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Healthy AdultsEarly Phase 1SOLVE-01NCT07605520

An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Participants Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines.

A Early Phase 1 study testing CD40.RBDv vaccine adjuvanted with Hiltonol®, CD40.Pan.CoV vaccine adjuvanted with Hiltonol® and Comirnaty® vaccine in people with Healthy Adults, run by ANRS, Emerging Infectious Diseases at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The SOLVE-01 trial is a study evaluating four SARS-CoV-2 vaccines as booster injections: two experimental vaccines (CD40.RBDv and CD40.Pan.CoV, both combined with the Hiltonol® adjuvant) and two authorised vaccines (Comirnaty® and NuvaxovidTM). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adults
What is being tested?
CD40.RBDv vaccine adjuvanted with Hiltonol®, CD40.Pan.CoV vaccine adjuvanted with Hiltonol® and Comirnaty® vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
3 sitesin 2 countries
Study dates
13 May 2026to Dec 2028
Phase
Early 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female subjects aged 18 to 65 years inclusive at the time of the screening visit
  • Having received at least two doses of COVID-19 mRNA vaccines in the past with the last dose received more than 6 months prior to IMP administration in the trial
  • In healthy condition or with stable health status which is defined as an existing disease that has not required a significant change in treatment or hospitalization for worsening before enrolment, and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future.
  • For woman of childbearing potential: a negative Beta-HCG blood test measure during the screening visit, and a negative highly sensitive pregnancy urinary test the day of the vaccination visit
  • if heterosexually active female, consistently using a highly effective method of contraception with partner from at least 21 days prior to enrolment through 4 months after the IMP administration. Highly effective contraception is defined as using any of the following methods:
  • Combined hormonal contraception with inhibition of ovulation (estrogen and progesterone containing);
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  • Intrauterine device (IUD);
  • Intrauterine hormone releasing system (IUS);
  • Hormonal contraception (progesterone only);
  • Successful vasectomy in the male partner (considered successful if a participant reports that a male partner has (i) documentation of azoospermia by microscopy, or (ii) a vasectomy more than 2 years ago with no resultant pregnancy despite unprotected sexual activity post vasectomy);
  • Or not be of reproductive potential, such as having reached menopause (no menses for 1 year without an alternative medical cause) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation.
  • Agree not to seek pregnancy including through alternative methods, such as artificial insemination or in vitro fertilization until 4 months after the IMP administration.
  • Participant who was born male, if heterosexually active male, using an effective method of contraception with their partner from the IMP administration until 4 months thereafter. All male participants also agree not to donate sperm during this period.
  • Negative nasopharyngeal antigenic test for SARS-CoV-2 on the day of screening and before randomisation
  • Participant who has normal biological values:
  • Hemoglobin ≥ 11.0 g/dL for participants who were born female, ≥ 13.0 g/dL for participants who were born male;
  • White blood cell count = 3,300 to 12,000 cells/mm3;
  • Total lymphocyte count ≥ 800 cells/mm3;
  • Platelets = 125,000 to 550,000/mm3;
  • ALT, AST, and alkaline phosphatase < 1.25 times the institutional upper limit of normal;
  • Creatinine <1.1x institutional upper limit of normal of the laboratory;
  • Normal urine test: absence of glucose, protein and haemoglobin
  • Negative HIV antigen/antibody test;
  • Negative Hepatitis B surface antigen (HBsAg);
  • Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive;
  • Willingness to undertake SARS-CoV-2 testing according to study protocol, and receive SARS-CoV-2 test results
  • Willingness and availability to be followed for the planned duration of the study in one of the dedicated trial centres
  • Informed and signed written consent form before performance of any trial-related screening procedures
  • Agree to be registered in the French Health Ministry computerised file (for France only)
  • Being covered by Health Insurance (for France only)

