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CompletedNCT01157897Updated May 29, 2019Results posted

Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults

A Phase 1/2 interventional study of VMP001 and P. vivax sporozoite challenge in Malaria and Plasmodium Vivax, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by U.S. Army Medical Research and Development Command · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be performed in malaria-naïve adults in the United States. Three doses of VMP001 formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and efficacy parameters will be studied.

Read the detailed description

This is a Phase 1/2a, non-randomized, open label, dose escalation study in healthy, malaria-naïve adults aged 18 to 55 years (inclusive). The vaccine will be administered with GlaxoSmithKline Biologicals' adjuvant system AS01B. This is a first-in-human study of VMP001; therefore the study design will incorporate a dose-escalation phase evaluating 15 µg, 30 µg, and 60 µg doses of VMP001 in 500 µL of AS01B. A total of 30 volunteers, divided into 3 groups (10 in each group), will receive 3 doses of the VMP001/AS01B vaccine. Group 1 will receive 15 µg of VMP001, Group 2 will receive 30 µg of VMP001, and Group 3 will receive 60 µg of VMP001 at each immunization. The dose of AS01B will be 500 µL for all groups. The first and second dose in each group will be separated by 28 days. The third dose in the three groups will be given at intervals scheduled to normalize the time to challenge between the last immunization and challenge. The second and third dose in Group 1 will be separated by 56 days, Group 2 by 42 days and Group 3 by 28 days. The challenge will occur 2 weeks following the third immunization. A group of 6-12 infectivity controls will begin participation in the study at the challenge stage. They will not receive any immunizations or placebos prior to challenge. All volunteers will receive a standard treatment regimen consisting of chloroquine and primaquine on the day that parasitemia is detected. Volunteers who do not become parasitemic will also begin the same treatment regimen on day 28 following the challenge (study day 126).

>

> Safety and immunogenicity will be evaluated during the study through the final study visit 6 months after challenge (study day 280).

02

Conditions studied

  • Malaria
  • Plasmodium Vivax

Keywords

  • Malaria
  • Plasmodium Vivax
  • Vaccine
03

In context

Malaria

1,315 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 41 is below the median of 220 across 1,041 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 153 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Browse U.S. Army Medical Research and Development Command studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects who meet all of the following criteria may participate in this study:
  • Healthy adults (male or non-pregnant, non-lactating female) 18 to 55 years of age (inclusive) at the time of enrollment
  • If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions until completion of the last study visit.
  • Free of significant health problems as established by medical history, laboratory and clinical examination before entering the study
  • Duffy positive phenotype (homozygous or heterozygous)
  • Normal (non-deficient) Glucose 6-phosphate dehydrogenase (G6PD) phenotype (range: 4.6 to 13.5 units/gm hemoglobin)
  • Volunteers must have low cardiac risk factors according to the NHANES I criteria and a non-significant electrocardiogram (EKG)
  • Available to participate and reachable by phone for duration of study (approximately 9 months)
  • No plans to travel to outside the Washington, District of Columbia (DC) area up until treatment course has been completed (post challenge)
  • No plans to travel to a malaria endemic area during the course of the study
  • Written informed consent must be obtained from the subject before screening procedures
  • Volunteers must score at least 80% correct on a 10 or 14 question multiple-choice quiz (control and immunization groups, respectively) that assesses their understanding of this study
  • If a subject is active duty military he or she must obtain approval from his or her supervisor per Walter Reed Army Institute of Research (WRAIR) Policy 06-15

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Any history of malaria infection
  • History of travel to P. vivax endemic areas in the last three months, and travel to Republic of Korea or China in the last 18 months
  • Any history of receiving malaria vaccine or any licensed vaccine within 7 days prior to first immunization
  • History of receipt of malaria prophylaxis during the previous 2 months or the use of any drugs with significant anti-malarial activity during the study period one month prior to challenge (for control volunteers). Examples include tetracycline, doxycycline, clindamycin, azithromycin or sulfa drugs
  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
  • Any history of allergic reaction or anaphylaxis to previous vaccination

