MalariaPhase 2MSP3-POCNCT01341704
Proof-of-Concept Study of MSP3-LSP Vaccine to Protect Against Malaria in Africa
A Phase 2 study testing MSP3-LSP/AlOH, Verorab Vaccine and 0.9% NaCl/Normal Saline in people with Malaria, run by Vac4All at 1 site in Mali.
Trial summary
Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days after the 3rd immunization until 1 year after. Read more about this study
- Who is it for?
- Ages 12 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- MSP3-LSP/AlOH, Verorab Vaccine and 0.9% NaCl/Normal Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteMali
- Study dates
- May 2011to Mar 2013
- Phase
- Phase 2
- 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 12 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 12-48 months old
- Healthy by medical history, physical examination and laboratory investigation
- Signed/thumb printed informed Consent by guardian/parent
- Resident in the study area villages during the whole trial period
Who cannot join
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the subjects
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
- Laboratory abnormalities on screened blood samples.
Show all 12Show fewer
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria/pertussis/tetanus vaccines) which may be given 14 days or more before or after vaccination
- Evidence of chronic or active hepatitis B or C infection
- Presence of chronic illness that, in the judgment of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- History of surgical splenectomy.
- Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2
Trial locations and contacts
1 site in 1 country.
Mali1 site
Malaria Research and Training Center Department of Epidemiology of Parasitic Diseases Faculty of Medicine, Pharmacy and Dentistry University of Bamako BP 1805, Point G Bamako, Mali, West Africa Tel/Fax 223-2022-8109
Bamako, 1805
About this study
Official title: Phase 2B Double Blind, Randomized, Controlled Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of MSP3-LSP Vaccine Candidate Adjuvanted in Aluminium Hydroxide (AIOH) Against Plasmodium Falciparum Clinical Malaria in Healthy Children Aged 12-48 Months in Mali
Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days after the 3rd immunization until 1 year after.
The primary objective of this double-blind, randomized, controlled trial will be to assess the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in children aged 12-48 months against all clinical malaria episodes occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization, when administered according to the following schedule:- Primary administration: Three doses of administered 4 weeks apart
Read more
Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the trial; and two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1
Case definition for an episode of malaria is a febrile illness with axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥ 5000 per μL
Read the detailed description
This is a Phase 2 b, randomized, controlled trial, comparing MSP3-LSP experimental malaria vaccine with the comparator Verorab rabies vaccine (primary series) and normal saline (secondary/booster series). The trial is being conducted in two sites, Doneguebougou and surroundings (Koulikoro) and Bougoula Hameau and surroundings (Sikasso).
Each site will enroll 400 subjects. Subjects aged 12-48 months will be enrolled and randomized in a 1:1 ratio to receive either 30 µg of MSP3-LSP/AlOH in 0.5 mL or the control vaccine, Verorab Rabies subcutaneously.
The primary series of vaccinations will be given on days 0, 28 and 56. The first of the secondary/booster series will be administered 3 months after completing the primary series (D146) in Year 1, and the subsequent booster doses will be administered one year after the 3rd dose (D416) and one year after the first booster dose (D506) in Year 2.
For safety, occurrence of adverse events will be solicited during daily home visit by field workers for 6 days after each vaccination. Unsolicited adverse events will be documented for the following 28 days after each dose.
For efficacy, suspect cases will be detected through weekly home visits following the 1st vaccination and continuing throughout the duration of the trial.
In addition to active case detection through home visits, parents and care-givers of the subjects will be advised of signs and symptom of illness and instructed to bring sick children to the on-site clinic for assessment and treatment. Study clinical staff will be available round-the clock for the entire duration of the trial. During these unscheduled visits malaria smears, blood paper filter and hemoglobin will be done in case of signs or symptoms compatible with clinical malaria.
Children will be followed for two years following the first vaccination. Clinic visits are scheduled throughout the follow-up period for clinical assessment, malaria smear, blood paper filter and hemoglobin systematically on days 0, 28, 56, 86, 116, 146, 180, 236, 326, 416, 446, 506, 536 and 730. The humoral immune response to the vaccine antigen will be assessed using ELISA on days 0, 28, 56, 86, 116, 146, 180, 236, 416, 446, 506, and 730. Cellular immune responses to the vaccine antigens (MSP3-LSP and peptides a,b,c,d) will be assessed on days 0, 86,146, and 416 using CBA on a subset of 50 MSP3 vaccinated individuals. The functionality of the induced immune responses using Western Blot (WB) method and ADCI technique will be evaluated at screening and on days 86, 146, 236, 416, 506 and 730.
