MalariaPhase 1MSP3TNNCT00469651
Phase Ib Trial of MSP3 LSP in Children in Tanzania
A Phase 1 study testing MSP 3 Long Synthetic Peptide, MSP3 vaccine and Hepatitis B vaccine in people with Malaria, run by African Malaria Network Trust at 1 site in Tanzania.
Trial summary
This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission. Written informed consent will be sought from all guardians/parents of potentially participating children. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- MSP 3 Long Synthetic Peptide, MSP3 vaccine and Hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTanzania
- Study dates
- Oct 2007to Aug 2008
- 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 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 1-2 years old
- Healthy by medical history and physical examination
- Signed /thumb printed informed Consent by guardian/parent
- Resident in the study area village 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 means prednisolone 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 out of range, more specifically refer to table 4.
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, 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 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.
Tanzania1 site, 1 recruiting
- Recruiting
Kwashemshi village
Korogwe, Tanga
John P Lusingu, MD, PhD, +255 787 679515, jlusingu@tanga.mimcom.net
John P Lusingu, MD, PhD
About this study
Official title: A Double Blind, Randomized, Controlled Phase Ib Field Trial in 12 to 24 Month Old Children in Tanzania to Evaluate the Safety and Immunogenicity of Candidate Malaria Vaccine MSP 3 Versus Hepatitis B Vaccine
This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission.
Written informed consent will be sought from all guardians/parents of potentially participating children. Eligible children will be randomly allocated to receive either the the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all the study children and neither the clinical investigators nor the children's parents will be aware of which vaccine has been administered during the initial four months of the study. The study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15 children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited symptoms will also be collected throughout the study duration.
The study will be overseen by an international safety monitoring committee who will follow safety matters closely as the trial progresses. The study will also be approved by the Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London school of hygiene and tropical medicine ethics committee. The study is planned to last 13 months for each participant.
Read the detailed description
The study is a double blind (observer blind, participant blind), randomized, controlled, dose escalation, Age deescalation, phase Ib study. It will include two parallel groups as follows:
- Group 1: 23 subjects (15 subjects receiving MSP3-LSP vaccine 15 µg and 8 subjects receiving Hepatitis B vaccine).
- Group 2: 22 subjects (15 subjects receiving MSP3-LSP vaccine 30 µg and 7 subjects receiving Hepatitis B vaccine).
The Immunization schedule will be 0, 1, and 2 months for all cohorts and provisionally as following for each group:
- Study days 0, 28 and 56 for group 1
- Study days 14, 42, 70 for group 2 Vaccinations of groups 1 and 2 will be staggered: immunization in group 2 will start 2 weeks after group 1. This interval may be extended if deemed necessary in case of serious adverse events or other safety concerns. Randomization will be done for each group at the time of first vaccinations and only the study pharmacist will be aware of which vaccine is allocated to a particular study ID number. The pharmacist will have no other role and will be sworn to confidentiality.
The study vaccine will be administered through the subcutaneous injection into right or left deltoid (alternately). Each child will be observed for at least 60 minutes after vaccination to evaluate and treat any acute adverse events.
This will be followed by a Seven (7) day follow-up period for solicited adverse events (day of vaccination plus 6 subsequent days; twenty eight (28) day follow-up period for unsolicited adverse events (Vaccination day plus 27 subsequent days). The follow-up of serious adverse events (SAE's) for 12 months after the first dose of study vaccine (9 months after dose 3). Biological safety will be evaluated through regular physical examinations, blood sampling for routine clinical chemistry, and hematology). At the end of the follow-up period for unsolicited AEs (i.e., one month after the third dose), children will be followed by field workers at home at monthly intervals to record SAEs. There are 10 clinic visits planned, however, participants will be advised to report to the clinic any time they feel unwell.
Data collection will be through participant record files from which transcription on to conventional Case Report Forms will be done. All the date on the CRFs will be verified by the clinical Monitor. The database will be locked after study day 84 to allow for an interim analysis to review safety and immunogenicity thus collected.
