MalariaPhase 1SUM-101NCT05644067
Assessment of the Malaria Vaccine Candidate SumayaVac-1 in Healthy Adults Aged 18-45 Years Living in a Malaria Endemic Country
A Phase 1 study testing SumayaVac-1(SUM-101) and Verorab in people with Malaria, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
Malaria remains a major infectious disease causing a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions. Large, international research efforts have been invested into the development of anti-malaria vaccination strategies, however, currently there is only one malaria… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- SumayaVac-1(SUM-101) and Verorab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTanzania
- Study dates
- 25 Aug 2023to 2 Apr 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent obtained before any study procedure.
- Literate participants aged 18-45 years of African origin.
- Female participants practicing contraception from 4 weeks before 1st immunization and both female and male participants willing to practice contraception up to 12 weeks after the last immunization.
- Available to participate in follow-up for the duration of the study.
- Contactable by phone during the whole study period.
- At least two years residence in the Bagamoyo district or nearby districts in Coastal and Dar-es-Salaam regions and planning to reside there for at least 9 more months.
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- Agreement to provide personal contact information and contact information of another household member or close friend.
- Female participants must be willing to avoid pregnancy if selected for participation in the trial and to undergo multiple serum pregnancy testing.
- Confirmation of understanding of design, procedures, risk and benefits of the study in a test with maximum of two attempts.
- General good health based on assessment of medical history and clinical examination.
Who cannot join
- Previous participation in any malaria vaccine trial in the last 3 years.
- Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
- Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
- Previous vaccination with a rabies vaccine.
- Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating drugs) during the 13 weeks preceding the screening visit or during the study period.
- Known hypersensitivity to any of the vaccine components (adjuvant or protein) or anti-malarial treatments.
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- Body mass index (BMI) of <18 or >30 Kg/m2.
- Participants unable to be closely followed for social, geographic or psychological reasons.
- Any vaccination from 4 weeks prior to the 1st vaccination and (none planned) up to 6 weeks after the 3rd vaccination.
- Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the participants.
- Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, clinically significant arrhythmias, left bundle branch block, secondary or tertiary A-V (atrio-ventricular) heart block.
- Any clinically significant laboratory values at screening outside of normal ranges for study participants.
- Malaria positivity at screening (microscopy or qPCR positive).
- Positive HIV, HBV or HCV tests.
- For females: Positive pregnancy test or actively breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Double-blind, Parallel Group, Single Center Phase Ib Trial to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Dual-stage Malaria Vaccine, SumayaVac-1 (MSP-1 With GLA-SE as Adjuvant) in Healthy Malaria Exposed Adults of African Origin Aged 18-45 Years
Malaria remains a major infectious disease causing a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions. Large, international research efforts have been invested into the development of anti-malaria vaccination strategies, however, currently there is only one malaria vaccine approved for use in the pediatric population, which provides a moderate and short-lived protection. Therefore, there is a need to develop a malaria vaccine that will be essential to further strengthen malaria control measures in future.
A Phase Ia trial with the same IMP (SumayaVac-1 vaccine developed using a full-length recombinant MSP-1 administered along with the adjuvant GLA-SE) in Caucasians in Heidelberg, Germany, proved to be well tolerated and safe. However, a Phase Ib clinical trial on healthy participants residing in a malaria endemic country would be essential to evaluate the safety and reactogenicity in the target population. The project aims to investigate the safety, reactogenicity, immunogenicity of the candidate malaria vaccine, SumayaVac-1 (SUM-101) in 40 healthy participants (men and women) of African origin in Bagamoyo, Tanzania.
Read the detailed description
Objectives:
To evaluate in healthy adults of African origin previously exposed to the malaria parasite receiving SumayaVac-1 (SUM-101) versus rabies control (Verorab®) vaccine:
Primary Objectives
- Safety and reactogenicity of SumayaVac-1 (SUM-101).
- Immunogenicity of SumayaVac-1 (SUM-101).
Secondary Objectives
- SumayaVac-1 (SUM-101) vaccine-induced antibody levels, in vitro effector functions.
