PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
ConditionMalaria (Plasmodium Falciparum)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-38
SponsorSanaria Inc.
About this trial
A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.
Participants will be randomized into two arms. Arm 1: (n= 150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 6, 29 days.
Arm 2: (n= 150) will receive 3 doses of normal saline (placebo) injection via DVI at 1, 6, 29 days.
All volunteers will receive antimalarial treatment with artemether/lumefantrine (AL) \~2 to 4 weeks prior to 1st (study day -14 to -28) and \~2 weeks prior to 3rd injection (study day 44). Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored closely for pregnancy as well post 3rd injection through the entire planned study duration (2 years post dose 1). If pregnant, women will be followed during the course of their pregnancy and for at least 1 year post-delivery (as well as their offspring) for safety and malaria infection. Malaria infections in participants and their offspring will be classified as asymptomatic or symptomatic (clinical cases).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Females of childbearing potential aged ≥ 18 and ≤ 38 years
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
In good general health and without clinically significant medical history
Willing to have blood samples stored for future research
Disqualifiers
Pregnancy at the time of enrollment/vaccination, as determined by a positive urine or serum human chorionic gonadotropin (β-hCG) test
Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for ≥12 months without an alternative medical cause)
Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)
Trial design
Design model
Parallel
Treatments tested in this trial
PfSPZ-LARC2 Vaccine
Biological/VaccinePfSPZ-LARC2 Vaccine (2x105 PfSPZ) via direct venous inoculation (DVI)
Normal Saline
Other interventionNormal Saline
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: PfSPZ-LARC2 VaccineExperimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of local AEs
Incidence of local adverse events (AEs) graded by severity occurring within 7 days after each vaccine administration on day 1, 6, and 29
Time frame
Day 1 to Day 352
Incidence of systemic adverse events
Incidence of systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine administration on day 1, 6, and 29
Time frame
Day 1 to Day 353
P.falciparum blood stage infection defined as time to first positive P.falciparum blood smear following 3rd injection to over 24 weeks
P. falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasites by microscopic examination of 0.5 µL) starting immediately following 3rd injection over 24 weeks (first malaria transmission season).
Time frame
Day 29 to 24 weeksSecondary outcomes
1
P. falciparum first clinical malaria from start of year 1 follow-up for 24 weeks
P. falciparum first clinical malaria defined as first positive thick blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) plus: a) measured axillary temperature ≥ 37.5°C or history of fever in the last 24 hours; OR b) at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; OR c) meeting criteria for severe malaria from the start of year 1 follow-up for 24 weeks.
Time frame
Start of year 1 upto 24 weeks later2
P. falciparum blood stage infection defined as time to first positive blood smear from the start of year 2 follow-up for 24 weeks.
P. falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) from the start of year 2 follow-up for 24 weeks.
Time frame
Start of year 2 follow-up for 24 weeks.3
P.falciparum clinical malaria from start of year 2 follow-up for 24 weeks
P. falciparum clinical malaria defined as first positive thick blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) plus: a) measured axillary temperature ≥ 37.5°C or history of fever in the last 24 hours; OR b) at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; OR c) meeting criteria for severe malaria from the start of year 2 follow-up for 24 weeks.
Time frame
Start of year 2 for 24 weeks4
P. falciparum clinical malaria starting immediately after 3rd injection to the end of year 2.
P. falciparum clinical malaria defined as first positive thick blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) plus: a) measured axillary temperature ≥ 37.5°C or history of fever in the last 24 hours; OR b) at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; OR c) meeting criteria for severe malaria starting immediately after 3rd injection to the end of year 2.
Time frame
Starting immediately after 3rd injection (Day 29) to the end of year 2.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sanaria Inc.
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
University of the Sciences, Techniques and Technologies of Bamako
Collaborator
Malaria Research and Training Center, Bamako, Mali
Collaborator
Source ClinicalTrials.gov