- Conditions
- Malaria
- Being tested
- MSP 3 Long Synthetic Peptide, MSP3 vaccine, Hepatitis B vaccine, MSP3 candidate vaccine, Hepatitis B control vaccine
- Keywords
- Malaria, vaccine, MSP3LSP, Safety, children, Tanzania
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP 3 Long Synthetic PeptideBiological
Lyophilized MSP3 vaccine adjuvanted in Aluminium hydroxide
MSP3 vaccineBiological
Lyophilized vaccine adjuvanted in Aluminium hydroxide
Hepatitis B vaccineBiological
Hepatitis B vaccine adjuvanted in Aluminium hydroxide
MSP3 candidate vaccineBiological
Lyophilized MSP3 adjuvanted in Aluminium hydroxide
Hepatitis B control vaccineBiological
Hepatitis B vaccine adjuvanted in Aluminium Hydroxide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 15 microgramme candidate vaccine Receives: Biological: MSP3 vaccine |
| 2 | Active comparator | Hepatitis B vaccine Receives: Biological: Hepatitis B vaccine |
| 3 | Experimental | 30 microgramme MSP3 candidate malaria vaccine Receives: Biological: MSP 3 Long Synthetic Peptide; Biological: MSP3 candidate vaccine |
| 4 | Active comparator | Hepatitis B control vaccine Receives: Biological: Hepatitis B control vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MSP3 by assessing the reactogenicity
Measured: Solicited and unsolicited adverse events (immediate reactogenicity within 60 minutes of each vaccination; 7-day assessment, and 28 days
Secondary outcomes (1)
The humoral response to vaccine antigens will be assessed by measuring by ELISA
Measured: ELISA on D0, D28, D56, D84, D168 and D365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startOct 2007
- Study completionAug 2008 (estimated)
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.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- African Malaria Network Trust
- Sponsor type
- Research network
- Collaborators
- London School of Hygiene and Tropical Medicine
- Investigators
- Martha M Lemnge, MS, PhD, Study director, National Institute For Medical Research in TanzaniaJohn P Lusingu, MD, PhD, Principal investigator, National Institute for Medical Research in Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469651
- Sponsor's protocol ID
- MSP3_TN_0303
- Other IDs
- MSP3 TN_03_03
- Acronym
- MSP3TN
- Status last verified
- Dec 2007
- First submitted
- 3 May 2007
- Last updated
- 14 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lusingu JP, Gesase S, Msham S, Francis F, Lemnge M, Seth M, Sembuche S, Rutta A, Minja D, Segeja MD, Bosomprah S, Cousens S, Noor R, Chilengi R, Druilhe P. Satisfactory safety and immunogenicity of MSP3 malaria vaccine candidate in Tanzanian children aged 12-24 months. Malar J. 2009 Jul 17;8:163. doi: 10.1186/1475-2875-8-163.
PubMed 19607731
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Controlled Phase Ib Field Trial in 12 to 24 Month Old Children in Tanzania to Evaluate the Safety and Immunogenicity of Candidate Malaria Vaccine MSP 3 Versus Hepatitis B Vaccine
- ClinicalTrials.gov ID
- NCT00469651
- Acronym / sponsor ID
- MSP3TN / MSP3_TN_0303
- Conditions
- Malaria
- Keywords
- Malaria, vaccine, MSP3LSP, Safety, children, Tanzania
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- African Malaria Network TrustResearch network
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Oct 2007
- Study completion
- Aug 2008 (estimated)
- First posted
- 4 May 2007 (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.
This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission.
Written informed consent will be sought from all guardians/parents of potentially participating children. Eligible children will be randomly allocated to receive either the the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all the study children and neither the clinical investigators nor the children's parents will be aware of which vaccine has been administered during the initial four months of the study. The study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15 children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited symptoms will also be collected throughout the study duration.
The study will be overseen by an international safety monitoring committee who will follow safety matters closely as the trial progresses. The study will also be approved by the Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London school of hygiene and tropical medicine ethics committee. The study is planned to last 13 months for each participant.
Detailed description
The study is a double blind (observer blind, participant blind), randomized, controlled, dose escalation, Age deescalation, phase Ib study. It will include two parallel groups as follows:
- Group 1: 23 subjects (15 subjects receiving MSP3-LSP vaccine 15 µg and 8 subjects receiving Hepatitis B vaccine).
- Group 2: 22 subjects (15 subjects receiving MSP3-LSP vaccine 30 µg and 7 subjects receiving Hepatitis B vaccine).