Exploratory Objectives
- Comparison of SumayaVac-1 (SUM-101) induced immunoglobulin isotype distribution and duration between malaria pre-exposed and malaria naïve participants from the previous Phase Ia study in Heidelberg.
- Fine scale epitope mapping of SumayaVac-1 (SUM-101) specific antibodies using peptide arrays, to investigate humoral immune response at baseline with vaccine induced responses.
- Comparison of SumayaVac-1 (SUM-101) induced cellular immunity between malaria pre-exposed and malaria naïve participants from the previous Phase Ia study in Heidelberg including fine scale epitope mapping of MSP-1 specific CD4+ and CD8+ T cells.
- Investigation of the B- and T-Cell repertoire before and after SumayaVac-1 (SUM-101) vaccination.
- Integrated transcriptome and immunoglobulin gene repertoire analyses of MSP-1 specific B-cells using single-cell technologies.
- Glycosylation patterns of MSP-1 specific functional antibodies.
- Investigate off-target IgG and IgM repertoire after SumayaVac-1 (SUM-101) vaccination using immunoproteomics.
- Investigate the structure of MSP-1 protein bound to functional antibodies by cryo-electron tomography to map conformational epitopes.
- To evaluate mechanisms of malaria specific antibody diversity generation, post-translational modification of antibodies, and B- and T-cell memory generation and maintenance.
- Ex vivo assessment of changes in human peripheral blood transcriptome in participants having received SumayaVac-1 (SUM-101) versus Verorab® rabies vaccine.
- Description of ɣδ T-cell receptor repertoire, transcriptome, functional activity and phenotypes in participants having received SumayaVac-1 (SUM-101) versus Verorab® rabies vaccine.
- Investigate impact of presence of intestinal helminth infections on SumayaVac-1(SUM-101) induced humoral immune response.
- Investigate impact of presence of intestinal helminth infections on SumayaVac-1(SUM-101) induced cellular immune response.
Study Design:
This is a randomised, controlled, double-blind, parallel group, single center Phase Ib trial to assess the safety, reactogenicity, and immunogenicity of SumayaVac-1 (SUM-101) in healthy, malaria-exposed adults of African origin aged 18-45 years.
In total, 40 participants will be enrolled (male and female). 20 participants will be randomised to receive three monthly inoculations (on D0, D28 and D56) with the investigational product, SumayaVac-1 (SUM-101), and 20 participants will be randomised to receive the registered rabies vaccine, Verorab®, as controls.
For operational reasons the participants will be split in two groups of 20 participants.
- Group 1 will have a sentinel subgroup (2 SumayaVac-1 (SUM-101) \& 1 Verorab® rabies vaccine) with a 48 hours safety surveillance period before the remaining 17 participants (8 SumayaVac-1 (SUM-101) \& 9 Verorab® rabies vaccine) of the group 1 receive their 1st vaccination.
- Group 2 will be composed of 20 participants (10 SumayaVac-1 (SUM-101) \& 10 Verorab® rabies vaccine). All visits in group 2 will be shifted by at least 3 weeks compared to group 1 to create minimal overlap of study-related activities.
After each vaccination (done on D0, D28 and D56), the participants will remain at the facility for 2 hours prior to their discharge for home. The participant will be called daily by phone (or home visits if required) until 6 days post vaccination for follow-up.
For all participants, vaccination follow-up visits at the site will occur at 7, 14 and 28 days after each vaccination.
Measurements and Procedures:
Written informed consent will be taken prior to any study procedure. Healthy participants will be screened and randomised before administration of the study IMP.
On the day of the 1st vaccination, the health status of the participant is re-checked and eligibility confirmed. Samples for safety, humoral, cellular and exploratory measurements are taken before 1st vaccination (baseline). Vaccination is administered and the participant remains at site for 2 hours before being discharged. Telephone follow-ups (or home visits if required) will be performed daily until 6 days after each vaccination. On 7, 14 and 28 days after each vaccination (done on D0, D28 and D56), the participant will be invited to come back to the facility and health status is checked.
Further participant follow-up visits will take place at D112 (W16) and D140 (W20) post 1st vaccination. Sampling for humoral and cellular responses will be performed at D112 (W16) and D140 (W20). Additionally, sampling for exploratory measurements will be performed at D112 (W16) (Vac1 + 4 month follow-up site visit).