Who cannot join

  • Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 or SARS-CoV-2 infection within the previous 28 days or having been in contact with an infected individual for the last 14 days before the inclusion visit
  • Any medical condition that could impair the immune response: clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
  • A process that would affect the immune response;
  • A process that would require medication that affects the immune response;
  • Any contraindication to repeated injections or blood draws;
  • A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period;
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  • A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
  • Any condition specifically listed among the exclusion criteria below.
  • Pregnancy or breastfeeding that is currently ongoing, or positive pregnancy test at screening visit and the day of the vaccination
  • Immunodeficiency
  • Asthma: a condition that requires active medical intervention or monitoring to avert grave danger to asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a participant who:
  • Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
  • Uses moderate/high dose inhaled corticosteroids, or
  • In the past year has either of the following: (i) Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids or (ii) Needed emergency care, urgent care, hospitalization, or intubation for asthma.
  • Diabetes type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes).
  • Thyroidectomy, or thyroid disease requiring medication during the last 12 months
  • Hypertension:
  • If a person has been diagnosed with hypertension, exclude for blood pressure that is not well controlled (well-controlled blood pressure is defined as consistently ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic). For these participants, blood pressure must be ≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic at enrolment;
  • If a person has NOT been diagnosed with hypertension, exclude for systolic blood pressure ≥ 150 mm Hg at enrolment or diastolic blood pressure ≥ 100 mm Hg at enrolment. (the measurement must be performed on a person who has been lying down for at least 5 minutes and repeat at the end of the consultation, if appropriated). Tension must be confirmed outside the clinical site to rule out hypertension.
  • Contraindication to the IMPs including hypersensitivity
  • BMI ≥ 40 kg/m2; ≤ 18 kg/m2; or BMI ≥ 35 kg/m2 with 2 or more of the following: age > 45, systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current smoker, known hyperlipidemia
  • Bleeding disorder diagnosed (e.g., coagulation factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Malignancy (Not excluded: volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
  • Asplenia: any condition resulting in the absence of a functional spleen
  • Seizure disorder: History of seizure(s) within past three years. Also excluded if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
  • History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including arrhythmia requiring medication, treatment, or clinical follow-up)
  • History of autoimmune disease
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety, or a volunteer's ability to give informed consent
  • Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
  • History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child)
  • Investigational research agents received within 30 days before IMP administration
  • Experimental vaccine(s) received within the last 5 years in a prior vaccine trial
  • Live attenuated vaccines (e.g., measles, mumps, and rubella (MMR); oral polio vaccine (OPV); varicella; yellow fever) received within 30 days before IMP administration or scheduled within 28 days after the injection scheduled within the protocol
  • Vaccines that are not live attenuated vaccines and were received within 21 days prior to IMP administration (e.g., tetanus, pneumococcal, Hepatitis A or B)
  • Blood-derived products or immunoglobulin received within 6 months before IMP administration*
  • Current anti-tuberculosis (TB) prophylaxis or therapy received within 3 months before IMP administration *
  • Allergy treatment with antigen injections within 30 days before IMP administration or that are scheduled within 14 days after IMP administration*
  • Immunosuppressive medications or immunomodulators (such as cytokines or interferons) received within last three months before IMP administration. (Not excluded: (1) corticosteroid nasal spray; [2] topical corticosteroids for mild, uncomplicated dermatitis; or (2) a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrolment) or low dose oral corticosteroids (≤10 mg prednisone/day) or corticosteroids for the treatment of immune-related adverse events*
  • Other prohibited medications: Corticosteroids > 10 mg prednisone equivalent/day (not excluded: topical preparations) *
  • Person participating in another research involving the human person or participating in another research involving the human person with an exclusion period still in progress at screening
  • Intent to participate in another study of an investigational research agent during the planned duration of the study
  • Participants who are not able to understand and to follow all required study procedures for the whole period of the study in the judgment of the investigator
  • Under tutorship (only for France), guardianship, or deprived of liberty by a juridical or administrative decision
  • Planned absence that could affect participation in the study (travel abroad, relocation, impending professional mutation...)
  • The scheduled use of these treatments up to 6 months after the injection also represents a contraindication

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Yves LEVY, Pr contact

+33(0)149814442

yves.levy@aphp.fr

Giuseppe PANTALEO, Pr contact

+41(0)213141063

Giuseppe.Pantaleo@chuv.ch

3 sites in 2 countries

France2 sites, 2 recruiting

  • Hôpital Henri Mondor

    Créteil

    Jean-Daniel LELIEVRE, Pr, jean-daniel.lelievre@aphp.fr

    Recruiting

  • CIC 1417 - Hôpital Cochin

    Paris

    Odile LAUNAY, odile.launay@aphp.fr

    Recruiting

Other trials in France

Switzerland1 site, 1 recruiting

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne

    Fabio CANDOTTI, Pr, Fabio.Candotti@chuv.ch

    Recruiting

Other trials in Switzerland

About this study

The SOLVE-01 trial is a study evaluating four SARS-CoV-2 vaccines as booster injections: two experimental vaccines (CD40.RBDv and CD40.Pan.CoV, both combined with the Hiltonol® adjuvant) and two authorised vaccines (Comirnaty® and NuvaxovidTM). This trial is designed for healthy adults aged 18 to 65 at the time of signing the informed consent form.

