MalariaPhase 1STOP-TRANSNCT04862416
Safety and Efficacy of R0.6C Vaccine
A Phase 1 study testing R0.6C transmission blocking vaccine in people with Malaria and Malaria,Falciparum, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant combinations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Malaria,Falciparum
- What is being tested?
- R0.6C transmission blocking vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 May 2021to 29 Jun 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must sign written informed consent to participate in the trial.
- Subject is a male or non-pregnant and non-lactating female age ≥ 18 and ≤ 55 years and in good health.
- Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of study by passing a quiz (assessment of understanding).
- In the opinion of the investigator, the subject can and will comply with the requirements of the protocol.
- Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until day 224 (end of study).
- The subject will remain within reasonable travelling distance from the study center from day -1 until day 7 after each R0.6C administration and agrees not to travel to a malaria-endemic area during the study period
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- Subject agrees to their general practitioner (GP) being informed about participation in the study and agrees to sign a form to request the release by their GP, and medical specialist when necessary, of any relevant medical information concerning possible contra-indications for participation in the study to the investigator(s).
- The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines.
- Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All subjects of childbearing potential must agree to use continuous adequate contraception* until 2 months after completion of the study. Female subjects must agree not to breastfeed from 30 days prior to R0.6C administration until 2 months after completion of the study. Female subjects must have a negative pregnancy test at the inclusion visit.
Who cannot join
- Acute or chronic disease at time of R0.6C administration, clinically significant pulmonary, cardiovascular, hepatic, renal, neurological or immunological functional abnormality, as determined by medical history, physical examination or laboratory screening tests:
- Acute disease is defined as the presence of a moderate or severe illness with or without fever. For subjects with an illness on the day of R0.6C administration, the vaccination may be postponed up to 7 days.
- Fever is defined as an oral, axillary or tympanic temperature ≥ 38.0°C.
- Any abnormal and clinically significant baseline laboratory screening tests of ALT, AST, creatinine, hemoglobin, platelet count or total white blood cell count, as defined in the protocol according to the FDA Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials (appendix 1).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Chronic use of i) immunosuppressive drugs, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
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- History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening or at inclusion.
- Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
- Use of any other investigational or non-registered product (drug or vaccine) during the study period.
- Known hypersensitivity to macrolides.
- Participation in any other clinical study involving an investigational product in the 30 days prior to the start of the study or during the study period.
- Receipt of any other vaccination within 30 days prior to the first R0.6C vaccination or planned vaccinations during the study period. Exceptions are made for vaccination against influenza and the novel coronavirus SARS-CoV2.
- Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria (vaccine) study or CHMI.
- Body weight > 115 kg
- Being an employee or student of the department of Medical Microbiology of the Radboudumc at the time of screening, or a person otherwise related to the investigator.
- Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525GA
About this study
Official title: Safety, Tolerability and Plasmodium Falciparum Transmission-reducing Activity of R0.6C Vaccine Adjuvanted With Alhydrogel Alone or Combined With Matrix-M in Healthy Malaria-naïve Adults in the Netherlands
This is a first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant combinations.
Read the detailed description
Thirty-two healthy adult volunteers will be recruited and divided over the study arms that will receive four vaccinations on days 0, 28, 56 and 168 with either 30μg or 100μg of R0.6C adjuvanted with Alhydrogel alone, or combined with Matrix-M1.
Three volunteers (Group 1A, n=3) will receive four vaccinations with the lower dose of 30μg R0.6C with Alhydrogel, and, in parallel, three volunteers (Group 1B, n=3) will receive four vaccinations with the lower dose of 30μg R0.6C with Alhydrogel and Matrix-M1. Volunteers will be closely monitored for adverse events for a period of minimally 14 days after the first vaccination. If safe, an additional 5 volunteers per adjuvant arm (groups 2A and 2B) will then receive four vaccinations with the lower dose (30μg R0.6C). If considered safe following a minimum of 14 days of follow-up after the first R0.6C administration of groups 2A and 2B, three volunteers per adjuvant arm (groups 3A and 3B) will start the vaccination regimen with the higher dose of 100μg R0.6C. Finally, a minimum of 14 days after administration of the first vaccination in groups 3A and 3B, if considered safe, an additional 5 volunteers per adjuvant arm (groups 4A and 4B) will initiate the vaccination regimen with the higher dose of 100μg R0.6C. There will be no placebo group. All volunteers will be followed up for adverse events until 84 days after the last immunisation. Total trial duration is approximately 8 months for each subject. Blood will be collected to assess functional Plasmodium falciparum transmission reducing activity (TRA) and transmission blocking activity (TBA) by standard membrane feeding assay (SMFA), as well as immunogenicity, at pre-specified time points after R0.6C vaccinations compared to pre-vaccination values.