Number of Participants with Rationale:
Vaccination: 40 adult participants Overall: 20 SumayaVac-1 (SUM-101) and 20 Verorab® control
Group 1 Sentinel sub-group
- 2 SumayaVac-1 (SUM-101)
- 1 Verorab® control
Group 1 Follower Group
- 8 SumayaVac-1 (SUM-101)
- 9 Verorab® control
Group 2
- 10 SumayaVac-1 (SUM-101)
- 10 Verorab® control
As this is a Phase I trial, no formal sample size calculation has been done. The sample size is considered sufficient to examine the safety and reactogenicity of SumayaVac-1 (SUM-101), and humoral and cellular immunogenicity.
Study Product / Intervention:
Vaccination: Intra-muscular injection of SumayaVac-1 (SUM-101) composed of 150 µg MSP-1 drug product + 5 μg GLA-SE adjuvant CHMI: Direct venous inoculation of 3.2 x 103 purified, infectious P. falciparum sporozoites
Control Intervention: Vaccination control: Intra-muscular injection of rabies vaccine (Verorab®)
Study Duration: The total study duration including the screening period (~4 weeks) combining Group 1 and 2 will be approximately 35 weeks.
The study duration for each participant will be ~24 weeks (4 weeks of screening period plus 20 weeks of vaccinations and long-term follow-up visits).
Study Centre: The Ifakara Health Institute Bagamoyo Clinical Trial Facility.
Statistical Analysis incl. Power Analysis:
See above for sample size justification. To evaluate the safety and reactogenicity primary endpoints, AEs and SAEs will be presented according to the endpoint definitions above. AE reporting will include verbatim term, preferred term (PT), system organ class (SOC), treatment, severity, relationship to the interventional products, and seriousness, reporting numbers of participants experiencing each event and total numbers of each event. Laboratory safety parameters will be summarized as absolute values and changes at 28 days after each vaccination compared to baseline (before 1st vaccination) and compared to values just prior to each vaccination.
To evaluate the immunogenicity primary endpoints as defined above, SumayaVac-1 (SUM-101) vaccine induced humoral immunogenicity will be summarized as antibody responses to SumayaVac-1 (SUM-101) by ELISA over time, and fold changes of antibody responses relative to baseline.
For all analyses, data will be listed for each participant. Descriptive analyses will be performed (number of observations, arithmetic or geometric mean, standard deviation, minimum, maximum, median, interquartile range, as appropriate, for continuous data, and counts and percentages for categorical data). Results will be presented by vaccination received.
Further details will be elaborated in a Statistical Analysis Plan (SAP), including for the secondary and exploratory objectives.
- Conditions
- Malaria
- Being tested
- SumayaVac-1(SUM-101), Verorab
- Keywords
- Plasmodium falciparum, MSP-1, Tanzania, Phase Ib, Vaccine, GLA-SE
- 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.
SumayaVac-1(SUM-101)Biological
One immunization every 4 weeks for 3 months (total 3 immunizations)
VerorabBiological
One immunization every 4 weeks for 3 months (total 3 immunizations)
| Study group | Role | What they receive |
|---|---|---|
| SumayaVac-1(SUM-101) | Experimental | Candidate malaria Vaccine (Investigational Medicinal Product (IMP)). 20 participants will be randomised to receive three monthly inoculations of the IMP Receives: Biological: SumayaVac-1(SUM-101) |
| Verorab | Placebo comparator | Comparator used as a control. 20 participants will be randomised to receive three monthly inoculations of the comparator. Receives: Biological: Verorab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic adverse events (AEs) at least possibly related to the IMP after vaccination
Local and systemic solicited adverse events (AEs) at least possibly related to the investigational medicinal product (IMP) recorded after each vaccination (done on Day 0, Day 28 and Day 56 up to 7 days later to evaluate safety and reactogenicity of SumayaVac-1 (SUM-101)
Measured: Recorded up to 7 days after each vaccination
Local and systemic unsolicited reactogenicity after vaccination
Local and systemic unsolicited reactogenicity recorded after each vaccination (done on Day 0, Day 28 and Day 56 up to 28 days later to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Measured: Recorded up to 28 days after each vaccination
Any serious adverse events (SAE) occurring after the 1st vaccination until the participant's last visit
Any serious adverse events (SAE) occurring after the 1st vaccination until the participant's last visit to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Measured: Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)
Changes in laboratory safety parameters between baseline and 28 days after vaccination