The main objectives of this trial are:

Read more
  • to evaluate the safety of the two experimental vaccines,
  • to determine the antibody response induced by the vaccines and its durability.

Participants will:

  • Receive one injection of vaccine and two intradermal skin tests
  • Come to the hospital 10 visits for medical exams and blood and saliva sample collection
  • Keep a diary of their symptoms and the treatments taken
Conditions
Healthy Adults
Being tested
CD40.RBDv vaccine adjuvanted with Hiltonol®, CD40.Pan.CoV vaccine adjuvanted with Hiltonol®, Comirnaty® vaccine, Nuvaxovid™ vaccine
Keywords
COVID19 vaccine, phase 1, experimental medicine trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD40.RBDv vaccine adjuvanted with Hiltonol®Biological

    used at the dose of 1.0 mg subcutaneously

    Poly-ICLC adjuvant (Hiltonol) used at a dose of 1.0 mg and will be mixed with CD40.RBDv vaccine just prior to subcutaneous injection at day 0.

  • CD40.Pan.CoV vaccine adjuvanted with Hiltonol®Biological

    used at the dose of 1.0 mg subcutaneously

    Poly-ICLC adjuvant (Hiltonol) used at a dose of 1.0 mg and will be mixed with CD40.Pan.CoV vaccine just prior to subcutaneous injection at day 0.

  • Comirnaty® vaccineBiological

    administered intramuscularly at day 0.

    The version of the Comirnaty® vaccine and the dose will be the one adapted to the variant circulating at the start of trial and authorised by EMA.

  • Nuvaxovid™ vaccineBiological

    administered intramuscularly at day 0.

    The version of the Nuvaxovid™ vaccine and the dose will be the one commercialised at the start of trial and authorised by EMA.

Study groups in NCT07605520
Study groupRoleWhat they receive
CD40.RBDv/HiltonolExperimentalCD40.RBDv vaccine adjuvanted with Poly-ICLC (Hiltonol)
Receives: Biological: CD40.RBDv vaccine adjuvanted with Hiltonol®
CD40.Pan.CoV/HiltonolExperimentalCD40.Pan.CoV vaccine adjuvanted with Poly-ICLC (Hiltonol)
Receives: Biological: CD40.Pan.CoV vaccine adjuvanted with Hiltonol®
ComirnatyActive comparatorNot described
Receives: Biological: Comirnaty® vaccine
NuvaxovidActive comparatorNot described
Receives: Biological: Nuvaxovid™ vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety_Proportion of participants without any grade 3 or 4 adverse event

    Proportion of participants without any grade 3 or 4 solicited local/systemic or unsolicited AEs between Day 0 and Week 4 and considered to be related or possibly related to IMP administration

    Measured: Between Day 0 and Week 4

  2. Immunogenicity_Geometric mean titers of neutralizing antibodies

    Geometric mean titers of neutralizing antibodies against the original strain D614G and the relevant circulating variants measured at Week 4 and Week 48

    Measured: At Week 4 and Week 48

Secondary outcomes (20)

  1. Safety_Number of Solicited local and systemic Adverse Reactions

    overall; by grade

    Measured: up to Day 7 (7 days post vaccination) for local ARs and Week 2 (14 days post vaccination) for systemic ARs

  2. Safety_Number of Unsolicited adverse events

    overall; by grade; by relationship to the vaccine

    Measured: from Day 0 to end of trial

  3. Safety_Number of Serious Adverse Events

    overall; by grade; by relationship to the vaccine

    Measured: from Day 0 to end of the trial

  4. Immunogenicity_humoral immune response (IgG binding)

    Geometric mean titers of IgG binding/neutralizing antibodies titers against the original strain D614G and the relevant circulating variants

    Measured: at Day 0 (before vaccination), Day 7, Week 2, Week 4, Week 12, Week 24, Week 36 and Week 48

  5. Immunogenicity_humoral immune response (IgG binding)

    Responders as defined by an increase of neutralizing antibodies at least 4-fold

    Measured: at Day 0 (before vaccination), Day 7, Week 2, Week 4, Week 12, Week 24, Week 36 and Week 48

  6. Immunogenicity_persistence of immune imprinting

    Estimation of the IgG ratio VOC/Wuhan

    Measured: at Day 0 (before vaccination), Day 7, Week 2, Week 4, Week 12, Week 24, Week 36 and Week 48

  7. Immunogenicity_humoral immune response (neutralizing antibody titers)

    Geometric mean titers of neutralizing antibodies titers against the original strain D614G and the relevant strain circulating

