Malaria, FalciparumPhase 1/2MAL019NCT01556945
Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
A Phase 1/2 study testing FMP1/AS02, RTS,S/AS02 and AS02 adjuvant alone in people with Malaria, Falciparum, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- FMP1/AS02, RTS,S/AS02 and AS02 adjuvant alone
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Feb 2002
- Phase
- Phase 1/2
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult, 18-45
- Available for duration of study (9 months)
- Written informed consent prior to any study procedures
Who cannot join
- Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21
- Use of any investigational or non-registered drug/vaccine or planned administration of vaccine not foreseen by study protocol; each issue within 30 days preceding the first dose of study vaccine
- Administration of chronic immunosuppressants
- Chronic use of antibiotics
- History of malaria ever, or use of malaria chemoprophylaxis within 60 days prior to vaccination
- Known exposure to malaria within the past 12 months or planned travel to malarious area during the study period
Show all 17Show fewer
- Confirmed or suspected immunosuppressive or immunodeficient condition
- Family history of congenital or hereditary immunodeficiency
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
- Chronic or active neurologic disease including seizures
- History of splenectomy
- Seropositive for hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV), or other abnormal labs such as significant anemia, elevated creatinine
- Hepatomegaly, or right upper quadrant abdominal pain
- Pregnant or lactating female
- Chronic or active drug or alcohol use
- History of severe reactions to mosquito bites
- Any history of anaphylaxis to vaccinations
Trial locations and contacts
1 site in 1 country.
United States1 site
WRAIR Clinical Trials Center
Silver Spring, Maryland, 20910
About this study
Official title: Phase I/IIa Safety, Immunogenicity, and Preliminary Efficacy of an Administration Schedule of FMP1 and SmithKlineBeecham Biologicals' Candidate Malaria Vaccine RTS,S Each Adjuvanted With SBAS2, Given Concomitantly in Separate Injections
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection.
The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.
- Conditions
- Malaria, Falciparum
- Being tested
- FMP1/AS02, RTS,S/AS02, AS02 adjuvant alone, Malaria challenge
- Keywords
- P. falciparum, vaccine, healthy volunteers
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMP1/AS02Biological
The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02.
RTS,S/AS02Biological
The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S.
AS02 adjuvant aloneOther
AS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml.
Malaria challengeOther
Experimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored.
| Study group | Role | What they receive |
|---|---|---|
| Group A : FMP1/AS02 + RTS,S/AS02 | Experimental | FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Receives: Biological: FMP1/AS02; Biological: RTS,S/AS02; Other: Malaria challenge |
| Group B : FMP1/AS02 + RTS,S/AS02 | Experimental | FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Receives: Biological: FMP1/AS02; Biological: RTS,S/AS02; Other: Malaria challenge |
| Group C: FMP1/AS02 + AS02 | Experimental | FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Receives: Biological: FMP1/AS02; Other: AS02 adjuvant alone; Other: Malaria challenge |
| Group D : RTS,S/AS02 + AS02 | Experimental | RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. Receives: Biological: RTS,S/AS02; Other: AS02 adjuvant alone; Other: Malaria challenge |
| Control cohort | Placebo comparator | Infectivity controls (unvaccinated). Non-randomized infectivity controls were recruited specifically for the malaria challenge phase of the trial. Receives: Other: Malaria challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured through adverse event collection and immunogenicity results
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startApr 2001
- Primary completionFeb 2002
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 Malaria, FalciparumStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556945
- Sponsor's protocol ID
- WRAIR #849
- Acronym
- MAL019
- Status last verified
- May 2014
- First submitted
- 14 Mar 2012
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cummings JF, Polhemus ME, Kester KE, Ockenhouse CF, Gasser RA Jr, Coyne P, Wortmann G, Nielsen RK, Schaecher K, Holland CA, Krzych U, Tornieporth N, Soisson LA, Angov E, Heppner DG; RTS,S Vaccine Evaluation Group. A phase IIa, randomized, double-blind, safety, immunogenicity and efficacy trial of Plasmodium falciparum vaccine antigens merozoite surface protein 1 and RTS,S formulated with AS02 adjuvant in healthy, malaria-naive adults. Vaccine. 2024 Apr 30;42(12):3066-3074. doi: 10.1016/j.vaccine.2024.03.072. Epub 2024 Apr 6.
