A Phase 1/2 interventional study of Acne mRNA vaccine and Placebo in Acne, sponsored by Sanofi Pasteur, a Sanofi Company. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 1/2, Interventional, and Treatment
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 228 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of mild facial acne vulgaris with:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 2 Acne mRNA Vaccine injections
Biological: Acne mRNA vaccine
Participants will receive 2 Placebo injections
Other: Placebo
Participants will receive 2 Acne mRNA Vaccine injections
Biological: Acne mRNA vaccine
Participants will receive 2 Placebo injections
Other: Placebo
Pharmaceutical form: suspension for injection Route of administration: intramuscular
Pharmaceutical form: liquid solution for injection Route of administration: intramuscular
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
pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
Time frame: Up to 7 days after each administration
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)
Presence of all SAEs
Time frame: 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)
Time frame: 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
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)
Presence of all SAEs and AESIs
Time frame: Up to 38 months after first administration
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
pre-listed in the participant diary \[PDi\] and in the case report form \[CRF\]
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)
Presence of all 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
Presence of out-of-range biological test results (including shift from baseline values)
Time frame: Through 7 days after administration (Day 08)
Plan to share: 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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Sanofi Pasteur, a Sanofi Company →