- Conditions
- Malaria
- Being tested
- MSP3-LSP/AlOH, Verorab Vaccine, 0.9% NaCl/Normal Saline
- Keywords
- malaria, vaccine, clinical trials, proof of concept, efficacy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP3-LSP/AlOHBiological
30 µg of test vaccine MSP3-LSP/AlOH, administered by subcutaneous route according to the following schedule:- Primary administration: Three doses administered at 4 weeks interval: D0, D28 (± 2 days), D56 (± 4 days)
Secondary administration (Boost):
Year 1: One dose 3 months after the third dose Year 2: Two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1
Verorab VaccineBiological
The Verorab rabies vaccine will be given as control for the primary series of the experimental vaccine. It consists of inactivated rabies virus produced in vero cells (Wistar Rabies PM/W138 1503-3M (inactivated). Manufacturer SANOFI PASTEUR SA. Presentation is 0.5 ml per dose in a pre-filled syringe.
0.9% NaCl/Normal SalineOther
0.5 ml per dose; to be given as control for the secondary/booster doses of experimental vaccine
| Study group | Role | What they receive |
|---|---|---|
| MSP3-LSP/AlOH | Experimental | Synthetic polyprotein of 96 amino acids (186-276 in 3D7 strain) manufactured by solid-phase synthesis by SYNPROSIS, France; lyophilized product was formulated extemporaneously with aluminum hydroxide (Reheis). 30 microgram per dose; three dose schedule on study day 0, 28 and 56 for primary series Receives: Biological: MSP3-LSP/AlOH |
| Control | Placebo comparator | Primary series: Verorab Rabies vaccine; Secondary/Booster series: 0.9% NaCL/Normal Saline Receives: Biological: Verorab Vaccine; Other: 0.9% NaCl/Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of clinical malaria occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization in all subjects.
A clinical malaria episode is defined as a febrile illness with a documented axillary temperature of
Measured: 3 months
Secondary outcomes (3)
Number of subjects with solicited adverse events
In this study, the following symptoms will directly be solicited for during 7 days immediately following each vaccination.
Solicited Local (injection site) adverse events
- Pain at injection site
- Swelling at injection site
- Induration at injection site
- Erythema at injection site
- Pruritus at injection
Solicited systemic adverse events
- Fever (defined as axillary temperature ≥ 37.5°C)
- Drowsiness
- Loss of appetite
- Irritability/fussiness
Measured: 7 days following each vaccination
Number of subjects with unsolicited adverse events
All the adverse events/reactions, whether observed by the investigator or reported by the subject, will be documented. For each event/reaction the following details will be recorded: 1) description of the event(s)/reaction(s), 2) date and time of occurrence, 3) duration, 4) intensity, 5)assessment of relationship to the vaccine, 6) action taken including treatment, 7) outcome.
Measured: 30 days following each vaccination
Number of subjects with serious adverse events
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,
- results in persistent or significant disability/incapacity, or
- is a congenital anomaly/birth defect.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vac4All
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bamako
- Responsible party
- Sponsor
- Investigators
- Mahamadou Sissoko, MD, Principal investigator, Malaria Research and Training Center Department of Epidemiology of Parasitic Diseases Faculty of Medicine, Pharmacy and Dentistry University of Bamako BP 1805, Point G Bamako, Mali, West AfricaPierre L Druilhe, MD, Study director, CEO, Vac4AllOgobara Doumbo, MD, Study director, Chief, MRTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341704
- Sponsor's protocol ID
- MMVDU-013
- Acronym
- MSP3-POC
- Status last verified
- Aug 2015
- First submitted
- 23 Apr 2011
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2B Double Blind, Randomized, Controlled Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of MSP3-LSP Vaccine Candidate Adjuvanted in Aluminium Hydroxide (AIOH) Against Plasmodium Falciparum Clinical Malaria in Healthy Children Aged 12-48 Months in Mali
- ClinicalTrials.gov ID
- NCT01341704
- Acronym / sponsor ID
- MSP3-POC / MMVDU-013
- Conditions
- Malaria
- Keywords
- malaria, vaccine, clinical trials, proof of concept, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Vac4AllIndustry (pharma, biotech, devices)
- Collaborators
- University of Bamako
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Apr 2011 (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.
Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days after the 3rd immunization until 1 year after.
The primary objective of this double-blind, randomized, controlled trial will be to assess the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in children aged 12-48 months against all clinical malaria episodes occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization, when administered according to the following schedule:- Primary administration: Three doses of administered 4 weeks apart
Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the trial; and two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1
Case definition for an episode of malaria is a febrile illness with axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥ 5000 per μL
Detailed description
This is a Phase 2 b, randomized, controlled trial, comparing MSP3-LSP experimental malaria vaccine with the comparator Verorab rabies vaccine (primary series) and normal saline (secondary/booster series). The trial is being conducted in two sites, Doneguebougou and surroundings (Koulikoro) and Bougoula Hameau and surroundings (Sikasso).
Each site will enroll 400 subjects. Subjects aged 12-48 months will be enrolled and randomized in a 1:1 ratio to receive either 30 µg of MSP3-LSP/AlOH in 0.5 mL or the control vaccine, Verorab Rabies subcutaneously.
