Healthy VolunteersPhase 1NCT05163834
Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV
A Phase 1 study testing Efgartigimod and PNEUMOVAX 23 in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.
Trial summary
This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Efgartigimod and PNEUMOVAX 23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2021to 8 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age at the time of signing the informed consent form (ICF)
- Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body mass index (BMI) between 18 kg/m2 to 30 kg/m2 (inclusive)
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants must agree not to donate sperm from the time the ICF was signed until the end of the study
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered.
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- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Abstains from smoking for at least 3 months prior to screening
- Negative urine drug screen and negative alcohol urine test
- Agrees to restrict excessive strenuous physical activities 96 hours prior to screening, 96 hours prior to the visits in the treatment period, and 96 hours prior to the visits in follow-up period.
Who cannot join
- Clinically significant active or chronic bacterial, viral, including or fungal infection at day -1
- History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of study intervention. Participants with the following cancers can be included at any time: Adequately treated basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix and Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b).
- Clinical evidence of other significant serious diseases, a recent major surgery, or any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk
- Use of an investigational product within 2 months or 5 half-lives (whichever is longer) before the first dose of study intervention; Use of any monoclonal antibody within 3 months prior to the initial study intervention administration; Use of any systemic immunosuppressant agent within 6 months prior to the initial study intervention administration; Use of any systemic steroid within 3 months prior to the initial study intervention administration; Use of B-cell depleting agents in the year before the initial screening visit
- Previously participated in a clinical study with efgartigimod and received at least 1 dose of efgartigimod
- Positive serum test screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV) based on test results that are associated with an acquired immunodeficiency syndrome (AIDS)-defining condition, or a CD4 count ≤200 cells/mm3.
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- Positive nasopharyngeal swab antigen test for SARS-CoV-2 on day -1. Any contact with SARS-CoV-2 positive or COVID-19 patients within the last 2 weeks prior to admission.
- Total IgG ≤6 g/L at screening
- Current or history of (ie, within 12 months of screening) alcohol, drug, or medication abuse
- Known hypersensitivity reaction to any of the excipients of study intervention, the PNEUMOVAX 23 vaccine, or any of its excipients
- Pregnant or lactating females and those who intend to become pregnant during the study or within 90 days after the last dose of study intervention
- Received a live or live-attenuated vaccine less than 4 weeks before screening. The receipt of any inactivated, subunit, polysaccharide, or conjugate vaccine at any time before screening is not considered exclusionary
- Received a pneumococcal vaccine within the past 10 years
- Documented pneumococcal infection within the past 5 years prior to first administration of the study intervention
- Has a clinically relevant abnormality detected on ECG recording regarding either rhythm or conduction. A first-degree heart block or sinus arrhythmia will not be considered a significant abnormality.
- Had significant blood loss (including blood donation ≥500 mL) within 12 weeks prior to the (first) study intervention administration
- Has any condition impairing phlebotomy
- Is an employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as a family member of an employee or the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Placebo-Controlled, Parallel-Group Study to Evaluate the Immune Response to the Polyvalent Pneumococcal Vaccine (PNEUMOVAX 23) in Healthy Participants Receiving Intravenous Efgartigimod or Placebo
This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.
- Conditions
- Healthy Volunteers
- Being tested
- Efgartigimod, Placebo, PNEUMOVAX 23
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfgartigimodBiological
intravenous infusion of efgartigimod
PlaceboOther
intravenous infusion of placebo
PNEUMOVAX 23Biological
PNEUMOVAX 23 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod-1 | Experimental | Weekly efgartigimod infusions and the pneumovax 23 vaccine on day 22 Receives: Biological: Efgartigimod; Biological: PNEUMOVAX 23 |
| Efgartigimod-2 | Experimental | Weekly efgartigimod infusions and the pneumovax 23 vaccine on day 36 Receives: Biological: Efgartigimod; Biological: PNEUMOVAX 23 |
| Placebo | Placebo comparator | Weekly placebo infusions and the pneumovax 23 vaccine on day 22 Receives: Other: Placebo; Biological: PNEUMOVAX 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the immune response assessed by comparing pneumococcal capsular polysaccharide (PCP) titers pre- and postadministration of the PNEUMOVAX 23 vaccine between study arms
Measured: throughout the study (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start17 Nov 2021
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by argenxThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163834
- Sponsor's protocol ID
- ARGX-113-2102
- Other IDs
- 2021-004878-53
- Status last verified
- Mar 2022
- First submitted
- 23 Nov 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Azar AE, Sleasman JW, Steeland S, Verhamme FM, Winthrop KL. Humoral immune response to polyvalent pneumococcal vaccine in healthy participants receiving efgartigimod: a randomized, open-label, placebo-controlled, parallel-group phase 1 trial. Front Immunol. 2026 May 7;17:1799480. doi: 10.3389/fimmu.2026.1799480. eCollection 2026.