Changes in laboratory safety parameters as defined in the protocol for every participant between baseline (Day 0 before 1st vaccination) to 28 days after each of the vaccinations to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Measured: Changes recorded between baseline (Day 0 before 1st vaccination) to 28 days after each vaccination
Changes in laboratory safety parameter prior to vaccination to 28 days after that vaccination
Changes in laboratory safety parameters as defined in the protocol for every participant between values recorded just prior to each vaccination (on Day 0, Day 28 and Day 56) and values found 28 days after proceeding with vaccination to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Measured: Changes prior to each vaccination to 28 days after proceeding with vaccination
Longevity of antibody responses to SumayaVac-1 (SUM-101) by ELISA
Longevity of antibody responses to SumayaVac-1 (SUM-101) by ELISA for all participants at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20), to evaluate the humoral immunogenicity
Measured: Titres assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Fold change of antibody responses to SumayaVac-1 (SUM-101) in comparison to baseline
Fold change of antibody responses to SumayaVac-1 (SUM-101) by ELISA in comparison to baseline (Day 0 pre-vaccination) for all participants to Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20), to evaluate the humoral immunogenicity
Measured: Fold changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Secondary outcomes (6)
Evaluation of the opsonic phagocytosis activity of vaccine induced antibodies
In vitro immunological assay to evaluate immune responses by measuring opsonic phagocytosis activity in the sera or blood of all participants, at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20).
Measured: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of complement fixation, activation and/or membrane attack complex (MAC) formation of vaccine-induced antibodies
In vitro immunological assay to evaluate immune responses by assessing complement fixation, activation and/or membrane attack complex (MAC) formation in the sera or blood of all participants, at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20).
Measured: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of antibody-dependent respiratory burst (ADRB) activity of vaccine-induced antibodies
In vitro lab immunological assay to evaluate immune responses by assessing antibody-dependent respiratory burst (ADRB) activity measured in the sera or blood of all participants, at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20).
Measured: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of antibody-dependent cellular cytotoxicity (ADCC-NK cells) activity of vaccine-induced antibodies
In vitro immunological assay to evaluate immune responses by assessing antibody-dependent cellular cytotoxicity (ADCC-NK cells) activity in the sera or blood of all participants, at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20).
Measured: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of immune-mediated growth inhibition activity on Plasmodium falciparum asexual blood stage cell lines
In vitro functional assay to evaluate immune-mediated growth inhibition activity on a panel of Plasmodium falciparum asexual blood stage cell lines measured in the sera or blood of all participants, at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20).
Measured: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Comparison of MSP-1 IgG antibody concentrations by ELISA
Comparison of MSP-1 IgG antibody concentrations by ELISA between malaria pre-exposed participants in the current study and historical data obtained from malaria naïve participants of previous Phase Ia study conducted in Heidelberg that are assessed among SumayaVac-1 (SUM-101) participants only
Measured: Antibody concentrations compared between Day 0 (pre-vaccination) up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start25 Aug 2023
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- A randomised, controlled, double-blind, parallel group, single center Phase Ib trial to assess safety, reactogenicity, immunogenicity of a candidate dual-stage malaria vaccine, SumayaVac-1 (MSP-1 with GLA-SE as adjuvant) in healthy participants aged 18-45 years.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute, Sumaya Biotech GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Claudia Daubenberger, PhD, Study chair, Swiss Tropical & Public Health InstituteAlly Olotu, MD, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644067
- Sponsor's protocol ID
- P2267-22
- Acronym
- SUM-101
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blank A, Furle K, Jaschke A, Mikus G, Lehmann M, Husing J, Heiss K, Giese T, Carter D, Bohnlein E, Lanzer M, Haefeli WE, Bujard H. Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial. NPJ Vaccines. 2020 Jan 31;5(1):10. doi: 10.1038/s41541-020-0160-2. eCollection 2020.