PubMed 38584058
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Safety, Immunogenicity, and Preliminary Efficacy of an Administration Schedule of FMP1 and SmithKlineBeecham Biologicals' Candidate Malaria Vaccine RTS,S Each Adjuvanted With SBAS2, Given Concomitantly in Separate Injections
- ClinicalTrials.gov ID
- NCT01556945
- Acronym / sponsor ID
- MAL019 / WRAIR #849
- Conditions
- Malaria, Falciparum
- Keywords
- P. falciparum, vaccine, healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2001
- Primary completion
- Feb 2002 (actual)
- First posted
- 19 Mar 2012 (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.
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection.
The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A : FMP1/AS02 + RTS,S/AS02 | Experimental | Biological: FMP1/AS02, Biological: RTS,S/AS02, Other: Malaria challengeFMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Group B : FMP1/AS02 + RTS,S/AS02 | Experimental | Biological: FMP1/AS02, Biological: RTS,S/AS02, Other: Malaria challengeFMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Group C: FMP1/AS02 + AS02 | Experimental | Biological: FMP1/AS02, Other: AS02 adjuvant alone, Other: Malaria challengeFMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Group D : RTS,S/AS02 + AS02 | Experimental | Biological: RTS,S/AS02, Other: AS02 adjuvant alone, Other: Malaria challengeRTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Control cohort | Placebo comparator | Other: Malaria challengeInfectivity controls (unvaccinated). Non-randomized infectivity controls were recruited specifically for the malaria challenge phase of the trial. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult, 18-45
- Available for duration of study (9 months)
- Written informed consent prior to any study procedures
Key exclusion criteria (17 listed)
- Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21
- Use of any investigational or non-registered drug/vaccine or planned administration of vaccine not foreseen by study protocol; each issue within 30 days preceding the first dose of study vaccine
- Administration of chronic immunosuppressants
- Chronic use of antibiotics
- History of malaria ever, or use of malaria chemoprophylaxis within 60 days prior to vaccination
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 |
|---|---|---|
| FMP1/AS02The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02. | Biological | Group A : FMP1/AS02 + RTS,S/AS02, Group B : FMP1/AS02 + RTS,S/AS02, Group C: FMP1/AS02 + AS02 |
| RTS,S/AS02The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S. | Biological | Group A : FMP1/AS02 + RTS,S/AS02, Group B : FMP1/AS02 + RTS,S/AS02, Group D : RTS,S/AS02 + AS02 |
| AS02 adjuvant aloneAS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml. | Other | Group C: FMP1/AS02 + AS02, Group D : RTS,S/AS02 + AS02 |
| Malaria challengeExperimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored. | Other | Control cohort, Group A : FMP1/AS02 + RTS,S/AS02, Group B : FMP1/AS02 + RTS,S/AS02, Group C: FMP1/AS02 + AS02, Group D : RTS,S/AS02 + AS02 |
Primary outcome
Safety
Time frame: two years
Measured through adverse event collection and immunogenicity results
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 2 May 2014.
- Derived from this study: PubMed 38584058Cummings JF, Polhemus ME, Kester KE, Ockenhouse CF, Gasser RA Jr, Coyne P, Wortmann G, Nielsen RK, Schaecher K, Holland CA, Krzych U, Tornieporth N, Soisson LA, Angov E, Heppner DG; RTS,S Vaccine Evaluation Group. A phase IIa, randomized, double-blind, safety, immunogenicity and efficacy trial of Plasmodium falciparum vaccine antigens merozoite surface protein 1 and RTS,S formulated with AS02 adjuvant in healthy, malaria-naive adults. Vaccine. 2024 Apr 30;42(12):3066-3074. doi: 10.1016/j.vaccine.2024.03.072. Epub 2024 Apr 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FMP1/AS02, RTS,S/AS02 and AS02 adjuvant alone in people with Malaria, Falciparum, run by U.S. Army Medical Research and Development Command at 1 site in United States.
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 3 inclusion and 17 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 2 May 2014. 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 United States. 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 combined 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.
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?
Safety (time frame: two years). 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 NCT01556945, 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 2 May 2014.