Malaria, Plasmodium Falciparum Malaria
Conditions
Keywords
Plasmodium falciparum Malaria, Mali, adjuvant
Brief summary
Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs that are spread by mosquito bites. This study will look at the safety, effectiveness, and best dose of an experimental malaria vaccine in people who are regularly exposed to malaria. Study participants will be 60 adults, 18-55 years old, who live in Bandiagara, Mali. Volunteers will get either 3 full doses of the experimental malaria vaccine, 3 half doses of the malaria vaccine, or a rabies vaccine that has been approved in Mali. (Rabies is an infection of the brain that usually causes death, and can be caught from being bitten by infected dogs or bats.) The 3 vaccinations will be given by injection into the upper arm 30 days apart. Volunteers will be enrolled in the study for approximately 12 months after the first vaccination. Volunteers will have 14 blood samples collected during the study for testing to make sure that the vaccine is not harmful and to measure the effect of the vaccine.
Detailed description
The primary objective of this study is to evaluate the safety and reactogenicity of two dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Secondary objectives are to: (1) measure the magnitude and duration of antibody response to FMP2.1; (2) measure cellular immune responses to FMP2.1 at baseline and after immunization; (3) measure the inhibition of parasite growth by the in vitro GIA; and (4) determine the specificity of the antibodies to diverse AMA1 genotypes in addition to 3D7, by measuring by ELISA, and GIA on parasites with typed AMA1. A double-blind controlled dose escalation trial will allow assessment of vaccine safety in each of three groups, one group each to receive medium and full dose levels of the experimental vaccine, and one group to receive the comparator vaccine. Thirty adults will be randomized to receive the medium dose level of FMP2.1 (n=20) or rabies vaccine (n=10) and thirty to receive the full dose level of FMP2.1 (n=20) or rabies vaccine (n=10). The division of the rabies group into two groups of ten is done to maintain blinding at each immunization time point, and all participants who receive the rabies vaccine will be analyzed as a single group. The sample size of the groups, however, will not allow detection of anything other than very large differences in the occurrence of adverse events among the three groups. The advantage of double blinding is to remove the potential for investigator and participant prejudgment about the effects of the vaccines in the reporting of adverse events.
Interventions
BIOLOGICALFMP2.1/AS02A
FMP2.1 in GSK Biologicals' AS02A
BIOLOGICALRabies vaccine (RabAvert)
RabAvert Rabies vaccine
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
University of Maryland
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. A male or non-pregnant female aged 18-55 years inclusive at the time of screening 2. For women, willingness not to become pregnant until 1 month after the last immunization (pre-menopausal female participants will be referred to the local family planning clinic in Bandiagara, which offers several means of contraception that are approved and recommended by the Malian Ministry of Health) 3. Separate written informed consent obtained from the participant before screening and study start, respectively 4. Available and willing to participate in follow-up for the duration of study (12 months)
Exclusion criteria
1. Previous vaccination with any investigational vaccine or with any rabies vaccine 2. Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization 3. Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first immunization. This will include any dose level of oral steroids or inhaled steroids, but not topical steroids 4. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study immunization with the exception of tetanus toxoid 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 6. Any confirmed or suspected autoimmune disease 7. History of allergic reactions or anaphylaxis to immunizations or to any vaccine component 8. History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care 9. History of allergy to tetracycline, doxycycline, nickel, Imidazole, chicken eggs, processed bovine gelatin, chicken protein, neomycin, or amphotericin B 10. History of splenectomy 11. Serum ALT \>/=43 IU/L 12. Serum creatinine level \>113 µmol /L for males and 70 µmol /L for females 13. Hgb \<11 g/dL for males and \<10 g/dL for females 14. WBC \<4.0 x 1000/cubic mm or \>13 x 1000/cubic mm 15. Absolute lymphocyte count \</=1.4 x 1000 /µl 16. Thrombocytopenia \< 108,000/µl 17. More than trace protein, more than trace hemoglobin or positive glucose in urine 18. Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period 19. Suspected or known current alcohol or illicit drug abuse 20. Pregnancy or positive urine beta-HCG on the day of or prior to immunization 21. Breastfeeding 22. Simultaneous participation in any other interventional clinical trial 23. Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, or any other findings that in the opinion of the Principal Investigator (PI) may increase the risk of participating in the study 24. Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Reactogenicity (SAEs and AEs) | 12 months | The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to FMP2.1 Over Time | 90 Days | Measurement of anti-AMA1 antibody titers over time |
| Anti-AMA1 Log Antibody Titers Over Time | 90 Days | Summary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90 |
| Geometric Mean Antibody Titers Over Time | 90 Days | Measurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90 |
| Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | 90 Days | Proportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90 |
Countries
Mali
Participant flow
Recruitment details
175 participants were screened; 115 were excluded; 60 subjects were randomized in a 2:1 ratio into 2 cohorts
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: 25ug FMP2.1 / AS02A 20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A | 20 |
| Cohort 2: 50ug FMP2.1 / AS02A 20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A
FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A | 20 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) 20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2
Rabies vaccine (RabAvert): RabAvert Rabies vaccine | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Cohort 1: 25ug FMP2.1 / AS02A | Cohort 2: 50ug FMP2.1 / AS02A | Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Region of Enrollment Mali | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 17 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 20 / 20 | 20 / 20 | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Safety and Reactogenicity (SAEs and AEs)
The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.