PubMed 32025341Kahatano AE, Mpina M, Vanobberghen F, Hassan O, Urasa N, Sasamalo I, Mswata S, Paris D, Gajewski S, Saxena M, Furle K, Kiehl V, Bohnlein E, Aschenbrenner A, Lanzer M, Thomson-Luque R, Olotu A, Daubenberger C. Full-length merozoite surface protein 1 formulated with GLA-SE adjuvant in malaria pre-exposed adults: a randomised, controlled, double-blind, parallel-group, single-centre Phase Ib trial. EClinicalMedicine. 2025 Oct 25;89:103585. doi: 10.1016/j.eclinm.2025.103585. eCollection 2025 Nov.
PubMed 41210385
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double-blind, Parallel Group, Single Center Phase Ib Trial to Assess Safety, Reactogenicity and Immunogenicity of a Candidate Dual-stage Malaria Vaccine, SumayaVac-1 (MSP-1 With GLA-SE as Adjuvant) in Healthy Malaria Exposed Adults of African Origin Aged 18-45 Years
- ClinicalTrials.gov ID
- NCT05644067
- Acronym / sponsor ID
- SUM-101 / P2267-22
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, MSP-1, Tanzania, Phase Ib, Vaccine, GLA-SE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Ifakara Health Institute, Sumaya Biotech GmbH & Co. KG
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 9 Dec 2022 (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.
Malaria remains a major infectious disease causing a heavy burden of mortality and morbidity in populations living in tropical and subtropical regions. Large, international research efforts have been invested into the development of anti-malaria vaccination strategies, however, currently there is only one malaria vaccine approved for use in the pediatric population, which provides a moderate and short-lived protection. Therefore, there is a need to develop a malaria vaccine that will be essential to further strengthen malaria control measures in future.
A Phase Ia trial with the same IMP (SumayaVac-1 vaccine developed using a full-length recombinant MSP-1 administered along with the adjuvant GLA-SE) in Caucasians in Heidelberg, Germany, proved to be well tolerated and safe. However, a Phase Ib clinical trial on healthy participants residing in a malaria endemic country would be essential to evaluate the safety and reactogenicity in the target population. The project aims to investigate the safety, reactogenicity, immunogenicity of the candidate malaria vaccine, SumayaVac-1 (SUM-101) in 40 healthy participants (men and women) of African origin in Bagamoyo, Tanzania.
Detailed description
Objectives:
To evaluate in healthy adults of African origin previously exposed to the malaria parasite receiving SumayaVac-1 (SUM-101) versus rabies control (Verorab®) vaccine:
Primary Objectives
- Safety and reactogenicity of SumayaVac-1 (SUM-101).
- Immunogenicity of SumayaVac-1 (SUM-101).
Secondary Objectives
- SumayaVac-1 (SUM-101) vaccine-induced antibody levels, in vitro effector functions.
Exploratory Objectives
- Comparison of SumayaVac-1 (SUM-101) induced immunoglobulin isotype distribution and duration between malaria pre-exposed and malaria naïve participants from the previous Phase Ia study in Heidelberg.
- Fine scale epitope mapping of SumayaVac-1 (SUM-101) specific antibodies using peptide arrays, to investigate humoral immune response at baseline with vaccine induced responses.
- Comparison of SumayaVac-1 (SUM-101) induced cellular immunity between malaria pre-exposed and malaria naïve participants from the previous Phase Ia study in Heidelberg including fine scale epitope mapping of MSP-1 specific CD4+ and CD8+ T cells.
- Investigation of the B- and T-Cell repertoire before and after SumayaVac-1 (SUM-101) vaccination.
- Integrated transcriptome and immunoglobulin gene repertoire analyses of MSP-1 specific B-cells using single-cell technologies.
- Glycosylation patterns of MSP-1 specific functional antibodies.
- Investigate off-target IgG and IgM repertoire after SumayaVac-1 (SUM-101) vaccination using immunoproteomics.
- Investigate the structure of MSP-1 protein bound to functional antibodies by cryo-electron tomography to map conformational epitopes.
- To evaluate mechanisms of malaria specific antibody diversity generation, post-translational modification of antibodies, and B- and T-cell memory generation and maintenance.
