Malaria placental malaria, pregnancy associated malaria
Conditions
Interventions
PRIMVAC-Alhydrogel 50 µg
NaCl vaccination
PRIMVAC Alhydrogel 20 µg
PRIMVAC GLA-SE 20 µg
PRIMVAC-GLA-SE 50 µg
PRIMVAC GLA-SE 100 g
PRIMVAC Alhydrogel 100 µg
Sponsors
INSERM
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Written informed consent (must be obtained prior initiation of any study related intervention) ¿ Nulligest Female of age ¿18 years to ¿35 years ¿ Healthy as a result of review of medical history and/or l clinical examination at the time of screening and clinical judgment of the investigator ¿ Available for the duration of the trial (15 months) ¿ Willingness to use reliable contraceptive methods such as: birth control pills or birth control patches or vaginal ring, diaphragm, IUD (intrauterine device), condom, progestin implant or injection, or surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation) prior to enrollment at V0 and up to 4 weeks after last vaccination (V6)
Exclusion criteria
Exclusion criteria: ¿ Pregnancy ongoing as determined by a positive urinary test ¿ Intention to become pregnant during the trial ¿ Volunteers who are not able to understand and to follow all required study procedures for the whole period of the study in the opinion of the investigator. ¿ Volunteers with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the volunteers due to participation in the study. ¿ Volunteers participating in any clinical study with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. ¿ History of psychiatric condition that may affect participation in the study (i.e. depression, anti-depressant treatment) ¿ Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the study data based on investigator¿s judgment. PRIMALVAC 44/159 Version V2.0_ 17-11-2015 ¿ Volunteer has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. ¿ History of allergic disease or reactions likely to be exacerbated by any component of the vaccine ¿ History of a serious adverse reaction to any vaccine, including Guillain-Barre syndrome. ¿ Administration or planned administration of a vaccine or gammaglobulin not foreseen by the clinical study protocol within 30 days prior to the first immunization and up to 4 weeks after the last immunization. ¿ Volunteers with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. ¿ Administration of immunoglobulins and/or any blood products within the three months preceding the inclusion. ¿ Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 3 months (inhaled and topical steroids are allowed) ¿ Seropositive for hepatitis B virus surface antigen (HBsAg) ¿ Seropositive for hepatitis C virus (antibodies to HCV) ¿ Seropositive for human immunodeficiency virus (antibodies to HIV 1-2) ¿ Any other serious chronic illness requiring hospital specialist supervision. ¿ Any clinically significant abnormal finding on screening biochemistry or hematology blood tests or urinalysis ¿ Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: proportion of volunteers per cohort and arm reporting any Grade 3 or higher clinical or laboratory ARI by the site investigator and persisting at Grade 3 for > 48 hours between D0 and D35. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary safety endpoints: number, nature and timing of any SAEFI for the entire duration of the study ;Secondary safety endpoints: number, nature and timing of any: AEFI measured until 1 month post-dose 3 (M3);Secondary safety endpoints: number, nature and timing of any: AEFI measured between M3 and the end of the study (phase Ia only; cohorts A and B) | — |
Countries
Burkina Faso, France
Contacts
Public ContactGUEGUEN Sonia
Deputy Director of Inserm Clinical Research Department
Outcome results
None listed