Time frame: 12 months
Population: Summary of Adverse Events by Group and Immunization Group
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Myalgia | 3 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Arm Motion Limitation | 5 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Myalgia | 2 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Nausea | 4 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Injection Site Swelling | 37 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Scratch | 1 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Cold | 21 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Injection Site Pain | 45 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Diarrhea | 1 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Headaches | 11 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Pruritus | 1 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Malaise | 4 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Chills | 4 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Coughing | 8 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Arthralgia | 0 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Headache | 7 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Flu | 6 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Erythema | 0 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Elevated Temperature | 6 Number of events |
| Cohort 1: 25ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Wound | 3 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Arthralgia | 2 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Headaches | 11 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Myalgia | 6 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Erythema | 0 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Cold | 10 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Coughing | 3 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Flu | 3 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Wound | 2 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Myalgia | 2 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Scratch | 2 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Diarrhea | 2 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Pruritus | 4 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Injection Site Pain | 53 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Injection Site Swelling | 35 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Arm Motion Limitation | 3 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Elevated Temperature | 6 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Headache | 17 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Chills | 2 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Malaise | 5 Number of events |
| Cohort 2: 50ug FMP2.1 / AS02A | Safety and Reactogenicity (SAEs and AEs) | Solicited: Nausea | 1 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Wound | 4 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Malaise | 3 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Arm Motion Limitation | 0 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Flu | 3 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Erythema | 0 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Elevated Temperature | 1 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Coughing | 3 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Arthralgia | 1 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Headache | 9 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Headaches | 5 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Nausea | 1 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Diarrhea | 3 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Chills | 4 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Pruritus | 1 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Scratch | 3 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Cold | 7 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Injection Site Pain | 22 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Unsolicited: Myalgia | 4 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Myalgia | 3 Number of events |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Safety and Reactogenicity (SAEs and AEs) | Solicited: Injection Site Swelling | 11 Number of events |
Secondary
Anti-AMA1 Log Antibody Titers Over Time
Summary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90
Time frame: 90 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 30 | 4.5 log antibody titers | Standard Deviation 0.6 |
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 60 | 4.8 log antibody titers | Standard Deviation 0.5 |
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 44 | 4.7 log antibody titers | Standard Deviation 0.5 |
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 90 | 4.8 log antibody titers | Standard Deviation 0.4 |
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 0 | 4.3 log antibody titers | Standard Deviation 0.7 |
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 74 | 4.9 log antibody titers | Standard Deviation 0.4 |
| Cohort 1: 25ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 14 | 4.5 log antibody titers | Standard Deviation 0.6 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 0 | 44.4 log antibody titers | Standard Deviation 0.9 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 30 | 4.7 log antibody titers | Standard Deviation 0.6 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 14 | 4.8 log antibody titers | Standard Deviation 0.6 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 44 | 5.0 log antibody titers | Standard Deviation 0.5 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 60 | 5.1 log antibody titers | Standard Deviation 0.5 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 74 | 5.2 log antibody titers | Standard Deviation 0.4 |
| Cohort 2: 50ug FMP2.1 / AS02A | Anti-AMA1 Log Antibody Titers Over Time | Day 90 | 5.0 log antibody titers | Standard Deviation 0.4 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 60 | 4.2 log antibody titers | Standard Deviation 0.8 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 0 | 4.2 log antibody titers | Standard Deviation 0.8 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 90 | 4.0 log antibody titers | Standard Deviation 0.9 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 74 | 4.1 log antibody titers | Standard Deviation 0.8 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 44 | 4.1 log antibody titers | Standard Deviation 0.8 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 30 | 4.1 log antibody titers | Standard Deviation 0.8 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Anti-AMA1 Log Antibody Titers Over Time | Day 14 | 4.1 log antibody titers | Standard Deviation 0.8 |
Secondary
Antibody Response to FMP2.1 Over Time
Measurement of anti-AMA1 antibody titers over time
Time frame: 90 Days
Population: Anti-AMA1 Antibody titers on days, 0, 14, 30, 44, 60, 74, and 90
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 14 | 62963.8 Antibody Titers | Standard Deviation 77633.3 |
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 60 | 103966.8 Antibody Titers | Standard Deviation 117998.7 |