- Ex vivo assessment of changes in human peripheral blood transcriptome in participants having received SumayaVac-1 (SUM-101) versus Verorab® rabies vaccine.
- Description of ɣδ T-cell receptor repertoire, transcriptome, functional activity and phenotypes in participants having received SumayaVac-1 (SUM-101) versus Verorab® rabies vaccine.
- Investigate impact of presence of intestinal helminth infections on SumayaVac-1(SUM-101) induced humoral immune response.
- Investigate impact of presence of intestinal helminth infections on SumayaVac-1(SUM-101) induced cellular immune response.
Study Design:
This is a randomised, controlled, double-blind, parallel group, single center Phase Ib trial to assess the safety, reactogenicity, and immunogenicity of SumayaVac-1 (SUM-101) in healthy, malaria-exposed adults of African origin aged 18-45 years.
In total, 40 participants will be enrolled (male and female). 20 participants will be randomised to receive three monthly inoculations (on D0, D28 and D56) with the investigational product, SumayaVac-1 (SUM-101), and 20 participants will be randomised to receive the registered rabies vaccine, Verorab®, as controls.
For operational reasons the participants will be split in two groups of 20 participants.
- Group 1 will have a sentinel subgroup (2 SumayaVac-1 (SUM-101) \& 1 Verorab® rabies vaccine) with a 48 hours safety surveillance period before the remaining 17 participants (8 SumayaVac-1 (SUM-101) \& 9 Verorab® rabies vaccine) of the group 1 receive their 1st vaccination.
- Group 2 will be composed of 20 participants (10 SumayaVac-1 (SUM-101) \& 10 Verorab® rabies vaccine). All visits in group 2 will be shifted by at least 3 weeks compared to group 1 to create minimal overlap of study-related activities.
After each vaccination (done on D0, D28 and D56), the participants will remain at the facility for 2 hours prior to their discharge for home. The participant will be called daily by phone (or home visits if required) until 6 days post vaccination for follow-up.
For all participants, vaccination follow-up visits at the site will occur at 7, 14 and 28 days after each vaccination.
Measurements and Procedures:
Written informed consent will be taken prior to any study procedure. Healthy participants will be screened and randomised before administration of the study IMP.
On the day of the 1st vaccination, the health status of the participant is re-checked and eligibility confirmed. Samples for safety, humoral, cellular and exploratory measurements are taken before 1st vaccination (baseline). Vaccination is administered and the participant remains at site for 2 hours before being discharged. Telephone follow-ups (or home visits if required) will be performed daily until 6 days after each vaccination. On 7, 14 and 28 days after each vaccination (done on D0, D28 and D56), the participant will be invited to come back to the facility and health status is checked.
Further participant follow-up visits will take place at D112 (W16) and D140 (W20) post 1st vaccination. Sampling for humoral and cellular responses will be performed at D112 (W16) and D140 (W20). Additionally, sampling for exploratory measurements will be performed at D112 (W16) (Vac1 + 4 month follow-up site visit).
Number of Participants with Rationale:
Vaccination: 40 adult participants Overall: 20 SumayaVac-1 (SUM-101) and 20 Verorab® control
Group 1 Sentinel sub-group
- 2 SumayaVac-1 (SUM-101)
- 1 Verorab® control
Group 1 Follower Group
- 8 SumayaVac-1 (SUM-101)
- 9 Verorab® control
Group 2
- 10 SumayaVac-1 (SUM-101)
- 10 Verorab® control
As this is a Phase I trial, no formal sample size calculation has been done. The sample size is considered sufficient to examine the safety and reactogenicity of SumayaVac-1 (SUM-101), and humoral and cellular immunogenicity.
Study Product / Intervention:
Vaccination: Intra-muscular injection of SumayaVac-1 (SUM-101) composed of 150 µg MSP-1 drug product + 5 μg GLA-SE adjuvant CHMI: Direct venous inoculation of 3.2 x 103 purified, infectious P. falciparum sporozoites
Control Intervention: Vaccination control: Intra-muscular injection of rabies vaccine (Verorab®)
Study Duration: The total study duration including the screening period (~4 weeks) combining Group 1 and 2 will be approximately 35 weeks.