Allergy to kanamycin, nickel, or imidazole

  • Pregnant (positive β-HCG) or nursing at screening or plans to become pregnant or nurse from the time of enrollment until study completion.
  • Allergy to antimalarial drugs or use of medications known to cause drug reactions with chloroquine and/or primaquine
  • Significant (e.g. systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of mosquito bites are not an exclusion criterion)
  • History of sickle cell disease
  • History of psoriasis or porphyria
  • History of splenectomy
  • Any confirmed or suspected immunodeficiency, including HIV infection
  • Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within 6 months of immunization. For corticosteroids, this is defined as >20 mg/day prednisone or equivalent. -Inhaled and topical steroids are allowed
  • A family history of congenital or hereditary immunodeficiency
  • Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation
  • History of diabetes or hypertension even if well controlled on medication
  • An abnormal baseline screening electrocardiogram (EKG) suggestive of cardiac disease as determined by a clinical investigator
  • Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
  • Any abnormal baseline laboratory screening tests: Alanine Aminotransferase (ALT) above normal range, -Creatinine above normal range, Hemoglobin out of normal range, Platelet count out of normal range, Total white blood cell count out of normal range
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness
  • Seropositive for HIV or hepatitis C virus, or HBsAg positive
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or any planned administration during the study period
  • Suspected or known current alcohol or drug abuse as determined from the medical history or by physical examination
  • Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Cohort 1: 15 μg VMP001

    15ug VMP001 per vaccination on days -1 or 0, 28, and 84. P. vivax sporozoite challenge on day 98.

    Biological: VMP001 · Other: P. vivax sporozoite challenge

  • Experimental
    Cohort 2: 30 μg VMP001

    30ug VMP001 per vaccination on days 14, 42, and 84. P. vivax sporozoite challenge on day 98.

    Biological: VMP001 · Other: P. vivax sporozoite challenge

  • Experimental
    Cohort 3: 60 μg VMP001

    60ug VMP001 per vaccination on days 28, 56, and 84. P. vivax sporozoite challenge on day 98.

    Biological: VMP001 · Other: P. vivax sporozoite challenge

  • Other
    Control

    No Vaccinations given for controls. P. vivax sporozoite challenge on day 98.

    Other: P. vivax sporozoite challenge

Interventions

  • BiologicalVMP001

    Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B

  • OtherP. vivax sporozoite challenge

    P. vivax sporozoite challenge

06

What researchers measure

Primary outcomes

  1. Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase

    Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.

    Time frame: 7 days after immunization

  2. Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase

    Adverse events were evaluated over a 28 day follow-up period after each vaccination during the vaccine phase

    Time frame: 28 days following immunization

  3. Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)

    Occurrence of serious adverse events at any time during the approximately 463 day study period

    Time frame: up to 463 days

Secondary outcomes

  1. Time to Parasitemia for Immunogenicity Population

    Subjects were ranked according to time of onset of parasitemia and a non-parametric rankorder statistical test (eg, Log-Rank or Mann-Whitney) was performed to evaluate delays in parasitemia induced by vaccination. Cox Proportional Hazards model was used to calculate days to parasitemia and Kaplan-Meier plots were used to display time to first positive malaria blood smear. Hazard Ratio (HR). Time starts once subject has received t infectious bites. Time stops when subject has first positive blood smear. If subject does not become parasitemic then time stops the day he/she begins anti-malarial therapy.

    Time frame: 280 day (during the study through 6 months aftr challenge)

  2. Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population

    Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '\>50' were converted to '1'.

    Time frame: study duration

  3. Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population

    Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '\>50' were converted to '1'.

    Time frame: study duration

07

Results

Posted May 29, 2019

Participant flow

41 patients were enrolled (30 vaccination group, 6 infectivity control group and 5 alternates) and received treatment at the Clinical Trials Center (CTC) at Walter Reed Army Institute of Research (WRAIR)

Participant flow — Overall Study
MilestoneCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001Control
Started1010106
Completed88105
Not completed2201
Withdrew: Lost to follow-up2001
Withdrew: Relocated0200

Outcome measures

PrimaryOccurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase

Adverse events were evaluated for 7 days after each vaccination during the vaccine phase.

Time frame:
7 days after immunization
Reported as:
Number · participants with AEs
Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination Phase
participants with AEsCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001
Solicited Local: Injection site erythema236
Solicited Local: Injection site induration012
Solicited Local: Injection site pain101010
Solicited Systemic: Diarrhea001
Solicited Systemic: Nausea534
Solicited Systemic: Vomiting202
Solicited Systemic: Fatigue847
Solicited Systemic: Pyrexia421
Solicited Systemic: Arthralgia423
Solicited Systemic: Myalgia447
Solicited Systemic: Headache865
PrimaryOccurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase

Adverse events were evaluated over a 28 day follow-up period after each vaccination during the vaccine phase