The Immunization schedule will be 0, 1, and 2 months for all cohorts and provisionally as following for each group:
- Study days 0, 28 and 56 for group 1
- Study days 14, 42, 70 for group 2 Vaccinations of groups 1 and 2 will be staggered: immunization in group 2 will start 2 weeks after group 1. This interval may be extended if deemed necessary in case of serious adverse events or other safety concerns. Randomization will be done for each group at the time of first vaccinations and only the study pharmacist will be aware of which vaccine is allocated to a particular study ID number. The pharmacist will have no other role and will be sworn to confidentiality.
The study vaccine will be administered through the subcutaneous injection into right or left deltoid (alternately). Each child will be observed for at least 60 minutes after vaccination to evaluate and treat any acute adverse events.
This will be followed by a Seven (7) day follow-up period for solicited adverse events (day of vaccination plus 6 subsequent days; twenty eight (28) day follow-up period for unsolicited adverse events (Vaccination day plus 27 subsequent days). The follow-up of serious adverse events (SAE's) for 12 months after the first dose of study vaccine (9 months after dose 3). Biological safety will be evaluated through regular physical examinations, blood sampling for routine clinical chemistry, and hematology). At the end of the follow-up period for unsolicited AEs (i.e., one month after the third dose), children will be followed by field workers at home at monthly intervals to record SAEs. There are 10 clinic visits planned, however, participants will be advised to report to the clinic any time they feel unwell.
Data collection will be through participant record files from which transcription on to conventional Case Report Forms will be done. All the date on the CRFs will be verified by the clinical Monitor. The database will be locked after study day 84 to allow for an interim analysis to review safety and immunogenicity thus collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MSP3 vaccine15 microgramme candidate vaccine |
| 2 | Active comparator | Biological: Hepatitis B vaccineHepatitis B vaccine |
| 3 | Experimental | Biological: MSP 3 Long Synthetic Peptide, Biological: MSP3 candidate vaccine30 microgramme MSP3 candidate malaria vaccine |
| 4 | Active comparator | Biological: Hepatitis B control vaccineHepatitis B control vaccine |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1-2 years old
- Healthy by medical history and physical examination
- Signed /thumb printed informed Consent by guardian/parent
- Resident in the study area village 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 means prednisolone 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 |
|---|---|---|
| MSP 3 Long Synthetic PeptideLyophilized MSP3 vaccine adjuvanted in Aluminium hydroxide | Biological | 3 |
| MSP3 vaccineLyophilized vaccine adjuvanted in Aluminium hydroxide | Biological | 1 |
| Hepatitis B vaccineHepatitis B vaccine adjuvanted in Aluminium hydroxide | Biological | 2 |
| MSP3 candidate vaccineLyophilized MSP3 adjuvanted in Aluminium hydroxide | Biological | 3 |
| Hepatitis B control vaccineHepatitis B vaccine adjuvanted in Aluminium Hydroxide | Biological | 4 |
Primary outcome
Safety of MSP3 by assessing the reactogenicity
Time frame: Solicited and unsolicited adverse events (immediate reactogenicity within 60 minutes of each vaccination; 7-day assessment, and 28 days
1 secondary outcome
The humoral response to vaccine antigens will be assessed by measuring by ELISA
Time frame: ELISA on D0, D28, D56, D84, D168 and D365
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2007.
- Derived from this study: PubMed 19607731Lusingu JP, Gesase S, Msham S, Francis F, Lemnge M, Seth M, Sembuche S, Rutta A, Minja D, Segeja MD, Bosomprah S, Cousens S, Noor R, Chilengi R, Druilhe P. Satisfactory safety and immunogenicity of MSP3 malaria vaccine candidate in Tanzanian children aged 12-24 months. Malar J. 2009 Jul 17;8:163. doi: 10.1186/1475-2875-8-163.
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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.
Martha M Lemnge, MS, PhD study director
National Institute For Medical Research in Tanzania
John P Lusingu, MD, PhD principal investigator
National Institute for Medical Research in Tanzania
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 MSP 3 Long Synthetic Peptide, MSP3 vaccine and Hepatitis B vaccine in people with Malaria, run by African Malaria Network Trust 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 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: status not confirmed, as of the sponsor's last update on 14 Dec 2007. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roma Chilengi, MD, MSc (+255 22 2700018, chilengi@amanet-trust.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of MSP3 by assessing the reactogenicity (time frame: Solicited and unsolicited adverse events (immediate reactogenicity within 60 minutes of each vaccination; 7-day assessment, and 28 days). 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 NCT00469651, 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 14 Dec 2007.