The study duration for each participant will be ~24 weeks (4 weeks of screening period plus 20 weeks of vaccinations and long-term follow-up visits).
Study Centre: The Ifakara Health Institute Bagamoyo Clinical Trial Facility.
Statistical Analysis incl. Power Analysis:
See above for sample size justification. To evaluate the safety and reactogenicity primary endpoints, AEs and SAEs will be presented according to the endpoint definitions above. AE reporting will include verbatim term, preferred term (PT), system organ class (SOC), treatment, severity, relationship to the interventional products, and seriousness, reporting numbers of participants experiencing each event and total numbers of each event. Laboratory safety parameters will be summarized as absolute values and changes at 28 days after each vaccination compared to baseline (before 1st vaccination) and compared to values just prior to each vaccination.
To evaluate the immunogenicity primary endpoints as defined above, SumayaVac-1 (SUM-101) vaccine induced humoral immunogenicity will be summarized as antibody responses to SumayaVac-1 (SUM-101) by ELISA over time, and fold changes of antibody responses relative to baseline.
For all analyses, data will be listed for each participant. Descriptive analyses will be performed (number of observations, arithmetic or geometric mean, standard deviation, minimum, maximum, median, interquartile range, as appropriate, for continuous data, and counts and percentages for categorical data). Results will be presented by vaccination received.
Further details will be elaborated in a Statistical Analysis Plan (SAP), including for the secondary and exploratory objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised, controlled, double-blind, parallel group, single center Phase Ib trial to assess safety, reactogenicity, immunogenicity of a candidate dual-stage malaria vaccine, SumayaVac-1 (MSP-1 with GLA-SE as adjuvant) in healthy participants aged 18-45 years.
| Arm | Type | Receives |
|---|---|---|
| SumayaVac-1(SUM-101) | Experimental | Biological: SumayaVac-1(SUM-101)Candidate malaria Vaccine (Investigational Medicinal Product (IMP)). 20 participants will be randomised to receive three monthly inoculations of the IMP |
| Verorab | Placebo comparator | Biological: VerorabComparator used as a control. 20 participants will be randomised to receive three monthly inoculations of the comparator. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Written informed consent obtained before any study procedure.
- Literate participants aged 18-45 years of African origin.
- Female participants practicing contraception from 4 weeks before 1st immunization and both female and male participants willing to practice contraception up to 12 weeks after the last immunization.
- Available to participate in follow-up for the duration of the study.
- Contactable by phone during the whole study period.
Key exclusion criteria (15 listed)
- Previous participation in any malaria vaccine trial in the last 3 years.
- Participation in any other clinical trial involving investigational medicinal products within 30 days prior to the screening assessment.
- Previous history of drug or alcohol abuse interfering with normal social function within one year prior to enrolment.
- Previous vaccination with a rabies vaccine.
- Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating drugs) during the 13 weeks preceding the screening visit or during the study period.