The primary series of vaccinations will be given on days 0, 28 and 56. The first of the secondary/booster series will be administered 3 months after completing the primary series (D146) in Year 1, and the subsequent booster doses will be administered one year after the 3rd dose (D416) and one year after the first booster dose (D506) in Year 2.
For safety, occurrence of adverse events will be solicited during daily home visit by field workers for 6 days after each vaccination. Unsolicited adverse events will be documented for the following 28 days after each dose.
For efficacy, suspect cases will be detected through weekly home visits following the 1st vaccination and continuing throughout the duration of the trial.
In addition to active case detection through home visits, parents and care-givers of the subjects will be advised of signs and symptom of illness and instructed to bring sick children to the on-site clinic for assessment and treatment. Study clinical staff will be available round-the clock for the entire duration of the trial. During these unscheduled visits malaria smears, blood paper filter and hemoglobin will be done in case of signs or symptoms compatible with clinical malaria.
Children will be followed for two years following the first vaccination. Clinic visits are scheduled throughout the follow-up period for clinical assessment, malaria smear, blood paper filter and hemoglobin systematically on days 0, 28, 56, 86, 116, 146, 180, 236, 326, 416, 446, 506, 536 and 730. The humoral immune response to the vaccine antigen will be assessed using ELISA on days 0, 28, 56, 86, 116, 146, 180, 236, 416, 446, 506, and 730. Cellular immune responses to the vaccine antigens (MSP3-LSP and peptides a,b,c,d) will be assessed on days 0, 86,146, and 416 using CBA on a subset of 50 MSP3 vaccinated individuals. The functionality of the induced immune responses using Western Blot (WB) method and ADCI technique will be evaluated at screening and on days 86, 146, 236, 416, 506 and 730.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSP3-LSP/AlOH | Experimental | Biological: MSP3-LSP/AlOHSynthetic polyprotein of 96 amino acids (186-276 in 3D7 strain) manufactured by solid-phase synthesis by SYNPROSIS, France; lyophilized product was formulated extemporaneously with aluminum hydroxide (Reheis). 30 microgram per dose; three dose schedule on study day 0, 28 and 56 for primary series |
| Control | Placebo comparator | Biological: Verorab Vaccine, Other: 0.9% NaCl/Normal SalinePrimary series: Verorab Rabies vaccine; Secondary/Booster series: 0.9% NaCL/Normal Saline |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 12-48 months old
- Healthy by medical history, physical examination and laboratory investigation
- Signed/thumb printed informed Consent by guardian/parent
- Resident in the study area villages during the whole trial period
Key exclusion criteria (12 listed)
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the subjects
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
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 |
|---|---|---|
| MSP3-LSP/AlOH30 µg of test vaccine MSP3-LSP/AlOH, administered by subcutaneous route according to the following schedule:- Primary administration: Three doses administered at 4 weeks interval: D0, D28 (± 2 days), D56 (± 4 days) Secondary administration (Boost): Year 1: One dose 3 months after the third dose Year 2: Two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1 | Biological | MSP3-LSP/AlOH |
| Verorab VaccineThe Verorab rabies vaccine will be given as control for the primary series of the experimental vaccine. It consists of inactivated rabies virus produced in vero cells (Wistar Rabies PM/W138 1503-3M (inactivated). Manufacturer SANOFI PASTEUR SA. Presentation is 0.5 ml per dose in a pre-filled syringe. | Biological | Control |
| 0.9% NaCl/Normal Saline0.5 ml per dose; to be given as control for the secondary/booster doses of experimental vaccine | Other | Control |
Primary outcome
Number of episodes of clinical malaria occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization in all subjects.
Time frame: 3 months
A clinical malaria episode is defined as a febrile illness with a documented axillary temperature of
3 secondary outcomes
Number of subjects with solicited adverse events
Time frame: 7 days following each vaccination
Number of subjects with unsolicited adverse events
Time frame: 30 days following each vaccination
Number of subjects with serious adverse events
Time frame: 2 years
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 31 Aug 2015.
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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.
Mahamadou Sissoko, MD principal investigator
Malaria Research and Training Center Department of Epidemiology of Parasitic Diseases Faculty of Medicine, Pharmacy and Dentistry University of Bamako BP 1805, Point G Bamako, Mali, West Africa
Pierre L Druilhe, MD study director
CEO, Vac4All
Ogobara Doumbo, MD study director
Chief, MRTC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSP3-LSP/AlOH, Verorab Vaccine and 0.9% NaCl/Normal Saline in people with Malaria, run by Vac4All at 1 site in Mali.
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 4 inclusion and 12 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 31 Aug 2015. 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 Mali. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of episodes of clinical malaria occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization in all subjects. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2015; AzTrials last refreshed its copy on 26 Oct 2026.