels compared with placebo in 12 to 17 years old participants with moderate to severe acne.
An early safety data review (ESDR) will be conducted after each subcohort has completed an injection round; enrollment of the next higher dose level subcohort or progression of a subcohort to the subsequent injection round will only proceed if no safety concerns are identified. This sequential process will allow a cautious approach to vaccine injection in the adolescent population.
Study details are as follows:
- Before being enrolled in the study, participants complete a 4-week (ie, 1-month) screening period during which they will be called over the telephone approximately in the middle of the screening period to check they are not using prohibited medications and to remind them about the facial hygiene requirements.
- Once the screening period has been completed, the study duration will be up to 13 months for each participant
- Participants will be invited to a long-term extension study through a separate protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Dose 1 sub-cohort - Group 1 | Experimental | Biological: Acne mRNA (messenger ribonucleic acid) vaccine3 injections |
| Dose 1 sub-cohort - Group 2 | Placebo comparator | Biological: Placebo3 injections |
| Dose 2 sub-cohort - Group 3 | Experimental | Biological: Acne mRNA (messenger ribonucleic acid) vaccine3 injections |
| Dose 2 sub-cohort - Group 4 | Placebo comparator | Biological: Placebo3 injections |
| Dose 3 sub-cohort - Group 5 | Experimental | Biological: Acne mRNA (messenger ribonucleic acid) vaccine3 injections |
| Dose 3 sub-cohort - Group 6 | Placebo comparator | Biological: Placebo3 injections |
| Dose 1 main cohort - Group 7 | Experimental | Biological: Acne mRNA (messenger ribonucleic acid) vaccine3 injections |
| Dose 2 main cohort - Group 8 | Experimental | Biological: Acne mRNA (messenger ribonucleic acid) vaccine3 injections |
| Dose 3 main cohort - Group 9 | Experimental | Biological: Acne mRNA (messenger ribonucleic acid) vaccine3 injections |
| Main cohort - Group 10 | Placebo comparator | Biological: Placebo3 injections |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 12 to 17 years on the day of the first study intervention administration
- 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 moderate or severe facial acne vulgaris with Investigator's Global Assessment (IGA) score of Moderate or Severe (grade 3 or grade 4 on the 5-grade IGA scale) and ≥ 25 non-inflammatory lesions (ie, open and closed comedones) and ≥ 20 inflammatory lesions (ie, papules and pustules) and ≤ 2 nodulocystic lesions (ie, nodules and cysts)
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 study intervention components or history of life-threatening reaction to study intervention(s) or products with the same substances
- Active nodulocystic acne, acne conglobate, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica)
- Use of any acne-affecting treatment without an appropriate wash-out period
- Any vaccine given in the 4 weeks before or after any injection of study intervention
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 (messenger ribonucleic acid) vaccineIM injection | Biological | Dose 1 main cohort - Group 7, Dose 1 sub-cohort - Group 1, Dose 2 main cohort - Group 8, Dose 2 sub-cohort - Group 3, Dose 3 main cohort - Group 9, Dose 3 sub-cohort - Group 5 |
| PlaceboIM injection | Biological | Dose 1 sub-cohort - Group 2, Dose 2 sub-cohort - Group 4, Dose 3 sub-cohort - Group 6, Main cohort - Group 10 |
Primary outcome
Unsolicited systemic AEs (Adverse Events)
Time frame: 30 minutes after each injection
Presence of unsolicited systemic adverse events (AEs) reported
Solicited injection site and systemic adverse reactions
Time frame: 8 days, including the day of each injection
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])
Unsolicited AEs
Time frame: 28 days, including the day of each injection
Presence of unsolicited adverse events (AEs) reported
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Time frame: Up to 2 months after last injection
Presence of SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Out-of-range biological test results (including shift from baseline values)
Time frame: Within 8 days after each injection, including the day of injection
5 secondary outcomes
Percentage change from baseline in total number of acne lesions on the face
Time frame: At 2 months after last injection
SAEs (Serious Adverse Events), MAAEs (Medically Attended Adverse Event), AESIs (Adverse Event of Special Interest) and AEs (Adverse Events) leading to study discontinuation
Time frame: Up to 13 months
Absolute and percentage change from baseline in the number of inflammatory acne lesions on the face
Time frame: At 1 month after first injection until 9 months after last injection
Absolute and percentage change from baseline in the number of non- inflammatory acne lesions on the face
Time frame: At 1 month after first injection until 9 months after last injection
Absolute and percentage change from baseline in total number of acne lesions on the face
Time frame: At 1 month after first injection until 9 months after last injection
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 18 Sep 2026.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acne mRNA (messenger ribonucleic acid) vaccine in people with Acne, run by Sanofi.
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 3 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: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Unsolicited systemic AEs (Adverse Events) (time frame: 30 minutes after each injection). The study lists 5 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 18 Sep 2026.