MalariaPhase 1P27ANCT01949909
Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib
A Phase 1 study testing CH-Alum50, CH-GLA2.5/50 and TZ Ver in people with Malaria, run by Centre Hospitalier Universitaire Vaudois at 2 sites in 2 countries.
Trial summary
P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed… 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?
- CH-Alum50, CH-GLA2.5/50 and TZ Ver
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Jul 2015
- 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
- Phase Ia Inclusion criteria:
- Healthy volunteers aged 18-45 years
- General good health based on history and clinical examination
- Written informed consent obtained before any study procedure
- Female volunteers practicing contraception before and up to 13 weeks after the last immunisation
- Available to participate in follow-up for the duration of study (34 weeks)
Show all 14Show fewer
- Reachable by phone during the whole study period
- Phase Ib inclusion criteria
- Healthy male volunteers aged 18-45 years
- General good health based on history and clinical examination
- Written informed consent obtained before any study procedure
- Available to participate in follow-up for the duration of study (34 weeks)
- Reachable by phone during the whole study period
- Having always lived in an area of low malaria transmission
Who cannot join
- Phase Ia Exclusion criteria:
- Positive pregnancy test for females
- Actively breast feeding females
- Previous participation in any malaria vaccine trial
- 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 volunteers
- Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site
Show all 33Show fewer
- Enrolment in any other clinical trial during the whole trial period
- Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- Known hypersensitivity to any of the vaccine components (adjuvant or peptide)
- Vaccination or infusion of gammaglobulin from 4 weeks prior to the first vaccination and up to 6 weeks after the third vaccination
- Any history of malaria
- History of living in a malaria endemic area for more than five (5) years OR living in a malaria endemic area in early childhood. For practical purposes, all regions for which malaria chemoprophylaxis is advised by travel clinic are considered malaria endemic (cf. www.safetravel.ch).
- Known exposure to malaria in the previous six (6) months, defined as a visit to a malaria endemic region
- P27A ELISA positive OR parasite ELISA antibody positive AND Known exposure to malaria in a malaria endemic area
- P27A ELISA positive AND parasite ELISA antibody positive (with or without history of stay in a malaria endemic area)
- Intention to travel to malaria endemic countries during the study period
- Positive HIV, HBV or HCV tests
- Phase Ib exclusion criteria
- Previously participated in any malaria vaccine trial
- 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 volunteers
- Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site
- Enrolment in any other clinical trial during the whole trial period
- Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the thirteen weeks preceding the screening visit or during the trial period except topical and inhaled steroids
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- Known hypersensitivity to any of the vaccine components (adjuvant or peptide) or to any of the control vaccine components
- Vaccination OR infusion of gammaglobulins from four (4) weeks prior to the first vaccination and up to six (6) weeks after the third vaccination
- Previous vaccination with the control vaccine
- Positive HIV, HCV test or HBVsAg positive
- Malaria parasite positivity by microscopy and/or RDT
- Having had a history of confirmed malaria episode in the last five year
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial
P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).
- Conditions
- Malaria
- Being tested
- CH-Alum50, CH-GLA2.5/50, TZ Ver, TZ Alum 50, TZ GLA 2.5/10
- Keywords
- plasmodium falciparum, long synthetic peptide, antibody, T cell, cytokine, vaccine, safety, phase 1
- 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.
CH-Alum50Biological
intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)
CH-GLA2.5/50Biological
intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)
TZ VerBiological
intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections
TZ Alum 50Biological
intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg)
TZ GLA 2.5/10Biological
intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg)
TZ GLA5/50Biological
intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg)
TZ GLA2.5/50Biological
intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)
| Study group | Role | What they receive |
|---|---|---|
| Alhydrogel CH-Alum50 | Experimental | intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg) Receives: Biological: CH-Alum50 |
| CH-GLA2.5/50 | Experimental | intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg) Receives: Biological: CH-GLA2.5/50 |
| Control rabies vaccine Verorub TM TZ Ver | Placebo comparator | intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections Receives: Biological: TZ Ver |
| Alhydrogel TZ Alum 50 | Experimental | intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg) Receives: Biological: TZ Alum 50 |
| GLA-SE TZ GLA 2.5/10 | Experimental | intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg) Receives: Biological: TZ GLA 2.5/10 |
| GLA-SE TZ GLA5/50 | Experimental | intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg) Receives: Biological: TZ GLA5/50 |
| GLA-SE TZ GLA2.5/50 | Experimental | intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg) Receives: Biological: TZ GLA2.5/50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite
The safety profile will be assessed on the basis of immediate local and systemic reactogenicity measured from Day 0 to Day 28 after each vaccination
Measured: 15 months
Secondary outcomes (2)
Assessment of the humoral immune response to the vaccine antigen
The humoral response to the vaccine antigen will be assessed in all volunteers by ELISA to measure the level of total antigen specific IgG.