PubMed 42183242
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Placebo-Controlled, Parallel-Group Study to Evaluate the Immune Response to the Polyvalent Pneumococcal Vaccine (PNEUMOVAX 23) in Healthy Participants Receiving Intravenous Efgartigimod or Placebo
- ClinicalTrials.gov ID
- NCT05163834
- Acronym / sponsor ID
- ARGX-113-2102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 20 Dec 2021 (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 is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod-1 | Experimental | Biological: Efgartigimod, Biological: PNEUMOVAX 23Weekly efgartigimod infusions and the pneumovax 23 vaccine on day 22 |
| Efgartigimod-2 | Experimental | Biological: Efgartigimod, Biological: PNEUMOVAX 23Weekly efgartigimod infusions and the pneumovax 23 vaccine on day 36 |
| Placebo | Placebo comparator | Other: Placebo, Biological: PNEUMOVAX 23Weekly placebo infusions and the pneumovax 23 vaccine on day 22 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age at the time of signing the informed consent form (ICF)
- Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body mass index (BMI) between 18 kg/m2 to 30 kg/m2 (inclusive)
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants must agree not to donate sperm from the time the ICF was signed until the end of the study
Key exclusion criteria (18 listed)
- Clinically significant active or chronic bacterial, viral, including or fungal infection at day -1
- History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of study intervention. Participants with the following cancers can be included at any time: Adequately treated basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix and Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b).
- Clinical evidence of other significant serious diseases, a recent major surgery, or any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk
- Use of an investigational product within 2 months or 5 half-lives (whichever is longer) before the first dose of study intervention; Use of any monoclonal antibody within 3 months prior to the initial study intervention administration; Use of any systemic immunosuppressant agent within 6 months prior to the initial study intervention administration; Use of any systemic steroid within 3 months prior to the initial study intervention administration; Use of B-cell depleting agents in the year before the initial screening visit
- Previously participated in a clinical study with efgartigimod and received at least 1 dose of efgartigimod
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 |
|---|---|---|
| Efgartigimodintravenous infusion of efgartigimod | Biological | Efgartigimod-1, Efgartigimod-2 |
| Placebointravenous infusion of placebo | Other | Placebo |
| PNEUMOVAX 23PNEUMOVAX 23 vaccine | Biological | Efgartigimod-1, Efgartigimod-2, Placebo |
Primary outcome
Variation in the immune response assessed by comparing pneumococcal capsular polysaccharide (PCP) titers pre- and postadministration of the PNEUMOVAX 23 vaccine between study arms
Time frame: throughout the study (up to 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 42183242Azar AE, Sleasman JW, Steeland S, Verhamme FM, Winthrop KL. Humoral immune response to polyvalent pneumococcal vaccine in healthy participants receiving efgartigimod: a randomized, open-label, placebo-controlled, parallel-group phase 1 trial. Front Immunol. 2026 May 7;17:1799480. doi: 10.3389/fimmu.2026.1799480. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efgartigimod and PNEUMOVAX 23 in people with Healthy Volunteers, run by argenx at 1 site in Netherlands.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation in the immune response assessed by comparing pneumococcal capsular polysaccharide (PCP) titers pre- and postadministration of the PNEUMOVAX 23 vaccine between study arms (time frame: throughout the study (up to 12 weeks)). 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 NCT05163834, which also lists 1 linked publication.
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 17 Mar 2022.