Time frame:
28 days following immunization
Reported as:
Number · participants with AEs
Occurrence of Unsolicited Adverse Events Over a 28 Day Follow-up Period After Each Immunization (the Day of the Immunization and 27 Subsequent Days) During the Vaccination Phase
participants with AEsCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001
Ear discomfort100
Abdominal discomfort100
Abdominal pain001
Feces discolored001
Food poisoning100
Nausea100
Toothache200
Axillary pain010
Chills557
Feeling hot567
Injection site erythema001
Injection site pruritus001
Injection site swelling023
Injection site warmth012
Malaise357
Hypertransaminasaemia121
Seasonal allergy101
Nasopharyngitis100
Upper respiratory tract infection202
Contusion001
Excoriation001
Postprocedural discomfort010
Posttraumatic pain001
Scratch001
Skin laceration002
Haemoglobin decreased011
Platelet count decreased011
Gout100
Back pain011
Muscle spasms100
Musculoskeletal discomfort101
Myalgia100
Pain in extremity202
Dizziness101
Headache100
Sinus headache001
Nasal Congestion001
Cold sweat242
Dermatitis contact010
Erythema010
Hypertension100
PrimaryOccurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)

Occurrence of serious adverse events at any time during the approximately 463 day study period

Time frame:
up to 463 days
Reported as:
Count of participants · Participants
Occurrence of Serious Adverse Events at Any Time During the Study Period (Enrollment to Final Follow up Visit)
ParticipantsCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001Control
Not Related to study drug - Breast cancer (left)1000
Related to study drug0000
Patients without SAE910106
SecondaryTime to Parasitemia for Immunogenicity Population

Subjects were ranked according to time of onset of parasitemia and a non-parametric rankorder statistical test (eg, Log-Rank or Mann-Whitney) was performed to evaluate delays in parasitemia induced by vaccination. Cox Proportional Hazards model was used to calculate days to parasitemia and Kaplan-Meier plots were used to display time to first positive malaria blood smear. Hazard Ratio (HR). Time starts once subject has received t infectious bites. Time stops when subject has first positive blood smear. If subject does not become parasitemic then time stops the day he/she begins anti-malarial therapy.

Time frame:
280 day (during the study through 6 months aftr challenge)
Reported as:
Mean · days
Time to Parasitemia for Immunogenicity Population
daysCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001
Time to Parasitemia for Immunogenicity Population0.137 ± 2.0250.073 ± 2.1060.042 ± 2.154
SecondaryGeometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population

Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '\>50' were converted to '1'.

Time frame:
study duration
Reported as:
Mean · Geometric Mean Titer of European Units
Geometric Mean of Anti-VMP001 Antibody Titers in Serum Per Immunogenicity Population
Geometric Mean Titer of European UnitsCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001
Pre-vaccination1 (1 to 1)1.5 (0.6 to 3.76)3.09 (0.56 to 17.05)
2wks post first vaccination151.39 (31.62 to 724.71)526.18 (194.01 to 1427.06)836.68 (147.84 to 4735.05)
Day of second vaccination281.79 (53.6 to 1481.36)1175.41 (391.29 to 3530.89)1711.63 (685.48 to 4273.89)
2wks post second vaccination21862.22 (10775.91 to 44354.18)74608.62 (51309.78 to 108487.04)61711.8 (33584.06 to 113397.42)
Day of third vaccination9921.61 (5707.48 to 17247.25)28498.43 (18863.52 to 43054.55)36405.66 (19839.55 to 66804.57)
2wks post third vaccination59883.77 (38915.79 to 92149.38)68730.4 (48391.1 to 97618.54)41879.99 (22137.62 to 79228.66)
4wks post challenge54843.38 (34557.05 to 87038.59)56472.17 (38216.28 to 83448.88)32178.39 (17659.05 to 58635.6)
6months post challenge10860.7 (5151.41 to 22897.6)12519.16 (5950.55 to 26338.62)5500.73 (2751.67 to 10996.23)
SecondaryGeometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population

Anti-VMP001 antibody concentrations were measured and summarized by geometric mean titers (GMT) with 95% confidence interval (CI). Peak responses were compared by performing Student's t-test on data normalized by log transformation to ascertain the presence or absence of significant dose response differences. ELISA Units (EU) were converted to log10 values for calculations and statistical comparison of geometric means. Units that were reported as '\>50' were converted to '1'.