- Conditions
- Malaria, Malaria,Falciparum
- Being tested
- R0.6C transmission blocking vaccine
- Keywords
- Transmission, Transmission blocking vaccine, Malaria, Plasmodium falciparum, R0.6C, Vaccine
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R0.6C transmission blocking vaccineBiological
Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
| Study group | Role | What they receive |
|---|---|---|
| 1A 30μg R0.6C Alhydrogel | Experimental | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 1B 30μg R0.6C Alhydrogel + Matrix M1 | Experimental | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 2A 30μg R0.6C Alhydrogel | Experimental | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 2B 30μg R0.6C Alhydrogel + Matrix M1 | Experimental | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 3A 100μg R0.6C Alhydrogel | Experimental | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 3B 100μg R0.6C Alhydrogel + Matrix M1 | Experimental | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 4A 100μg R0.6C Alhydrogel | Experimental | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
| 4B 100μg R0.6C Alhydrogel + Matrix M1 | Experimental | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. Receives: Biological: R0.6C transmission blocking vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events and Grade 3 Adverse Events
The number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
Measured: From first immunization up to 84 days after the last immunization
Transmission Reducing Activity
The functional transmission reducing activity in the standard membrane feeding assay of volunteer sera collected two weeks after the fourth R0.6C immunization (I4+14), compared to baseline (I1-1) within each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I4+14 sera by total number of oocysts in mosquitoes fed with I1-1 sera.
Measured: 14 days after the fourth immunization
Secondary outcomes (3)
Number of Grade 1 and 2 Adverse Events
The number of solicited and unsolicited grade 1 and 2 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
Measured: From first immunization up to 84 days after the last immunization
Transmission Reducing Activity
The transmission reducing activity at other timepoint (I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84 sera by total number of oocysts in mosquitoes fed with I1-1 sera.
Measured: 14 days after immunization 1, 2 and 3. One day before immunization 4 and 84 days after immunization 4.
Anti-6C Antibody Quantities
The anti-6C antibody quantity in volunteer sera collected two weeks after fourth R0.6C immunization (I4+14) and at other time points (I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant combinations, as determined by ELISA.
Measured: 14 days after each immunization. One day before immunization 4 and 84 days after immunization 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start17 May 2021
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Study groups will be assigned sequentially to low and high doses of R0.6C Vaccine. Within each dose group, participants will be assigned randomly (1:1) to one of two adjuvant arms (either Alhydrogel alone or Alhydrogel + Matrix-M).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, Novavax
- Responsible party
- Principal investigator, Matthew McCall, Radboud University Medical Center
- Investigators
- Matthew McCall, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862416
- Sponsor's protocol ID
- STOP-TRANS
- Other IDs
- 2021-000017-17
- Acronym
- STOP-TRANS
- Status last verified
- Feb 2025
- First submitted
- 26 Apr 2021
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alkema M, Smit MJ, Marin-Mogollon C, Totte K, Teelen K, van Gemert GJ, van de Vegte-Bolmer M, Mordmuller BG, Reimer JM, Lovgren-Bengtsson KL, Sauerwein RW, Bousema T, Plieskatt J, Theisen M, Jore MM, McCall MBB. A Pfs48/45-based vaccine to block Plasmodium falciparum transmission: phase 1, open-label, clinical trial. BMC Med. 2024 Apr 23;22(1):170. doi: 10.1186/s12916-024-03379-y.
PubMed 38649867
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Plasmodium Falciparum Transmission-reducing Activity of R0.6C Vaccine Adjuvanted With Alhydrogel Alone or Combined With Matrix-M in Healthy Malaria-naïve Adults in the Netherlands
- ClinicalTrials.gov ID
- NCT04862416
- Acronym / sponsor ID
- STOP-TRANS / STOP-TRANS
- Conditions
- Malaria, Malaria,Falciparum
- Keywords
- Transmission, Transmission blocking vaccine, Malaria, Plasmodium falciparum, R0.6C, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Statens Serum Institut, Novavax
- Study start
- 17 May 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Posted 5 Mar 2025
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 first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant combinations.
Detailed description
Thirty-two healthy adult volunteers will be recruited and divided over the study arms that will receive four vaccinations on days 0, 28, 56 and 168 with either 30μg or 100μg of R0.6C adjuvanted with Alhydrogel alone, or combined with Matrix-M1.
Three volunteers (Group 1A, n=3) will receive four vaccinations with the lower dose of 30μg R0.6C with Alhydrogel, and, in parallel, three volunteers (Group 1B, n=3) will receive four vaccinations with the lower dose of 30μg R0.6C with Alhydrogel and Matrix-M1. Volunteers will be closely monitored for adverse events for a period of minimally 14 days after the first vaccination. If safe, an additional 5 volunteers per adjuvant arm (groups 2A and 2B) will then receive four vaccinations with the lower dose (30μg R0.6C). If considered safe following a minimum of 14 days of follow-up after the first R0.6C administration of groups 2A and 2B, three volunteers per adjuvant arm (groups 3A and 3B) will start the vaccination regimen with the higher dose of 100μg R0.6C. Finally, a minimum of 14 days after administration of the first vaccination in groups 3A and 3B, if considered safe, an additional 5 volunteers per adjuvant arm (groups 4A and 4B) will initiate the vaccination regimen with the higher dose of 100μg R0.6C. There will be no placebo group. All volunteers will be followed up for adverse events until 84 days after the last immunisation. Total trial duration is approximately 8 months for each subject. Blood will be collected to assess functional Plasmodium falciparum transmission reducing activity (TRA) and transmission blocking activity (TBA) by standard membrane feeding assay (SMFA), as well as immunogenicity, at pre-specified time points after R0.6C vaccinations compared to pre-vaccination values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Study groups will be assigned sequentially to low and high doses of R0.6C Vaccine. Within each dose group, participants will be assigned randomly (1:1) to one of two adjuvant arms (either Alhydrogel alone or Alhydrogel + Matrix-M).