    Measured: at Day 0 (before vaccination), Day 7, Week 2, Week 4, Week 12, Week 24, Week 36 and Week 48

  8. Immunogenicity_humoral immune response (neutralizing antibody titers)

    Responders as defined by an increase of neutralizing antibodies at least 4-fold

    Measured: at Day 0 (before vaccination), Day 7, Week 2, Week 4, Week 12, Week 24, Week 36 and Week 48

  9. Immunogenicity_specific antibody responses

    Estimation and modelling of the slopes of antibody (binding and neutralizing) taking account all Ig measures collected during the follow-up

    Measured: between Day 0 and Week 48

  10. Immunogenicity_T-cell immunogenicity (polyfunctional cross reactive specific T-cells)

    Cytokine expression patterns of T-cells measured by intracellular cytokine staining assay

    Measured: at Day 0 (before vaccination), Week 4, Week 12, Week 24, Week 36 and Week 48

  11. Immunogenicity_T-cell immunogenicity (polyfunctional cross reactive specific T-cells)

    Magnitude (percentage) of cells producing at least one cytokine

    Measured: at Day 0 (before vaccination), Week 4, Week 12, Week 24, Week 36 and Week 48

  12. Immunogenicity_durability of T-cell immune responses (polyfunctional cross reactive specific T-cells)

    Frequency of specific T-cell responses

    Measured: at Day 0 (before vaccination), Week 24 and Week 48

  13. Immunogenicity_correlation between the magnitude of CD4+ specific T-cell responses and levels of IgG specific responses

    Frequency of specific CD4+ T-cell producing cytokines (ICS) and titers of binding and neutralizing antibody levels at the peak of IgG responses

    Measured: at Day 0 (before vaccination), Week 4, Week 12, Week 24, Week 36 and Week 48

  14. Immunogenicity_repertoire of blood SARS-CoV-2 specific B-cells

    Frequency and breadth of the SARS-CoV-2 specific memory B-cell responses

    Measured: at Day 0 (before vaccination), Day 7, Week 12, Week 24, and Week 48

  15. Immunogenicity_innate immune responses

    Correlation of innate immune responses to the different vaccines with the induction of long-lasting T- and B-cells adaptive immunity.

    Evaluation of the pre-vaccine innate immune profile and how it correlates with the magnitude, breadth, and durability of the adaptive immune response. Combined analysis of the mass cytometry cell specific analysis of the innate immune profile with the gene expression analysis performed at the same time points.

    Measured: at Day 0 (before vaccination), Day 1, Day 7, Week 2, Week 4 and Week 12

  16. Immunogenicity_Gene expression

    Changes in gene expression at each time point. Comparison of changes in gene abundance at each time point versus baseline

    Measured: at Day 0 (before vaccination), Day 1, Day 7, Week 2, and Week 4

  17. Immunogenicity_T lymphocyte response

    Analysis of TCR profiles in the blood and on sorted specific T-cells by single-cell approach

    Measured: at Day 0 (before vaccination), Day 1, Day 7, Week 2, and Week 4

  18. Immunogenicity_mucosal immunity

    Comparative analysis of anti-SARS-CoV-2 IgG and IgA mucosal antibody levels

    Measured: at Day 0, Day 7, Week 4, Week 12, and Week 24

  19. Immunogenicity_T-cell memory responses

    Size (area) of the intradermal skin test reaction

    Measured: at Week 24 and Week 48

  20. Immunogenicity_serum levels of cytokine, chemokine and growth factor

    Correlation of the serum cytokine, chemokine and growth factor profile with the magnitude, breadth and durability of the adaptive immune response induced by the different vaccines. These data will be combined with innate immune and gene expression analysis to provide a comprehensive systems biology evaluation of the factors contributing to an effective vaccine candidate.

    Measured: at Day 0, Day 1, Day 7, Week 2, Week 4 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study start13 May 2026
  3. Primary completionMay 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07605520
Sponsor's protocol ID
ANRS0711s SOLVE-01
Acronym
SOLVE-01
Status last verified
Jun 2026
First submitted
7 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD40.RBDv vaccine adjuvanted with Hiltonol®, CD40.Pan.CoV vaccine adjuvanted with Hiltonol® and Comirnaty® vaccine in people with Healthy Adults, run by ANRS, Emerging Infectious Diseases at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 46 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Switzerland. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Yves LEVY, Pr (+33(0)149814442, yves.levy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety_Proportion of participants without any grade 3 or 4 adverse event (time frame: Between Day 0 and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07605520.

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 2 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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