Time frame:
study duration
Reported as:
Mean · Geometric Mean Titier of European Units
Geometric Mean of Anti-VMP001 Anti-body Titers in Serum Per Efficacy Population
Geometric Mean Titier of European UnitsCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001
Pre-vaccination1 (1 to 1)1 (1 to 1)3.09 (0.56 to 17.05)
2wks post first vaccination133.72 (23.1 to 774)750.38 (251.51 to 2238.74)836.68 (147.84 to 4735.05)
Day of second vaccination244.35 (38.22 to 1562.29)1450.22 (460.04 to 4571.68)1711.63 (685.48 to 4273.89)
2wks post second vaccination20161.18 (9253.42 to 43926.79)81143.72 (55905.91 to 117774.72)61711.8 (33584.06 to 113397.42)
Day of third vaccination9053.32 (5047.3 to 16238.9)31071.01 (20413.38 to 47292.88)36405.66 (19839.55 to 66804.57)
2wks post third vaccination61203.48 (37570.19 to 99703.16)68730.4 (48391.1 to 97618.54)41879.99 (22137.62 to 79228.66)
4wks post challenge54843.38 (34557.05 to 87038.59)56472.17 (38216.28 to 83448.88)32178.39 (17659.05 to 58635.6)
6mths post challenge10860.7 (5151.41 to 22897.6)12519.16 (5950.55 to 26338.62)5500.73 (2751.67 to 10996.23)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1: 15 μg VMP0010/9 (0%)1/9 (11.1%)9/9 (100%)
Cohort 2: 30 μg VMP0010/8 (0%)0/8 (0%)8/8 (100%)
Cohort 3: 60 μg VMP0010/10 (0%)0/10 (0%)10/10 (100%)
Cohort 4: Control0/6 (0%)1/6 (16.7%)6/6 (100%)
Most frequent serious events
Most frequent serious events
EventCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001Cohort 4: Control
Breast cancer in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/90/80/101/6
Most frequent other events
Showing 10 of 55
Most frequent other events
EventCohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001Cohort 4: Control
FatigueGeneral disorders5/96/810/105/6
NauseaGastrointestinal disorders5/96/89/101/6
Back painMusculoskeletal and connective tissue disorders4/94/89/100/6
MyalgiaMusculoskeletal and connective tissue disorders5/95/88/100/6
ChillsGeneral disorders4/96/87/100/6
PyrexiaGeneral disorders5/96/85/101/6
Abdominal painGastrointestinal disorders3/91/87/101/6
Feeling hotGeneral disorders1/91/83/104/6
ArthralgiaMusculoskeletal and connective tissue disorders4/95/85/101/6
DizzinessNervous system disorders1/90/84/101/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001ControlTotal
Mean32.1 ± 8.329.4 ± 8.228.7 ± 8.025.0 ± 7.230.1 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001ControlTotal
Female424313
Male686323
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Cohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001ControlTotal
Hispanic or Latino00000
Not Hispanic or Latino101010636
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001ControlTotal
American Indian or Alaska Native00000
Asian20013
Native Hawaiian or Other Pacific Islander00000
Black or African American11204
White798428
More than one race00000
Unknown or Not Reported00011
Region of Enrollment
Region of Enrollment(participants)Cohort 1: 15 μg VMP001Cohort 2: 30 μg VMP001Cohort 3: 60 μg VMP001ControlTotal
United States101010636
08

Study locations

1 site
  • Clinical Trials Center, Walter Reed Army Institute of Reserach
    Silver Spring, Maryland 20910, United States
09

References and documents

Publications

  • Bennett JW, Pybus BS, Yadava A, Tosh D, Sousa JC, McCarthy WF, Deye G, Melendez V, Ockenhouse CF. Primaquine failure and cytochrome P-450 2D6 in Plasmodium vivax malaria. N Engl J Med. 2013 Oct 3;369(14):1381-2. doi: 10.1056/NEJMc1301936. No abstract available. PubMed 24088113 ↗
  • Kamau E, Bennett JW, Yadava A. Safety and Tolerability of Mosquito Bite-Induced Controlled Human Infection with Plasmodium vivax in Malaria-Naive Study Participants-Clinical Profile and Utility of Molecular Diagnostic Methods. J Infect Dis. 2022 Jan 5;225(1):146-156. doi: 10.1093/infdis/jiab332. PubMed 34161579 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2010 to primary completion in Jan 2012, 18 months.

Results were first posted in May 2019, 7 years 4 months after primary completion.

Of 25 phase 1/2 interventional studies under Malaria, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's 18 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2010
First posted
Jul 7, 2010
StartActual
Jul 2010
Primary completionActual
Jan 2012
CompletionActual
Jan 2012
Results first posted
May 29, 2019
Last update
May 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01157897
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborators
The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR), United States Department of Defense, GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 7, 2010
Start date
Jul 2010
Primary completion
Jan 2012
Completion
Jan 2012
Results posted
May 29, 2019
Last update
May 29, 2019

Study contacts

Jason Bennett, MD
principal investigator · Division of Malaria Vaccine Development (DMVD), Walter Reed Army Institute of Research (WRAIR)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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