| Arm | Type | Receives |
|---|---|---|
| 1A 30μg R0.6C Alhydrogel | Experimental | Biological: R0.6C transmission blocking vaccine3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 1B 30μg R0.6C Alhydrogel + Matrix M1 | Experimental | Biological: R0.6C transmission blocking vaccine3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| 2A 30μg R0.6C Alhydrogel | Experimental | Biological: R0.6C transmission blocking vaccine5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 2B 30μg R0.6C Alhydrogel + Matrix M1 | Experimental | Biological: R0.6C transmission blocking vaccine5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| 3A 100μg R0.6C Alhydrogel | Experimental | Biological: R0.6C transmission blocking vaccine3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 3B 100μg R0.6C Alhydrogel + Matrix M1 | Experimental | Biological: R0.6C transmission blocking vaccine3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
| 4A 100μg R0.6C Alhydrogel | Experimental | Biological: R0.6C transmission blocking vaccine5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
| 4B 100μg R0.6C Alhydrogel + Matrix M1 | Experimental | Biological: R0.6C transmission blocking vaccine5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject must sign written informed consent to participate in the trial.
- Subject is a male or non-pregnant and non-lactating female age ≥ 18 and ≤ 55 years and in good health.
- Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of study by passing a quiz (assessment of understanding).
- In the opinion of the investigator, the subject can and will comply with the requirements of the protocol.
- Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until day 224 (end of study).
Key exclusion criteria (16 listed)
- Acute or chronic disease at time of R0.6C administration, clinically significant pulmonary, cardiovascular, hepatic, renal, neurological or immunological functional abnormality, as determined by medical history, physical examination or laboratory screening tests:
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Chronic use of i) immunosuppressive drugs, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
- History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening or at inclusion.
- Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
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 |
|---|---|---|
| R0.6C transmission blocking vaccineVaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | Biological | 1A 30μg R0.6C Alhydrogel, 1B 30μg R0.6C Alhydrogel + Matrix M1, 2A 30μg R0.6C Alhydrogel, 2B 30μg R0.6C Alhydrogel + Matrix M1, 3A 100μg R0.6C Alhydrogel, 3B 100μg R0.6C Alhydrogel + Matrix M1, 4A 100μg R0.6C Alhydrogel, 4B 100μg R0.6C Alhydrogel + Matrix M1 |
Primary outcome
Number of Serious Adverse Events and Grade 3 Adverse Events
Time frame: From first immunization up to 84 days after the last immunization
The number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization.
Transmission Reducing Activity
Time frame: 14 days after the fourth immunization
The functional transmission reducing activity in the standard membrane feeding assay of volunteer sera collected two weeks after the fourth R0.6C immunization (I4+14), compared to baseline (I1-1) within each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I4+14 sera by total number of oocysts in mosquitoes fed with I1-1 sera.
3 secondary outcomes
Number of Grade 1 and 2 Adverse Events
Time frame: From first immunization up to 84 days after the last immunization
Transmission Reducing Activity
Time frame: 14 days after immunization 1, 2 and 3. One day before immunization 4 and 84 days after immunization 4.
Anti-6C Antibody Quantities
Time frame: 14 days after each immunization. One day before immunization 4 and 84 days after immunization 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38649867Alkema M, Smit MJ, Marin-Mogollon C, Totte K, Teelen K, van Gemert GJ, van de Vegte-Bolmer M, Mordmuller BG, Reimer JM, Lovgren-Bengtsson KL, Sauerwein RW, Bousema T, Plieskatt J, Theisen M, Jore MM, McCall MBB. A Pfs48/45-based vaccine to block Plasmodium falciparum transmission: phase 1, open-label, clinical trial. BMC Med. 2024 Apr 23;22(1):170. doi: 10.1186/s12916-024-03379-y.
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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. This study is not recruiting at the moment.
Matthew McCall, MD, PhD principal investigator
Radboud University Medical Center
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 R0.6C transmission blocking vaccine in people with Malaria and Malaria,Falciparum, run by Radboud University Medical Center 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 9 inclusion and 16 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 5 Mar 2025. 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. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Serious Adverse Events and Grade 3 Adverse Events (time frame: From first immunization up to 84 days after the last immunization). 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 NCT04862416, 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 5 Mar 2025.