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 44 | 101478.2 Antibody Titers | Standard Deviation 139781.1 |
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 0 | 53295.3 Antibody Titers | Standard Deviation 76881 |
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 90 | 87684.2 Antibody Titers | Standard Deviation 99596.7 |
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 74 | 128323.7 Antibody Titers | Standard Deviation 109759 |
| Cohort 1: 25ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 30 | 68251.2 Antibody Titers | Standard Deviation 87406.5 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 44 | 159449.2 Antibody Titers | Standard Deviation 152111.2 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 0 | 56779.4 Antibody Titers | Standard Deviation 53811.2 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 14 | 120677.4 Antibody Titers | Standard Deviation 104675.9 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 30 | 101464.5 Antibody Titers | Standard Deviation 99045.2 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 60 | 187453.9 Antibody Titers | Standard Deviation 162090.9 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 74 | 227692.0 Antibody Titers | Standard Deviation 236420.5 |
| Cohort 2: 50ug FMP2.1 / AS02A | Antibody Response to FMP2.1 Over Time | Day 90 | 162739.7 Antibody Titers | Standard Deviation 182897.2 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 60 | 77418.1 Antibody Titers | Standard Deviation 147844.9 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 14 | 63697.6 Antibody Titers | Standard Deviation 119009.9 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 90 | 52575.5 Antibody Titers | Standard Deviation 99568 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 74 | 82794.3 Antibody Titers | Standard Deviation 173534.6 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 44 | 62498.3 Antibody Titers | Standard Deviation 115667.3 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 30 | 51436.1 Antibody Titers | Standard Deviation 95888.9 |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Antibody Response to FMP2.1 Over Time | Day 0 | 59852 Antibody Titers | Standard Deviation 101952.4 |
Secondary
Geometric Mean Antibody Titers Over Time
Measurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90
Time frame: 90 Days
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 14 | 30795.3 Geometric Mean of Antibody Titers |
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 60 | 61438.6 Geometric Mean of Antibody Titers |
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 44 | 55246.5 Geometric Mean of Antibody Titers |
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 0 | 19161.2 Geometric Mean of Antibody Titers |
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 90 | 60967.1 Geometric Mean of Antibody Titers |
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 74 | 89856.7 Geometric Mean of Antibody Titers |
| Cohort 1: 25ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 30 | 31804.9 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 44 | 100589.6 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 0 | 23499.7 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 14 | 69751.6 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 30 | 55085.8 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 60 | 119191.3 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 74 | 150738.4 Geometric Mean of Antibody Titers |
| Cohort 2: 50ug FMP2.1 / AS02A | Geometric Mean Antibody Titers Over Time | Day 90 | 102813.0 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 60 | 16030.5 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 14 | 13856.7 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 90 | 10425.1 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 74 | 14064.5 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 44 | 13941.2 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 30 | 12690.7 Geometric Mean of Antibody Titers |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Geometric Mean Antibody Titers Over Time | Day 0 | 14354.8 Geometric Mean of Antibody Titers |
Secondary
Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Proportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90
Time frame: 90 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 14 2-fold increase | 5 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 14 4-fold increase | 1 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 30 2-fold increase | 2 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 30 4-fold increase | 2 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 44 2-fold increase | 3 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 44 4-fold increase | 3 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 60 2-fold increase | 6 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 60 4-fold increase | 6 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 74 2-fold increase | 9 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 74 4-fold increase | 9 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 90 2-fold increase | 6 number of participants with increase |
| Cohort 1: 25ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 90 4-fold increase | 6 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 90 4-fold increase | 7 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 14 2-fold increase | 9 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 60 2-fold increase | 7 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 74 2-fold increase | 11 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 14 4-fold increase | 5 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 44 4-fold increase | 6 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 90 2-fold increase | 7 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 30 2-fold increase | 4 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 60 4-fold increase | 7 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 44 2-fold increase | 6 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 30 4-fold increase | 4 number of participants with increase |
| Cohort 2: 50ug FMP2.1 / AS02A | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 74 4-fold increase | 11 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 30 4-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 44 2-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 74 4-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 44 4-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 60 2-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 60 4-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 90 2-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 14 2-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 14 4-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 74 2-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 30 2-fold increase | 0 number of participants with increase |
| Cohorts 1 and 2: Rabies Vaccine (RabAvert) | Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time | Day 90 4-fold increase | 0 number of participants with increase |