Phase 1
N=60
FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali
Malaria · Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT00349713 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Safety and Reactogenicity (SAEs and AEs) — 45; 53; 22; 37 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- FMP2.1/AS02A (Biological); Rabies vaccine (RabAvert) (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Reactogenicity (SAEs and AEs) |
45; 53; 22; 37; 35; 11 | — |
| SECONDARY Antibody Response to FMP2.1 Over Time |
53295.3; 56779.4; 59852; 62963.8; 120677.4; 63697.6 | — |
| SECONDARY Anti-AMA1 Log Antibody Titers Over Time |
4.3; 44.4; 4.2; 4.5; 4.8; 4.1 | — |
| SECONDARY Geometric Mean Antibody Titers Over Time |
19161.2; 23499.7; 14354.8; 30795.3; 69751.6; 13856.7 | — |
| SECONDARY Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time |
5; 9; 0; 1; 5; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A male or non-pregnant female aged 18-55 years inclusive at the time of screening
- 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)
- Separate written informed consent obtained from the participant before screening and study start, respectively
- Available and willing to participate in follow-up for the duration of study (12 months)
Exclusion Criteria
- Previous vaccination with any investigational vaccine or with any rabies vaccine
- 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
- 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
- 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
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Any confirmed or suspected autoimmune disease
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
- History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
- History of allergy to tetracycline, doxycycline, nickel, Imidazole, chicken eggs, processed bovine gelatin, chicken protein, neomycin, or amphotericin B
- History of splenectomy
- Serum ALT >/=43 IU/L
- Serum creatinine level >113 µmol /L for males and 70 µmol /L for females
- Hgb 13 x 1000/cubic mm
- Absolute lymphocyte count </=1.4 x 1000 /µl
- Thrombocytopenia < 108,000/µl
- More than trace protein, more than trace hemoglobin or positive glucose in urine
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period
- Suspected or known current alcohol or illicit drug abuse
- Pregnancy or positive urine beta-HCG on the day of or prior to immunization
- Breastfeeding
- Simultaneous participation in any other interventional clinical trial
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00349713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.