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 |
|---|---|---|
| SumayaVac-1(SUM-101)One immunization every 4 weeks for 3 months (total 3 immunizations) | Biological | SumayaVac-1(SUM-101) |
| VerorabOne immunization every 4 weeks for 3 months (total 3 immunizations) | Biological | Verorab |
Primary outcome
Local and systemic adverse events (AEs) at least possibly related to the IMP after vaccination
Time frame: Recorded up to 7 days after each vaccination
Local and systemic solicited adverse events (AEs) at least possibly related to the investigational medicinal product (IMP) recorded after each vaccination (done on Day 0, Day 28 and Day 56 up to 7 days later to evaluate safety and reactogenicity of SumayaVac-1 (SUM-101)
Local and systemic unsolicited reactogenicity after vaccination
Time frame: Recorded up to 28 days after each vaccination
Local and systemic unsolicited reactogenicity recorded after each vaccination (done on Day 0, Day 28 and Day 56 up to 28 days later to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Any serious adverse events (SAE) occurring after the 1st vaccination until the participant's last visit
Time frame: Recorded from after 1st vaccination (Day 0 post-vaccination) until the participant's last visit (Day 140)
Any serious adverse events (SAE) occurring after the 1st vaccination until the participant's last visit to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Changes in laboratory safety parameters between baseline and 28 days after vaccination
Time frame: Changes recorded between baseline (Day 0 before 1st vaccination) to 28 days after each vaccination
Changes in laboratory safety parameters as defined in the protocol for every participant between baseline (Day 0 before 1st vaccination) to 28 days after each of the vaccinations to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Changes in laboratory safety parameter prior to vaccination to 28 days after that vaccination
Time frame: Changes prior to each vaccination to 28 days after proceeding with vaccination
Changes in laboratory safety parameters as defined in the protocol for every participant between values recorded just prior to each vaccination (on Day 0, Day 28 and Day 56) and values found 28 days after proceeding with vaccination to evaluate the safety and reactogenicity of SumayaVac-1 (SUM-101)
Longevity of antibody responses to SumayaVac-1 (SUM-101) by ELISA
Time frame: Titres assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Longevity of antibody responses to SumayaVac-1 (SUM-101) by ELISA for all participants at Day 0 pre-vaccination, Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20), to evaluate the humoral immunogenicity
Fold change of antibody responses to SumayaVac-1 (SUM-101) in comparison to baseline
Time frame: Fold changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Fold change of antibody responses to SumayaVac-1 (SUM-101) by ELISA in comparison to baseline (Day 0 pre-vaccination) for all participants to Day 28 (Week 4), Day 56 (Week 8), Day 84 (Week 12), Day 112 (Week 16) and Day 140 (Week 20), to evaluate the humoral immunogenicity
6 secondary outcomes
Evaluation of the opsonic phagocytosis activity of vaccine induced antibodies
Time frame: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of complement fixation, activation and/or membrane attack complex (MAC) formation of vaccine-induced antibodies
Time frame: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of antibody-dependent respiratory burst (ADRB) activity of vaccine-induced antibodies
Time frame: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of antibody-dependent cellular cytotoxicity (ADCC-NK cells) activity of vaccine-induced antibodies
Time frame: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Evaluation of immune-mediated growth inhibition activity on Plasmodium falciparum asexual blood stage cell lines
Time frame: Changes assessed between Day 0 (pre-vaccination) up to Day 140 (last follow up visit)
Comparison of MSP-1 IgG antibody concentrations by ELISA
Time frame: Antibody concentrations compared between Day 0 (pre-vaccination) up to Day 84
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 15 Apr 2024.
- Background: PubMed 32025341Blank A, Furle K, Jaschke A, Mikus G, Lehmann M, Husing J, Heiss K, Giese T, Carter D, Bohnlein E, Lanzer M, Haefeli WE, Bujard H. Immunization with full-length Plasmodium falciparum merozoite surface protein 1 is safe and elicits functional cytophilic antibodies in a randomized first-in-human trial. NPJ Vaccines. 2020 Jan 31;5(1):10. doi: 10.1038/s41541-020-0160-2. eCollection 2020.
- Derived from this study: PubMed 41210385Kahatano AE, Mpina M, Vanobberghen F, Hassan O, Urasa N, Sasamalo I, Mswata S, Paris D, Gajewski S, Saxena M, Furle K, Kiehl V, Bohnlein E, Aschenbrenner A, Lanzer M, Thomson-Luque R, Olotu A, Daubenberger C. Full-length merozoite surface protein 1 formulated with GLA-SE adjuvant in malaria pre-exposed adults: a randomised, controlled, double-blind, parallel-group, single-centre Phase Ib trial. EClinicalMedicine. 2025 Oct 25;89:103585. doi: 10.1016/j.eclinm.2025.103585. eCollection 2025 Nov.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Claudia Daubenberger, PhD study chair
Swiss Tropical & Public Health Institute
Ally Olotu, MD principal investigator
Ifakara Health Institute
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 SumayaVac-1(SUM-101) and Verorab in people with Malaria, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
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 15 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 15 Apr 2024. 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 Tanzania. 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?
Local and systemic adverse events (AEs) at least possibly related to the IMP after vaccination (time frame: Recorded up to 7 days after each vaccination). The study lists 7 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 NCT05644067, which also lists 2 linked publications.
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 15 Apr 2024.