Measured: 15 months
Assessment of the cellular immune response to the vaccine antigen
The cellular immune response will be assessed in all volunteers by measuring the T cell proliferation and cytokine production following in vitro stimulation with the vaccine antigen (by Luminex on cell culture supernatant after in vitro stimulation of PBMC for 6 days with the P27A peptide). Proliferation of carboxyfluorescein diacetate succinimidyl ester (CFSE) loaded CD3+ CD4+ and CD3+CD8+ T cells will be assayed by using polychromatic flow cytometry.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
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 MalariaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Principal investigator, François Spertini, Centre Hospitalier Universitaire Vaudois
- Investigators
- François Spertini, MD, Principal investigator, Centre hospitalier universitaire vaudois (CHUV)Salim Abdulla, MD, Principal investigator, Bagamoyo Research and Training Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949909
- Sponsor's protocol ID
- P27A_1_13
- Acronym
- P27A
- Status last verified
- Jul 2018
- First submitted
- 29 Aug 2013
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Steiner-Monard V, Kamaka K, Karoui O, Roethlisberger S, Audran R, Daubenberger C, Fayet-Mello A, Erdmann-Voisin A, Felger I, Geiger K, Govender L, Houard S, Huber E, Mayor C, Mkindi C, Portevin D, Rusch S, Schmidlin S, Tiendrebeogo RW, Theisen M, Thierry AC, Vallotton L, Corradin G, Leroy O, Abdulla S, Shekalaghe S, Genton B, Spertini F, Jongo SA. The Candidate Blood-stage Malaria Vaccine P27A Induces a Robust Humoral Response in a Fast Track to the Field Phase 1 Trial in Exposed and Nonexposed Volunteers. Clin Infect Dis. 2019 Jan 18;68(3):466-474. doi: 10.1093/cid/ciy514.
PubMed 29945169
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial
- ClinicalTrials.gov ID
- NCT01949909
- Acronym / sponsor ID
- P27A / P27A_1_13
- Conditions
- Malaria
- Keywords
- plasmodium falciparum, long synthetic peptide, antibody, T cell, cytokine, vaccine, safety, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Sep 2013 (estimated)
- 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.
P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Alhydrogel CH-Alum50 | Experimental | Biological: CH-Alum50intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg) |
| CH-GLA2.5/50 | Experimental | Biological: CH-GLA2.5/50intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg) |
| Control rabies vaccine Verorub TM TZ Ver | Placebo comparator | Biological: TZ Verintramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections |
| Alhydrogel TZ Alum 50 | Experimental | Biological: TZ Alum 50intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg) |
| GLA-SE TZ GLA 2.5/10 | Experimental | Biological: TZ GLA 2.5/10intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg) |
| GLA-SE TZ GLA5/50 | Experimental | Biological: TZ GLA5/50intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg) |
| GLA-SE TZ GLA2.5/50 | Experimental | Biological: TZ GLA2.5/50intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Phase Ia Inclusion criteria:
- Phase Ib inclusion criteria
Key exclusion criteria (33 listed)
- Phase Ia Exclusion criteria:
- Phase Ib exclusion criteria
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 |
|---|---|---|
| CH-Alum50intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg) | Biological | Alhydrogel CH-Alum50 |
| CH-GLA2.5/50intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg) | Biological | CH-GLA2.5/50 |
| TZ Verintramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections | Biological | Control rabies vaccine Verorub TM TZ Ver |
| TZ Alum 50intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg) | Biological | Alhydrogel TZ Alum 50 |
| TZ GLA 2.5/10intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg) | Biological | GLA-SE TZ GLA 2.5/10 |
| TZ GLA5/50intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg) | Biological | GLA-SE TZ GLA5/50 |
| TZ GLA2.5/50intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg) | Biological | GLA-SE TZ GLA2.5/50 |
Primary outcome
To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite
Time frame: 15 months
The safety profile will be assessed on the basis of immediate local and systemic reactogenicity measured from Day 0 to Day 28 after each vaccination
2 secondary outcomes
Assessment of the humoral immune response to the vaccine antigen
Time frame: 15 months
Assessment of the cellular immune response to the vaccine antigen
Time frame: 15 months
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 18 Jul 2018.
- Derived from this study: PubMed 29945169Steiner-Monard V, Kamaka K, Karoui O, Roethlisberger S, Audran R, Daubenberger C, Fayet-Mello A, Erdmann-Voisin A, Felger I, Geiger K, Govender L, Houard S, Huber E, Mayor C, Mkindi C, Portevin D, Rusch S, Schmidlin S, Tiendrebeogo RW, Theisen M, Thierry AC, Vallotton L, Corradin G, Leroy O, Abdulla S, Shekalaghe S, Genton B, Spertini F, Jongo SA. The Candidate Blood-stage Malaria Vaccine P27A Induces a Robust Humoral Response in a Fast Track to the Field Phase 1 Trial in Exposed and Nonexposed Volunteers. Clin Infect Dis. 2019 Jan 18;68(3):466-474. doi: 10.1093/cid/ciy514.
- European Vaccine InitiativeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
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.
François Spertini, MD principal investigator
Centre hospitalier universitaire vaudois (CHUV)
Salim Abdulla, MD principal investigator
Bagamoyo Research and Training Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CH-Alum50, CH-GLA2.5/50 and TZ Ver in people with Malaria, run by Centre Hospitalier Universitaire Vaudois at 2 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 14 inclusion and 33 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, 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?
To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite (time frame: 15 months). 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 NCT01949909, 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 18 Jul 2018.